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MEDICINES CONTROL COUNCIL
CONDITIONS OF REGISTRATION OF A MEDICINE IN TERMS OF THE PROVISIONSOF SECTION 15(7) OF THE MEDICINES AND RELATED SUBSTANCES ACT, 1965
(ACT 101 OF 1965)
1. The applicant shall ensure that the medicine is manufactured and controlled interms of the current Good Manufacturing Practices as determined by Council
2. The manufacture of this medicine is subject to regular investigation andinspections by the inspectors appointed in terms of Section 26 of the Act, toassess compliance with current Good Manufacturing Practices.
3. The information in the package insert shall be updated on a regular basis toconform to the package insert recently approved by Council.
4. The applicant must comply with all the legal requirements of the Medicines andRelated Substances Act, 1965 (Act 101 of 1965).
5. The registration of this medicine shall be subject to review at intervals asdetermined by Council regarding its quality, safety and efficacy, and theregistration of this medicine may be varied subject to issues Council may deemfit.
6. The first two production batches must be fully validated in terms of the detailedprocess validation protocol submitted at the time of application for registration,and the validation report must be submitted within a month after completion ofthe validation.
7. The product may be advertised to the professions only.8. The provisional shelf-life allocated must be confirmed with stability data over the
full shelf-life period on the first two production batches (well-known API) or firstthree production 'batches (NCE) in accordance with the Stability Guideline.Stability testing submitted on any pilot batches must also be completed andreported on. The stability report must be submitted within six months aftercompletion of the stability trial. However, Council has to be informed immediatelyif any parameter shows a significant change or out-of-specification result duringthe stability trial.
9. A post-registration inspection must be conducted on the first production batchmanufactured by each local manufacturer.
10. A post-registration inspection must be conducted on the first production batch ofthe imported product.
11. Marketing of the product may only commence following a satisfactory post-registration inspection report.
12. One sample of every batch, together with four copies of the protocol for testing ofthe bulk lot and filling lot, and six copies of the certificate of release issued by acompetent authority in the country in which the product was manufactured, mustbe submitted to the Council for lot release purposes.
13. The expiry date allocated shall be modified by adding a statement that the virusstrains are currently recommended for South African usage in the specific year.
14. The strains of the master seed viruses must be approved by the Department ofHealth for each year.
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 3
GENERAL NOTICE
ALGEMENE KENNISGEWING
NOTICE 915 OF 2012
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
41/1
0.2.
1/07
65
CO
-IP
RA
SA
L S
OLU
TIO
N
SO
LUT
ION
FO
R IN
HA
LAT
ION
EA
CH
2,5
ml V
IAL
CO
NT
AIN
S:
IPR
AT
RO
PIU
M B
RO
MID
E 0
,5 m
gS
ALB
UT
AM
OL
SU
LPH
AT
E 3
,0 m
g
1, 2
, 3, 4
, 5, 6
, 7
AR
RO
W P
HA
RM
A (
PT
Y)
LTD
LAB
OR
AT
OIR
E U
NIT
HE
R,
AM
IEN
S, F
RA
NC
E
LAB
OR
AT
OIR
E U
NIT
HE
R,
AM
IEN
S, F
RA
NC
ED
IVP
HA
RM
MA
NU
FA
CT
UR
ING
AN
D P
AC
KA
GIN
G (
PT
Y)
LTD
,LO
NG
DA
LE, I
ND
US
TR
IA, R
SA
TE
CH
NIK
ON
LA
BO
RA
TO
RIE
S(P
TY
) LT
D, R
OB
ER
TV
ILLE
,F
LOR
IDA
, RS
A
LAB
OR
AT
OIR
E U
NIT
HE
R,
AM
IEN
S, F
RA
NC
ET
EC
HN
IKO
N L
AB
OR
AT
OR
IES
(PT
Y)
LTD
, RO
BE
RT
VIL
LE,
FLO
RID
A, R
SA
M&
L LA
BO
RA
TO
RY
SE
RV
ICE
S,
LIM
BR
O B
US
INE
SS
PA
RK
,S
AN
DT
ON
, RS
A
AR
RO
W P
HA
RM
A (
PT
Y)
LTD
,W
OO
DM
EA
D, S
AN
DT
ON
, RS
A
36 m
onth
s
18 M
AY
201
2
MR
F15
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
42/2
1.12
/046
1
FIN
IDE
5 T
AB
LET
S
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:F
INA
ST
ER
IDE
5,0
mg
1, 2
, 3, 4
, 5, 6
, 7
ZY
DU
S H
EA
LTH
CA
RE
(P
TY
)LT
D
ZY
DU
S C
AD
ILA
HE
ALT
HC
AR
ELI
MIT
ED
, SA
NA
ND
,A
HM
ED
AB
AD
, IN
DIA
ZY
DU
S C
AD
ILA
HE
ALT
HC
AR
ELI
MIT
ED
, SA
NA
ND
,A
HM
ED
AB
AD
, IN
DIA
ZY
DU
S C
AD
ILA
HE
ALT
HC
AR
ELI
MIT
ED
, SA
NA
ND
,A
HM
ED
AB
AD
, IN
DIA
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
LS
ER
VIC
ES
, SIL
VE
RT
ON
DA
LE,
PR
ET
OR
IA, R
SA
RE
SE
AR
CH
INS
TIT
UT
E F
OR
IND
US
TR
IAL
PH
AR
MA
CY
,N
OR
TH
-WE
ST
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
, RS
A
ZY
DU
S H
EA
LTH
CA
RE
(P
TY
)LT
D, P
OT
CH
EF
ST
RO
OM
, RS
A
24 m
onth
s
18 M
AY
201
2
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
44/1
0.2.
2/02
03
SIN
TR
INE
10
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:M
ON
TE
LUK
AS
T S
OD
IUM
EQ
UIV
ALE
NT
TO
MO
NT
ELU
KA
ST
10,
0 m
g
1, 2
, 3, 4
, 5, 6
, 7, 8
SA
ND
OZ
SA
(P
TY
) LT
D
SA
ND
OZ
ILA
C S
AN
AY
I VE
TIC
AR
ET
A.S
., G
EB
ZE
-KO
CA
ELI
,T
UR
KE
Y
SA
ND
OZ
ILA
C S
AN
AY
I VE
TIC
AR
ET
A.S
., G
EB
ZE
-KO
CA
ELI
,T
UR
KE
YT
EC
HN
IKO
N L
AB
OR
AT
OR
IES
,R
OB
ER
TV
ILLE
, FLO
RID
A, R
SA
SA
ND
OZ
SA
, SP
AR
TA
N,
KE
MP
TO
N P
AR
K, R
SA
SA
ND
OZ
ILA
C S
AN
AY
I VE
TIC
AR
ET
A.S
., G
EB
ZE
- K
OC
AE
LI,
TU
RK
EY
CO
NS
ULT
ING
CH
EM
ICA
LLA
BO
RA
TO
RIE
S, A
TLA
SV
ILLE
,B
OK
SB
UR
G, R
SA
SA
BS
CO
MM
ER
CIA
L (P
TY
) LT
DP
HA
RM
AC
EU
TIC
AL
CH
EM
IST
RY
DE
PA
RT
ME
NT
, GR
OE
NK
LOO
F,
PR
ET
OR
IA, R
SA
SA
ND
OZ
SA
, SP
AR
TA
N,
KE
MP
TO
N P
AR
K, R
SA
SA
ND
OZ
SA
, SP
AR
TA
N,
KE
MP
TO
N P
AR
K, R
SA
24 m
onth
s (P
rovi
sion
al)
18 M
AY
201
2
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 5
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
44/1
0.2.
2/02
04
SA
ND
OZ
MO
NT
ELU
KA
ST
10
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:M
ON
TE
LUK
AS
T S
OD
IUM
EQ
UIV
ALE
NT
TO
MO
NT
ELU
KA
ST
10,
0 m
g
1, 2
, 3, 4
, 5, 6
, 7, 8
SA
ND
OZ
SA
(P
TY
) LT
D
SA
ND
OZ
ILA
C S
AN
AY
I VE
TIC
AR
ET
A.S
., G
EB
ZE
-KO
CA
ELI
,T
UR
KE
Y
SA
ND
OZ
ILA
C S
AN
AY
I VE
TIC
AR
ET
A.S
., G
EB
ZE
-KO
CA
ELI
,T
UR
KE
YT
EC
HN
IKO
N L
AB
OR
AT
OR
IES
,R
OB
ER
TV
ILLE
, FLO
RID
A, R
SA
SA
ND
OZ
SA
, SP
AR
TA
N,
KE
MP
TO
N P
AR
K, R
SA
SA
ND
OZ
ILA
C S
AN
AY
I VE
TIC
AR
ET
A.S
., G
EB
ZE
-KO
CA
ELI
,T
UR
KE
YC
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
AT
OR
IES
, AT
LAS
VIL
LE,
BO
KS
BU
RG
, RS
AS
AB
S C
OM
ME
RC
IAL
(PT
Y)
LTD
PH
AR
MA
CE
UT
ICA
L C
HE
MIS
TR
YD
EP
AR
TM
EN
T, G
RO
EN
KLO
OF
,P
RE
TO
RIA
, RS
AS
AN
DO
Z S
A, S
PA
RT
AN
,K
EM
PT
ON
PA
RK
, RS
A
SA
ND
OZ
SA
, SP
AR
TA
N,
KE
MP
TO
N P
AR
K, R
SA
24 m
onth
s (P
rovi
sion
al)
18 M
AY
201
2
MR
F15
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
44/1
0.2.
2/04
85
SIN
TR
INE
4
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:M
ON
TE
LUK
AS
T S
OD
IUM
EQ
UIV
ALE
NT
TO
MO
NT
ELU
KA
ST
4,0
mg
1, 2
, 3, 4
, 5, 6
, 7, 8
SA
ND
OZ
SA
(P
TY
) LT
D
SA
ND
OZ
ILA
C S
AN
AY
I VE
TIC
AR
ET
A.S
., G
EB
ZE
-KO
CA
ELI
, TU
RK
EY
SA
ND
OZ
ILA
C S
AN
AY
I VE
TIC
AR
ET
A.S
., G
EB
ZE
-KO
CA
ELI
, TU
RK
EY
TE
CH
NIK
ON
LA
BO
RA
TO
RIE
S,
RO
BE
RT
VIL
LE, F
LOR
IDA
, RS
AS
AN
DO
Z S
A, S
PA
RT
AN
, KE
MP
TO
NP
AR
K, R
SA
SA
ND
OZ
ILA
C S
AN
AY
I VE
TIC
AR
ET
A.S
., G
EB
ZE
-KO
CA
ELI
, TU
RK
EY
CO
NS
ULT
ING
CH
EM
ICA
LLA
BO
RA
TO
RIE
S, A
TLA
SV
ILLE
,B
OK
SB
UR
G, R
SA
SA
BS
CO
MM
ER
CIA
L (P
TY
) LT
DP
HA
RM
AC
EU
TIC
AL
CH
EM
IST
RY
DE
PA
RT
ME
NT
, GR
OE
NK
LOO
F,
PR
ET
OR
IA, R
SA
SA
ND
OZ
SA
, SP
AR
TA
N, K
EM
PT
ON
PA
RK
, RS
A
SA
ND
OZ
SA
, SP
AR
TA
N, K
EM
PT
ON
PA
RK
, RS
A
24 m
onth
s (P
rovi
sion
al)
18 M
AY
201
2
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
fre
gist
ratio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
44/1
0.2.
2/04
86
SIN
TR
INE
5
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:M
ON
TE
LUK
AS
T S
OD
IUM
EQ
UIV
ALE
NT
TO
MO
NT
ELU
KA
ST
5,0
mg
1, 2
, 3, 4
, 5, 6
, 7
SA
ND
OZ
SA
(P
TY
) LT
D
SA
ND
OZ
ILA
C S
AN
AY
I VE
TIC
AR
ET
A.S
., G
EB
ZE
-KO
CA
ELI
TU
RK
EY
SA
ND
OZ
ILA
C S
AN
AY
I VE
TIC
AR
ET
A.S
., G
EB
ZE
-KO
CA
ELI
,T
UR
KE
YT
EC
HN
IKO
N L
AB
OR
AT
OR
IES
,R
OB
ER
TV
ILLE
, FLO
RID
A, R
SA
SA
ND
OZ
SA
, SP
AR
TA
N,
KE
MP
TO
N P
AR
K, R
SA
SA
ND
OZ
ILA
C S
AN
AY
I VE
TIC
AR
ET
A.S
., G
EB
ZE
-KO
CA
ELI
,T
UR
KE
YC
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
AT
OR
IES
, AT
LAS
VIL
LE,
BO
KS
BU
RG
, RS
AS
AB
S C
OM
ME
RC
IAL
(PT
Y)
LTD
PH
AR
MA
CE
UT
ICA
L C
HE
MIS
TR
YD
EP
AR
TM
EN
T, G
RO
EN
KLO
OF
,P
RE
TO
RIA
, RS
AS
AN
DO
Z S
A, S
PA
RT
AN
,K
EM
PT
ON
PA
RK
, RS
A
SA
ND
OZ
SA
, SP
AR
TA
N,
KE
MP
TO
N P
AR
K, R
SA
24 m
onth
s
18 M
AY
201
2
6 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15v1
RF
15
Reg
istr
atio
nnu
mbe
r:44
/10.
2.2/
0487
Reg
istr
atio
n nu
mbe
r:44
/10.
2.2/
0488
Reg
istr
atio
n nu
mbe
r:38
/21.
12/0
173
Nam
e of
med
icin
e:S
AN
DO
Z M
ON
TE
LUK
AS
T 4
Nam
e of
med
icin
e:S
AN
DO
Z M
ON
TE
LUK
AS
T 5
Nam
e of
med
icin
e:A
SP
EN
FLU
TA
MID
E 2
50 m
g
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H T
AB
LET
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:M
ON
TE
LUK
AS
T S
OD
IUM
MO
NT
ELU
KA
ST
SO
DIU
MF
LUT
AM
IDE
250,
0 m
gE
QU
IVA
LEN
T T
O M
ON
TE
LUK
AS
TE
QU
IVA
LEN
T T
O M
ON
TE
LUK
AS
T4,
0 m
g5,
0 m
g
Con
ditio
ns o
fre
gist
ratio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
fre
gist
ratio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
App
lican
t:S
AN
DO
Z S
A (
PT
Y)
LTD
App
lican
t:S
AN
DO
Z S
A (
PT
Y)
LTD
App
lican
t:P
HA
RM
AC
AR
E L
IMIT
ED
Man
ufac
ture
r:S
AN
DO
Z IL
AC
SA
NA
YI V
ET
ICA
RE
T A
.S.,
GE
BZ
E-K
OC
AE
LI,
TU
RK
EY
Man
ufac
ture
r:S
AN
DO
Z IL
AC
SA
NA
YI V
ET
ICA
RE
T A
.S.,
GE
BZ
E-K
OC
AE
LI,
TU
RK
EY
Man
ufac
ture
r:G
EN
ER
ICS
(U
K)
LIM
ITE
D, P
OT
TE
RS
BA
R,
HE
RT
FO
RD
SH
IRE
, UN
ITE
D K
ING
DO
MG
ER
AR
D L
AB
OR
AT
OR
IES
, GR
AN
GE
RO
AD
, DU
BLI
N, I
RE
LAN
DP
HA
RM
AC
AR
E L
TD
, KO
RT
SE
N, P
OR
TE
LIZ
AB
ET
H, R
SA
Pac
ker:
SA
ND
OZ
ILA
C S
AN
AY
I VE
TIC
AR
ET
A.S
., G
EB
ZE
-KO
CA
ELI
,T
UR
KE
Y
Pac
ker:
SA
ND
OZ
ILA
C S
AN
AY
I VE
TIC
AR
ET
A.S
., G
EB
ZE
-KO
CA
ELI
,T
UR
KE
Y
Pac
ker
GE
NE
RIC
S (
UK
) LI
MIT
ED
, PO
TT
ER
S B
AR
,H
ER
TF
OR
DS
HIR
E, U
NIT
ED
KIN
GD
OM
GE
RA
RD
LA
BO
RA
TO
RIE
S, G
RA
NG
ET
EC
HN
IKO
N L
AB
OR
AT
OR
IES
,R
OB
ER
TV
ILLE
, FLO
RID
A, R
SA
TE
CH
NIK
ON
LA
BO
RA
TO
RIE
S,
RO
BE
RT
VIL
LE, F
LOR
IDA
, RS
AR
OA
D, D
UB
LIN
, IR
ELA
ND
PH
AR
MA
CA
RE
LT
D, K
OR
TS
EN
, PO
RT
SA
ND
OZ
SA
, SP
AR
TA
N,
KE
MP
TO
N P
AR
K, R
SA
SA
ND
OZ
SA
, SP
AR
TA
N, K
EM
PT
ON
PA
RK
, RS
AE
LIZ
AB
ET
H, R
SA
Labo
rato
ry: F
PR
C:
SA
ND
OZ
ILA
C S
AN
AY
I VE
TIC
AR
ET
A.S
., G
EB
ZE
-KO
CA
ELI
,T
UR
KE
Y
Labo
rato
ry:
FP
RC
:S
AN
DO
Z IL
AC
SA
NA
YI V
ET
ICA
RE
T A
.S.,
GE
BZ
E-K
OC
AE
LI,
TU
RK
EY
Labo
rato
ry: F
PR
CG
EN
ER
ICS
(U
K)
LIM
ITE
D, P
OT
TE
RS
BA
R,
HE
RT
FO
RD
SH
IRE
, UN
ITE
D K
ING
DO
MG
ER
AR
D L
AB
OR
AT
OR
IES
, GR
AN
GE
CO
NS
ULT
ING
CH
EM
ICA
LC
ON
SU
LTIN
G C
HE
MIC
AL
RO
AD
, DU
BLI
N, I
RE
LAN
DLA
BO
RA
TO
RIE
S, A
TLA
SV
ILLE
,B
OK
SB
UR
G, R
SA
LAB
OR
AT
OR
IES
, AT
LAS
VIL
LE,
BO
KS
BU
RG
, RS
AS
AB
S C
OM
ME
RC
IAL
(PT
Y)
LTD
PH
AR
MA
CE
UT
ICA
L C
HE
MIS
TR
YS
AB
S C
OM
ME
RC
IAL
(PT
Y)
LTD
PH
AR
MA
CE
UT
ICA
L C
HE
MIS
TR
YS
AB
S C
OM
ME
RC
IAL
(PT
Y)
LTD
PH
AR
MA
CE
UT
ICA
L C
HE
MIS
TR
YD
EP
AR
TM
EN
T G
RO
EN
KLO
OF
, PR
ET
OR
IA,
RS
AD
EP
AR
TM
EN
T, G
RO
EN
KLO
OF
,P
RE
TO
RIA
, RS
AS
AN
DO
Z S
A, S
PA
RT
AN
,K
EM
PT
ON
PA
RK
, RS
A
DE
PA
RT
ME
NT
, GR
OE
NK
LOO
F,
RE
TO
RIA
, RS
AS
AN
DO
Z S
A, S
PA
RT
AN
, KE
MP
TO
NP
AR
K, R
SA
RE
SE
AR
CH
INS
TIT
UT
E F
OR
IND
US
TR
IAL
PH
AR
MA
CY
, NO
RT
H-W
ES
T U
NIV
ER
SIT
Y,
PO
TC
HE
FS
TR
OO
M, R
SA
FP
RR
:S
AN
DO
Z S
A, S
PA
RT
AN
,K
EM
PT
ON
PA
RK
, RS
AF
PR
R:
SA
ND
OZ
SA
, SP
AR
TA
N, K
EM
PT
ON
PA
RK
, RS
A
FP
RC
/FP
RR
:P
HA
RM
AC
AR
E L
TD
,K
OR
TS
EN
, PO
RT
ELI
ZA
BE
TH
, RS
A
She
lf-lif
e:24
mon
ths
She
lf-lif
e:24
mon
ths
FP
RR
:P
HA
RM
AC
AR
E L
TD
, WO
OD
ME
AD
,S
AN
DT
ON
, RS
A
Dat
e of
regi
stra
tion:
18 M
AY
201
2D
ate
of r
egis
trat
ion:
18 M
AY
201
2S
helf-
life:
24 m
onth
s
Dat
e of
reg
istr
atio
n07
JU
NE
201
2
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 7
MR
F 1
5M
RF
15v1
RF
15
Reg
istr
atio
nnu
mbe
r:A
38/7
.5/0
729
Reg
istr
atio
n nu
mbe
r:A
40/1
5.1/
0048
Reg
istr
atio
nnu
mbe
r:A
40/2
.9/0
355
Nam
e of
med
icin
e:O
MA
CO
RN
ame
of m
edic
ine:
CE
PR
OLE
N E
YE
DR
OP
SN
ame
ofm
edic
ine:
SA
BA
X T
RA
MA
DO
L 10
0 m
g/2
ml
Dos
age
form
:C
AP
SU
LED
osag
eform:
EY
E D
RO
P S
OLU
TIO
ND
osag
e fo
rm:
INJE
CT
ION
Act
ive
ingr
edie
nts:
EA
CH
CA
PS
ULE
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
100
,0 m
l SO
LUT
ION
Act
ive
ingr
edie
nts:
EA
CH
2,0
ml C
ON
TA
INS
:E
icos
apen
t (E
PA
) et
hyl e
ster
s 46
,0 %
CO
NT
AIN
S:
TR
AM
AD
OL
HY
DR
OC
HLO
RID
ED
ocon
exen
t (D
HA
) et
hyl e
ster
s 38
,0 %
Cip
roflo
xaci
n H
ydro
chlo
ride
equi
vale
nt to
Cip
roflo
xaci
n10
0,0
mg
0,3
g
Con
ditio
ns o
fre
gist
ratio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of
regi
stra
tion:
1, 2
, 3, 4
, 5, 6
, 7, 8
App
lican
tA
BB
OT
T L
AB
OR
AT
OR
IES
SA
(P
TY
)A
pplic
ant:
ME
DIV
ISIO
N (
PT
Y)
LTD
App
lican
t:A
DC
OC
K IN
GR
AM
CR
ITIC
AL
CA
RE
LTD
(PT
Y)
LTD
Man
ufac
ture
r:C
AR
DIN
AL
HE
ALT
H U
K, S
WIN
DO
N,
WIL
TS
HIR
E, U
NIT
ED
KIN
GD
OM
Man
ufac
ture
r:IN
DO
CO
RE
ME
DIE
S, V
ER
NA
IND
US
TR
IAL
ES
TA
TE
, GO
A,
IND
IA
Man
ufac
ture
r:P
HA
RM
A-Q
(P
TY
) LT
D, I
ND
US
TR
IA,
JOH
AN
NE
SB
UR
G, R
SA
Pac
ker:
CA
RD
INA
L H
EA
LTH
UK
, SW
IND
ON
,W
ILT
SH
IRE
, UN
ITE
D K
ING
DO
MG
MP
AC
K, H
AD
SU
ND
, DE
NM
AR
K
Pac
ker:
IND
OC
O R
EM
ED
IES
, VE
RN
AIN
DU
ST
RIA
L E
ST
AT
E, G
OA
,IN
DIA
Pac
ker:
PH
AR
MA
-Q (
PT
Y)
LTD
, IN
DU
ST
RIA
,JO
HA
NN
ES
BU
RG
, RS
A
Labo
rato
ry: F
PR
C:
CA
RD
INA
L H
EA
LTH
UK
, SW
IND
ON
,W
ILT
SH
IRE
, UN
ITE
D K
ING
DO
MP
RO
NO
VA
BIO
CA
RE
A.S
, LY
SA
KE
R,
NO
RW
AY
Labo
rato
ry: F
PR
C:
IND
OC
O R
EM
ED
IES
, VE
RN
AIN
DU
ST
RIA
L E
ST
AT
E, G
OA
,IN
DIA
SA
BS
CO
MM
ER
CIA
L (P
TY
)
Labo
rato
ry:
FP
RC
:P
HA
RM
A-Q
(P
TY
) LT
D, I
ND
US
TR
IA,
JOH
AN
NE
SB
UR
G, R
SA
SO
LVA
Y P
HA
RM
AC
EU
TIC
ALS
Gm
bH,
NE
US
TA
DT
, GE
RM
AN
YLT
D P
HA
RM
AC
EU
TIC
AL
CH
EM
IST
RY
DE
PA
RT
ME
NT
GR
OE
NK
LOO
F, P
RE
TO
RIA
,R
SA
CO
NS
ULT
ING
CH
EM
ICA
LLA
BO
RA
TO
RIE
S (
PT
Y)
LTD
,A
TLA
SV
ILLE
, BO
KS
BU
RG
,R
SA
RE
SE
AR
CH
INS
TIT
UT
E F
OR
IND
US
TR
IAL
PH
AR
MA
CY
,N
OR
TH
-WE
ST
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
, RS
A
FP
RC
/FP
RR
:A
BB
OT
T L
AB
OR
AT
OR
IES
(P
TY
) LT
D,
CO
NS
TA
NT
IA K
LOO
F, R
SA
FP
RR
:M
ED
IVIS
ION
(P
TY
) LT
D,
KR
AM
ER
VIL
LE, S
AN
DT
ON
,R
SA
FP
RR
PH
AR
MA
-Q (
PT
Y)
LTD
, IN
DU
ST
RIA
,JO
HA
NN
ES
BU
RG
, RS
AA
DC
OC
K IN
GR
AM
CR
ITIC
AL
CA
RE
(PT
Y)
LTD
, AE
RO
TO
N,
JOH
AN
NE
SB
UR
G, R
SA
She
lf-lif
e:36
mon
ths
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)S
helf-
life:
24 m
onth
s (P
rovi
sion
al)
Dat
e of
regi
stra
tion:
07 J
UN
E 2
012
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2D
ate
ofre
gist
ratio
n:07
JU
NE
201
2
8 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15F
15
Reg
istr
atio
n nu
mbe
r:A
40/2
1.5.
1/07
48R
egis
trat
ion
num
ber:
42/2
.2/0
045
Reg
istr
atio
n nu
mbe
r:42
/2.2
/004
6N
ame
of m
edic
ine:
FR
ES
EN
IUS
Nam
e of
med
icin
e:M
IDA
ZO
LAM
SA
FE
LIN
EN
ame
of m
edic
ine:
MID
AZ
OLA
M S
AF
ELI
NE
50
mg
DE
XA
ME
TH
AS
ON
E15
mg
4 m
g/1
ml
Dos
age
form
:IN
JEC
TIO
ND
osag
e fo
rm:
INJE
CT
ION
Dos
age
form
:IN
JEC
TIO
N
Act
ive
ingr
edie
nts:
EA
CH
1,0
ml C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H 3
,0 m
l AM
PO
ULE
Act
ive
ingr
edie
nts:
EA
CH
3,0
ml A
MP
OU
LE C
ON
TA
INS
:D
exam
etha
sone
sod
ium
phos
phat
e eq
uiva
lent
toC
ON
TA
INS
:M
IDA
ZO
LAM
MID
AZ
OLA
M H
YD
RO
CH
LOR
IDE
50,0
mg
Dex
amet
haso
ne p
hosp
hate
HY
DR
OC
HLO
RID
E 1
5,0
mg
4,0
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of
regi
stra
tion:
1, 2
, 3, 4
, 5, 6
, 7C
ondi
tions
of
regi
stra
tion:
1, 2
, 3, 4
, 5, 6
, 7
App
lican
t:B
OD
EN
E (
PT
Y)
LIM
ITE
DA
pplic
ant:
SA
FE
LIN
EA
pplic
ant:
SA
FE
LIN
E P
HA
RM
AC
EU
TIC
ALS
(P
TY
)T
RA
DIN
G A
S IN
TR
AM
ED
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
LTD
LTD
Man
ufac
ture
r:B
OD
EN
E (
PT
Y)
LIM
ITE
DT
RA
DIN
G A
S IN
TR
AM
ED
,K
OR
ST
EN
, PO
RT
ELI
ZA
BE
TH
, RS
A
Man
ufac
ture
r:D
EM
O S
.A.,
PH
AR
MA
CE
UT
ICA
LIN
DU
ST
RY
, AT
HE
NS
,G
RE
EC
E
Man
ufac
ture
r:D
EM
O S
.A.,
PH
AR
MA
CE
UT
ICA
L
IND
US
TR
Y, A
TH
EN
S, G
RE
EC
E
Pac
ker:
BO
DE
NE
(P
TY
) LI
MIT
ED
TR
AD
ING
AS
INT
RA
ME
D,
KO
RS
TE
N, P
OR
TE
LIZ
AB
ET
H, R
SA
Pac
ker:
DE
MO
S.A
.,P
HA
RM
AC
EU
TIC
AL
IND
US
TR
Y, A
TH
EN
S,
GR
EE
CE
Pac
ker:
DE
MO
S.A
., P
HA
RM
AC
EU
TIC
AL
IND
US
TR
Y, A
TH
EN
S, G
RE
EC
E
Labo
rato
ry: F
PR
C :
BO
DE
NE
(P
TY
) LI
MIT
ED
TR
AD
ING
AS
INT
RA
ME
D,
KO
RS
TE
N, P
OR
TE
LIZ
AB
ET
H, R
SA
Labo
rato
ry: F
PR
C:
DE
MO
S.A
.,P
HA
RM
AC
EU
TIC
AL
IND
US
TR
Y, A
TH
EN
S,
GR
EE
CE
INS
TIT
UT
E F
OR
Labo
rato
ry: F
PR
CD
EM
O S
.A.,
PH
AR
MA
CE
UT
ICA
L
IND
US
TR
Y, A
TH
EN
S, G
RE
EC
EIN
ST
ITU
TE
FO
R P
HA
RM
AC
EU
TIC
AL
SE
RV
ICE
S, S
ILV
ER
TO
ND
ALE
,
PR
ET
OR
IA, R
SA
PH
AR
MA
CE
UT
ICA
LS
ER
VIC
ES
,S
ILV
ER
TO
ND
ALE
,P
RE
TO
RIA
, RS
A
FP
RR
:B
OD
EN
E (
PT
Y)
LIM
ITE
DF
PR
RS
AF
ELI
NE
FP
RR
:S
AF
ELI
NE
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
TR
AD
ING
AS
INT
RA
ME
D,
KO
RS
TE
N, P
OR
TP
HA
RM
AC
EU
TIC
ALS
(P
TY
)LT
D, F
LOR
IDA
, RS
ALT
D, F
LOR
IDA
, RS
A
ELI
ZA
BE
TH
, RS
A
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)S
helf-
life:
36 m
onth
sS
helf-
life:
36 m
onth
s
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2D
ate
of r
egis
trat
ion:
07 J
UN
E 2
012
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 9
201166—B
MR
F 1
5M
RF
15F
15
Reg
istr
atio
n nu
mbe
r:42
/20.
1.1/
0511
Reg
istr
atio
n nu
mbe
r:42
/20.
1.1/
0512
Reg
istr
atio
n nu
mbe
r:42
/34/
0513
Nam
e of
med
icin
e:A
SP
EN
TE
ICO
PLA
NIN
200
Nam
e of
med
icin
e:A
SP
EN
TE
ICO
PLA
NIN
400
Nam
e of
med
icin
e:A
SP
EN
DIL
UE
NT
FO
R T
EIC
OP
LAN
IN
Dos
age
form
:P
OW
DE
R F
OR
SO
LUT
ION
FO
R IN
JEC
TIO
ND
osag
e fo
rm:
PO
WD
ER
FO
R S
OLU
TIO
N F
OR
INJE
CT
ION
Dos
age
form
:S
OLU
TIO
N F
OR
INJE
CT
ION
Act
ive
ingr
edie
nts:
EA
CH
3,2
ml C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H 3
,2 m
l CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
3,2
ml C
ON
TA
INS
:T
EIC
OP
LAN
IN 2
00,0
mg
TE
ICO
PLA
NIN
400
,0 m
gW
AT
ER
FO
R IN
JEC
TIO
N 3
,2 m
l
Con
ditio
ns o
fre
gist
ratio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7, 8
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8
App
lican
t:P
HA
RM
AC
AR
E L
IMIT
ED
App
lican
t:P
HA
RM
AC
AR
E L
IMIT
ED
App
lican
t:P
HA
RM
AC
AR
E L
IMIT
ED
Man
ufac
ture
r:LA
BIA
NA
PH
AR
MA
CE
UT
ICA
LS, S
.L.U
,B
AR
BE
RA
DE
L V
ALL
ES
, BA
RC
ELO
NA
,S
PA
IN
Man
ufac
ture
r.LA
BIA
NA
PH
AR
MA
CE
UT
ICA
LS, S
. L. U
,B
AR
BE
RA
DE
L V
ALL
ES
BA
RC
ELO
NA
,M
anuf
actu
rer:
LAB
IAN
A P
HA
RM
AC
EU
TIC
ALS
, S.L
.U,
BA
RB
ER
A D
EL
VA
LLE
S, B
AR
CE
LON
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RM
AC
AR
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AD
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AN
DT
ON
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A
She
lf-lif
e:24
mon
ths
(pro
visi
onal
)S
helf-
life:
24 m
onth
s (p
rovi
sion
al)
She
lf-lif
e:24
mon
ths
(pro
visi
onal
)
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2D
ate
of r
egis
trat
ion:
07 J
UN
E 2
012
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2
10 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15V
IRF
15
Reg
istr
atio
n nu
mbe
r:42
/24/
0518
Reg
istr
atio
n nu
mbe
r:42
/20.
1.1/
0617
Reg
istr
atio
nnu
mbe
r:42
/20.
1.1/
0618
Nam
e of
med
icin
e:R
ING
ER
FU
ND
INN
ame
of m
edic
ine:
AU
RO
CE
FU
RO
XIM
E 2
50 m
gN
ame
of m
edic
ine:
AU
RO
CE
FU
RO
XIM
E 7
50 m
g
Dos
age
form
:S
OLU
TIO
N F
OR
INF
US
ION
Dos
age
form
:IN
JEC
TIO
ND
osag
e fo
rm:
INJE
CT
ION
Act
ive
ingr
edie
nts:
EA
CH
PLA
ST
IC IN
FU
SIO
N B
AG
Act
ive
ingr
edie
nts:
EA
CH
VIA
L C
ON
TA
INS
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ctiv
e in
gred
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s:E
AC
H V
IAL
CO
NT
AIN
S:
CO
NT
AIN
S:
CE
FU
RO
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EQ
UIV
ALE
NT
CE
FU
RO
XIM
E S
OD
IUM
Cal
cium
Chl
orid
e D
ihyd
rate
0,3
7 g
TO
CE
FU
RO
XIM
E 2
50,0
mg
EQ
UIV
ALE
NT
TO
Mag
nesi
um C
hlor
ide
0,20
gC
EF
UR
OX
IME
750
,0 m
gM
alic
Aci
d 0,
67 g
Pot
assi
um C
hlor
ide
0,30
gS
odiu
m A
ceta
te 3
,27
gS
odiu
m C
hlor
ide
6,80
g
Con
ditio
ns o
fre
gist
ratio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of
regi
stra
tion:
1, 2
, 3, 4
, 5, 6
, 7, 8
Con
ditio
ns o
fre
gist
ratio
n:1,
2, 3
, 4, 5
, 6, 7
, 8
App
lican
t:B
BR
AU
N M
ED
ICA
L (P
TY
) LT
DA
pplic
ant:
AU
RO
BIN
DO
PH
AR
MA
(P
TY
) LT
DA
pplic
ant:
AU
RO
BIN
DO
PH
AR
MA
(P
TY
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D
Man
ufac
ture
r:B
BR
AU
N M
ELS
UN
GE
N A
G, G
ER
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Man
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H IN
DIA
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RA
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S.A
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WIT
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ND
Labo
rato
ry: F
PR
C:
B B
RA
UN
ME
LSU
NG
EN
AG
, GE
RM
AN
YLa
bora
tory
: FP
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IND
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ITLa
bora
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BR
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ED
ICA
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TY
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FO
UR
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HA
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RG
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AF
PR
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AU
RO
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PH
AR
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(P
TY
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D,
ME
YE
RS
DA
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OH
AN
NE
SB
UR
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SA
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UR
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IND
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HA
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A (
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Y)
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YE
RS
DA
L,JO
HA
NN
ES
BU
RG
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A
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
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helf-
life:
24 m
onth
s (P
rovi
sion
al)
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2D
ate
of r
egis
trat
ion:
07 J
UN
E 2
012
Dat
e of
regi
stra
tion:
07 J
UN
E 2
012
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 11
MR
IF 1
5M
RF
15vI
RF
15
Reg
istr
atio
n nu
mbe
r:42
/20.
1.1/
0619
Reg
istr
atio
n nu
mbe
r:42
/26/
0739
Reg
istr
atio
n nu
mbe
r:42
/26/
0740
Nam
e of
med
icin
e:A
UR
O C
EF
UR
OX
IME
Nam
e of
med
icin
e:H
YC
AM
TIN
0,2
5 m
gN
ame
of m
edic
ine:
HY
CA
MT
IN 1
,0 m
g15
00 m
g
Dos
age
form
:IN
JEC
TIO
ND
osag
e fo
rm:
CA
PS
ULE
Dos
age
form
:C
AP
SU
LE
Act
ive
ingr
edie
nts:
EA
CH
VIA
L C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H C
AP
SU
LEA
ctiv
e in
gred
ient
s:E
AC
H C
AP
SU
LE C
ON
TA
INS
:C
EF
UR
OX
IME
SO
DIU
MC
ON
TA
INS
:T
opot
ecan
Hyd
roch
lorid
e eq
uiva
lent
toE
QU
IVA
LEN
T T
OC
EF
UR
OX
IME
150
0,0
mg
Top
otec
an H
ydro
chlo
ride
equi
vale
nt to
Top
otec
an1,
0 m
g
Top
otec
an 0
,25
mg
Con
ditio
ns o
fre
gist
ratio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7, 8
Con
ditio
ns o
fre
gist
ratio
n:1,
2, 3
, 4, 5
, 6, 7
, 8
App
lican
t:A
UR
OB
IND
O P
HA
RM
AA
pplic
ant:
GLA
XO
SM
ITH
KLI
NE
SA
App
lican
t:G
LAX
OS
MIT
HK
LIN
E S
A (
PT
Y)
LTD
(PT
Y)
LTD
(PT
Y)
LTD
Man
ufac
ture
r:A
UR
OB
IND
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HA
RM
AM
anuf
actu
rer:
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ITH
KLI
NE
Man
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ture
r:G
LAX
OS
MIT
HK
LIN
ELI
MIT
ED
, UN
IT V
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AT
AN
CH
ER
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AN
DA
L,M
ED
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DIS
TR
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ND
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SH
IND
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FA
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ALY
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Pac
ker:
AU
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DO
PH
AR
MA
Pac
ker:
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SM
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NE
Pac
ker:
GLA
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SM
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KLI
NE
LIM
ITE
D, U
NIT
VI,
PA
TA
NC
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RU
MA
ND
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ME
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S.p
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(P
TY
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D,
EP
PIN
G, C
AP
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OW
N, R
SA
Labo
rato
ry: F
PR
C:
AU
RO
BIN
DO
PH
AR
MA
Labo
rato
ry: F
PR
C:
GLA
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Labo
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PR
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HA
RM
A(P
TY
) LT
D, M
EY
ER
SD
AL,
JOH
AN
NE
SB
UR
G, R
SA
FP
RR
:G
LAX
OS
MIT
HK
LIN
E S
A(P
TY
) LT
D, E
PP
ING
,C
AP
E T
OW
N, R
SA
FP
RR
:G
LAX
OS
MIT
HK
LIN
E S
A (
PT
Y)
LTD
,E
PP
ING
, CA
PE
TO
WN
, RS
A
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)S
helf-
life:
24 m
onth
s (P
rovi
sion
al)
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2D
ate
of r
egis
trat
ion:
07 J
UN
E 2
012
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2
12 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15.F
15
Reg
istr
atio
n nu
mbe
r:42
/2.6
.5/0
792
Reg
istr
atio
n nu
mbe
r:42
/2.6
.5/0
793
Reg
istr
atio
n nu
mbe
r:42
/2.6
.5/0
794
Nam
e of
med
icin
e:R
ISN
IA 0
,5 m
gN
ame
of m
edic
ine:
RIS
NIA
1 m
gN
ame
of m
edic
ine:
RIS
NIA
2 m
g
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H T
AB
LET
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:R
ISP
ER
IDO
NE
0,5
mg
RIS
PE
RID
ON
E 1
,0 m
gR
ISP
ER
IDO
NE
2,0
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
App
lican
t:C
IPLA
ME
DP
RO
(P
TY
) LT
DA
pplic
ant:
CIP
LA M
ED
PR
O (
PT
Y)
LTD
App
lican
t:C
IPLA
ME
DP
RO
(P
TY
) LT
D
Man
ufac
ture
r:C
IPLA
LT
D, K
UR
KU
MB
H, P
UN
E,
IND
IAM
anuf
actu
rer:
CIP
LA L
TD
, KU
RK
UM
BH
,P
UN
E, I
ND
IA
Man
ufac
ture
r:C
IPLA
LT
D, K
UR
KU
MB
H, P
UN
E, I
ND
IA
Pac
ker:
CIP
LA L
TD
, KU
RK
UM
BH
, PU
NE
,IN
DIA
Pac
ker:
CIP
LA L
TD
, KU
RK
UM
BH
,P
UN
E, I
ND
IA
Pac
ker:
CIP
LA L
TD
, KU
RK
UM
BH
, PU
NE
, IN
DIA
Labo
rato
ry: F
P R
CC
IPLA
LT
D, K
UR
KU
MB
H, P
UN
E,
IND
IALa
bora
tory
: FP
RC
:C
IPLA
LT
D, K
UR
KU
MB
H,
PU
NE
, IN
DIA
Labo
rato
ry: F
PR
C:
CIP
LA L
TD
, KU
RK
UM
BH
, PU
NE
, IN
DIA
FP
RR
:C
IPLA
ME
DP
RO
(P
TY
) LT
D,
RO
SE
N H
EIG
HT
S, B
ELL
VIL
LE,
RS
A
FP
RR
:C
IPLA
ME
DP
RO
(P
TY
) LT
D,
RO
SE
N H
EIG
HT
S,
BE
LLV
ILLE
, RS
A
FP
RR
:C
IPLA
ME
DP
RO
(P
TY
) LT
D, R
OS
EN
HE
IGH
TS
, BE
LLV
ILLE
, RS
A
She
lf-lif
e:24
mon
ths
She
lf-lif
e:24
mon
ths
She
lf-lif
e:24
mon
ths
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2D
ate
of r
egis
trat
ion:
07 J
UN
E 2
012
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 13
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
42/2
.6.5
/079
5
RIS
NIA
3 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:R
ISP
ER
IDO
NE
3,0
mg
1, 2
, 3, 4
, 5, 6
, 7
CIP
LA M
ED
PR
O (
PT
Y)
LTD
CIP
LA L
TD
, KU
RK
UM
BH
,P
UN
E, I
ND
IA
CIP
LA L
TD
, KU
RK
UM
BH
,P
UN
E, I
ND
IA
CIP
LA L
TD
, KU
RK
UM
BH
,P
UN
E, I
ND
IA
CIP
LA M
ED
PR
O (
PT
Y)
LTD
,R
OS
EN
HE
IGH
TS
, BE
LLV
ILLE
,R
SA
24 m
onth
s
07 J
UN
E 2
012
MR
F15
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
42/2
.6.5
/079
6
RIS
NIA
4 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:R
ISP
ER
IDO
NE
4,0
mg
1, 2
, 3, 4
, 5, 6
, 7
CIP
LA M
ED
PR
O (
PT
Y)
LTD
CIP
LA L
TD
, KU
RK
UM
BH
, PU
NE
,IN
DIA
CIP
LA L
TD
, KU
RK
UM
BH
, PU
NE
,IN
DIA
FP
RC
:C
IPLA
LT
D, K
UR
KU
MB
H, P
UN
E,
IND
IA
CIP
LA M
ED
PR
O (
PT
Y)
LTD
,R
OS
EN
HE
IGH
TS
, BE
LLV
ILLE
,R
SA
24 m
onth
s
07 J
UN
E 2
012
MR
F 1
5 Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
fre
gist
ratio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
42/2
.6.5
/079
7
RIS
NIA
6 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:R
ISP
ER
IDO
NE
6,0
mg
1, 2
, 3, 4
, 5, 6
, 7
CIP
LA M
ED
PR
O (
PT
Y)
LTD
CIP
LA L
TD
, KU
RK
UM
BH
, PU
NE
, IN
DIA
CIP
LA L
TD
, KU
RK
UM
BH
, PU
NE
, IN
DIA
CIP
LA L
TD
, KU
RK
UM
BH
, PU
NE
, IN
DIA
CIP
LA M
ED
PR
O (
PT
Y)
LTD
, RO
SE
NH
EIG
HT
S, B
ELL
VIL
LE, R
SA
24 m
onth
s
07 J
UN
E 2
012
14 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:42
/2.6
.5/0
798
Reg
istr
atio
n nu
mbe
r:42
/2.6
.5/0
799
Reg
istr
atio
n nu
mbe
r:42
/2.6
.5/0
800
Nam
e of
med
icin
e:C
IPLA
RIS
PE
RID
ON
E 0
,5 m
gN
ame
of m
edic
ine:
CIP
LA R
ISP
ER
IDO
NE
1 m
gN
ame
of m
edic
ine:
CIP
LA R
ISP
ER
IDO
NE
2 m
g
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H T
AB
LET
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:R
ISP
ER
IDO
NE
0,5
mg
RIS
PE
RID
ON
E1,
0 m
gR
ISP
ER
IDO
NE
2,0
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
App
lican
t:C
IPLA
LIF
E S
CIE
NC
ES
(P
TY
)A
pplic
ant:
CIP
LA L
IFE
SC
IEN
CE
S (
PT
Y)
App
lican
t:C
IPLA
LIF
E S
CIE
NC
ES
LTD
LTD
(PT
Y)
LTD
Man
ufac
ture
r:C
IPLA
LT
D, K
UR
KU
MB
H, P
UN
E,
IND
IAM
anuf
actu
rer:
CIP
LA L
TD
, KU
RK
UM
BH
,P
UN
E, I
ND
IAM
anuf
actu
rer:
CIP
LA L
TD
, KU
RK
UM
BH
,P
UN
E, I
ND
IA
Pac
ker:
CIP
LA L
TD
, KU
RK
UM
BH
, PU
NE
,IN
DIA
Pac
ker:
CIP
LA L
TD
, KU
RK
UM
BH
,P
UN
E, I
ND
IAP
acke
r:C
IPLA
LT
D, K
UR
KU
MB
H,
PU
NE
, IN
DIA
Labo
rato
ry: F
PR
C:
CIP
LA L
TD
, KU
RK
UM
BH
, PU
NE
,IN
DIA
Labo
rato
ry:
FP
RC
:C
IPLA
LT
D, K
UR
KU
MB
H,
PU
NE
, IN
DIA
Labo
rato
ry: F
PR
CC
IPLA
LT
D, K
UR
KU
MB
H,
PU
NE
, IN
DIA
FP
RR
:C
IPLA
LIF
E S
CIE
NC
ES
(P
TY
)F
PR
R:
CIP
LA L
IFE
SC
IEN
CE
S (
PT
Y)
FP
RR
:C
IPLA
LIF
E S
CIE
NC
ES
LTD
, RO
SE
N H
EIG
HT
S,
BE
LLV
ILLE
, RS
ALT
D, R
OS
EN
HE
IGH
TS
,B
ELL
VIL
LE, R
SA
(PT
Y)
LTD
, RO
SE
NH
EIG
HT
S, B
ELL
VIL
LE, R
SA
She
lf-lif
e:24
mon
ths
She
lf-lif
e:24
mon
ths
She
lf-lif
e:24
mon
ths
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2D
ate
of r
egis
trat
ion:
07 J
UN
E 2
012
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 15
MR
F 1
5M
RF
15
Reg
istr
atio
n nu
mbe
r:42
/2.6
.5/0
801
Reg
istr
atio
n nu
mbe
r:42
/2.6
.5/0
802
Reg
istr
atio
n nu
mbe
r:42
/2.6
.5/0
803
Nam
e of
med
icin
e:C
IPLA
RIS
PE
RID
ON
E 3
mg
Nam
e of
med
icin
e:C
IPLA
RIS
PE
RID
ON
E 4
mg
Nam
e of
med
icin
e:C
IPLA
RIS
PE
RID
ON
E 6
mg
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H T
AB
LET
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:R
ISP
ER
IDO
NE
3,0
mg
CO
NT
AIN
S:
RIS
PE
RID
ON
E6,
0 m
gR
ISP
ER
IDO
NE
4,0
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
App
lican
t:C
IPLA
LIF
E S
CIE
NC
ES
(P
TY
)A
pplic
ant:
CIP
LA L
IFE
SC
IEN
CE
SA
pplic
ant:
CIP
LA L
IFE
SC
IEN
CE
S (
PT
Y)
LTD
(PT
Y)
LTD
LTD
Man
ufac
ture
r:C
IPLA
LT
D, K
UR
KU
MB
H,
PU
NE
, IN
DIA
Man
ufac
ture
r:C
IPLA
LT
D, K
UR
KU
MB
H,
PU
NE
, IN
DIA
Man
ufac
ture
r:C
IPLA
LT
D, K
UR
KU
MB
H, P
UN
E,
IND
IA
Pac
ker:
CIP
LA L
TD
, KU
RK
UM
BH
,P
UN
E, I
ND
IA
Pac
ker:
CIP
LA L
TD
, KU
RK
UM
BH
,P
UN
E, I
ND
IA
Pac
ker:
CIP
LA L
TD
, KU
RK
UM
BH
, PU
NE
,IN
DIA
Labo
rato
ry: F
PR
C:
CIP
LA L
TD
, KU
RK
UM
BH
,P
UN
E, I
ND
IALa
bora
tory
: FP
RC
:C
IPLA
LT
D, K
UR
KU
MB
H,
PU
NE
, IN
DIA
Labo
rato
ry: F
PR
C:
CIP
LA L
TD
, KU
RK
UM
BH
, PU
NE
,IN
DIA
FP
RR
:C
IPLA
LIF
E S
CIE
NC
ES
(P
TY
)F
PR
R:
CIP
LA L
IFE
SC
IEN
CE
SF
PR
R:
CIP
LA L
IFE
SC
IEN
CE
S (
PT
Y)
LTD
, RO
SE
N H
EIG
HT
S,
BE
LLV
ILLE
, RS
A(P
TY
) LT
D, R
OS
EN
HE
IGH
TS
, BE
LLV
ILLE
,R
SA
LTD
, RO
SE
N H
EIG
HT
S,
BE
LLV
ILLE
, RS
A
She
lf-lif
e:24
mon
ths
She
lf-lif
e:24
mon
ths
She
lf-lif
e:24
mon
ths
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2D
ate
of r
egis
trat
ion:
07 J
UN
E 2
012
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2
16 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:42
/20.
1.1/
0888
Reg
istr
atio
n nu
mbe
r:42
/20.
1.1/
0889
Reg
istr
atio
n nu
mbe
r:42
/34/
1056
Nam
e of
med
icin
e:S
PE
C T
EIC
OP
LAN
IN 2
00N
ame
of m
edic
ine:
SP
EC
TE
ICO
PLA
NIN
400
Nam
e of
med
icin
e:S
PE
C T
EIC
OP
LAN
IN S
OLV
EN
T
Dos
age
form
:P
OW
DE
R F
OR
SO
LUT
ION
Dos
age
form
:P
OW
DE
R F
OR
SO
LUT
ION
Dos
age
form
:LI
QU
IDF
OR
INJE
CT
ION
FO
R IN
JEC
TIO
N
Act
ive
ingr
edie
nts:
EA
CH
VIA
L C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H V
IAL
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
AM
PO
ULE
CO
NT
AIN
S:
TE
ICO
PLA
NIN
200
,0 m
gT
EIC
OP
LAN
IN 4
00,0
mg
WA
TE
R F
OR
INJE
CT
ION
3,0
ml
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7, 8
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
App
lican
t:S
PE
CP
HA
RM
(P
TY
) LT
DA
pplic
ant:
SP
EC
PH
AR
M (
PT
Y)
LTD
App
lican
t:S
PE
CP
HA
RM
(P
TY
) LT
D
Man
ufac
ture
r:S
IRT
ON
, VIL
LA G
UA
RD
IA,
ITA
LYM
anuf
actu
rer:
SIR
TO
N, V
ILLA
GU
AR
DIA
,IT
ALY
Man
ufac
ture
r:S
IRT
ON
, VIL
LA G
UA
RD
IA, I
TA
LY
Pac
ker:
SIR
TO
N, V
ILLA
GU
AR
DIA
,IT
ALY
Pac
ker:
SIR
TO
N, V
ILLA
GU
AR
DIA
,IT
ALY
Pac
ker:
SIR
TO
N, V
ILLA
GU
AR
DIA
, IT
ALY
Labo
rato
ry: F
PR
C:
SIR
TO
N, V
ILLA
GU
AR
DIA
,IT
ALY
Labo
rato
ry: F
PR
C:
SIR
TO
N, V
ILLA
GU
AR
DIA
,IT
ALY
Labo
rato
ry: F
PR
CS
IRT
ON
, VIL
LA G
UA
RD
IA, I
TA
LYC
ON
SU
LTIN
G C
HE
MIC
AL
CO
NS
ULT
ING
CH
EM
ICA
LLA
BO
RA
TO
RIE
S (
PT
Y)
LTD
,A
TLA
SV
ILLE
, BO
KS
BU
RG
,R
SA
SP
EC
PH
AR
M H
OLD
ING
S
CO
NS
ULT
ING
CH
EM
ICA
LLA
BO
RA
TO
RIE
S (
PT
Y)
LTD
, AT
LAS
VIL
LE,
BO
KS
BU
RG
, RS
AS
PE
CP
HA
RM
HO
LDIN
GS
LAB
OR
AT
OR
IES
(P
TY
) LT
D,
AT
LAS
VIL
LE, B
OK
SB
UR
G, R
SA
SP
EC
PH
AR
M H
OLD
ING
S (
PT
Y)
LTD
, HA
LFW
AY
HO
US
E, M
IDR
AN
D,
RS
A
(PT
Y)
LTD
, HA
LFW
AY
(PT
Y)
LTD
, HA
LFW
AY
HO
US
E, M
IDR
AN
D, R
SA
HO
US
E, M
IDR
AN
D, R
SA
FP
RR
:S
PE
CP
HA
RM
(P
TY
) LT
D,
HA
LFW
AY
HO
US
E,
MID
RA
ND
, RS
A
FP
RR
:S
PE
CP
HA
RM
(P
TY
) LT
D,
HA
LFW
AY
HO
US
E,
MID
RA
ND
, RS
A
FP
RR
:S
PE
CP
HA
RM
(P
TY
) LT
D,
HA
LFW
AY
HO
US
E, M
IDR
AN
D, R
SA
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)*S
helf-
life:
24 m
onth
s (P
rovi
sion
al)*
She
lf-lif
e:24
mon
ths
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2D
ate
of r
egis
trat
ion:
07 J
UN
E 2
012
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2
*A p
rovi
sion
al s
helf-
life
of 2
4 m
onth
s is
app
rove
d fo
r th
is p
rodu
ct m
anuf
actu
red
by S
irton
with
AP
I man
ufac
ture
d by
Zhe
jiang
Med
icin
e. A
she
lf-lif
e of
24
hour
sat
2-8
°C
is a
ppro
ved
for
the
reco
nstit
uted
and
dilu
ted
prod
uct.
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 17
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
43/5
.3/0
251
DO
NE
SP
ES
5
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
43/5
.3/0
252
DO
NE
SP
ES
10
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
43/5
.3/0
253
DO
NE
RIN
5
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:D
ON
EP
EZ
IL H
CI
5,0
mg
DO
NE
PE
ZIL
HC
I10
,0 m
gD
ON
EP
EZ
IL H
CI
5,0
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7, 8
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8
App
lican
t:LA
SA
RA
TR
AD
ER
S (
PT
Y)
LTD
App
lican
t:LA
SA
RA
TR
AD
ER
S (
PT
Y)
LTD
App
lican
t:LA
SA
RA
TR
AD
ER
S (
PT
Y)
LTD
Man
ufac
ture
r:S
PE
CIF
AR
S.A
, VA
RV
AR
A,
AT
HE
NS
, GR
EE
CE
Man
ufac
ture
r:S
PE
CIF
AR
S.A
, VA
RV
AR
A,
AT
HE
NS
, GR
EE
CE
Man
ufac
ture
r:S
PE
CIF
AR
S.A
, VA
RV
AR
A,
AT
HE
NS
, GR
EE
CE
Pac
ker:
SP
EC
IFA
R S
.A, V
AR
VA
RA
,A
TH
EN
S, G
RE
EC
E
Pac
ker:
SP
EC
IFA
R S
.A, V
AR
VA
RA
,A
TH
EN
S, G
RE
EC
EP
acke
r:S
PE
CIF
AR
S.A
, VA
RV
AR
A,
AT
HE
NS
, GR
EE
CE
SP
EC
PH
AR
M H
OLD
ING
S (
PT
Y)
SP
EC
PH
AR
M H
OLD
ING
SS
PE
CP
HA
RM
HO
LDIN
GS
LTD
, MID
RA
ND
, RS
A(P
TY
) LT
D, M
IDR
AN
D, R
SA
(PT
Y)
LTD
, MID
RA
ND
, RS
A
Labo
rato
ry: F
PR
C:
SP
EC
IFA
R S
.A, V
AR
VA
RA
,A
TH
EN
S, G
RE
EC
ELa
bora
tory
:F
PR
C:
SP
EC
IFA
R S
.A, V
AR
VA
RA
,A
TH
EN
S, G
RE
EC
ELa
bora
tory
: FP
RC
SP
EC
IFA
R S
.A, V
AR
VA
RA
,A
TH
EN
S, G
RE
EC
ES
PE
CP
HA
RM
HO
LDIN
GS
(P
TY
)S
PE
CP
HA
RM
HO
LDIN
GS
SP
EC
PH
AR
M H
OLD
ING
S
LTD
, MID
RA
ND
, RS
A(P
TY
) LT
D, M
IDR
AN
D, R
SA
(PT
Y)
LTD
, MID
RA
ND
, RS
A
FP
RR
:LA
SA
RA
TR
AD
ER
S (
PT
Y)
LTD
,M
OR
ELE
TA
PA
RK
, PR
ET
OR
IA,
RS
A
FP
RR
:LA
SA
RA
TR
AD
ER
S (
PT
Y)
LTD
,M
OR
ELE
TA
PA
RK
, PR
ET
OR
IA,
RS
A
FP
RR
:LA
SA
RA
TR
AD
ER
S (
PT
Y)
LTD
, MO
RE
LET
A P
AR
K,
PR
ET
OR
IA, R
SA
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)*S
helf-
life:
24 m
onth
s (P
rovi
sion
al)*
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)*
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2D
ate
of r
egis
trat
ion:
07 J
UN
E 2
012
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2
*A p
rovi
sion
al s
helf-
life
of 2
4 m
onth
s is
app
rove
d fo
r th
is p
rodu
ct m
anuf
actu
red
with
AP
I fro
m J
ubila
nt O
rano
sys
and
Ran
baxy
Lab
orat
orie
s Li
mite
d
18 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:43
/5.3
/025
4R
egis
trat
ion
num
ber:
43/8
.3/0
675
Reg
istr
atio
n nu
mbe
r:43
/7.1
.3/0
716
Nam
e of
med
icin
e:D
ON
ER
IN 1
0N
ame
of m
edic
ine:
FE
RR
OU
S G
LUC
ON
AT
E S
YR
UP
Nam
e of
med
icin
e:D
YN
A IR
BE
SA
RT
AN
75
mg
BA
RR
S
Dos
age
form
:T
AB
LET
Dos
age
form
:S
YR
UP
Dos
age
form
:T
AB
LET
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H 5
,0 m
l CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:D
ON
EP
EZ
IL H
CI
10,0
mg
FE
RR
OU
S G
LUC
ON
AT
E 3
50,0
mg
IRB
ES
AR
TA
N 7
5,0
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7, 8
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8
App
lican
t:LA
SA
RA
TR
AD
ER
S (
PT
Y)
LTD
App
lican
t:B
AR
RS
PH
AR
MA
CE
UT
ICA
LA
pplic
ant:
PH
AR
MA
DY
NA
MIC
S (
PT
Y)
LTD
IND
US
TR
IES
cc
Man
ufac
ture
r:S
PE
CIF
AR
S.A
, VA
RV
AR
A,
AT
HE
NS
, GR
EE
CE
Man
ufac
ture
r:B
AR
RS
PH
AR
MA
CE
UT
ICA
LIN
DU
ST
RIE
S c
c, N
DA
BE
NI,
CA
PE
Man
ufac
ture
r:LA
BO
RA
TO
RIO
S C
INF
A, S
.A.,
HU
AR
TE
-PA
MP
LON
A, S
PA
INT
OW
N, R
SA
LAB
OR
AT
OR
IOS
LIC
ON
SA
, S.A
.,A
ZU
QU
EC
A D
E H
EN
AR
ES
(GU
AD
ALA
JAR
A),
SP
AIN
Pac
ker:
SP
EC
IFA
R S
.A, V
AR
VA
RA
,A
TH
EN
S, G
RE
EC
EP
acke
r:B
AR
RS
PH
AR
MA
CE
UT
ICA
LIN
DU
ST
RIE
S c
c, N
DA
BE
NI,
CA
PE
Pac
ker:
LAB
OR
AT
OR
IOS
CIN
FA
, S.A
.,H
UA
RT
E-P
AM
PLO
NA
, SP
AIN
SP
EC
PH
AR
M H
OLD
ING
S (
PT
Y)
LTD
, MID
RA
ND
, RS
AT
OW
N, R
SA
LAB
OR
AT
OR
IOS
LIC
ON
SA
, S.A
.,A
ZU
QU
EC
A D
E H
EN
AR
ES
(GU
AD
ALA
JAR
A),
SP
AIN
TE
CH
NIK
ON
LA
BO
RA
TO
RIE
S(P
TY
) LT
D, R
OB
ER
TV
ILLE
,F
LOR
IDA
, RS
AP
HA
RM
AC
EU
TIC
AL
EN
TE
RP
RIS
ES
(P
TY
) LT
D,
N'D
AB
EN
I, P
INE
LAN
DS
, RS
AS
PE
CP
HA
RM
HO
LDIN
GS
(P
TY
)LT
D, H
ALF
WA
Y H
OU
SE
,M
IDR
AN
D, R
SA
Labo
rato
ry: F
PR
C:
SP
EC
IFA
R S
.A, V
AR
VA
RA
,A
TH
EN
S, G
RE
EC
ELa
bora
tory
:F
PR
C:
BA
RR
S P
HA
RM
AC
EU
TIC
AL
IND
US
TR
IES
cc,
ND
AB
EN
I, C
AP
ELa
bora
tory
: FP
RC
LAB
OR
AT
OR
IOS
CIN
FA
, S.A
.,H
UA
RT
E-P
AM
PLO
NA
, SP
AIN
SP
EC
PH
AR
M H
OLD
ING
S (
PT
Y)
LTD
, MID
RA
ND
, RS
AT
OW
N, R
SA
LAB
OR
AT
OR
IOS
LIC
ON
SA
, S.A
.,A
ZU
QU
EC
A D
E H
EN
AR
ES
(GU
AD
ALA
JAR
A),
SP
AIN
LAB
OR
AT
OR
IOS
EC
HE
VA
RN
E,
BA
RC
ELO
NA
, SP
AIN
CO
NS
ULT
ING
CH
EM
ICA
LLA
BO
RA
TO
RIE
S (
PT
Y)
LTD
,A
TLA
SV
ILLE
, BO
KS
BU
RG
, RS
A
FP
RR
:LA
SA
RA
TR
AD
ER
S (
PT
Y)
LTD
,M
OR
ELE
TA
PA
RK
, PR
ET
OR
IA,
RS
A
FP
RR
:B
AR
RS
PH
AR
MA
CE
UT
ICA
LIN
DU
ST
RIE
S c
c, N
DA
BE
NI,
CA
PE
TO
WN
, RS
A
FP
RR
:P
HA
RM
A D
YN
AM
ICS
(P
TY
) LT
D,
WE
ST
LAK
E, C
AP
E T
OW
N, R
SA
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)*S
helf-
life:
24 m
onth
s (P
rovi
sion
al)
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2D
ate
of r
egis
trat
ion:
07 J
UN
E 2
012
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2
A p
rovi
sion
al s
helf-
life
of 2
4 m
onth
s is
app
rove
d fo
r th
is p
rodu
ct m
anuf
actu
red
with
AP
I fro
m J
ubila
nt O
rano
sys
and
Ran
baxy
Lab
orat
orie
s Li
mite
d
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 19
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:43
/7.1
.3/0
717
Reg
istr
atio
n nu
mbe
r:43
/7.1
.3/0
718
Reg
istr
atio
n nu
mbe
r:43
/7.1
.3/0
719
Nam
e of
med
icin
e:D
YN
A IR
BE
SA
RT
AN
150
mg
Nam
e of
med
icin
e:D
YN
A IR
BE
SA
RT
AN
300
mg
Nam
e of
med
icin
e:D
YN
AR
B 7
5 m
g
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H T
AB
LET
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:IR
BE
SA
RT
AN
150
,0 m
gIR
BE
SA
RT
AN
300
,0 m
gIR
BE
SA
RT
AN
75,
0 m
g
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7, 8
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8
App
lican
t:P
HA
RM
A D
YN
AM
ICS
(P
TY
) LT
DA
pplic
ant:
PH
AR
MA
DY
NA
MIC
S (
PT
Y)
LTD
App
lican
t:P
HA
RM
A D
YN
AM
ICS
(P
TY
) LT
D
Man
ufac
ture
r:LA
BO
RA
TO
RIO
S C
INF
A, S
.A.,
HU
AR
TE
-PA
MP
LON
A, S
PA
INM
anuf
actu
rer:
LAB
OR
AT
OR
IOS
CIN
FA
, S.A
.,H
UA
RT
E-P
AM
PLO
NA
, SP
AIN
Man
ufac
ture
r:LA
BO
RA
TO
RIO
S C
INF
A, S
.A.,
HU
AR
TE
-PA
MP
LON
A, S
PA
INLA
BO
RA
TO
RIO
S L
ICO
NS
A, S
.A.,
AZ
UQ
UE
CA
DE
HE
NA
RE
SLA
BO
RA
TO
RIO
S L
ICO
NS
A, S
.A.,
AZ
UQ
UE
CA
DE
HE
NA
RE
SLA
BO
RA
TO
RIO
S L
ICO
NS
A,
S.A
., A
ZU
QU
EC
A D
E H
EN
AR
ES
(GU
AD
ALA
JAR
A),
SP
AIN
(GU
AD
ALA
JAR
A),
SP
AIN
(GU
AD
ALA
JAR
A),
SP
AIN
Pac
ker:
LAB
OR
AT
OR
IOS
CIN
FA
, S.A
.,H
UA
RT
E-P
AM
PLO
NA
, SP
AIN
Pac
ker:
LAB
OR
AT
OR
IOS
CIN
FA
, S.A
.,H
UA
RT
E-P
AM
PLO
NA
, SP
AIN
Pac
ker:
LAB
OR
AT
OR
IOS
CIN
FA
, S.A
.,H
UA
RT
E-P
AM
PLO
NA
, SP
AIN
LAB
OR
AT
OR
IOS
LIC
ON
SA
, S.A
.,A
ZU
QU
EC
A D
E H
EN
AR
ES
LAB
OR
AT
OR
IOS
LIC
ON
SA
, S.A
.,A
ZU
QU
EC
A D
E H
EN
AR
ES
LAB
OR
AT
OR
IOS
LIC
ON
SA
,S
.A.,
AZ
UQ
UE
CA
DE
HE
NA
RE
S(G
UA
DA
LAJA
RA
), S
PA
IN(G
UA
DA
LAJA
RA
), S
PA
IN(G
UA
DA
LAJA
RA
), S
PA
INT
EC
HN
IKO
N L
AB
OR
AT
OR
IES
TE
CH
NIK
ON
LA
BO
RA
TO
RIE
ST
EC
HN
IKO
N L
AB
OR
AT
OR
IES
(PT
Y)
LTD
, RO
BE
RT
VIL
LE,
FLO
RID
A, R
SA
(PT
Y)
LTD
, RO
BE
RT
VIL
LE,
FLO
RID
A, R
SA
(PT
Y)
LTD
, RO
BE
RT
VIL
LE,
FLO
RID
A, R
SA
PH
AR
MA
CE
UT
ICA
LP
HA
RM
AC
EU
TIC
AL
EN
TE
RP
RIS
ES
PH
AR
MA
CE
UT
ICA
LE
NT
ER
PR
ISE
S (
PT
Y)
LTD
,N
'DA
BE
NI,
PIN
ELA
ND
S, R
SA
(PT
Y)
LTD
, N'D
AB
EN
I, P
INE
LAN
DS
,R
SA
EN
TE
RP
RIS
ES
(P
TY
) LT
D,
N'D
AB
EN
I, P
INE
LAN
DS
, RS
AS
PE
CP
HA
RM
HO
LDIN
GS
(P
TY
)S
PE
CP
HA
RM
HO
LDIN
GS
(P
TY
)S
PE
CP
HA
RM
HO
LDIN
GS
(P
TY
)LT
D, H
ALF
WA
Y H
OU
SE
,M
IDR
AN
D, R
SA
LTD
, HA
LFW
AY
HO
US
E, M
IDR
AN
D,
RS
ALT
D, H
ALF
WA
Y H
OU
SE
,M
IDR
AN
D, R
SA
Labo
rato
ry: F
PR
C:
LAB
OR
AT
OR
IOS
CIN
FA
, S.A
.,H
UA
RT
E-P
AM
PLO
NA
, SP
AIN
Labo
rato
ry: F
PR
C:
LAB
OR
AT
OR
IOS
CIN
FA
, S.A
.,H
UA
RT
E-P
AM
PLO
NA
, SP
AIN
Labo
rato
ry: F
PR
CLA
BO
RA
TO
RIO
S C
INF
A, S
.A.,
HU
AR
TE
-PA
MP
LON
A, S
PA
INLA
BO
RA
TO
RIO
S L
ICO
NS
A, S
.A.,
AZ
UQ
UE
CA
DE
HE
NA
RE
SLA
BO
RA
TO
RIO
S L
ICO
NS
A, S
.A.,
AZ
UQ
UE
CA
DE
HE
NA
RE
SLA
BO
RA
TO
RIO
S L
ICO
NS
A,
S.A
., A
ZU
QU
EC
A D
E H
EN
AR
ES
(GU
AD
ALA
JAR
A),
SP
AIN
(GU
AD
ALA
JAR
A),
SP
AIN
(GU
AD
ALA
JAR
A),
SP
AIN
LAB
OR
AT
OR
IOS
EC
HE
VA
RN
E,
BA
RC
ELO
NA
, SP
AIN
LAB
OR
AT
OR
IOS
EC
HE
VA
RN
E,
BA
RC
ELO
NA
, SP
AIN
LAB
OR
AT
OR
IOS
EC
HE
VA
RN
E,
BA
RC
ELO
NA
, SP
AIN
CO
NS
ULT
ING
CH
EM
ICA
LC
ON
SU
LTIN
G C
HE
MIC
AL
CO
NS
ULT
ING
CH
EM
ICA
LLA
BO
RA
TO
RIE
S (
PT
Y)
LTD
,A
TLA
SV
ILLE
, BO
KS
BU
RG
, RS
ALA
BO
RA
TO
RIE
S (
PT
Y)
LTD
,A
TLA
SV
ILLE
, BO
KS
BU
RG
, RS
ALA
BO
RA
TO
RIE
S (
PT
Y)
LTD
,A
TLA
SV
ILLE
, BO
KS
BU
RG
, RS
A
FP
RR
:P
HA
RM
A D
YN
AM
ICS
(P
TY
) LT
D,
WE
ST
LAK
E, C
AP
E T
OW
N, R
SA
FP
RR
:P
HA
RM
A D
YN
AM
ICS
(P
TY
) LT
D,
WE
ST
LAK
E, C
AP
E T
OW
N, R
SA
FP
RR
:P
HA
RM
A D
YN
AM
ICS
(P
TY
) LT
D,
WE
ST
LAK
E, C
AP
E T
OW
N, R
SA
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)S
helf-
life:
24 m
onth
s (P
rovi
sion
al)
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2D
ate
of r
egis
trat
ion:
07 J
UN
E 2
012
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2
20 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
43/7
.1.3
/072
0
DY
NA
RB
150
mg
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:IR
BE
SA
RT
AN
150
,0 m
g
1, 2
, 3, 4
, 5, 6
, 7, 8
PH
AR
MA
DY
NA
MIC
S (
PT
Y)
LTD
LAB
OR
AT
OR
IOS
CIN
FA
, S.A
.,H
UA
RT
E-P
AM
PLO
NA
, SP
AIN
LAB
OR
AT
OR
IOS
LIC
ON
SA
, S.A
.,A
ZU
QU
EC
A D
E H
EN
AR
ES
(GU
AD
ALA
JAR
A),
SP
AIN
LAB
OR
AT
OR
IOS
CIN
FA
, S.A
.,H
UA
RT
E-P
AM
PLO
NA
, SP
AIN
LAB
OR
AT
OR
IOS
LIC
ON
SA
, S.A
.,A
ZU
QU
EC
A D
E H
EN
AR
ES
(GU
AD
ALA
JAR
A),
SP
AIN
TE
CH
NIK
ON
LA
BO
RA
TO
RIE
S (
PT
Y)
LTD
, RO
BE
RT
VIL
LE, F
LOR
IDA
, RS
AP
HA
RM
AC
EU
TIC
AL
EN
TE
RP
RIS
ES
(PT
Y)
LTD
, N'D
AB
EN
I, P
INE
LAN
DS
,R
SA
SP
EC
PH
AR
M H
OLD
ING
S (
PT
Y)
LTD
,H
ALF
WA
Y H
OU
SE
, MID
RA
ND
, RS
A
LAB
OR
AT
OR
IOS
CIN
FA
, S.A
.,H
UA
RT
E-P
AM
PLO
NA
, SP
AIN
LAB
OR
AT
OR
IOS
LIC
ON
SA
, S.A
.,A
ZU
QU
EC
A D
E H
EN
AR
ES
(GU
AD
ALA
JAR
A),
SP
AIN
LAB
OR
AT
OR
IOS
EC
HE
VA
RN
E,
BA
RC
ELO
NA
, SP
AIN
CO
NS
ULT
ING
CH
EM
ICA
LLA
BO
RA
TO
RIE
S (
PT
Y)
LTD
,A
TLA
SV
ILLE
, BO
KS
BU
RG
, RS
A
PH
AR
MA
DY
NA
MIC
S (
PT
Y)
LTD
,W
ES
TLA
KE
, CA
PE
TO
WN
, RS
A
24 m
onth
s (P
rovi
sion
al)
07 J
UN
E 2
012
MR
F15
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
43/7
.1.3
/072
1
DY
NA
RB
300
mg
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:IR
BE
SA
RT
AN
300
,0 m
g
1, 2
, 3, 4
, 5, 6
, 7, 8
PH
AR
MA
DY
NA
MIC
S (
PT
Y)
LTD
LAB
OR
AT
OR
IOS
CIN
FA
, S.A
.,H
UA
RT
E-P
AM
PLO
NA
, SP
AIN
LAB
OR
AT
OR
IOS
LIC
ON
SA
, S.A
.,A
ZU
QU
EC
A D
E H
EN
AR
ES
(GU
AD
ALA
JAR
A),
SP
AIN
LAB
OR
AT
OR
IOS
CIN
FA
, S.A
.,H
UA
RT
E-P
AM
PLO
NA
, SP
AIN
LAB
OR
AT
OR
IOS
LIC
ON
SA
, S.A
.,A
ZU
QU
EC
A D
E H
EN
AR
ES
(GU
AD
ALA
JAR
A),
SP
AIN
TE
CH
NIK
ON
LA
BO
RA
TO
RIE
S(P
TY
) LT
D, R
OB
ER
TV
ILLE
,F
LOR
IDA
, RS
AP
HA
RM
AC
EU
TIC
AL
EN
TE
RP
RIS
ES
(PT
Y)
LTD
, N'D
AB
EN
I, P
INE
LAN
DS
,R
SA
SP
EC
PH
AR
M H
OLD
ING
S (
PT
Y)
LTD
, HA
LFW
AY
HO
US
E, M
IDR
AN
D,
RS
A
LAB
OR
AT
OR
IOS
CIN
FA
, S.A
.,H
UA
RT
E-P
AM
PLO
NA
, SP
AIN
LAB
OR
AT
OR
IOS
LIC
ON
SA
, S.A
.,A
ZU
QU
EC
A D
E H
EN
AR
ES
(GU
AD
ALA
JAR
A),
SP
AIN
LAB
OR
AT
OR
IOS
EC
HE
VA
RN
E,
BA
RC
ELO
NA
, SP
AIN
CO
NS
ULT
ING
CH
EM
ICA
LLA
BO
RA
TO
RIE
S (
PT
Y)
LTD
,A
TLA
SV
ILLE
, BO
KS
BU
RG
, RS
A
PH
AR
MA
DY
NA
MIC
S (
PT
Y)
LTD
,W
ES
TLA
KE
, CA
PE
TO
WN
, RS
A
24 m
onth
s (P
rovi
sion
al)
07 J
UN
E 2
012
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
43/2
0.1.
1/10
26
AU
RO
CE
FT
AZ
IDIM
E 2
50 m
g
PO
WD
ER
FO
R IN
JEC
TIO
N
EA
CH
VIA
L C
ON
TA
INS
:C
efta
zidi
me
Pen
tahy
drat
e eq
uiva
lent
to C
efta
zidi
me
250,
0 m
g
1, 2
, 3, 4
, 5, 6
, 7
AU
RO
BIN
DO
PH
AR
MA
(P
TY
) LT
D
AU
RO
BIN
DO
PH
AR
MA
LIM
ITE
D,
UN
IT V
I, P
AT
AN
CH
ER
U M
AN
DA
L,M
ED
AK
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H IN
DIA
AU
RO
BIN
DO
PH
AR
MA
LIM
ITE
D,
UN
IT V
I, P
AT
AN
CH
ER
U M
AN
DA
L,M
ED
AK
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H IN
DIA
AU
RO
BIN
DO
PH
AR
MA
LIM
ITE
D,
UN
IT V
I, P
AT
AN
CH
ER
U M
AN
DA
L,M
ED
AK
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H, I
ND
IAM
& L
LA
BO
RA
TO
RY
SE
RV
ICE
S,
LIM
BR
O B
US
INE
SS
PA
RK
,S
AN
DT
ON
, RS
AK
HU
LULE
KA
NI L
AB
OR
AT
OR
YS
ER
VIC
ES
cc,
CO
VE
NT
RY
PA
RK
,M
IDR
AN
D, R
SA
AU
RO
BIN
DO
PH
AR
MA
(P
TY
) LT
D,
ME
YE
RS
DA
L, J
OH
AN
NE
SB
UR
G,
RS
A
36 m
onth
s
07 J
UN
E 2
012
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 21
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:43
/20.
1.1/
1027
Reg
istr
atio
n nu
mbe
r:43
/20.
1.1/
1028
Reg
istr
atio
n nu
mbe
r:43
/20.
1.1/
1029
Nam
e of
med
icin
e:A
UR
O C
EF
TA
ZID
IME
500
mg
Nam
e of
med
icin
e:A
UR
O C
EF
TA
ZID
IME
1,0
gN
ame
of m
edic
ine:
AU
RO
CE
FT
AZ
IDIM
E 2
,0 g
Dos
age
form
:P
OW
DE
R F
OR
INJE
CT
ION
Dos
age
form
:P
OW
DE
R F
OR
INJE
CT
ION
Dos
age
form
:P
OW
DE
R F
OR
INJE
CT
ION
Act
ive
ingr
edie
nts:
EA
CH
VIA
L C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H V
IAL
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
VIA
L C
ON
TA
INS
:C
efta
zidi
me
Pen
tahy
drat
e eq
uiva
lent
to C
efta
zidi
me
500,
0 m
gC
efta
zidi
me
Pen
tahy
drat
eeq
uiva
lent
to C
efta
zidi
me
1,0
gC
efta
zidi
me
Pen
tahy
drat
eeq
uiva
lent
to C
efta
zidi
me
2,0
g
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
App
lican
t:A
UR
OB
IND
O P
HA
RM
A (
PT
Y)
LTD
App
lican
tA
UR
OB
IND
O P
HA
RM
A (
PT
Y)
App
lican
t:A
UR
OB
IND
O P
HA
RM
A (
PT
Y)
LTD
LTD
Man
ufac
ture
r:A
UR
OB
IND
O P
HA
RM
A L
IMIT
ED
,U
NIT
VI,
PA
TA
NC
HE
RU
MA
ND
AL,
ME
DA
K D
IST
RIC
T, A
ND
HR
AP
RA
DE
SH
, IN
DIA
Man
ufac
ture
r:A
UR
OB
IND
O P
HA
RM
ALI
MIT
ED
, UN
IT V
I,P
AT
AN
CH
ER
U M
AN
DA
L,M
ED
AK
DIS
TR
ICT
, AN
DH
RA
Man
ufac
ture
r:A
UR
OB
IND
O P
HA
RM
ALI
MIT
ED
, UN
IT V
I,P
AT
AN
CH
ER
U M
AN
DA
L,M
ED
AK
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H, I
ND
IAP
RA
DE
SH
, IN
DIA
Pac
ker:
AU
RO
BIN
DO
PH
AR
MA
LIM
ITE
D,
UN
IT V
I, P
AT
AN
CH
ER
U M
AN
DA
L,M
ED
AK
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H, I
ND
IA
Pac
ker:
AU
RO
BIN
DO
PH
AR
MA
LIM
ITE
D, U
NIT
VI,
PA
TA
NC
HE
RU
MA
ND
AL,
ME
DA
K D
IST
RIC
T, A
ND
HR
A
Pac
ker:
AU
RO
BIN
DO
PH
AR
MA
LIM
ITE
D, U
NIT
VI,
PA
TA
NC
HE
RU
MA
ND
AL,
ME
DA
K D
IST
RIC
T, A
ND
HR
AP
RA
DE
SH
, IN
DIA
PR
AD
ES
H, I
ND
IA
Labo
rato
ry: F
PR
C:
AU
RO
BIN
DO
PH
AR
MA
LIM
ITE
D,
UN
IT V
I, P
AT
AN
CH
ER
U M
AN
DA
L,M
ED
AK
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H, I
ND
IA
Labo
rato
ry:
FP
RC
:A
UR
OB
IND
O P
HA
RM
ALI
MIT
ED
, UN
IT V
I,P
AT
AN
CH
ER
U M
AN
DA
L,M
ED
AK
DIS
TR
ICT
, AN
DH
RA
Labo
rato
ry: F
PR
CA
UR
OB
IND
O P
HA
RM
ALI
MIT
ED
, UN
IT V
I,P
AT
AN
CH
ER
U M
AN
DA
L,M
ED
AK
DIS
TR
ICT
, AN
DH
RA
M &
L L
AB
OR
AT
OR
Y S
ER
VIC
ES
,LI
MB
RO
BU
SIN
ES
S P
AR
K,
SA
ND
TO
N, R
SA
PR
AD
ES
H, I
ND
IAM
& L
LA
BO
RA
TO
RY
SE
RV
ICE
S, L
IMB
RO
PR
AD
ES
H, I
ND
IAM
& L
LA
BO
RA
TO
RY
SE
RV
ICE
S, L
IMB
RO
KH
ULU
LEK
AN
I LA
BO
RA
TO
RY
SE
RV
ICE
S c
c, C
OV
EN
TR
Y P
AR
K,
MID
RA
ND
, RS
A
BU
SIN
ES
S P
AR
K, S
AN
DT
ON
,R
SA
KH
ULU
LEK
AN
I LA
BO
RA
TO
RY
BU
SIN
ES
S P
AR
K, S
AN
DT
ON
,R
SA
KH
ULU
LEK
AN
IS
ER
VIC
ES
cc,
CO
VE
NT
RY
PA
RK
, MID
RA
ND
, RS
ALA
BO
RA
TO
RY
SE
RV
ICE
S c
c,C
OV
EN
TR
Y P
AR
K,
MID
RA
ND
, RS
A
FP
RR
:A
UR
OB
IND
O P
HA
RM
A (
PT
Y)
LTD
,M
EY
ER
SD
AL,
JO
HA
NN
ES
BU
RG
,R
SA
FP
RR
:A
UR
OB
IND
O P
HA
RM
A (
PT
Y)
LTD
, ME
YE
RS
DA
L,JO
HA
NN
ES
BU
RG
, RS
A
FP
RR
:A
UR
OB
IND
O P
HA
RM
A (
PT
Y)
LTD
, ME
YE
RS
DA
L,JO
HA
NN
ES
BU
RG
, RS
A
She
lf-lif
e:36
mon
ths
She
lf-lif
e:36
mon
ths
She
lf-lif
e:36
mon
ths
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2D
ate
of r
egis
trat
ion:
07 J
UN
E 2
012
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2
22 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15R
F 1
5
Reg
istr
atio
n nu
mbe
r:43
/20.
1.1/
1035
Reg
istr
atio
n nu
mbe
r:43
/20.
1.1/
1036
Reg
istr
atio
n nu
mbe
r:43
/20.
1.1/
1037
Nam
e of
med
icin
e:A
UR
IZE
F 2
50 m
gN
ame
of m
edic
ine:
AU
RIZ
EF
500
mg
Nam
e of
med
icin
e:A
UR
IZE
F 1
,0 g
Dos
age
form
:P
OW
DE
R F
OR
INJE
CT
ION
Dos
age
form
:P
OW
DE
R F
OR
INJE
CT
ION
Dos
age
form
:P
OW
DE
R F
OR
INJE
CT
ION
Act
ive
ingr
edie
nts:
EA
CH
VIA
L C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H V
IAL
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
VIA
L C
ON
TA
INS
:C
efta
zidi
me
Pen
tahy
drat
eeq
uiva
lent
to C
efta
zidi
me
Cef
tazi
dim
e P
enta
hydr
ate
equi
vale
nt to
Cef
tazi
dim
eC
efta
zidi
me
Pen
tahy
drat
eeq
uiva
lent
to C
efta
zidi
me
250,
0 m
g50
0,0
mg
1,0
gC
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7
App
lican
t:A
UR
OB
IND
O P
HA
RM
A (
PT
Y)
App
lican
tA
UR
OB
IND
O P
HA
RM
A (
PT
Y)
App
lican
t:A
UR
OB
IND
O P
HA
RM
ALT
DLT
D(P
TY
) LT
DM
anuf
actu
rer:
AU
RO
BIN
DO
PH
AR
MA
Man
ufac
ture
r:A
UR
OB
IND
O P
HA
RM
AM
anuf
actu
rer:
AU
RO
BIN
DO
PH
AR
MA
LIM
ITE
D, U
NIT
VI,
PA
TA
NC
HE
RU
MA
ND
AL,
ME
DA
K D
IST
RIC
T, A
ND
HR
A
LIM
ITE
D, U
NIT
VI,
PA
TA
NC
HE
RU
MA
ND
AL,
ME
DA
K D
IST
RIC
T, A
ND
HR
A
LIM
ITE
D, U
NIT
VI,
PA
TA
NC
HE
RU
MA
ND
AL,
ME
DA
K D
IST
RIC
T, A
ND
HR
AP
RA
DE
SH
, IN
DIA
PR
AD
ES
H, I
ND
IAP
RA
DE
SH
, IN
DIA
Pac
ker:
AU
RO
BIN
DO
PH
AR
MA
Pac
ker:
AU
RO
BIN
DO
PH
AR
MA
Pac
ker:
AU
RO
BIN
DO
PH
AR
MA
LIM
ITE
D, U
NIT
VI,
PA
TA
NC
HE
RU
MA
ND
AL,
ME
DA
K D
IST
RIC
T, A
ND
HR
AP
RA
DE
SH
, IN
DIA
LIM
ITE
D, U
NIT
VI,
PA
TA
NC
HE
RU
MA
ND
AL,
ME
DA
K D
IST
RIC
T, A
ND
HR
AP
RA
DE
SH
, IN
DIA
LIM
ITE
D, U
NIT
VI,
PA
TA
NC
HE
RU
MA
ND
AL,
ME
DA
K D
IST
RIC
T,
AN
DH
RA
PR
AD
ES
H, I
ND
IALa
bora
tory
: FP
RC
:A
UR
OB
IND
O P
HA
RM
ALa
bora
tory
:F
PR
C:
AU
RO
BIN
DO
PH
AR
MA
Labo
rato
ry: F
PR
CA
UR
OB
IND
O P
HA
RM
ALI
MIT
ED
, UN
IT V
I,P
AT
AN
CH
ER
U M
AN
DA
L,M
ED
AK
DIS
TR
ICT
, AN
DH
RA
LIM
ITE
D, U
NIT
VI,
PA
TA
NC
HE
RU
MA
ND
AL,
ME
DA
K D
IST
RIC
T, A
ND
HR
A
LIM
ITE
D, U
NIT
VI,
PA
TA
NC
HE
RU
MA
ND
AL,
ME
DA
K D
IST
RIC
T, A
ND
HR
AP
RA
DE
SH
, IN
DIA
PR
AD
ES
H, I
ND
IAP
RA
DE
SH
, IN
DIA
M &
L L
AB
OR
AT
OR
YM
& L
LA
BO
RA
TO
RY
M &
L L
AB
OR
AT
OR
YS
ER
VIC
ES
, LIM
BR
O B
US
INE
SS
SE
RV
ICE
S, L
IMB
RO
SE
RV
ICE
S, L
IMB
RO
PA
RK
, SA
ND
TO
N, R
SA
KH
ULU
LEK
AN
I LA
BO
RA
TO
RY
BU
SIN
ES
S P
AR
K, S
AN
DT
ON
,R
SA
BU
SIN
ES
S P
AR
K,
SA
ND
TO
N, R
SA
SE
RV
ICE
S c
c, C
OV
EN
TR
YK
HU
LULE
KA
NI L
AB
OR
AT
OR
YK
HU
LULE
KA
NI
PA
RK
, MID
RA
ND
, RS
AS
ER
VIC
ES
cc,
CO
VE
NT
RY
PA
RK
, MID
RA
ND
, RS
ALA
BO
RA
TO
RY
SE
RV
ICE
Scc
, CO
VE
NT
RY
PA
RK
,M
IDR
AN
D, R
SA
FP
RR
:A
UR
OB
IND
O P
HA
RM
A (
PT
Y)
FP
RR
:A
UR
OB
IND
O P
HA
RM
A (
PT
Y)
FP
RR
:A
UR
OB
IND
O P
HA
RM
ALT
D, M
EY
ER
SD
AL,
JOH
AN
NE
SB
UR
G, R
SA
LTD
, ME
YE
RS
DA
L,JO
HA
NN
ES
BU
RG
, RS
A(P
TY
) LT
D, M
EY
ER
SD
AL,
JOH
AN
NE
SB
UR
G, R
SA
She
lf-lif
e:36
mon
ths
She
lf-lif
e:36
mon
ths
She
lf-lif
e:36
mon
ths
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2D
ate
of r
egis
trat
ion:
07 J
UN
E 2
012
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 23
MR
F 1
5M
RF
15IF
15
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
43/2
0.1.
1/10
38
AU
RIZ
EF
2,0
g
PO
WD
ER
FO
R IN
JEC
TIO
N
EA
CH
VIA
L C
ON
TA
INS
:C
efta
zidi
me
Pen
tahy
drat
e eq
uiva
lent
toC
efta
zidi
me
2,0
g
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
44/3
0.1/
0039
ME
NC
EV
AX
AC
WI3
5Y M
ULT
IDO
SE
INJE
CT
ION
EA
CH
0,5
ml D
OS
E C
ON
TA
INS
:N
EIS
SE
RIA
ME
NIN
GIT
IDIS
GR
OU
P A
50,0
pg
NE
ISS
ER
IA M
EN
ING
ITID
IS G
RO
UP
C50
,0 p
gN
EIS
SE
RIA
ME
NIN
GIT
IDIS
GR
OU
P Y
50,0
pg
NE
ISS
ER
IA M
EN
ING
ITID
IS G
RO
UP
W13
550
,0 p
g
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
44/1
0.2.
2/00
59
MO
NT
E-A
IR 4
mg
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:M
ON
TE
LUK
AS
T S
OD
IUM
EQ
UIV
ALE
NT
TO
MO
NT
ELU
KA
ST
4,0
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
App
lican
t:A
UR
OB
IND
O P
HA
RM
A (
PT
Y)
LTD
App
lican
t:G
LAX
OS
MIT
HK
LIN
E S
OU
TH
AF
RIC
AA
pplic
ant:
MS
D (
PT
Y)
LTD
(PT
Y)
LTD
Man
ufac
ture
r:A
UR
OB
IND
O P
HA
RM
A L
IMIT
ED
, UN
IT V
I,P
AT
AN
CH
ER
U M
AN
DA
L, M
ED
AK
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H, I
ND
IA
Man
ufac
ture
r:G
LAX
OS
MIT
HK
LIN
E B
IOLO
GIC
ALS
S.A
.,R
IXE
NS
AR
T, B
ELG
IUM
GLA
XO
SM
ITH
KLI
NE
BIO
LOG
ICA
LS,
DR
ES
DE
N, G
ER
MA
NY
Man
ufac
ture
r:M
ER
CK
SH
AR
P &
DO
HM
E,
CR
AM
LIN
GT
ON
,N
OR
TH
UM
BE
RLA
ND
, UK
Pac
ker:
AU
RO
BIN
DO
PH
AR
MA
LIM
ITE
D, U
NIT
VI,
PA
TA
NC
HE
RU
MA
ND
AL,
ME
DA
KD
IST
RIC
T, A
ND
HR
A P
RA
DE
SH
, IN
DIA
Pac
ker:
GLA
XO
SM
ITH
KLI
NE
BIO
LOG
ICA
LS S
.A.,
RIX
EN
SA
RT
, BE
LGIU
MG
LAX
OS
MIT
HK
LIN
E B
IOLO
GIC
ALS
S.A
.,W
AV
RE
, BE
LGIU
M
Pac
ker:
ME
RC
K S
HA
RP
& D
OH
ME
,C
RA
MLI
NG
TO
N,
NO
RT
HU
MB
ER
LAN
D, U
KM
MD
HA
AR
LEM
, HA
AR
LEM
, TH
EG
LAX
OS
MIT
HK
LIN
E B
IOLO
GIC
ALS
,D
RE
SD
EN
, GE
RM
AN
YG
LAX
OS
MIT
HK
LIN
E, E
PP
ING
, CA
PE
NE
TH
ER
LAN
DS
MS
D, H
ALF
WA
Y H
OU
SE
, MID
RA
ND
,R
SA
TO
WN
Labo
rato
ry: F
PR
C:
AU
RO
BIN
DO
PH
AR
MA
LIM
ITE
D, U
NIT
VI,
PA
TA
NC
HE
RU
MA
ND
AL,
ME
DA
KD
IST
RIC
T, A
ND
HR
A P
RA
DE
SH
, IN
DIA
Labo
rato
ryF
PR
C:
GLA
XO
SM
ITH
KLI
NE
BIO
LOG
ICA
LS S
.A.,
RIX
EN
SA
RT
, BE
LGIU
MLa
bora
tory
: FP
RC
ME
RC
K S
HA
RP
& D
OH
ME
,C
RA
MLI
NG
TO
N,
NO
RT
HU
MB
ER
LAN
D, U
KM
& L
LA
BO
RA
TO
RY
SE
RV
ICE
S, L
IMB
RO
MM
D H
AA
RLE
M, H
AA
RLE
M, T
HE
BU
SIN
ES
S P
AR
K, S
AN
DT
ON
, RS
AN
ET
HE
RLA
ND
SK
HU
LULE
KA
NI L
AB
OR
AT
OR
Y S
ER
VIC
ES
cc, C
OV
EN
TR
Y P
AR
K M
IDR
AN
D, R
SA
FP
RR
:A
UR
OB
IND
O P
HA
RM
A (
PT
Y)
LTD
,M
EY
ER
SD
AL,
JO
HA
NN
ES
BU
RG
, RS
AF
PR
C/F
PR
R:
GLA
XO
SM
ITH
KLI
NE
, EP
PIN
G, C
AP
ET
OW
NF
PR
C/F
PR
R:
MS
D, H
ALF
WA
Y H
OU
SE
, MID
RA
ND
,R
SA
She
lf-lif
e:36
mon
ths
She
lf-lif
e:36
mon
ths
at 2
-8
°C (
Lyop
hilis
ed v
acci
ne)
hour
s at
2 -
8 °C
(R
econ
stitu
ted
vacc
ine)
She
lf-lif
e:24
mon
ths
60 m
onth
s at
2 -
25
°C (
Dilu
ent)
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2D
ate
of r
egis
trat
ion:
07 J
UN
E 2
012
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2
24 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15A
RF
15
Reg
istr
atio
n nu
mbe
r:44
/10.
2.2/
0060
Reg
istr
atio
n nu
mbe
r44
/10.
2.2/
0061
Reg
istr
atio
n nu
mbe
r:44
/10.
2.2/
0062
Nam
e of
med
icin
e:M
ON
TE
-AIR
5 m
gN
ame
of m
edic
ine:
MO
NT
E-A
IR 1
0 m
gN
ame
of m
edic
ine:
MO
NT
E-A
IR S
PR
INK
LES
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Dos
age
form
:G
RA
NU
LES
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H T
AB
LET
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
SA
CH
ET
OF
MO
NT
ELU
KA
ST
SO
DIU
MM
ON
TE
LUK
AS
T S
OD
IUM
GR
AN
ULE
S C
ON
TA
INS
:E
QU
IVA
LEN
T T
OE
QU
IVA
LEN
T T
OM
ON
TE
LUK
AS
T S
OD
IUM
MO
NT
ELU
KA
ST
5,0
mg
MO
NT
ELU
KA
ST
10,
0 m
gE
QU
IVA
LEN
T T
OM
ON
TE
LUK
AS
T 4
,0 m
gC
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7
App
lican
t:M
SD
(P
TY
) LT
DA
pplic
ant:
MS
D (
PT
Y)
LTD
App
lican
t:M
SD
(P
TY
) LT
DM
anuf
actu
rer
ME
RC
K S
HA
RP
& D
OH
ME
,C
RA
MLI
NG
TO
N,
NO
RT
HU
MB
ER
LAN
D, U
K
Man
ufac
ture
rM
ER
CK
SH
AR
P &
DO
HM
E,
CR
AM
LIN
GT
ON
,N
OR
TH
UM
BE
RLA
ND
, UK
Man
ufac
ture
rM
ER
CK
MA
NU
FA
CT
UR
ING
DIV
ISIO
N, W
ES
T P
OIN
T,
PE
NN
SY
LVA
NIA
, US
AP
acke
r:M
ER
CK
SH
AR
P &
DO
HM
E,
CR
AM
LIN
GT
ON
,N
OR
TH
UM
BE
RLA
ND
, UK
Pac
ker
ME
RC
K S
HA
RP
& D
OH
ME
,C
RA
MLI
NG
TO
N,
NO
RT
HU
MB
ER
LAN
D, U
K
Pac
ker
ME
RC
K M
AN
UF
AC
TU
RIN
GD
IVIS
ION
, WIL
SO
N, N
OR
TH
CA
RO
LIN
A, U
SA
MM
D H
AA
RLE
M, H
AA
RLE
M,
TH
E N
ET
HE
RLA
ND
SM
SD
, HA
LFW
AY
HO
US
E,
MID
RA
ND
, RS
A
MM
D H
AA
RLE
M, H
AA
RLE
M,
TH
E N
ET
HE
RLA
ND
SM
SD
, HA
LFW
AY
HO
US
E,
MID
RA
ND
, RS
A
AN
DE
RS
ON
PA
CK
AG
ING
INC
, RO
CK
FO
RD
, ILL
INO
IS,
US
AM
MD
HA
AR
LEM
, HA
AR
LEM
,T
HE
NE
TH
ER
LAN
DS
MS
D, H
ALF
WA
Y H
OU
SE
,M
IDR
AN
D, R
SA
Labo
rato
ry: F
PR
C:
ME
RC
K S
HA
RP
& D
OH
ME
,C
RA
MLI
NG
TO
N,
NO
RT
HU
MB
ER
LAN
D, U
K
Labo
rato
ryF
PR
C:
ME
RC
K S
HA
RP
& D
OH
ME
,C
RA
MLI
NG
TO
N,
NO
RT
HU
MB
ER
LAN
D, U
K
Labo
rato
ry: F
PR
CM
ER
CK
MA
NU
FA
CT
UR
ING
DIV
ISIO
N, W
ES
T P
OIN
T,
PE
NN
SY
LVA
NIA
, US
AM
MD
HA
AR
LEM
, HA
AR
LEM
,T
HE
NE
TH
ER
LAN
DS
MM
D H
AA
RLE
M, H
AA
RLE
M,
TH
E N
ET
HE
RLA
ND
SM
ER
CK
MA
NU
FA
CT
UR
ING
DIV
ISIO
N, W
ILS
ON
, NO
RT
HC
AR
OLI
NA
, US
AM
MD
HA
AR
LEM
, HA
AR
LEM
,T
HE
NE
TH
ER
LAN
DS
FP
RR
:M
SD
, HA
LFW
AY
HO
US
E,
MID
RA
ND
, RS
AF
PR
R:
MS
D, H
ALF
WA
Y H
OU
SE
,M
IDR
AN
D, R
SA
FP
RC
/FP
RR
:M
SD
, HA
LFW
AY
HO
US
E,
MID
RA
ND
, RS
A
She
lf-lif
e:24
mon
ths
She
lf-lif
e:24
mon
ths
She
lf-lif
e:24
mon
ths
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2D
ate
of r
egis
trat
ion:
07 J
UN
E 2
012
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 25
201166—C
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:44
/10.
2.1/
0544
Reg
istr
atio
n nu
mbe
r:44
/10.
2.2/
0791
Reg
istr
atio
n nu
mbe
r:44
/10.
2.2/
0792
Nam
e of
med
icin
e:O
NB
RE
Z B
RE
EZ
HA
LER
150
pg
Nam
e of
med
icin
e:M
ON
TE
LUK
AS
T Z
YD
US
10
mg
Nam
e of
med
icin
e:LU
MO
NT
10
mg
Dos
age
form
:D
RY
PO
WD
ER
INH
ALA
TIO
ND
osag
e fo
rm:
TA
BLE
TD
osag
e fo
rm:
TA
BLE
TC
AP
SU
LES
Act
ive
ingr
edie
nts:
EA
CH
CA
PS
ULE
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H T
AB
LET
CO
NT
AIN
S:
IND
AC
AT
ER
OL
MA
LEA
TE
MO
NT
ELU
KA
ST
SO
DIU
MM
ON
TE
LUK
AS
T S
OD
IUM
EQ
UIV
ALE
NT
TO
EQ
UIV
ALE
NT
TO
EQ
UIV
ALE
NT
TO
IND
AC
AT
ER
OL
150,
0 pg
MO
NT
ELU
KA
ST
10,0
mg
MO
NT
ELU
KA
ST
10,0
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7, 8
App
lican
t:N
OV
AR
TIS
SA
(P
TY
) LT
DA
pplic
ant:
ZY
DU
S H
EA
LTH
CA
RE
(P
TY
) LT
DA
pplic
ant:
ZY
DU
S H
EA
LTH
CA
RE
(P
TY
)LT
D
Man
ufac
ture
r:N
OV
AR
TIS
PH
AR
MA
ST
EIN
AG
,S
TE
IN, S
WIT
ZE
RLA
ND
Man
ufac
ture
r:Z
YD
US
CA
DIL
A H
EA
LTH
CA
RE
LT
D,
MO
RA
IYA
, SA
NA
ND
, AH
ME
DA
BA
D,
IND
IA
Man
ufac
ture
r:Z
YD
US
CA
DIL
A H
EA
LTH
CA
RE
LTD
, MO
RA
IYA
, SA
NA
ND
,A
HM
ED
AB
AD
, IN
DIA
Pac
ker:
NO
VA
RT
IS P
HA
RM
A S
TE
IN A
G,
ST
EIN
, SW
ITZ
ER
LAN
DA
LLP
AC
K A
G, R
EIN
AC
H,
SW
ITZ
ER
LAN
D
Pac
ker:
ZY
DU
S C
AD
ILA
HE
ALT
HC
AR
E L
TD
,M
OR
AIY
A, S
AN
AN
D, A
HM
ED
AB
AD
,IN
DIA
Pac
ker:
ZY
DU
S C
AD
ILA
HE
ALT
HC
AR
ELT
D, M
OR
AIY
A, S
AN
AN
D,
AH
ME
DA
BA
D, I
ND
IA
KO
NA
PH
AR
MA
AG
, PR
AT
TE
LN,
SW
ITZ
ER
LAN
DN
OV
AR
TIS
PH
AR
MA
Gm
bH,
WE
HR
/BA
DE
N, G
ER
MA
NY
NO
VA
RT
IS S
A (
PT
Y)
LTD
,S
PA
RT
AN
, KE
MP
TO
N P
AR
K, R
SA
IVE
RS
-LE
E A
G, B
UR
GD
OR
F,
SW
ITZ
ER
LAN
D
Labo
rato
ry: F
PR
C:
NO
VA
RT
IS P
HA
RM
A S
TE
IN A
G,
ST
EIN
, SW
ITZ
ER
LAN
DN
OV
AR
TIS
PH
AR
MA
NA
LYT
ICA
SA
,LO
CA
RN
O, S
WIT
ZE
RLA
ND
Labo
rato
ry: F
PR
C:
ZY
DU
S C
AD
ILA
HE
ALT
HC
AR
E L
TD
,M
OR
AIY
A, S
AN
AN
D, A
HM
ED
AB
AD
,IN
DIA
RE
SE
AR
CH
INS
TIT
UT
E F
OR
Labo
rato
ry: F
PR
CZ
YD
US
CA
DIL
A H
EA
LTH
CA
RE
LTD
, MO
RA
IYA
, SA
NA
ND
,A
HM
ED
AB
AD
, IN
DIA
RE
SE
AR
CH
INS
TIT
UT
E F
OR
NO
VA
RT
IS S
A (
PT
Y)
LTD
,S
PA
RT
AN
, KE
MP
TO
N P
AR
K, R
SA
M&
L LA
BO
RA
TO
RY
SE
RC
ICE
S
IND
US
TR
IAL
PH
AR
MA
CY
, NO
RT
H-
WE
ST
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
IND
US
TR
IAL
PH
AR
MA
CY
,N
OR
TH
-WE
ST
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
(PT
Y)
LTD
, LIM
BR
O B
US
INE
SS
INS
TIT
UT
E F
OR
INS
TIT
UT
E F
OR
PA
RK
, SA
ND
TO
N, R
SA
PH
AR
MA
CE
UT
ICA
L S
ER
VIC
ES
,S
ILV
ER
TO
ND
ALE
, PR
ET
OR
IA, R
SA
PH
AR
MA
CE
UT
ICA
L S
ER
VIC
ES
,S
ILV
ER
TO
ND
ALE
, PR
ET
OR
IA,
RS
A
FP
RR
:N
OV
AR
TIS
SA
(P
TY
) LT
D,
SP
AR
TA
N, K
EM
PT
ON
PA
RK
, RS
AF
PR
C/ F
PR
R:
ZY
DU
S H
EA
LHC
AR
E (
PT
Y)
LTD
,V
AN
DE
R H
OF
F P
AR
K,
PO
TC
HE
FS
TR
OO
M, R
SA
FP
RC
/FP
RR
:Z
YD
US
HE
ALH
CA
RE
(P
TY
) LT
D,
VA
N D
ER
HO
FF
PA
RK
,P
OT
CH
EF
ST
RO
OM
, RS
A
She
lf-lif
e:24
mon
ths
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)S
helf-
life:
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2D
ate
of r
egis
trat
ion:
07 J
UN
E 2
012
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2
26 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
152F
15
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
44/1
0.2.
2/08
21
MO
NT
ELU
KA
ST
ZY
DU
S 4
mg
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:M
ON
TE
LUK
AS
T S
OD
IUM
EQ
UIV
ALE
NT
TO
MO
NT
ELU
KA
ST
4,0
mg
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
44/1
0.2.
2/08
22
MO
NT
ELU
KA
ST
ZY
DU
S 5
mg
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:M
ON
TE
LUK
AS
T S
OD
IUM
EQ
UIV
ALE
NT
TO
MO
NT
ELU
KA
ST
5,0
mg
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
44/1
0.2.
2/08
23
LUM
ON
T 4
mg
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:M
ON
TE
LUK
AS
T S
OD
IUM
EQ
UIV
ALE
NT
TO
MO
NT
ELU
KA
ST
4,0
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7, 8
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8A
pplic
ant:
ZY
DU
S H
EA
LTH
CA
RE
(P
TY
)A
pplic
ant:
ZY
DU
S H
EA
LTH
CA
RE
(P
TY
)A
pplic
ant:
ZY
DU
S H
EA
LTH
CA
RE
(P
TY
)LT
DLT
DLT
D
Man
ufac
ture
r:Z
YD
US
CA
DIL
A H
EA
LTH
CA
RE
Man
ufac
ture
r.Z
YD
US
CA
DIL
A H
EA
LTH
CA
RE
Man
ufac
ture
r:Z
YD
US
CA
DIL
ALT
D, M
OR
AIY
A, S
AN
AN
D,
AH
ME
DA
BA
D, I
ND
IALT
D, M
OR
AIY
A, S
AN
AN
D,
AH
ME
DA
BA
D, I
ND
IAH
EA
LTH
CA
RE
LT
D,
MO
RA
IYA
, SA
NA
ND
,A
HM
ED
AB
AD
, IN
DIA
Pac
ker:
ZY
DU
S C
AD
ILA
HE
ALT
HC
AR
EP
acke
r:Z
YD
US
CA
DIL
A H
EA
LTH
CA
RE
Pac
ker
ZY
DU
S C
AD
ILA
LTD
, MO
RA
IYA
, SA
NA
ND
,A
HM
ED
AB
AD
, IN
DIA
LTD
, MO
RA
IYA
, SA
NA
ND
,A
HM
ED
AB
AD
, IN
DIA
HE
ALT
HC
AR
E L
TD
,M
OR
AIY
A, S
AN
AN
D,
AH
ME
DA
BA
D, I
ND
IALa
bora
tory
: FP
RC
:Z
YD
US
CA
DIL
A H
EA
LTH
CA
RE
Labo
rato
ry:
FP
RC
:Z
YD
US
CA
DIL
A H
EA
LTH
CA
RE
Labo
rato
ry: F
PR
CZ
YD
US
CA
DIL
ALT
D, M
OR
AIY
A, S
AN
AN
D,
AH
ME
DA
BA
D, I
ND
IAR
ES
EA
RC
H IN
ST
ITU
TE
FO
R
LTD
, MO
RA
IYA
, SA
NA
ND
,A
HM
ED
AB
AD
, IN
DIA
RE
SE
AR
CH
INS
TIT
UT
E F
OR
HE
ALT
HC
AR
E L
TD
,M
OR
AIY
A, S
AN
AN
D,
AH
ME
DA
BA
D, I
ND
IAIN
DU
ST
RIA
L P
HA
RM
AC
Y,
NO
RT
H-W
ES
T U
NIV
ER
SIT
Y,
PO
TC
HE
FS
TR
OO
M
IND
US
TR
IAL
PH
AR
MA
CY
,N
OR
TH
-WE
ST
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
RE
SE
AR
CH
INS
TIT
UT
EF
OR
IND
US
TR
IAL
PH
AR
MA
CY
, NO
RT
H-W
ES
TIN
ST
ITU
TE
FO
RP
HA
RM
AC
EU
TIC
AL
SE
RV
ICE
S,
SIL
VE
RT
ON
DA
LE, P
RE
TO
RIA
,R
SA
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
LS
ER
VIC
ES
, SIL
VE
RT
ON
DA
LE,
PR
ET
OR
IA, R
SA
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
LS
ER
VIC
ES
,S
ILV
ER
TO
ND
ALE
,P
RE
TO
RIA
, RS
AF
PR
C/F
PR
R:
ZY
DU
S H
EA
LHC
AR
E (
PT
Y)
FP
RC
/FP
RR
:Z
YD
US
HE
ALH
CA
RE
(P
TY
)F
PR
C/F
PR
R:
ZY
DU
S H
EA
LHC
AR
E (
PT
Y)
LTD
, VA
N D
ER
HO
FF
PA
RK
,P
OT
CH
EF
ST
RO
OM
, RS
ALT
D, V
AN
DE
R H
OF
F P
AR
K,
PO
TC
HE
FS
TR
OO
M, R
SA
LTD
, VA
N D
ER
HO
FF
PA
RK
,P
OT
CH
EF
ST
RO
OM
, RS
A
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)S
helf-
life:
24 m
onth
s (P
rovi
sion
al)
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)D
ate
of r
egis
trat
ion:
07 J
UN
E 2
012
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2D
ate
of r
egis
trat
ion:
07 J
UN
E 2
012
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 27
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C:
44/1
0.2.
2/08
24
LUM
ON
T 5
mg
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:M
ON
TE
LUK
AS
T S
OD
IUM
EQ
UIV
ALE
NT
TO
MO
NT
ELU
KA
ST
5,0
mg
1, 2
, 3, 4
, 5, 6
, 7, 8
ZY
DU
S H
EA
LTH
CA
RE
(P
TY
) LT
D
ZY
DU
S C
AD
ILA
HE
ALT
HC
AR
E L
TD
,M
OR
AIY
A, S
AN
AN
D, A
HM
ED
AB
AD
, IN
DIA
ZY
DU
S C
AD
ILA
HE
ALT
HC
AR
E L
TD
,M
OR
AIY
A, S
AN
AN
D, A
HM
ED
AB
AD
, IN
DIA
ZY
DU
S C
AD
ILA
HE
ALT
HC
AR
E L
TD
,M
OR
AIY
A, S
AN
AN
D, A
HM
ED
AB
AD
, IN
DIA
RE
SE
AR
CH
INS
TIT
UT
E F
OR
IND
US
TR
IAL
PH
AR
MA
CY
, NO
RT
H-W
ES
T U
NIV
ER
SIT
Y,
PO
TC
HE
FS
TR
OO
MIN
ST
ITU
TE
FO
R P
HA
RM
AC
EU
TIC
AL
SE
RV
ICE
S, S
ILV
ER
TO
ND
ALE
, PR
ET
OR
IA,
RS
A
FP
RC
/FP
RR
:Z
YD
US
HE
ALH
CA
RE
(P
TY
) LT
D, V
AN
DE
RH
OF
F P
AR
K, P
OT
CH
EF
ST
RO
OM
, RS
A
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2
MR
F15
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
2F 1
5
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
44/7
.1.3
/085
7
TV
VY
NS
TA
40/
5 m
g T
AB
LET
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:T
ELM
ISA
RT
AN
40,0
mg
AM
LOD
IPIN
E B
ES
YLA
TE
EQ
UIV
ALE
NT
TO
AM
LOD
IPIN
E5,
0 m
g
1, 2
, 3, 4
, 5, 6
, 7, 8
ING
ELH
EIM
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
LTD
BO
EH
RIN
GE
R IN
GE
LHE
IM P
HA
RM
AG
mbH
& C
O. K
G, I
NG
ELH
EIM
AM
RH
EIN
,G
ER
MA
NY
CIP
LA L
IMIT
ED
(U
nit I
V),
VE
RN
A, G
OA
,IN
DIA
BO
EH
RIN
GE
R IN
GE
LHE
IM P
HA
RM
AG
mbH
& C
O. K
G, I
NG
ELH
EIM
AM
RH
EIN
,G
ER
MA
NY
CIP
LA L
IMIT
ED
(U
nit I
V),
VE
RN
A, G
OA
,IN
DIA
BO
EH
RIN
GE
R IN
GE
LHE
IM P
HA
RM
AG
mbH
& C
O. K
G, I
NG
ELH
EIM
AM
RH
EIN
,G
ER
MA
NY
CIP
LA L
IMIT
ED
(U
nit I
V),
VE
RN
A, G
OA
,IN
DIA
PH
AS
T G
mbH
, HO
MB
UR
G/S
AA
R,
GE
RM
AN
YA
&M
ST
AB
TE
ST
, MA
INZ
, GE
RM
AN
YLA
BO
R L
+ S
AG
, BA
D B
OC
KLE
T-
GR
OS
SE
NB
RA
CH
, GE
RM
AN
YW
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
LTD
, WA
LTLO
O, P
RE
TO
RIA
, RS
AR
ES
EA
RC
H IN
ST
ITU
TE
FO
R IN
DU
ST
RIA
LP
HA
RM
AC
Y, N
OR
TH
-WE
ST
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
, RS
A
ING
ELH
EIM
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
LTD
, RA
ND
BU
RG
, RS
A
24 m
onth
s (P
rovi
sion
al)
07 J
UN
E 2
012
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C
44/7
.1.3
/085
8
TW
YN
ST
A 4
0/10
mg
TA
BLE
T
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:T
ELM
ISA
RT
AN
40,0
mg
AM
LOD
IPIN
E B
ES
YLA
TE
EQ
UIV
ALE
NT
TO
AM
LOD
IPIN
E10
,0 m
g
1, 2
, 3, 4
, 5, 6
, 7, 8
ING
ELH
EIM
PH
AR
MA
CE
UT
ICA
LS(P
TY
) LT
D
BO
EH
RIN
GE
R IN
GE
LHE
IM P
HA
RM
AG
mbH
& C
O. K
G, I
NG
ELH
EIM
AM
RH
EIN
, GE
RM
AN
YC
IPLA
LIM
ITE
D (
Uni
t IV
), V
ER
NA
,G
OA
, IN
DIA
BO
EH
RIN
GE
R IN
GE
LHE
IM P
HA
RM
AG
mbH
& C
O. K
G, I
NG
ELH
EIM
AM
RH
EIN
, GE
RM
AN
YC
IPLA
LIM
ITE
D (
Uni
t IV
), V
ER
NA
,G
OA
, IN
DIA
BO
EH
RIN
GE
R IN
GE
LHE
IM P
HA
RM
AG
mbH
& C
O. K
G, I
NG
ELH
EIM
AM
RH
EIN
, GE
RM
AN
YC
IPLA
LIM
ITE
D (
Uni
t IV
), V
ER
NA
,G
OA
, IN
DIA
PH
AS
T G
mbH
, HO
MB
UR
G/S
AA
R,
GE
RM
AN
YA
&M
ST
AB
TE
ST
, MA
INZ
, GE
RM
AN
YLA
BO
R L
+ S
AG
, BA
D B
OC
KLE
T-
GR
OS
SE
NB
RA
CH
, GE
RM
AN
YW
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LS(P
TY
) LT
D, W
ALT
LOO
, PR
ET
OR
IA,
RS
AR
ES
EA
RC
H IN
ST
ITU
TE
FO
RIN
DU
ST
RIA
L P
HA
RM
AC
Y, N
OR
TH
-W
ES
T U
NIV
ER
SIT
Y,
PO
TC
HE
FS
TR
OO
M, R
SA
FP
RR
:IN
GE
LHE
IM P
HA
RM
AC
EU
TIC
ALS
(PT
Y)
LTD
, RA
ND
BU
RG
, RS
A
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2
28 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C:
FP
RR
:
She
lf-lif
e:
44/7
.1.3
/085
9
TW
YN
ST
A 8
0/5
mg
TA
BLE
T
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:T
ELM
ISA
RT
AN
80,0
mg
AM
LOD
IPIN
E B
ES
YLA
TE
EQ
UIV
ALE
NT
TO
AM
LOD
IPIN
E5,
0 m
g
1, 2
, 3, 4
, 5, 6
, 7, 8
ING
ELH
EIM
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
LTD
BO
EH
RIN
GE
R IN
GE
LHE
IM P
HA
RM
AG
mbH
& C
O. K
G, I
NG
ELH
EIM
AM
RH
EIN
,G
ER
MA
NY
CIP
LA L
IMIT
ED
(U
nit I
V),
VE
RN
A, G
OA
,IN
DIA
BO
EH
RIN
GE
R IN
GE
LHE
IM P
HA
RM
AG
mbH
& C
O. K
G, I
NG
ELH
EIM
AM
RH
EIN
,G
ER
MA
NY
CIP
LA L
IMIT
ED
(U
nit I
V),
VE
RN
A, G
OA
,IN
DIA
BO
EH
RIN
GE
R IN
GE
LHE
IM P
HA
RM
AG
mbH
& C
O. K
G, I
NG
ELH
EIM
AM
RH
EIN
,G
ER
MA
NY
CIP
LA L
IMIT
ED
(U
nit I
V),
VE
RN
A, G
OA
,IN
DIA
PH
AS
T G
mbH
, HO
MB
UR
G/S
AA
R,
GE
RM
AN
YA
&M
ST
AB
TE
ST
, MA
INZ
, GE
RM
AN
YLA
BO
R L
+ S
AG
, BA
D B
OC
KLE
T-
GR
OS
SE
NB
RA
CH
, GE
RM
AN
YW
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
LTD
, WA
LTLO
O, P
RE
TO
RIA
, RS
AR
ES
EA
RC
H IN
ST
ITU
TE
FO
R IN
DU
ST
RIA
LP
HA
RM
AC
Y, N
OR
TH
-WE
ST
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
, RS
A
ING
ELH
EIM
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
LTD
, RA
ND
BU
RG
, RS
A
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istr
atio
n:07
JU
NE
201
2
MR
F15
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
44/7
.1.3
/086
0
1WY
NS
TA
80/
10 m
g T
AB
LET
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:T
ELM
ISA
RT
AN
80,0
mg
AM
LOD
IPIN
E B
ES
YLA
TE
EQ
UIV
ALE
NT
TO
AM
LOD
IPIN
E10
,0 m
g
1, 2
, 3, 4
, 5, 6
, 7, 8
ING
ELH
EIM
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
LTD
BO
EH
RIN
GE
R IN
GE
LHE
IM P
HA
RM
AG
mbH
& C
O. K
G, I
NG
ELH
EIM
AM
RH
EIN
,G
ER
MA
NY
CIP
LA L
IMIT
ED
(U
nit I
V),
VE
RN
A, G
OA
,IN
DIA
BO
EH
RIN
GE
R IN
GE
LHE
IM P
HA
RM
AG
mbH
& C
O. K
G, I
NG
ELH
EIM
AM
RH
EIN
,G
ER
MA
NY
CIP
LA L
IMIT
ED
(U
nit I
V),
VE
RN
A, G
OA
,IN
DIA
BO
EH
RIN
GE
R IN
GE
LHE
IM P
HA
RM
AG
mbH
& C
O. K
G, I
NG
ELH
EIM
AM
RH
EIN
,G
ER
MA
NY
CIP
LA L
IMIT
ED
(U
nit I
V),
VE
RN
A, G
OA
,IN
DIA
PH
AS
T G
mbH
, HO
MB
UR
G/S
AA
R,
GE
RM
AN
YA
&M
ST
AB
TE
ST
, MA
INZ
, GE
RM
AN
YLA
BO
R L
+ S
AG
, BA
D B
OC
KLE
T-
GR
OS
SE
NB
RA
CH
, GE
RM
AN
YW
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
LTD
, WA
LTLO
O, P
RE
TO
RIA
, RS
AR
ES
EA
RC
H IN
ST
ITU
TE
FO
R IN
DU
ST
RIA
LP
HA
RM
AC
Y, N
OR
TH
-WE
ST
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
, RS
A
ING
ELH
EIM
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
LTD
, RA
ND
BU
RG
, RS
A
24 m
onth
s (P
rovi
sion
al)
07 J
UN
E 2
012
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r
Pac
ker:
Labo
rato
ry: F
PR
C
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
45/2
0.2.
8/01
71
EF
LAT
EN
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:T
EN
OF
OV
IR D
ISO
PR
OX
ILF
UM
AR
AT
E30
0,0
mg
LAM
IVU
DIN
E30
0,0
mg
EF
AV
IRE
NZ
600,
0 m
g
1, 2
, 3, 4
, 5, 6
, 7, 8
*
MY
LAN
(P
TY
) LT
D
MA
TR
IX L
AB
OR
AT
OR
IES
LIM
ITE
D, S
INN
AR
, NA
SH
IK,
MA
HA
RA
SH
TR
A, I
ND
IA
MA
TR
IX L
AB
OR
AT
OR
IES
LIM
ITE
D, S
INN
AR
, NA
SH
IK,
MA
HA
RA
SH
TR
A, I
ND
IA
MA
TR
IX L
AB
OR
AT
OR
IES
LIM
ITE
D, S
INN
AR
, NA
SH
IK,
MA
HA
RA
SH
TR
A, I
ND
IAC
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
AT
OR
IES
,A
TLA
SV
ILLE
, BO
KS
BU
RG
,R
SA
AC
OR
NP
HA
RM
AC
EU
TIC
ALS
(P
TY
)LT
D, N
OR
TH
RID
ING
,JO
HA
NN
ES
BU
RG
, RS
A
MY
LAN
(P
TY
) LT
D,
MO
DD
ER
FO
NT
EIN
,JO
HA
NN
ES
BU
RG
, RS
A
24 m
onth
s (P
rovi
sion
al)
07 J
UN
E 2
012
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 29
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:45
/20.
2.8/
0172
Nam
e of
med
icin
e:A
TR
OIZ
A
Dos
age
form
:T
AB
LET
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:T
EN
OF
OV
IR D
ISO
PR
OX
ILF
UM
AR
AT
E30
0,0
mg
EF
AV
IRE
NZ
600,
0 m
gE
MT
RIC
ITA
BIN
E20
0,0
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8*
App
lican
t:M
YLA
N (
PT
Y)
LTD
Man
ufac
ture
r:M
AT
RIX
LA
BO
RA
TO
RIE
SLI
MIT
ED
, SIN
NA
R, N
AS
HIK
,M
AH
AR
AS
HT
RA
, IN
DIA
Pac
ker:
Labo
rato
ry: F
PR
C:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
MA
TR
IX L
AB
OR
AT
OR
IES
LIM
ITE
D, S
INN
AR
, NA
SH
IK,
MA
HA
RA
SH
TR
A, I
ND
IA
MA
TR
IX L
AB
OR
AT
OR
IES
LIM
ITE
D, S
INN
AR
, NA
SH
IK,
MA
HA
RA
SH
TR
A, I
ND
IAC
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
AT
OR
IES
, AT
LAS
VIL
LE,
BO
KS
BU
RG
, RS
AA
CO
RN
PH
AR
MA
CE
UT
ICA
LS(P
TY
) LT
D, N
OR
TH
RID
ING
,JO
HA
NN
ES
BU
RG
, RS
A
MY
LAN
(P
TY
) LT
D,
MO
DD
ER
FO
NT
EIN
,JO
HA
NN
ES
BU
RG
, RS
A
24 m
onth
s (P
rovi
sion
al)
07 J
UN
E 2
012
30 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C:
FP
RR
:
She
lf-lif
e:
07/3
.1.2
.2/2
3
ON
SIO
R IN
JEC
TIO
N
INJE
CT
ION
EA
CH
1,0
ml S
OLU
TIO
NC
ON
TA
INS
:R
OB
EN
AC
OX
IB20
,0 m
g
1, 2
, 3, 4
, 5, 6
, 7
NO
VA
RT
IS S
A (
PT
Y)
LTD
NO
VA
RT
IS S
AN
TE
AN
IMA
LES
.A.S
, HU
NIN
GU
E, F
RA
NC
E
NO
VA
RT
IS S
AN
TE
AN
IMA
LES
.A.S
, HU
NIN
GU
E, F
RA
NC
E
NO
VA
RT
IS S
AN
TE
AN
IMA
LES
.A.S
, HU
NIN
GU
E, F
RA
NC
EN
OV
AR
TIS
SA
(P
TY
) LT
D,
SP
AR
TA
N, K
EM
PT
ON
PA
RK
, RS
AM
&L
LAB
OR
AT
OR
Y S
ER
VIC
ES
,LI
MB
RO
BU
SIN
ES
S P
AR
K,
SA
ND
TO
N, R
SA
NO
VA
RT
IS S
A (
PT
Y)
LTD
,S
PA
RT
AN
, KE
MP
TO
N P
AR
K, R
SA
24 m
onth
s st
ored
at 2
-8 °
CIn
-use
she
lf lif
e of
28
days
sto
red
at2-
8 °C
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
37/1
5.4/
0224
LIP
OS
IC E
YE
GE
L
EY
E G
EL
EA
CH
1,0
g G
EL
CO
NT
AIN
S:
CA
RB
OM
ER
2,0
mg
1, 2
, 3, 4
, 5, 6
, 7
SO
FLE
NS
(P
TY
) LT
D
Dr
MA
NN
PH
AR
MA
, CH
EM
-P
HA
RM
FA
BR
IK G
mbH
,B
ER
LIN
, GE
RM
AN
Y
Dr
MA
NN
PH
AR
MA
, CH
EM
-P
HA
RM
FA
BR
IK G
mbH
,B
ER
LIN
, GE
RM
AN
YC
OLU
MB
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HA
RM
AC
EU
TIC
ALS
(P
TY
)LT
D, M
IDD
EL
RD
, BA
RD
EN
E,
BO
KS
BU
RG
, RS
A
Dr
MA
NN
PH
AR
MA
, CH
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LIN
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RM
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LTIN
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HE
MIC
AL
LAB
OR
AT
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TY
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AT
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VIL
LE, B
OK
SB
UR
G, R
SA
SO
FLE
NS
(P
TY
) LT
D, R
IVO
NIA
,S
AN
DT
ON
, RS
A
24 m
onth
s
27 J
ULY
201
2
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
37/1
5.2/
0588
LOT
EM
AX
OP
HT
HA
LMIC
SU
SP
EN
SIO
N
EY
E D
RO
PS
EA
CH
1,0
ml S
US
PE
NS
ION
CO
NT
AIN
S:
LOT
EP
RE
DN
OL
ET
AB
ON
AT
E5,
0 m
g
1, 2
, 3, 4
, 5, 6
, 7
SO
FLE
NS
(P
TY
) LT
D
BA
US
CH
& L
OM
B IN
C, H
IDD
EN
RIV
ER
PA
RK
WA
Y, T
AM
PA
,F
LOR
IDA
, US
A
BA
US
CH
& L
OM
B IN
C, H
IDD
EN
RIV
ER
PA
RK
WA
Y, T
AM
PA
,F
LOR
IDA
, US
A.
CO
LUM
BIA
PH
AR
MA
CE
UT
ICA
LS(P
TY
) LT
D, M
IDD
EL
RD
,B
AR
DE
NE
, BO
KS
BU
RG
, RS
A
BA
US
CH
& L
OM
B IN
C, H
IDD
EN
RIV
ER
PA
RK
WA
Y, T
AM
PA
,F
LOR
IDA
, US
AC
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
AT
OR
IES
(P
TY
) LT
D,
AT
LAS
VIL
LE, B
OK
SB
UR
G, R
SA
SO
FLE
NS
(P
TY
) LT
D, R
IVO
NIA
,S
AN
DT
ON
, RS
A
24 m
onth
s
27 J
ULY
201
2
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 31
MR
F 1
5M
RF
15
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C:
FP
RR
:
She
lf-lif
e:
A39
/7.1
/041
9
AP
EX
TE
RA
ZO
SIN
1 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:T
eraz
osin
hyd
roch
lorid
e eq
uiva
lent
to T
eraz
osin
1,0
mg
1, 2
, 3, 4
, 5, 6
, 7
CA
MO
X P
HA
RM
AC
EU
TIC
ALS
(PT
Y)
LTD
INT
AS
PH
AR
MA
CE
UT
ICA
LSLT
D, M
AT
OD
A, G
UJA
RA
T, I
ND
IAIN
TA
S P
HA
RM
AC
EU
TIC
ALS
LTD
, MA
TO
DA
, GU
JAR
AT
, IN
DIA
INT
AS
PH
AR
MA
CE
UT
ICA
LSLT
D, M
AT
OD
A, G
UJA
RA
T, I
ND
IAS
AB
S C
OM
ME
RC
IAL
(PT
Y)
LTD
PH
AR
MA
CE
UT
ICA
L C
HE
MIS
TR
YD
EP
AR
TM
EN
T G
RO
EN
KLO
OF
,P
RE
TO
RIA
, RS
AM
&L
LAB
OR
AT
OR
Y S
ER
VIC
ES
,LI
MB
RO
BU
SIN
ES
S P
AR
K,
SA
ND
TO
N, R
SA
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
L S
ER
VIC
ES
,S
ILV
ER
TO
ND
ALE
, PR
ET
OR
IA,
RS
A
CA
MO
X P
HA
RM
AC
EU
TIC
ALS
(PT
Y)
LTD
, CR
OW
N E
XT
EN
SIO
N3,
JO
HA
NN
ES
BU
RG
, RS
A
36 m
onth
s
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C:
FP
RR
:
She
lf-lif
e:
A39
/7.1
/042
0
AP
EX
TE
RA
ZO
SIN
2 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:T
eraz
osin
hyd
roch
lorid
e eq
uiva
lent
toT
eraz
osin
2,0
mg
1, 2
, 3, 4
, 5, 6
, 7
CA
MO
X P
HA
RM
AC
EU
TIC
ALS
(P
TY
)LT
D
INT
AS
PH
AR
MA
CE
UT
ICA
LS L
TD
,M
AT
OD
A, G
UJA
RA
T, I
ND
IAIN
TA
S P
HA
RM
AC
EU
TIC
ALS
LT
D,
MA
TO
DA
, GU
JAR
AT
, IN
DIA
INT
AS
PH
AR
MA
CE
UT
ICA
LS L
TD
,M
AT
OD
A, G
UJA
RA
T, I
ND
IAS
AB
S C
OM
ME
RC
IAL
(PT
Y)
LTD
PH
AR
MA
CE
UT
ICA
L C
HE
MIS
TR
YD
EP
AR
TM
EN
T G
RO
EN
KLO
OF
,P
RE
TO
RIA
, RS
AM
&L
LAB
OR
AT
OR
Y S
ER
VIC
ES
,LI
MB
RO
BU
SIN
ES
S P
AR
K,
SA
ND
TO
N, R
SA
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
LS
ER
VIC
ES
, SIL
VE
RT
ON
DA
LE,
PR
ET
OR
IA, R
SA
CA
MO
X P
HA
RM
AC
EU
TIC
ALS
(P
TY
)LT
D, C
RO
WN
EX
TE
NS
ION
3,
JOH
AN
NE
SB
UR
G, R
SA
36 m
onth
s
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
fre
gist
ratio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
A39
/7.1
/042
1
AP
EX
TE
RA
ZO
SIN
5 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:T
eraz
osin
hyd
roch
lorid
e eq
uiva
lent
to T
eraz
osin
5,0
mg
1, 2
, 3, 4
, 5, 6
, 7
CA
MO
X P
HA
RM
AC
EU
TIC
ALS
(PT
Y)
LTD
INT
AS
PH
AR
MA
CE
UT
ICA
LS L
TD
,M
AT
OD
A, G
UJA
RA
T, I
ND
IAIN
TA
S P
HA
RM
AC
EU
TIC
ALS
LT
D,
MA
TO
DA
, GU
JAR
AT
, IN
DIA
INT
AS
PH
AR
MA
CE
UT
ICA
LS L
TD
,M
AT
OD
A, G
UJA
RA
T, I
ND
IAS
AB
S C
OM
ME
RC
IAL
(PT
Y)
LTD
PH
AR
MA
CE
UT
ICA
L C
HE
MIS
TR
YD
EP
AR
TM
EN
T G
RO
EN
KLO
OF
,P
RE
TO
RIA
, RS
AM
&L
LAB
OR
AT
OR
Y S
ER
VIC
ES
,LI
MB
RO
BU
SIN
ES
S P
AR
K,
SA
ND
TO
N, R
SA
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
L S
ER
VIC
ES
,S
ILV
ER
TO
ND
ALE
, PR
ET
OR
IA,
RS
A
CA
MO
X P
HA
RM
AC
EU
TIC
ALS
(PT
Y)
LTD
, CR
OW
N E
XT
EN
SIO
N3,
JO
HA
NN
ES
BU
RG
, RS
A
36 m
onth
s
27 J
ULY
201
2
32 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15V
IRF
15
Reg
istr
atio
nnu
mbe
r:A
39/7
.1/0
422
Reg
istr
atio
n nu
mbe
r:A
39/7
.1/0
423
Reg
istr
atio
n nu
mbe
r:A
39/7
.1/0
424
Nam
e of
med
icin
e:A
PE
X T
ER
AZ
OS
IN 1
0 m
gN
ame
of m
edic
ine:
AP
EX
TE
RA
ZO
SIN
BP
H S
TA
RT
ER
Nam
e of
med
icin
e:T
ER
AP
RE
SS
BP
H S
TA
RT
ER
PA
CK
PA
CK
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H P
AC
K C
ON
TA
INS
Act
ive
ingr
edie
nts:
EA
CH
PA
CK
CO
NT
AIN
ST
eraz
osin
hyd
roch
lorid
e eq
uiva
lent
to T
eraz
osin
10,
0 m
g3
x A
pex
Ter
azos
in 1
mg
tabl
ets
cont
aini
ng T
eraz
osin
hyd
roch
lorid
eeq
uiva
lent
to T
eraz
osin
1,0
mg
3 x
Ter
apre
ss 1
mg
tabl
ets
cont
aini
ngT
eraz
osin
hyd
roch
lorid
e eq
uiva
lent
toT
eraz
osin
1,0
mg
11 x
Ape
x T
eraz
osin
2 m
g ta
blet
sco
ntai
ning
Ter
azos
in h
ydro
chlo
ride
equi
vale
nt to
Ter
azos
in 2
,0 m
g
11 x
Ter
apre
ss 2
mg
tabl
ets
cont
aini
ngT
eraz
osin
hyd
roch
lorid
e eq
uiva
lent
toT
eraz
osin
2,0
mg
Con
ditio
ns o
fre
gist
ratio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
fre
gist
ratio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
CA
MO
X P
HA
RM
AC
EU
TIC
ALS
CA
MO
X P
HA
RM
AC
EU
TIC
ALS
(P
TY
) LT
DA
pplic
ant:
CA
MO
X P
HA
RM
AC
EU
TIC
ALS
App
lican
t:(P
TY
) LT
DA
pplic
ant:
(PT
Y)
LTD
Man
ufac
ture
r:IN
TA
S P
HA
RM
AC
EU
TIC
ALS
LT
D,
MA
TO
DA
, GU
JAR
AT
, IN
DIA
Man
ufac
ture
r:IN
TA
S P
HA
RM
AC
EU
TIC
ALS
LT
D,
MA
TO
DA
, GU
JAR
AT
, IN
DIA
Man
ufac
ture
r:IN
TA
S P
HA
RM
AC
EU
TIC
ALS
LT
D,
MA
TO
DA
, GU
JAR
AT
, IN
DIA
Pac
ker:
INT
AS
PH
AR
MA
CE
UT
ICA
LS L
TD
,M
AT
OD
A, G
UJA
RA
T, I
ND
IAP
acke
r:IN
TA
S P
HA
RM
AC
EU
TIC
ALS
LT
D,
MA
TO
DA
, GU
JAR
AT
, IN
DIA
Pac
ker:
INT
AS
PH
AR
MA
CE
UT
ICA
LS L
TD
,M
AT
OD
A, G
UJA
RA
T, I
ND
IA
Labo
rato
ry: F
PR
C:
INT
AS
PH
AR
MA
CE
UT
ICA
LS L
TD
,M
AT
OD
A, G
UJA
RA
T, I
ND
IALa
bora
tory
:F
PR
C:
INT
AS
PH
AR
MA
CE
UT
ICA
LS L
TD
,M
AT
OD
A, G
UJA
RA
T, I
ND
IALa
bora
tory
: FP
RC
INT
AS
PH
AR
MA
CE
UT
ICA
LS L
TD
,M
AT
OD
A, G
UJA
RA
T, I
ND
IAS
AB
S C
OM
ME
RC
IAL
(PT
Y)
LTD
SA
BS
CO
MM
ER
CIA
L (P
TY
) LT
DS
AB
S C
OM
ME
RC
IAL
(PT
Y)
LTD
PH
AR
MA
CE
UT
ICA
L C
HE
MIS
TR
YP
HA
RM
AC
EU
TIC
AL
CH
EM
IST
RY
PH
AR
MA
CE
UT
ICA
L C
HE
MIS
TR
YD
EP
AR
TM
EN
T G
RO
EN
KLO
OF
,P
RE
TO
RIA
, RS
AD
EP
AR
TM
EN
T G
RO
EN
KLO
OF
,P
RE
TO
RIA
, RS
AD
EP
AR
TM
EN
T G
RO
EN
KLO
OF
, PR
ET
OR
IA,
RS
AM
&L
LAB
OR
AT
OR
Y S
ER
VIC
ES
,LI
MB
RO
BU
SIN
ES
S P
AR
K,
SA
ND
TO
N, R
SA
M&
L LA
BO
RA
TO
RY
SE
RV
ICE
S,
LIM
BR
O B
US
INE
SS
PA
RK
,S
AN
DT
ON
, RS
A IN
ST
ITU
TE
FO
R
M&
L LA
BO
RA
TO
RY
SE
RV
ICE
S, L
IMB
RO
BU
SIN
ES
S P
AR
K, S
AN
DT
ON
, RS
AIN
ST
ITU
TE
FO
R P
HA
RM
AC
EU
TIC
AL
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
L S
ER
VIC
ES
,S
ILV
ER
TO
ND
ALE
, PR
ET
OR
IA,
RS
A
PH
AR
MA
CE
UT
ICA
L S
ER
VIC
ES
,S
ILV
ER
TO
ND
ALE
, PR
ET
OR
IA, R
SA
SE
RV
ICE
S, S
ILV
ER
TO
ND
ALE
, PR
ET
OR
IA,
RS
A
CA
MO
X P
HA
RM
AC
EU
TIC
ALS
FP
RR
:C
AM
OX
FP
RR
:C
AM
OX
PH
AR
MA
CE
UT
ICA
LS(P
TY
) LT
D, C
RO
WN
EX
TE
NS
ION
3,
JOH
AN
NE
SB
UR
G, R
SA
FP
RR
:(P
TY
) LT
D, C
RO
WN
EX
TE
NS
ION
3,
JOH
AN
NE
SB
UR
G, R
SA
PH
AR
MA
CE
UT
ICA
LS(P
TY
) LT
D, C
RO
WN
EX
TE
NS
ION
3,
JOH
AN
NE
SB
UR
G, R
SA
She
lf-lif
e:36
mon
ths
She
lf-lif
e:36
mon
ths
She
lf-lif
e:36
mon
ths
Dat
e of
regi
stra
tion:
27 J
ULY
201
2D
ate
of r
egis
trat
ion:
27 J
ULY
201
2D
ate
of r
egis
trat
ion
27 J
ULY
201
2
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 33
MR
F 1
5M
RF
15v1
RF
15
Reg
istr
atio
nnu
mbe
r:A
39/7
.1/0
425
Reg
istr
atio
n nu
mbe
r:A
39/7
.1/0
426
Reg
istr
atio
nnu
mbe
r:A
39/7
.1/0
427
Nam
e of
med
icin
e:T
ER
AP
RE
SS
1 m
gN
ame
of m
edic
ine:
TE
RA
PR
ES
S 2
mg
Nam
e of
med
icin
e:T
ER
AP
RE
SS
5 m
g
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H T
AB
LET
CO
NT
AIN
S:
Act
ive
EA
CH
TA
BLE
T C
ON
TA
INS
:T
eraz
osin
hyd
roch
lorid
e eq
uiva
lent
to T
eraz
osin
1,0
mg
Ter
azos
in h
ydro
chlo
ride
equi
vale
nt to
Ter
azos
in 2
,0 m
gin
gred
ient
s:T
eraz
osin
hyd
roch
lorid
e eq
uiva
lent
toT
eraz
osin
5,0
mg
Con
ditio
ns o
fre
gist
ratio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
fre
gist
ratio
n:1,
2, 3
, 4, 5
, 6, 7
App
lican
tC
AM
OX
PH
AR
MA
CE
UT
ICA
LSA
pplic
ant
CA
MO
X P
HA
RM
AC
EU
TIC
ALS
App
lican
t:C
AM
OX
PH
AR
MA
CE
UT
ICA
LS(P
TY
) LT
D(P
TY
) LT
D(P
TY
) LT
D
Man
ufac
ture
r:IN
TA
S P
HA
RM
AC
EU
TIC
ALS
LT
D,
MA
TO
DA
, GU
JAR
AT
, IN
DIA
Man
ufac
ture
r:IN
TA
S P
HA
RM
AC
EU
TIC
ALS
LTD
, MA
TO
DA
, GU
JAR
AT
,IN
DIA
Man
ufac
ture
r:IN
TA
S P
HA
RM
AC
EU
TIC
ALS
LT
D,
MA
TO
DA
, GU
JAR
AT
, IN
DIA
Pac
ker:
INT
AS
PH
AR
MA
CE
UT
ICA
LS L
TD
,M
AT
OD
A, G
UJA
RA
T, I
ND
IAP
acke
r:IN
TA
S P
HA
RM
AC
EU
TIC
ALS
LTD
, MA
TO
DA
, GU
JAR
AT
,IN
DIA
Pac
ker:
INT
AS
PH
AR
MA
CE
UT
ICA
LS L
TD
,M
AT
OD
A, G
UJA
RA
T, I
ND
IA
Labo
rato
ry: F
PR
C:
INT
AS
PH
AR
MA
CE
UT
ICA
LS L
TD
,M
AT
OD
A, G
UJA
RA
T, I
ND
IAS
AB
S C
OM
ME
RC
IAL
(PT
Y)
LTD
,P
HA
RM
AC
EU
TIC
AL
CH
EM
IST
RY
Labo
rato
ry: F
PR
C:
INT
AS
PH
AR
MA
CE
UT
ICA
LSLT
D, M
AT
OD
A, G
UJA
RA
T,
IND
IAS
AB
S C
OM
ME
RC
IAL
(PT
Y)
Labo
rato
ry:
FP
RC
:IN
TA
S P
HA
RM
AC
EU
TIC
ALS
LT
D,
MA
TO
DA
, GU
JAR
AT
, IN
DIA
SA
BS
CO
MM
ER
CIA
L (P
TY
) LT
D,
PH
AR
MA
CE
UT
ICA
L C
HE
MIS
TR
YD
EP
AR
TM
EN
T, G
RO
EN
KLO
OF
,P
RE
TO
RIA
, RS
AM
&L
LAB
OR
AT
OR
Y S
ER
VIC
ES
(PT
Y)
LTD
, LIM
BR
O B
US
INE
SS
LTD
, PH
AR
MA
CE
UT
ICA
LC
HE
MIS
TR
Y D
EP
AR
TM
EN
T,
GR
OE
NK
LOO
F, P
RE
TO
RIA
,R
SA
DE
PA
RT
ME
NT
, GR
OE
NK
LOO
F,
PR
ET
OR
IA, R
SA
M&
L LA
BO
RA
TO
RY
SE
RV
ICE
S(P
TY
) LT
D, L
IMB
RO
BU
SIN
ES
SP
AR
K, S
AN
DT
ON
, RS
AM
&L
LAB
OR
AT
OR
YP
AR
K, S
AN
DT
ON
, RS
AIN
ST
ITU
TE
FO
RP
HA
RM
AC
EU
TIC
AL
SE
RV
ICE
S,
SIL
VE
RT
ON
DA
LE, P
RE
TO
RIA
,R
SA
SE
RV
ICE
S (
PT
Y)
LTD
,LI
MB
RO
BU
SIN
ES
S P
AR
K,
SA
ND
TO
N, R
SA
INS
TIT
UT
E F
OR
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
L S
ER
VIC
ES
,S
ILV
ER
TO
ND
ALE
, PR
ET
OR
IA, R
SA
PH
AR
MA
CE
UT
ICA
LS
ER
VIC
ES
,S
ILV
ER
TO
ND
ALE
,P
RE
TO
RIA
, RS
A
FP
RR
:C
AM
OX
PH
AR
MA
CE
UT
ICA
LSF
PR
R:
CA
MO
X P
HA
RM
AC
EU
TIC
ALS
FP
RR
CA
MO
X P
HA
RM
AC
EU
TIC
ALS
(PT
Y)
LTD
, CR
OW
N E
XT
EN
SIO
N3,
JO
HA
NN
ES
BU
RG
, RS
A(P
TY
) LT
D, C
RO
WN
EX
TE
NS
ION
3,
JOH
AN
NE
SB
UR
G, R
SA
(PT
Y)
LTD
, CR
OW
N E
XT
EN
SIO
N 3
,JO
HA
NN
ES
BU
RG
, RS
A
She
lf-lif
e:36
mon
ths
She
lf-lif
e:36
mon
ths
She
lf-lif
e:36
mon
ths
Dat
e of
regi
stra
tion:
27 J
ULY
201
2D
ate
of r
egis
trat
ion:
27 J
ULY
201
2D
ate
ofre
gist
ratio
n:27
JU
LY 2
012
34 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15F
15
Reg
istr
atio
n nu
mbe
r:A
39/7
.1/0
428
Reg
istr
atio
nnu
mbe
r:A
40/4
/021
4R
egis
trat
ion
num
ber:
41/2
6/00
34
Nam
e of
med
icin
e:T
ER
AP
RE
SS
10
mg
Nam
e of
med
icin
e:S
AB
AX
BU
PIV
AC
AIN
E 0
,1 %
VIA
FLE
XN
ame
ofm
edic
ine:
CIP
LA D
OX
OR
UB
ICIN
10
Dos
age
form
:T
AB
LET
Dos
age
form
:S
OLU
TIO
N F
OR
INF
US
ION
Dos
age
form
:IN
JEC
TIO
N
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H 1
000
,0 m
l CO
NT
AIN
SA
ctiv
e in
gred
ient
s:E
AC
H V
IAL
CO
NT
AIN
S:
Ter
azos
in h
ydro
chlo
ride
equi
vale
nt to
Ter
azos
inB
UP
IVA
CA
INE
HY
DR
OC
HLO
RID
E 1
,0 g
DO
XO
RU
BIC
INH
YD
RO
CH
LOR
IDE
10,
0 m
g10
,0 m
g
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
fre
gist
ratio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
fre
gist
ratio
n.1,
2, 3
, 4, 5
, 6, 7
App
lican
t:C
AM
OX
PH
AR
MA
CE
UT
ICA
LSA
pplic
ant:
AD
CO
CK
ING
RA
M C
RIT
ICA
LA
pplic
ant:
CIP
LA M
ED
PR
O (
PT
Y)
LTD
(PT
Y)
LTD
CA
RE
(P
TY
) LT
D
Man
ufac
ture
r:IN
TA
S P
HA
RM
AC
EU
TIC
ALS
LTD
, MA
TO
DA
, GU
JAR
AT
,IN
DIA
Man
ufac
ture
r:A
DC
OC
K IN
GR
AM
CR
ITIC
AL
CA
RE
(P
TY
) LT
D, A
ER
OT
ON
,JO
HA
NN
ES
BU
RG
, RS
A
Man
ufac
ture
r:C
IPLA
LT
D, U
NIT
V, V
ER
NA
,G
OA
, IN
DIA
Pac
ker:
INT
AS
PH
AR
MA
CE
UT
ICA
LSLT
D, M
AT
OD
A, G
UJA
RA
T,
IND
IA
Pac
ker:
AD
CO
CK
ING
RA
M C
RIT
ICA
LC
AR
E (
PT
Y)
LTD
, AE
RO
TO
N,
JOH
AN
NE
SB
UR
G, R
SA
Pac
ker
CIP
LA L
TD
, UN
IT V
, VE
RN
A,
GO
A, I
ND
IA
Labo
rato
ry: F
PR
C:
INT
AS
PH
AR
MA
CE
UT
ICA
LSLT
D, M
AT
OD
A, G
UJA
RA
T,
Labo
rato
ry: F
PR
C:
AD
CO
CK
ING
RA
M C
RIT
ICA
LC
AR
E (
PT
Y)
LTD
, AE
RO
TO
N,
Labo
rato
ry:
FP
RC
CIP
LA L
TD
, UN
IT V
, VE
RN
A,
GO
A, I
ND
IAIN
DIA
JOH
AN
NE
SB
UR
G, R
SA
SA
BS
CO
MM
ER
CIA
L (P
TY
)LT
D, P
HA
RM
AC
EU
TIC
AL
CH
EM
IST
RY
DE
PA
RT
ME
NT
,G
RO
EN
KLO
OF
, PR
ET
OR
IA,
RS
AM
&L
LAB
OR
AT
OR
YS
ER
VIC
ES
(P
TY
) LT
D,
LIM
BR
O B
US
INE
SS
PA
RK
,S
AN
DT
ON
, RS
AIN
ST
ITU
TE
FO
RP
HA
RM
AC
EU
TIC
AL
SE
RV
ICE
S,
SIL
VE
RT
ON
DA
LE,
PR
ET
OR
IA, R
SA
FP
RR
:C
AM
OX
PH
AR
MA
CE
UT
ICA
LS(P
TY
) LT
D, C
RO
WN
EX
TE
NS
ION
3,
JOH
AN
NE
SB
UR
G, R
SA
FP
RR
AD
CO
CK
ING
RA
M C
RIT
ICA
LC
AR
E (
PT
Y)
LTD
, AE
RO
TO
N,
JOH
AN
NE
SB
UR
G, R
SA
FP
RR
:C
IPLA
ME
DP
RO
(P
TY
) LT
D,
RO
SE
NP
AR
K, B
ELL
VIL
LE, R
SA
She
lf-lif
e:36
mon
ths
She
lf-lif
e:24
mon
ths
She
lf-lif
e:24
mon
ths
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
regi
stra
tion:
27 J
ULY
201
2D
ate
ofre
gist
ratio
n:27
JU
LY 2
012
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 35
MR
F 1
5M
RF
15F
15
Reg
istr
atio
nnu
mbe
r:41
/26/
0035
Reg
istr
atio
n nu
mbe
r:41
/5.1
0/02
41R
egis
trat
ion
num
ber:
41/5
.10/
0242
Nam
e of
med
icin
e:C
IPLA
DO
XO
RU
BIC
IN 5
0N
ame
of m
edic
ine:
ON
DA
NS
ET
RO
N S
AF
ELI
NE
4 m
gN
ame
of m
edic
ine:
ON
DA
NS
ET
RO
N S
AF
ELI
NE
INJE
CT
ION
8 m
g IN
JEC
TIO
N
Dos
age
form
:IN
JEC
TIO
ND
osag
e fo
rm:
INJE
CT
ION
Dos
age
form
:IN
JEC
TIO
N
Act
ive
ingr
edie
nts:
EA
CH
VIA
L C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H A
MP
OU
LE C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H A
MP
OU
LE C
ON
TA
INS
:D
OX
OR
UB
ICIN
HY
DR
OC
HLO
RID
E 5
0,0
mg
Ond
anse
tron
hyd
roch
lorid
e di
hydr
ate
equi
vale
nt to
Ond
anse
tron
4,0
mg
Ond
anse
tron
hyd
roch
lorid
edi
hydr
ate
equi
vale
nt to
Ond
anse
tron
8,0
mg
Con
ditio
ns o
fre
gist
ratio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7, 8
App
lican
t:C
IPLA
ME
DP
RO
(P
TY
) LT
DA
pplic
ant:
SA
FE
LIN
E P
HA
RM
AC
EU
TIC
ALS
(P
TY
)A
pplic
ant:
SA
FE
LIN
ELT
DP
HA
RM
AC
EU
TIC
ALS
(P
TY
)LT
D
Man
ufac
ture
r:C
IPLA
LT
D, (
UN
IT V
), V
ER
NA
,G
OA
, IN
DIA
Man
ufac
ture
r:D
EM
O S
.A.,
AT
HE
NS
-LA
MIA
,A
TH
EN
S, G
RE
EC
E
Man
ufac
ture
r:D
EM
O S
.A.,
AT
HE
NS
-LA
MIA
,A
TH
EN
S, G
RE
EC
E
Pac
ker:
CIP
LA L
TD
, (U
NIT
V),
VE
RN
A,
GO
A, I
ND
IAP
acke
r:D
EM
O S
.A.,
AT
HE
NS
-LA
MIA
,A
TH
EN
S, G
RE
EC
EP
acke
r:D
EM
O S
.A.,
AT
HE
NS
-LA
MIA
,A
TH
EN
S, G
RE
EC
E
Labo
rato
ry: F
PR
C:
CIP
LA L
TD
, (U
NIT
V),
VE
RN
A,
GO
A, I
ND
IALa
bora
tory
: FP
RC
:D
EM
O S
.A.,
AT
HE
NS
-LA
MIA
,A
TH
EN
S, G
RE
EC
ELa
bora
tory
::FP
RC
DE
MO
S.A
., A
TH
EN
S-L
AM
IA,
AT
HE
NS
, GR
EE
CE
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
LIN
ST
ITU
TE
FO
RS
ER
VIC
ES
, SIL
VE
RT
ON
DA
LE,
PR
ET
OR
IA, R
SA
PH
AR
MA
CE
UT
ICA
LS
ER
VIC
ES
,S
ILV
ER
TO
ND
ALE
,P
RE
TO
RIA
, RS
A
FP
RR
:C
IPLA
ME
DP
RO
(P
TY
) LT
D,
RO
SE
NP
AR
K, R
SA
FP
RR
:S
AF
ELI
NE
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
LTD
, FLO
RID
A, R
SA
FP
RR
SA
FE
LIN
EP
HA
RM
AC
EU
TIC
ALS
(P
TY
)LT
D, F
LOR
IDA
, RS
AS
helf-
life:
24 m
onth
sS
helf-
life:
24 m
onth
s (P
rovi
sion
al)
for
prod
uct
stor
ed a
t or
belo
w 2
5 °C
She
lf -li
fe:
24 m
onth
s (P
rovi
sion
al)
for
prod
uct s
tore
d at
or
belo
w24
hou
rs fo
r di
lute
d so
lutio
ns s
tore
d at
25 °
C2
-8 °
C24
hou
rs fo
r di
lute
d so
lutio
nsst
ored
at 2
-8
°CD
ate
ofre
gist
ratio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
36 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15vI
RF
15
Reg
istr
atio
n nu
mbe
r:41
/20.
1.1/
0947
Reg
istr
atio
n nu
mbe
r:41
/20.
1.1/
0948
Reg
istr
atio
nnu
mbe
r:41
/20.
1.1/
0949
Nam
e of
med
icin
e:T
EIC
OP
LAN
IN W
INT
HR
OP
200
Nam
e of
med
icin
e:T
EIC
OP
LAN
IN W
INT
HR
OP
400
Nam
e of
med
icin
e:T
EIC
OP
LAN
IN S
AN
OF
I-A
VE
NT
IS 2
00
Dos
age
form
:IN
JEC
TIO
ND
osag
e fo
rm:
INJE
CT
ION
Dos
age
form
:IN
JEC
TIO
N
Act
ive
ingr
edie
nts:
EA
CH
VIA
L C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H V
IAL
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
VIA
L C
ON
TA
INS
:T
EIC
OP
LAN
IN20
0,0
mg
TE
ICO
PLA
NIN
400,
0 m
gT
EIC
OP
LAN
IN 2
00,0
mg
Con
ditio
ns o
fre
gist
ratio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
fre
gist
ratio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
fre
gist
ratio
n:1,
2, 3
, 4, 5
, 6, 7
App
lican
t:W
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LSA
pplic
ant:
WIN
TH
RO
P P
HA
RM
AC
EU
TIC
ALS
App
lican
t:S
AN
OF
I-A
VE
NT
IS S
OU
TH
(PT
Y)
LTD
(PT
Y)
LTD
AF
RIC
A (
PT
Y)
LTD
Man
ufac
ture
r:G
RU
PP
O L
EP
ET
IT S
rl, A
NA
GN
I,IT
ALY
Man
ufac
ture
r:G
RU
PP
O L
EP
ET
IT S
rl, A
NA
GN
I,IT
ALY
Man
ufac
ture
r:G
RU
PP
O L
EP
ET
IT S
rl,A
NA
GN
I, IT
ALY
Pac
ker:
GR
UP
PO
LE
PE
TIT
Srl,
AN
AG
NI,
ITA
LYP
acke
r:G
RU
PP
O L
EP
ET
IT S
rl, A
NA
GN
I,IT
ALY
Pac
ker:
GR
UP
PO
LE
PE
TIT
Srl,
AN
AG
NI,
ITA
LYW
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LSW
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LSW
INT
HR
OP
(PT
Y)
LTD
, WA
LTLO
O, P
RE
TO
RIA
,R
SA
(PT
Y)
LTD
, WA
LTLO
O, P
RE
TO
RIA
,R
SA
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
LTD
, WA
LTLO
O,
PR
ET
OR
IA, R
SA
Labo
rato
ry: F
PR
C:
GR
UP
PO
LE
PE
TIT
Srl,
AN
AG
NI,
ITA
LYLa
bora
tory
: FP
RC
:G
RU
PP
O L
EP
ET
IT S
rl, A
NA
GN
I,IT
ALY
Labo
rato
ry: F
PR
C:
GR
UP
PO
LE
PE
TIT
Srl,
AN
AG
NI,
ITA
LYW
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LSW
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LSW
INT
HR
OP
(PT
Y)
LTD
, WA
LTLO
O, P
RE
TO
RIA
,R
SA
(PT
Y)
LTD
, WA
LTLO
O, P
RE
TO
RIA
,R
SA
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
LTD
, WA
LTLO
O,
PR
ET
OR
IA, R
SA
FP
RR
:W
INT
HR
OP
PH
AR
MA
CA
EU
TIC
ALS
FP
RR
:W
INT
HR
OP
PH
AR
MA
CA
EU
TIC
ALS
FP
RR
:W
INT
HR
OP
(PT
Y)
LTD
, WA
LTLO
O, P
RE
TO
RIA
,R
SA
WIN
TH
RO
P P
HA
RM
AC
EU
TIC
ALS
(PT
Y)
LTD
, WA
LTLO
O, P
RE
TO
RIA
,R
SA
WIN
TH
RO
P P
HA
RM
AC
EU
TIC
ALS
PH
AR
MA
CA
EU
TIC
ALS
(PT
Y)
LTD
, WA
LTLO
O,
PR
ET
OR
IA, R
SA
(PT
Y)
LTD
, MID
RA
ND
, RS
A(P
TY
) LT
D, M
IDR
AN
D, R
SA
SA
NO
FI-
AV
EN
TIS
SO
UT
HA
FR
ICA
(P
TY
) LT
D,
MID
RA
ND
, RS
A
She
lf-lif
e:36
mon
ths
She
lf-lif
e:36
mon
ths
She
lf-lif
e:36
mon
ths
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
regi
stra
tion:
27 J
ULY
201
2
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 37
MR
F 1
5M
RF
15v1
RF
15
Reg
istr
atio
n nu
mbe
r:41
/20.
1.1/
0950
Reg
istr
atio
n nu
mbe
r:41
/34/
1134
Reg
istr
atio
n nu
mbe
r:41
/34/
1135
Nam
e of
med
icin
e:T
EIC
OP
LAN
IN S
AN
OF
I-N
ame
of m
edic
ine:
TE
ICO
PLA
NIN
Nam
e of
med
icin
e:T
EIC
OP
LAN
IN S
AN
OF
I-A
VE
NT
ISA
VE
NT
IS 4
00W
INT
HR
OP
SO
LVE
NT
SO
LVE
NT
Dos
age
form
:IN
JEC
TIO
ND
osag
e fo
rm:
INJE
CT
ION
Dos
age
form
:IN
JEC
TIO
N
Act
ive
ingr
edie
nts:
EA
CH
VIA
L C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H A
MP
OU
LEA
ctiv
e in
gred
ient
s:E
AC
H A
MP
OU
LE C
ON
TA
INS
:T
EIC
OP
LAN
IN 4
00,0
mg
CO
NT
AIN
S:
WA
TE
R F
OR
INJE
CT
ION
3,0
ml
WA
TE
R F
OR
INJE
CT
ION
3,0
ml
Con
ditio
ns o
fre
gist
ratio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
fre
gist
ratio
n:1,
2, 3
, 4, 5
, 6, 7
App
lican
t:S
AN
OF
I-A
VE
NT
IS S
OU
TH
App
lican
t:W
INT
HR
OP
App
lican
t:S
AN
OF
I-A
VE
NT
IS S
OU
TH
AF
RIC
AA
FR
ICA
(P
TY
) LT
DP
HA
RM
AC
EU
TIC
ALS
(PT
Y)
LTD
(PT
Y)
LTD
Man
ufac
ture
r:G
RU
PP
O L
EP
ET
IT S
rl,A
NA
GN
I, IT
ALY
Man
ufac
ture
r:G
RU
PP
O L
EP
ET
IT S
rl,A
NA
GN
I, IT
ALY
Man
ufac
ture
r:G
RU
PP
O L
EP
ET
IT S
rl, A
NA
GN
I,IT
ALY
Pac
ker:
GR
UP
PO
LE
PE
TIT
Srl,
AN
AG
NI,
ITA
LYP
acke
r:G
RU
PP
O L
EP
ET
ITS
rI,A
NA
GN
I, IT
ALY
Pac
ker:
GR
UP
PO
LE
PE
TIT
Srl,
AN
AG
NI,
ITA
LYW
INT
HR
OP
WIN
TH
RO
PW
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LSP
HA
RM
AC
EU
TIC
ALS
(PT
Y)
LTD
, WA
LTLO
O,
PR
ET
OR
IA, R
SA
PH
AR
MA
CE
UT
ICA
LS(P
TY
) LT
D, W
ALT
LOO
,P
RE
TO
RIA
, RS
A
(PT
Y)
LTD
, WA
LTLO
O, P
RE
TO
RIA
,R
SA
Labo
rato
ry: F
PR
C:
GR
UP
PO
LE
PE
TIT
Srl,
AN
AG
NI,
ITA
LYLa
bora
tory
: FP
RC
:G
RU
PP
O L
EP
ET
IT S
rl,A
NA
GN
I, IT
ALY
Labo
rato
ry: F
PR
C:
GR
UP
PO
LE
PE
TIT
Srl,
AN
AG
NI,
ITA
LYW
INT
HR
OP
WIN
TH
RO
PW
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LSP
HA
RM
AC
EU
TIC
ALS
(PT
Y)
LTD
, WA
LTLO
O,
PR
ET
OR
IA, R
SA
PH
AR
MA
CE
UT
ICA
LS(P
TY
) LT
D, W
ALT
LOO
,P
RE
TO
RIA
, RS
A
(PT
Y)
LTD
, WA
LTLO
O, P
RE
TO
RIA
,R
SA
FP
RR
:W
INT
HR
OP
WIN
TH
RO
PF
PR
R:
WIN
TH
RO
P P
HA
RM
AC
AE
UT
ICA
LSP
HA
RM
AC
AE
UT
ICA
LS(P
TY
) LT
D, W
ALT
LOO
,P
RE
TO
RIA
, RS
A
FP
RR
:P
HA
RM
AC
AE
UT
ICA
LS(P
TY
) LT
D, W
ALT
LOO
,P
RE
TO
RIA
, RS
A
(PT
Y)
LTD
, WA
LTLO
O,
PR
ET
OR
IA, R
SA
SA
NO
FI-
AV
EN
TIS
SO
UT
H A
FR
ICA
SA
NO
FI-
AV
EN
TIS
SO
UT
HW
INT
HR
OP
(PT
Y)
LTD
, MID
RA
ND
, RS
AA
FR
ICA
(P
TY
) LT
D,
MID
RA
ND
, RS
AP
HA
RM
AC
EU
TIC
ALS
(PT
Y)
LTD
, MID
RA
ND
,R
SA
She
lf-lif
e:36
mon
ths
She
lf-lif
e:36
mon
ths
She
lf-lif
e:36
mon
ths
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
38 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15F
15
Reg
istr
atio
n nu
mbe
r:42
/28/
0102
Reg
istr
atio
n nu
mbe
r:42
/28/
0103
Reg
istr
atio
n nu
mbe
r:42
/28/
0104
Nam
e of
med
icin
e:O
PT
IMA
RK
10
Nam
e of
med
icin
e:O
PT
IMA
RK
15
Nam
e of
med
icin
e:O
PT
IMA
RK
20
Dos
age
form
:S
OLU
TIO
N F
OR
INJE
CT
ION
Dos
age
form
:S
OLU
TIO
N F
OR
INJE
CT
ION
Dos
age
form
:S
OLU
TIO
N F
OR
INJE
CT
ION
Act
ive
ingr
edie
nts:
EA
CH
10,
0 m
l CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
15,
0 m
l CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
20,
0 m
l CO
NT
AIN
S:
GA
DO
VE
RS
ET
AM
IDE
GA
DO
VE
RS
ET
AM
IDE
GA
DO
VE
RS
ET
AM
IDE
3 30
9,0
mg
4963
,5 m
g66
18,0
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
App
lican
t:C
OV
IDIE
N (
PT
Y)
LTD
App
lican
t:C
OV
IDIE
N (
PT
Y)
LTD
App
lican
t:C
OV
IDIE
N (
PT
Y)
LTD
Man
ufac
ture
r:T
YC
O H
EA
LTH
CA
RE
INC
,R
ALE
IGH
, NO
RT
H C
AR
OLI
NA
,U
SA
Man
ufac
ture
r:T
YC
O H
EA
LTH
CA
RE
INC
,R
ALE
IGH
, NO
RT
HC
AR
OLI
NA
, US
A
Man
ufac
ture
r:T
YC
O H
EA
LTH
CA
RE
INC
, RA
LEIG
H,
NO
RT
H C
AR
OLI
NA
, US
A
Pac
ker:
TY
CO
HE
ALT
HC
AR
E IN
C,
RA
LEIG
H, N
OR
TH
CA
RO
LIN
A,
US
A
Pac
ker:
TY
CO
HE
ALT
HC
AR
E IN
C,
RA
LEIG
H, N
OR
TH
CA
RO
LIN
A, U
SA
Pac
ker:
TY
CO
HE
ALT
HC
AR
E IN
C, R
ALE
IGH
,N
OR
TH
CA
RO
LIN
A, U
SA
Labo
rato
ry F
PR
CT
YC
O H
EA
LTH
CA
RE
INC
,R
ALE
IGH
, NO
RT
H C
AR
OLI
NA
,U
SA
Labo
rato
ry: F
PR
C:
TY
CO
HE
ALT
HC
AR
E IN
C,
RA
LEIG
H, N
OR
TH
CA
RO
LIN
A, U
SA
Labo
rato
ry: F
PR
C:
TY
CO
HE
ALT
HC
AR
E IN
C, R
ALE
IGH
,N
OR
TH
CA
RO
LIN
A, U
SA
PE
TLA
BS
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
PE
TLA
BS
PH
AR
MA
CE
UT
ICA
LSP
ET
LAB
SLT
D, G
RO
EN
KLO
OF
, PR
ET
OR
IA, R
SA
(PT
Y)
LTD
, GR
OE
NK
LOO
F,
PR
ET
OR
IA, R
SA
BIO
CH
EM
ICA
L A
ND
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
LTD
, GR
OE
NK
LOO
F,
PR
ET
OR
IA, R
SA
BIO
CH
EM
ICA
L A
ND
SC
IEN
TIF
IC c
c,H
ILT
ON
, KW
A-Z
ULU
NA
TA
L, R
SA
SC
IEN
TIF
IC c
c, H
ILT
ON
, KW
A-
ZU
LU N
AT
AL,
RS
AB
IOC
HE
MIC
AL
AN
DS
CIE
NT
IFIC
cc,
HIL
TO
N,
KW
A-Z
ULU
NA
TA
L, R
SA
FP
RR
:C
OV
IDIE
N (
PT
Y)
LTD
,R
AN
DJE
SP
AR
K, M
IDR
AN
D,
RS
A
FP
RR
:C
OV
IDIE
N (
PT
Y)
LTD
,R
AN
DJE
SP
AR
K, M
IDR
AN
D,
RS
A
FP
RR
:C
OV
IDIE
N (
PT
Y)
LTD
,R
AN
DJE
SP
AR
K, M
IDR
AN
D, R
SA
She
lf-lif
e:24
mon
ths
(Gla
ss v
ials
)S
helf-
life:
24 m
onth
s (G
lass
via
ls)
She
lf-lif
e:24
mon
ths
(Gla
ss v
ials
)36
mon
ths
(Pre
-fill
ed s
yrin
ges)
36 m
onth
s (P
re-f
illed
syrin
ges)
36 m
onth
s (P
re-f
illed
syr
inge
s)
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 39
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:42
/28/
0105
Reg
istr
atio
n nu
mbe
r:42
/7.1
.3/0
262
Reg
istr
atio
n nu
mbe
r:42
/20.
1.1/
0427
Nam
e of
med
icin
e:O
PT
IMA
RK
30
Nam
e of
med
icin
e:T
RA
ND
OP
RE
SS
2 m
gN
ame
of m
edic
ine:
LEV
OF
LOX
AC
IN S
PE
CP
HA
RM
250
IV
Dos
age
form
:S
OLU
TIO
N F
OR
INJE
CT
ION
Dos
age
form
:C
AP
SU
LED
osag
e fo
rm:
SO
LUT
ION
FO
R IV
INF
US
ION
Act
ive
ingr
edie
nts:
EA
CH
30,
0 m
l CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
CA
PS
ULE
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
50,
0 m
l SO
LUT
ION
CO
NT
AIN
S:
GA
DO
VE
RS
ET
AM
IDE
TR
AN
DO
LAP
RIL
2,0
mg
LEV
OF
LOX
AC
IN25
0,0
mg
9927
,0 m
g
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of
regi
stra
tion:
1, 2
, 3, 4
, 5, 6
, 7, 8
App
lican
t:C
OV
IDIE
N (
PT
Y)
LTD
App
lican
t:P
HA
RM
AC
AR
E L
IMIT
ED
App
lican
t:S
PE
CP
HA
RM
(P
TY
) LT
D
Man
ufac
ture
r:T
YC
O H
EA
LTH
CA
RE
INC
,R
ALE
IGH
, NO
RT
H C
AR
OLI
NA
, US
AM
anuf
actu
rer:
PH
AR
MA
TH
EN
S.A
, PA
LLIN
I, A
TT
IKIS
,G
RE
EC
EM
anuf
actu
rer:
BIO
ME
ND
I S.A
, BE
RN
ED
O, A
LVA
, SP
AIN
Pac
ker:
TY
CO
HE
ALT
HC
AR
E IN
C,
RA
LEIG
H, N
OR
TH
CA
RO
LIN
A, U
SA
Pac
ker:
PH
AR
MA
TE
N S
.A, P
ALL
INI,
AT
TIK
IS,
GR
EE
CE
Pac
ker:
BIO
ME
ND
I S.A
, BE
RN
ED
O, A
LVA
, SP
AIN
PH
AR
MA
CA
RE
LIM
ITE
D, K
OR
ST
EN
,P
OR
T E
LIZ
AB
ET
H, R
SA
AS
PE
N P
HA
RM
AC
AR
E E
AS
TLO
ND
ON
, WIL
SO
NIA
, EA
ST
LO
ND
ON
,R
SA
Labo
rato
ry: F
PR
C:
TY
CO
HE
ALT
HC
AR
E IN
C,
RA
LEIG
H, N
OR
TH
CA
RO
LIN
A, U
SA
PE
TLA
BS
PH
AR
MA
CE
UT
ICA
LS(P
TY
) LT
D, G
RO
EN
KLO
OF
,P
RE
TO
RIA
, RS
A
Labo
rato
ry:
FP
RC
:P
HA
RM
AT
EN
S.A
, PA
LLIN
I, A
TT
IKIS
,G
RE
EC
EP
HA
RM
AC
AR
E L
IMIT
ED
, KO
RS
TE
N,
PO
RT
ELI
ZA
BE
TH
, RS
AA
SP
EN
PH
AR
MA
CA
RE
EA
ST
Labo
rato
ry: F
PR
C:
BIO
ME
ND
I S.A
, BE
RN
ED
O, A
LVA
, SP
AIN
SP
EC
PH
AR
M H
OLD
ING
S (
PT
Y)
LTD
,H
ALF
WA
Y H
OU
SE
, MID
RA
ND
, RS
AC
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
AT
OR
IES
,(P
TY
) LT
D, A
TLA
SV
ILLE
, BO
KS
BU
RG
, RS
AB
IOC
HE
MIC
AL
AN
D S
CIE
NT
IFIC
cc, H
ILT
ON
, KW
A -
ZU
LU N
AT
AL,
RS
A
LON
DO
N, W
ILS
ON
IA, E
AS
T L
ON
DO
N,
RS
AS
AB
S C
OM
ME
RC
IAL
(PT
Y)
LTD
,P
HA
RM
AC
EU
TIC
AL
CH
EM
IST
RY
DE
PA
RT
ME
NT
, GR
OE
NK
LOO
F,
PR
ET
OR
IA, R
SA
RE
SE
AR
CH
INS
TIT
UT
E F
OR
IND
US
TR
IAL
PH
AR
MA
CY
,P
OT
CH
EF
ST
RO
OM
, RS
AM
&L
LAB
OR
AT
OR
Y S
ER
VIC
ES
(P
TY
)LT
D, L
IMB
RO
BU
SIN
ES
S P
AR
K,
SA
ND
TO
N, R
SA
FP
RR
:C
OV
IDIE
N (
PT
Y)
LTD
,R
AN
DJE
SP
AR
K, M
IDR
AN
D, R
SA
FP
RC
/FP
RR
:P
HA
RM
AC
AR
E L
IMIT
ED
, KO
RS
TE
N,
PO
RT
ELI
ZA
BE
TH
, RS
AF
PR
R:
SP
EC
PH
AR
M (
PT
Y)
LTD
, HA
FW
AY
HO
US
E, M
IDR
AN
D, R
SA
AS
PE
N P
HA
RM
AC
AR
E E
AS
TLO
ND
ON
, WIL
SO
NIA
, EA
ST
LO
ND
ON
,R
SA
She
lf-lif
e:24
mon
ths
(Gla
ss v
ials
)36
mon
ths
(Pre
-fill
ed s
yrin
ges)
FP
RR
:P
HA
RM
AC
AR
E L
IMIT
ED
,W
OO
DM
EA
D, S
AN
DT
ON
, RS
AS
helf-
life:
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)D
ate
of r
egis
trat
ion:
27 J
ULY
201
2
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
40 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:42
/20.
1.1/
0428
Reg
istr
atio
n nu
mbe
r:42
/20.
1.1/
0439
Reg
istr
atio
n nu
mbe
r:42
/20.
1.1/
0440
Nam
e of
med
icin
e:S
PE
C L
EV
OF
LOX
AC
IN 5
00 IV
Nam
e of
med
icin
e:LE
VO
FLO
XA
CIN
SP
EC
PH
AR
MN
ame
of m
edic
ine:
SP
EC
LE
VO
FLO
XA
CIN
250
500
IVIV
Dos
age
form
:S
OLU
TIO
N F
OR
IV IN
FU
SIO
ND
osag
e fo
rm:
SO
LUT
ION
FO
R IV
INF
US
ION
Dos
age
form
:S
OLU
TIO
N F
OR
IVIN
FU
SIO
N
Act
ive
ingr
edie
nts:
EA
CH
100
,0 m
l SO
LUT
ION
Act
ive
ingr
edie
nts:
EA
CH
100
,0 m
l SO
LUT
ION
Act
ive
ingr
edie
nts:
EA
CH
50,
0 m
l SO
LUT
ION
CO
NT
AIN
S:
CO
NT
AIN
S:
CO
NT
AIN
S:
LEV
OF
LOX
AC
IN50
0,0
mg
LEV
OF
LOX
AC
IN50
0,0
mg
LEV
OF
LOX
AC
IN25
0,0
mg
Con
ditio
ns o
fre
gist
ratio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of
regi
stra
tion:
1, 2
, 3, 4
, 5, 6
, 7, 8
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8
App
lican
t:S
PE
CP
HA
RM
(P
TY
) LT
DA
pplic
ant:
SP
EC
PH
AR
M (
PT
Y)
LTD
App
lican
t:S
PE
CP
HA
RM
(P
TY
) LT
D
Man
ufac
ture
r:B
IOM
EN
DI S
.A, B
ER
NE
DO
,A
LVA
, SP
AIN
Man
ufac
ture
r:B
IOM
EN
DI S
.A, B
ER
NE
DO
,A
LVA
, SP
AIN
Man
ufac
ture
r:B
IOM
EN
DI S
.A, B
ER
NE
DO
,A
LVA
, SP
AIN
Pac
ker:
BIO
ME
ND
I S.A
, BE
RN
ED
O,
ALV
A, S
PA
INP
acke
r:B
IOM
EN
DI S
.A, B
ER
NE
DO
,A
LVA
, SP
AIN
Pac
ker:
BIO
ME
ND
I S.A
, BE
RN
ED
O,
ALV
A, S
PA
IN
Labo
rato
ry: F
PR
C:
BIO
ME
ND
I S.A
, BE
RN
ED
O,
ALV
A, S
PA
INLa
bora
tory
: FP
RC
:B
IOM
EN
DI S
.A, B
ER
NE
DO
,A
LVA
, SP
AIN
Labo
rato
ry: F
PR
CB
IOM
EN
DI S
.A, B
ER
NE
DO
,A
LVA
, SP
AIN
SP
EC
PH
AR
M H
OLD
ING
S (
PT
Y)
SP
EC
PH
AR
M H
OLD
ING
SS
PE
CP
HA
RM
HO
LDIN
GS
LTD
, HA
LFW
AY
HO
US
E,
MID
RA
ND
, RS
A(P
TY
) LT
D, H
ALF
WA
Y H
OU
SE
,M
IDR
AN
D, R
SA
(PT
Y)
LTD
, HA
LFW
AY
HO
US
E, M
IDR
AN
D, R
SA
CO
NS
ULT
ING
CH
EM
ICA
LC
ON
SU
LTIN
G C
HE
MIC
AL
CO
NS
ULT
ING
CH
EM
ICA
LLA
BO
RA
TO
RIE
S, (
PT
Y)
LTD
,A
TLA
SV
ILLE
, BO
KS
BU
RG
, RS
ALA
BO
RA
TO
RIE
S, (
PT
Y)
LTD
,A
TLA
SV
ILLE
, BO
KS
BU
RG
,R
SA
LAB
OR
AT
OR
IES
, (P
TY
)LT
D, A
TLA
SV
ILLE
,B
OK
SB
UR
G, R
SA
FP
RR
:S
PE
CP
HA
RM
(P
TY
) LT
D,
HA
LFW
AY
HO
US
E, M
IDR
AN
D,
RS
A
FP
RR
:S
PE
CP
HA
RM
(P
TY
) LT
D,
HA
LFW
AY
HO
US
E, M
IDR
AN
D,
RS
A
FP
RR
:S
PE
CP
HA
RM
(P
TY
) LT
D,
HA
LFW
AY
HO
US
E,
MID
RA
ND
, RS
A
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)S
helf-
life:
24 m
onth
s (P
rovi
sion
al)
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 41
MR
F 1
5M
RF
15
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
42/2
0.1.
1/05
05
ZIT
RO
500
TA
BLE
TS
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:A
zith
rom
ycin
dih
ydra
teeq
uiva
lent
to A
zith
rom
ycin
500,
0 m
g
1, 2
, 3, 4
, 5, 6
, 7, 8
CIP
LA M
ED
PR
O (
PT
Y)
LTD
CIP
LA L
TD
, UN
IT V
II,V
ER
NA
, GO
A, I
ND
IA
CIP
LA L
TD
, UN
IT V
II,V
ER
NA
, GO
A, I
ND
IA
CIP
LA L
TD
, UN
IT V
II,V
ER
NA
, GO
A, I
ND
IA
CIP
LA M
ED
PR
O (
PT
Y)
LTD
,R
OS
EN
PA
RK
, SO
UT
HA
FR
ICA
24 m
onth
s (P
rovi
sion
al)
27 J
ULY
201
2
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r.
Pac
ker:
Labo
rato
ry: F
PR
C:
FP
RC
/FP
RR
: FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
42/2
0.1.
2/07
71
AD
CO
AM
OX
YC
LAV
BD
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:A
MO
XY
CIL
LIN
TR
IHY
DR
AT
EE
QU
IVA
LEN
T T
OA
MO
XY
CIL
LIN
875
,0 m
gP
OT
AS
SIU
M C
LAV
ULA
NA
TE
EQ
UIV
ALE
NT
TO
CLA
VU
LAN
IC A
CID
125,
0 m
g
1, 2
, 3, 4
, 5, 6
, 7, 8
AD
CO
CK
ING
RA
M L
IMIT
ED
ME
DR
EIC
H L
TD
, UN
IT 1
,V
IRG
ON
AG
AR
,B
AN
GA
LOR
E, I
ND
IA
ME
DR
EIC
H L
TD
, UN
IT 1
,V
IRG
ON
AG
AR
,B
AN
GA
LOR
E, I
ND
IAA
DC
OC
K IN
GR
AM
HE
ALT
HC
AR
E, W
AD
EV
ILLE
,G
ER
MIS
TO
N, R
SA
ME
DR
EIC
H L
TD
, UN
IT 1
,V
IRG
ON
AG
AR
,B
AN
GA
LOR
E, I
ND
IAA
DC
OC
K IN
GR
AM
LIM
ITE
D,
RE
SE
AR
CH
AN
DD
EV
ELO
PM
EN
T, A
ER
OT
ON
,JO
HA
NN
ES
BU
RG
, RS
A
AD
CO
CK
ING
RA
MH
EA
LTH
CA
RE
, WA
DE
VIL
LE,
GE
RM
IST
ON
, RS
A
AD
CO
CK
ING
RA
M L
IMIT
ED
,E
RA
ND
GA
RD
EN
S,
MID
RA
ND
, RS
A
24 m
onth
s (P
rovi
sion
al)
27 J
ULY
201
2
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
fre
gist
ratio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
42/3
4/07
86
AD
VA
GR
AF
0,5
mg
CA
PS
ULE
EA
CH
CA
PS
ULE
CO
NT
AIN
S:
TA
CR
OLI
MU
S0,
5 m
g
1, 2
, 3, 4
, 5, 6
, 7, 8
AS
TE
LLA
S P
HA
RM
A (
PT
Y)
LTD
AS
TE
LLA
S IR
ELA
ND
CO
. LT
D,
KIL
LOR
GLI
N, K
ER
RY
, IR
ELA
ND
AS
TE
LLA
S IR
ELA
ND
CO
. LT
D,
KIL
LOR
GLI
N, K
ER
RY
, IR
ELA
ND
AS
TE
LLA
S IR
ELA
ND
CO
. LT
D,
KIL
LOR
GLI
N, K
ER
RY
, IR
ELA
ND
CO
NS
ULT
ING
CH
EM
ICA
LLA
BO
RA
TO
RIE
S, A
TLA
SV
ILLE
,B
OK
SB
UR
G, R
SA
AS
TE
LLA
S P
HA
RM
A (
PT
Y)
LTD
,B
ED
FO
RD
VIE
W,
JOH
AN
NE
SB
UR
G, R
SA
24 m
onth
s (P
rovi
sion
al)
27 J
ULY
201
2
42 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15
Reg
istr
atio
n nu
mbe
r:42
/34/
0787
Reg
istr
atio
n nu
mbe
r:42
/34/
0788
Nam
e of
med
icin
e:A
DV
AG
RA
F 1
mg
Nam
e of
med
icin
e:A
DV
AG
RA
F 5
mg
Dos
age
form
:C
AP
SU
LED
osag
e fo
rm:
CA
PS
ULE
Act
ive
ingr
edie
nts:
EA
CH
CA
PS
ULE
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
CA
PS
ULE
TA
CR
OLI
MU
S1,
0 m
gC
ON
TA
INS
:T
AC
RO
LIM
US
5,0
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7, 8
App
lican
t:A
ST
ELL
AS
PH
AR
MA
(P
TY
)A
pplic
ant:
AS
TE
LLA
S P
HA
RM
A (
PT
Y)
LTD
LTD
Man
ufac
ture
r:A
ST
ELL
AS
IRE
LAN
D C
O.
Man
ufac
ture
r:A
ST
ELL
AS
IRE
LAN
D C
O.
LTD
, KIL
LOR
GLI
N, K
ER
RY
,IR
ELA
ND
LTD
, KIL
LOR
GLI
N, K
ER
RY
,IR
ELA
ND
Pac
ker
AS
TE
LLA
S IR
ELA
ND
CO
.P
acke
r:A
ST
ELL
AS
IRE
LAN
D C
O.
LTD
, KIL
LOR
GLI
N, K
ER
RY
,IR
ELA
ND
LTD
, KIL
LOR
GLI
N, K
ER
RY
,IR
ELA
ND
Labo
rato
ry: F
PR
C:
AS
TE
LLA
S IR
ELA
ND
CO
.La
bora
tory
: FP
RC
:A
ST
ELL
AS
IRE
LAN
D C
O.
LTD
, KIL
LOR
GLI
N, K
ER
RY
,IR
ELA
ND
LTD
, KIL
LOR
GLI
N, K
ER
RY
,IR
ELA
ND
CO
NS
ULT
ING
CH
EM
ICA
LC
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
AT
OR
IES
,A
TLA
SV
ILLE
, BO
KS
BU
RG
,R
SA
LAB
OR
AT
OR
IES
,A
TLA
SV
ILLE
, BO
KS
BU
RG
,R
SA
FP
RR
:A
ST
ELL
AS
PH
AR
MA
(P
TY
)F
PR
R:
AS
TE
LLA
S P
HA
RM
A (
PT
Y)
LTD
, BE
DF
OR
DV
IEW
,JO
HA
NN
ES
BU
RG
, RS
ALT
D, B
ED
FO
RD
VIE
W,
JOH
AN
NE
SB
UR
G, R
SA
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)S
helf-
life:
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
42/2
.5/0
810
RE
ST
AN
TO
PIR
AM
AT
E 2
5 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:T
OP
IRA
MA
TE
25,0
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C
FP
RC
/FP
RR
: FP
RR
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
AD
CO
CK
ING
RA
M L
IMIT
ED
AC
TA
VIS
hf,
HA
FN
AR
FJO
RD
UR
,IC
ELA
ND
AC
TA
VIS
hf,
HA
FN
AR
FJO
RD
UR
,IC
ELA
ND
AC
TA
VIS
hf,
HA
FN
AR
FJO
RD
UR
,IC
ELA
ND
AD
CO
CK
ING
RA
M H
EA
LTH
CA
RE
(PT
Y)
LTD
, WA
DE
VIL
LE,
GE
RM
IST
ON
, RS
AA
DC
OC
K IN
GR
AM
LT
D,
RE
SE
AR
CH
AN
D D
EV
ELO
PM
EN
T,
AE
RO
TO
N, J
OH
AN
NE
SB
UR
G, R
SA
AD
CO
CK
ING
RA
M L
TD
, ER
AN
DG
AR
DE
NS
, MID
RA
ND
, RS
A
36 m
onth
s
27 J
ULY
201
2
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 43
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
42/2
.5/0
811
RE
ST
AN
TO
PIR
AM
AT
E 5
0 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
42/2
.5/0
812
RE
ST
AN
TO
PIR
AM
AT
E 1
00 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
42/2
.5/0
813
RE
ST
AN
TO
PIR
AM
AT
E20
0 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:T
OP
IRA
MA
TE
50,0
mg
TO
PIR
AM
AT
E10
0,0
mg
TO
PIR
AM
AT
E20
0,0
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
App
lican
t:A
DC
OC
K IN
GR
AM
LIM
ITE
DA
pplic
ant:
AD
CO
CK
ING
RA
M L
IMIT
ED
App
lican
t:A
DC
OC
K IN
GR
AM
LIM
ITE
D
Man
ufac
ture
r:A
CT
AV
IS h
f,H
AF
NA
RF
JOR
DU
R, I
CE
LAN
D
Man
ufac
ture
r:A
CT
AV
IS h
f,H
AF
NA
RF
JOR
DU
R, I
CE
LAN
D
Man
ufac
ture
r:A
CT
AV
IS h
f,H
AF
NA
RF
JOR
DU
R,
ICE
LAN
D
Pac
ker:
AC
TA
VIS
hf,
HA
FN
AR
FJO
RD
UR
, IC
ELA
ND
Pac
ker:
AC
TA
VIS
hf,
HA
FN
AR
FJO
RD
UR
, IC
ELA
ND
Pac
ker:
AC
TA
VIS
hf,
HA
FN
AR
FJO
RD
UR
,IC
ELA
ND
Labo
rato
ry: F
PR
C:
AC
TA
VIS
hf,
HA
FN
AR
FJO
RD
UR
, IC
ELA
ND
Labo
rato
ry:
FP
RC
:A
CT
AV
IS h
f,H
AF
NA
RF
JOR
DU
R, I
CE
LAN
DLa
bora
tory
: FP
RC
AC
TA
VIS
hf,
HA
FN
AR
FJO
RD
UR
,IC
ELA
ND
FP
RC
/FP
RR
:A
DC
OC
K IN
GR
AM
FP
RC
/ FP
RR
:A
DC
OC
K IN
GR
AM
FP
RC
/FP
RR
:A
DC
OC
K IN
GR
AM
HE
ALT
HC
AR
E (
PT
Y)
LTD
,W
AD
EV
ILLE
, GE
RM
IST
ON
, RS
AA
DC
OC
K IN
GR
AM
LT
D,
RE
SE
AR
CH
AN
DD
EV
ELO
PM
EN
T, A
ER
OT
ON
,JO
HA
NN
ES
BU
RG
, RS
A
HE
ALT
HC
AR
E (
PT
Y)
LTD
,W
AD
EV
ILLE
, GE
RM
IST
ON
,R
SA
AD
CO
CK
ING
RA
M L
TD
,R
ES
EA
RC
H A
ND
DE
VE
LOP
ME
NT
, AE
RO
TO
N,
JOH
AN
NE
SB
UR
G, R
SA
HE
ALT
HC
AR
E (
PT
Y)
LTD
,W
AD
EV
ILLE
, GE
RM
IST
ON
,R
SA
AD
CO
CK
ING
RA
M L
TD
,R
ES
EA
RC
H A
ND
DE
VE
LOP
ME
NT
,A
ER
OT
ON
,JO
HA
NN
ES
BU
RG
, RS
A
FP
RR
:A
DC
OC
K IN
GR
AM
LT
D, E
RA
ND
GA
RD
EN
S, M
IDR
AN
D, R
SA
FP
RR
:A
DC
OC
K IN
GR
AM
LT
D,
ER
AN
D G
AR
DE
NS
, MID
RA
ND
,R
SA
FP
RR
:A
DC
OC
K IN
GR
AM
LT
D,
ER
AN
D G
AR
DE
NS
,M
IDR
AN
D, R
SA
She
lf-lif
e:36
mon
ths
She
lf-lif
e:36
mon
ths
She
lf-lif
e:36
mon
ths
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
44 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15t.F
15
Reg
istr
atio
n nu
mbe
r:42
/21.
12/0
995
Reg
istr
atio
n nu
mbe
r:42
/21.
12/1
037
Reg
istr
atio
n nu
mbe
r:43
/21.
2/00
02
Nam
e of
med
icin
e:C
AS
TR
A 1
Nam
e of
med
icin
e:A
SP
EN
AN
AS
TR
OZ
OLE
Nam
e of
med
icin
e:G
LAM
AR
YL
CO
MB
I 1/2
50
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H T
AB
LET
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
NA
ST
RO
ZO
LE1,
0 m
gA
NA
ST
RO
ZO
LE1,
0 m
gG
LIM
EP
IRID
E1,
0 m
gM
ET
FO
RM
IN H
YD
RO
CH
LOR
IDE
250,
0 m
g
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8
App
lican
t:Z
YD
US
HE
ALT
HC
AR
E S
A (
PT
Y)
LTD
App
lican
t:P
HA
RM
AC
AR
E L
IMIT
ED
App
lican
t:W
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
LTD
Man
ufac
ture
r:Z
YD
US
CA
DIL
A H
EA
LTH
CA
RE
LT
D,
MO
RA
IYA
, SA
NA
ND
, AH
ME
DA
BA
D,
IND
IA
Man
ufac
ture
r:H
AU
PT
PH
AR
MA
MU
NS
TE
R G
mbH
,M
UN
ST
ER
, GE
RM
AN
YP
HA
RM
AC
AR
E L
IMIT
ED
, KO
RS
TE
N, P
OR
T
Man
ufac
ture
r:H
AN
DO
K P
HA
RM
AC
EU
TIC
ALS
Co
LTD
,E
UM
SE
ON
G-G
UN
,C
HU
NG
CH
EO
NG
BU
K-D
O, K
OR
EA
ELI
ZA
BE
TH
, RS
AA
SP
EN
PH
AR
MA
CA
RE
EA
ST
LO
ND
ON
,W
ILS
ON
IA, E
AS
T L
ON
DO
N, R
SA
Pac
ker:
ZY
DU
S C
AD
ILA
HE
ALT
HC
AR
E L
TD
,M
OR
AIY
A, S
AN
AN
D, A
HM
ED
AB
AD
,IN
DIA
Pac
ker:
HA
UP
T P
HA
RM
A M
UN
ST
ER
Gm
bH,
MU
NS
TE
R, G
ER
MA
NY
PH
AR
MA
CA
RE
LIM
ITE
D, K
OR
ST
EN
, PO
RT
Pac
ker:
HA
ND
OK
PH
AR
MA
CE
UT
ICA
LS C
o LT
D,
EU
MS
EO
NG
-GU
N,
CH
UN
GC
HE
ON
GB
UK
-DO
, KO
RE
AE
LIZ
AB
ET
H, R
SA
AS
PE
N P
HA
RM
AC
AR
E E
AS
T L
ON
DO
N,
WIL
SO
NIA
, EA
ST
LO
ND
ON
, RS
A
WIN
TH
RO
P P
HA
RM
AC
EU
TIC
ALS
,(P
TY
) LT
D, W
ALT
LOO
, PR
ET
OR
IA, R
SA
Labo
rato
ry: F
PR
C:
ZY
DU
S C
AD
ILA
HE
ALT
HC
AR
E L
TD
,M
OR
AIY
A, S
AN
AN
D, A
HM
ED
AB
AD
,IN
DIA
RE
SE
AR
CH
INS
TIT
UT
E F
OR
Labo
rato
ry:
FP
RC
:S
AB
S C
OM
ME
RC
IAL
(PT
Y)
LTD
,P
HA
RM
AC
EU
TIC
AL
CH
EM
IST
RY
DE
PA
RT
ME
NT
, GR
OE
NK
LOO
F,
PR
ET
OR
IA, R
SA
Labo
rato
ry: F
PR
CH
AN
DO
K P
HA
RM
AC
EU
TIC
ALS
Co
LTD
,E
UM
SE
ON
G-G
UN
,C
HU
NG
CH
EO
NG
BU
K-D
O, K
OR
EA
IND
US
TR
IAL
PH
AR
MA
CY
, NO
RT
H-
WE
ST
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
M &
L L
AB
OR
AT
OR
Y S
ER
VIC
ES
(P
TY
)LT
D, L
IMB
RO
BU
SIN
ES
S P
AR
K,
SA
ND
TO
N, R
SA
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
LR
ES
EA
RC
H IN
ST
ITU
TE
FO
R IN
DU
ST
RIA
LS
ER
VIC
ES
, SIL
VE
RT
ON
DA
LE,
PR
ET
OR
IA, R
SA
PH
AR
MA
CY
,NO
RT
H-W
ES
T U
NIV
ER
SIT
Y,
PO
TC
HE
FS
TR
OO
M, R
SA
PH
AR
MA
SP
EC
LA
BO
RA
TO
RIE
S,
FE
RN
DA
LE, R
AN
DB
UR
G, R
SA
FP
RR
:Z
YD
US
HE
ALH
CA
RE
SA
(P
TY
) LT
D,
VA
N D
ER
HO
FF
PA
RK
,P
OT
CH
EF
ST
RO
OM
, RS
A
FP
RC
/FP
RR
:P
HA
RM
AC
AR
E L
IMIT
ED
, KO
RS
TE
N, P
OR
TE
LIZ
AB
ET
H, R
SA
AS
PE
N P
HA
RM
AC
AR
E E
AS
T L
ON
DO
N,
WIL
SO
NIA
, EA
ST
LO
ND
ON
, RS
A
FP
RC
/FP
RR
:W
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LS,
(PT
Y)
LTD
WA
LTLO
O, P
RE
TO
RIA
, RS
A
She
lf-lif
e:24
mon
ths
FP
RR
:P
HA
RM
AC
AR
E L
IMIT
ED
, WO
OD
ME
AD
,S
AN
DT
ON
, RS
AF
PR
R:
WIN
TH
RO
P P
HA
RM
AC
EU
TIC
ALS
,(P
TY
) LT
D M
IDR
AN
D,
JOH
AN
NE
SB
UR
G, R
SA
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
She
lf-lif
e:48
mon
ths
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
0
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 45
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:43
/21.
2/00
03R
egis
trat
ion
num
ber:
43/2
1.2/
0004
Reg
istr
atio
n nu
mbe
r:43
/21.
2/00
05
Nam
e of
med
icin
e:G
LAM
AR
YL
CO
MB
I 2/5
00N
ame
of m
edic
ine:
AM
AR
YL
CO
MB
I 1/2
50N
ame
of m
edic
ine:
AM
AR
YL
CO
MB
I 2/5
00
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H T
AB
LET
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:G
LIM
EP
IRID
E 2
,0 m
gG
LIM
EP
IRID
E1,
0 m
gG
LIM
EP
IRID
E 2
,0 m
gM
ET
FO
RM
INM
ET
FO
RM
INM
ET
FO
RM
INH
YD
RO
CH
LOR
IDE
500
,0 m
gH
YD
RO
CH
LOR
IDE
250
,0 m
gH
YD
RO
CH
LOR
IDE
500
,0 m
g
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7, 8
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8
App
lican
t:W
INT
HR
OP
App
lican
t:S
AN
OF
I-A
VE
NT
IS S
OU
TH
App
lican
t:S
AN
OF
I-A
VE
NT
IS S
OU
TH
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
AF
RIC
A (
PT
Y)
LTD
AF
RIC
A (
PT
Y)
LTD
LTD
Man
ufac
ture
r:H
AN
DO
KM
anuf
actu
rer:
HA
ND
OK
PH
AR
MA
CE
UT
ICA
LSM
anuf
actu
rer:
HA
ND
OK
PH
AR
MA
CE
UT
ICA
LS C
o LT
D,
EU
MS
EO
NG
-GU
N,
CH
UN
GC
HE
ON
GB
UK
-DO
,K
OR
EA
Co
LTD
, EU
MS
EO
NG
-G
UN
,C
HU
NG
CH
EO
NG
BU
K-D
O,
KO
RE
A
PH
AR
MA
CE
UT
ICA
LS C
oLT
D, E
UM
SE
ON
G-G
UN
,C
HU
NG
CH
EO
NG
BU
K-D
O,
KO
RE
A
Pac
ker:
HA
ND
OK
Pac
ker:
HA
ND
OK
PH
AR
MA
CE
UT
ICA
LSP
acke
r:H
AN
DO
KP
HA
RM
AC
EU
TIC
ALS
Co
LTD
,E
UM
SE
ON
G-G
UN
,C
HU
NG
CH
EO
NG
BU
K-D
O,
KO
RE
A
Co
LTD
, EU
MS
EO
NG
-GU
N,
CH
UN
GC
HE
ON
GB
UK
-DO
,K
OR
EA
WIN
TH
RO
P
PH
AR
MA
CE
UT
ICA
LS C
oLT
D, E
UM
SE
ON
G-G
UN
,C
HU
NG
CH
EO
NG
BU
K-D
O,
KO
RE
AW
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LS, (
PT
Y)
WIN
TH
RO
PP
HA
RM
AC
EU
TIC
ALS
, (P
TY
)LT
D, W
ALT
LOO
, PR
ET
OR
IA,
RS
A
LTD
WA
LTLO
O, P
RE
TO
RIA
,R
SA
PH
AR
MA
CE
UT
ICA
LS, (
PT
Y)
LTD
WA
LTLO
O, P
RE
TO
RIA
,R
SA
Labo
rato
ry: F
PR
C:
HA
ND
OK
Labo
rato
ry: F
PR
C:
HA
ND
OK
PH
AR
MA
CE
UT
ICA
LSLa
bora
tory
: FP
RC
HA
ND
OK
PH
AR
MA
CE
UT
ICA
LS C
o LT
D,
EU
MS
EO
NG
-GU
N,
CH
UN
GC
HE
ON
GB
UK
-DO
,K
OR
EA
Co
LTD
, EU
MS
EO
NG
-GU
N,
CH
UN
GC
HE
ON
GB
UK
-DO
,K
OR
EA
PH
AR
MA
CE
UT
ICA
LS C
OLT
D, E
UM
SE
ON
G-G
UN
,C
HU
NG
CH
EO
NG
BU
K-D
O,
KO
RE
A
FP
RC
/FP
RR
:W
INT
HR
OP
FP
RC
/FP
RR
:W
INT
HR
OP
FP
RC
/FP
RR
:W
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LS, (
PT
Y)
PH
AR
MA
CE
UT
ICA
LS, (
PT
Y)
PH
AR
MA
CE
UT
ICA
LS, (
PT
Y)
LTD
WA
LTLO
O, P
RE
TO
RIA
,R
SA
LTD
WA
LTLO
O, P
RE
TO
RIA
,R
SA
LTD
WA
LTLO
O, P
RE
TO
RIA
,R
SA
FP
RR
:W
INT
HR
OP
FP
RR
:S
AN
OF
I-A
VE
NT
IS S
.A. (
PT
Y)
FP
RR
:S
AN
OF
I-A
VE
NT
IS S
.A.
PH
AR
MA
CE
UT
ICA
LS, (
PT
Y)
LTD
MID
RA
ND
,JO
HA
NN
ES
BU
RG
, RS
A
LTD
, MID
RA
ND
,JO
HA
NN
ES
BU
RG
, RS
A(P
TY
) LT
D, M
IDR
AN
D,
JOH
AN
NE
SB
UR
G, R
SA
She
lf-lif
e:24
mon
ths
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)S
helf-
life:
24 m
onth
s(P
rovi
sion
al)
(Pro
visi
onal
)
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
46 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:43
/21.
12/0
074
Reg
istr
atio
n nu
mbe
r:43
/5.7
.1/0
079
Reg
istr
atio
n nu
mbe
r:43
/26/
0102
Nam
e of
med
icin
e:A
NA
MA
ST
1 m
gN
ame
of m
edic
ine:
AD
CO
DE
SLO
RA
TA
DIN
E S
YR
UP
Nam
e of
med
icin
e:O
XA
LIP
LAT
IN P
CH
50
Dos
age
form
:T
AB
LET
Dos
age
form
:S
YR
UP
Dos
age
form
:C
ON
CE
NT
RA
TE
FO
R S
OLU
TIO
N F
OR
INF
US
ION
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H 5
,0 m
l SY
RU
P C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H 1
0,0
ml V
IAL
CO
NT
AIN
S:
AN
AS
TR
AZ
OLE
1,0
mg
DE
SLO
RA
TA
DIN
E2,
5 m
gO
XA
LIP
LAT
IN 5
0,0
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7, 8
Con
ditio
ns o
f
regi
stra
tion:
1, 2
, 3, 4
, 5, 6
, 7, 8
App
lican
t:S
AN
DO
Z S
A (
PT
Y)
LTD
App
lican
t:A
DC
OC
K IN
GR
AM
LIM
ITE
DA
pplic
ant"
PH
AR
MA
CH
EM
IE (
PT
Y)
LTD
Man
ufac
ture
r:S
ALU
TA
S P
HA
RM
A G
mbH
,B
AR
LEB
EN
, GE
RM
AN
YM
anuf
actu
rer:
AD
CO
CK
ING
RA
M H
EA
LTH
CA
RE
(P
TY
)LT
D (
WA
DE
VIL
LE),
WA
DE
VIL
LE,
GE
RM
IST
ON
, RS
A
Man
ufac
ture
r:P
HA
RM
AC
HE
MIE
B.V
, HA
AR
LEM
, TH
EN
ET
HE
RLA
ND
S
PH
AR
MA
-Q (
PT
Y)
LTD
, IN
DU
ST
RIA
,JO
HA
NN
ES
BU
RG
, RS
A
Pac
ker:
SA
LUT
AS
PH
AR
MA
Gm
bH,
BA
RLE
BE
N, G
ER
MA
NY
SA
ND
OZ
SA
(P
TY
) LT
D, S
PA
RT
AN
,K
EM
PT
ON
PA
RK
Pac
ker:
AD
CO
CK
ING
RA
M H
EA
LTH
CA
RE
(P
TY
)LT
D (
WA
DE
VIL
LE),
WA
DE
VIL
LE,
GE
RM
IST
ON
, RS
AP
HA
RM
A-Q
(P
TY
) LT
D, I
ND
US
TR
IA,
JOH
AN
NE
SB
UR
G, R
SA
Pac
ker:
PH
AR
MA
CH
EM
IE B
.V, H
AA
RLE
M, T
HE
NE
TH
ER
LAN
DS
Labo
rato
ry: F
PR
C:
SA
LUT
AS
PH
AR
MA
Gm
bH,
BA
RLE
BE
N, G
ER
MA
NY
Labo
rato
ry: F
PR
C:
PH
AR
MA
-Q (
PT
Y)
LTD
, IN
DU
ST
RIA
,JO
HA
NN
ES
BU
RG
, RS
ALa
bora
tory
: FP
RC
PH
AR
MA
CH
EM
IE B
.V, H
AA
RLE
M, T
HE
NE
TH
ER
LAN
DS
SA
ND
OZ
SA
(P
TY
) LT
D, S
PA
RT
AN
,K
EM
PT
ON
PA
RK
SA
BS
CO
MM
ER
CIA
L (P
TY
) LT
D,
PH
AR
MA
CE
UT
ICA
L C
HE
MIS
TR
YS
AB
S C
OM
ME
RC
IAL
(PT
Y)
LTD
PH
AR
MA
CE
UT
ICA
L C
HE
MIS
TR
YD
EP
AR
TM
EN
T, G
RO
EN
KLO
OF
,P
RE
TO
RIA
, RS
AD
EP
AR
TM
EN
T G
RO
EN
KLO
OF
,P
RE
TO
RIA
, RS
AR
ES
EA
RC
H IN
ST
ITU
TE
FO
R IN
DU
ST
RIA
LP
HA
RM
AC
Y,N
OR
TH
WE
ST
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
, RS
AC
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
AT
OR
IES
(P
TY
) LT
D A
TLA
SV
ILLE
,B
OK
SB
UR
G, R
SA
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
LS
ER
VIC
ES
, SIL
VE
RT
ON
DA
LE,
PR
ET
OR
IA, R
SA
FP
RR
:S
AN
DO
Z S
A (
PT
Y)
LTD
, SP
AR
TA
N,
KE
MP
TO
N P
AR
KF
PR
C/F
PR
R:
AD
CO
CK
ING
RA
M H
EA
LTH
CA
RE
(P
TY
)LT
D (
WA
DE
VIL
LE),
WA
DE
VIL
LE,
GE
RM
IST
ON
, RS
A
FP
RR
:P
HA
RM
AC
HE
MIE
(P
TY
) LT
D, R
UIM
SIG
,R
OO
DE
PO
OR
T, G
AU
TE
NG
, RS
A
AD
CO
CK
ING
RA
M L
IMIT
ED
(RE
SE
AR
CH
& D
EV
ELO
PM
EN
T),
AE
RO
TO
N, J
OH
AN
NE
SB
UR
G, R
SA
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)F
PR
R;
AD
CO
CK
ING
RA
M L
TD
, ER
AN
DS
helf-
life:
24 m
onth
s (P
rovi
sion
al)
GA
RD
EN
S, M
IDR
AN
D, R
SA
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)D
ate
of r
egis
trat
ion:
27 J
ULY
201
2
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 47
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker
Labo
rato
ry: F
PR
C:
FP
RR
:
She
lf-lif
e:
43/2
6/01
03
OX
ALI
PLA
TIN
PC
H 1
00
CO
NC
EN
TR
AT
E F
OR
SO
LUT
ION
FO
RIN
FU
SIO
N
EA
CH
20,
0 m
l VIA
L C
ON
TA
INS
:O
XA
LIP
LAT
IN 1
00,0
mg
1, 2
, 3, 4
, 5, 6
, 7, 8
PH
AR
MA
CH
EM
IE (
PT
Y)
LTD
PH
AR
MA
CH
EM
IE B
.V, H
AA
RLE
M, T
HE
NE
TH
ER
LAN
DS
PH
AR
MA
CH
EM
IE B
.V, H
AA
RLE
M, T
HE
NE
TH
ER
LAN
DS
PH
AR
MA
CH
EM
IE B
.V, H
AA
RLE
M, T
HE
NE
TH
ER
LAN
DS
SA
BS
CO
MM
ER
CIA
L (P
TY
) LT
D,
PH
AR
MA
CE
UT
ICA
L C
HE
MIS
TR
YD
EP
AR
TM
EN
T, G
RO
EN
KLO
OF
,P
RE
TO
RIA
, RS
AR
ES
EA
RC
H IN
ST
ITU
TE
FO
R IN
DU
ST
RIA
LP
HA
RM
AC
Y,N
OR
TH
WE
ST
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
, RS
AC
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
AT
OR
IES
(PT
Y)
LTD
AT
LAS
VIL
LE, B
OK
SB
UR
G, R
SA
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
LS
ER
VIC
ES
, SIL
VE
RT
ON
DA
LE, P
RE
TO
RIA
,R
SA
PH
AR
MA
CH
EM
IE (
PT
Y)
LTD
, RU
IMS
IG,
RO
OD
EP
OO
RT
, GA
UT
EN
G, R
SA
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
MR
F15
Reg
istr
atio
n nu
mbe
r
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
2F 1
5
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker
Labo
rato
ry:
FP
RC
:
FP
RC
/FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
43/3
0.1/
0127
PR
IOR
IX T
ET
RA
PO
WD
ER
AN
D D
ILU
EN
T F
OR
SO
LUT
ION
FO
R IN
JEC
TIO
N
EA
CH
0,5
ml C
ON
TA
INS
:Li
ve a
ttenu
ated
mea
sles
viru
s (S
chw
arz
stra
in)
a101
°CC
ID5o
Live
atte
nuat
ed m
umps
viru
s (R
IT43
85 s
trai
n).1
044C
CID
5oLi
ve a
ttenu
ated
rub
ella
viru
s (W
ista
r R
A 2
7/3
stra
in)
z10"
CC
ID50
Live
atte
nuat
ed v
aric
ella
viru
s (O
KA
str
ain)
PF
U
1, 2
, 3, 4
, 5, 6
, 7
GLA
XO
SM
ITH
KLI
NE
SA
(P
TY
) LT
D
GLA
XO
SM
ITH
KLI
NE
BIO
LOG
ICA
LS S
.A,
RIX
EN
SA
RT
, BE
LGIU
MS
AC
HS
ISC
HE
S S
ER
UW
ER
K D
RE
SD
EN
, NI
der
SM
ITH
KLI
NE
BE
EC
HA
M P
HA
RM
A G
mbH
, DR
ES
DE
N,
GE
RM
AN
Y
GLA
XO
SM
ITH
KLI
NE
BIO
LOG
ICA
LS S
.A,
WA
VR
E, B
ELG
IUM
SA
CH
SIS
CH
ES
SE
RU
WE
RK
DR
ES
DE
N, N
Ide
r S
MIT
HK
LIN
EB
EE
CH
AM
PH
AR
MA
Gm
bH, D
RE
SD
EN
,G
ER
MA
NY
GLA
XO
SM
ITH
KLI
NE
SA
(P
TY
) LT
D,
EP
PIN
G, C
AP
E T
OW
N, R
SA
GLA
XO
SM
ITH
KLI
NE
BIO
LOG
ICA
LS S
.A,
RIX
EN
SA
RT
, BE
LGIU
MG
LAX
OS
MIT
HK
LIN
E B
IOLO
GIC
ALS
S.A
,W
AV
RE
, BE
LGIU
M
GLA
XO
SM
ITH
KLI
NE
SA
(P
TY
) LT
D,
EP
PIN
G, C
AP
E T
OW
N, R
SA
60 m
onth
s (D
iluen
t sto
red
at o
r be
low
25
°C)
24 m
onth
s (P
rodu
ct s
tore
d at
-20
°C
18 m
onth
s (P
rodu
ct s
tore
d at
2 -
8 °C
In-u
se s
helf-
life
of 2
4 ho
urs
for
prod
uct s
tore
dat
2 -
8 °C
27 J
ULY
201
2
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
43/2
1.2/
0140
AC
CO
RD
PIO
GLI
TA
ZO
NE
15
mg
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:P
IOG
LIT
AZ
ON
EH
YD
RO
CH
LOR
IDE
EQ
UIV
ALE
NT
TO PIO
GLI
TA
ZO
NE
15,0
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8
App
lican
t:A
CC
OR
D H
EA
LTH
CA
RE
(P
TY
)LT
D
Man
ufac
ture
r
Pac
ker:
Labo
rato
ry: F
PR
C
FP
RR
:
She
lf-lif
e:
INT
AS
PH
AR
MA
CE
UT
ICA
LSLI
MIT
ED
, MA
TO
DA
, TA
LUK
A,
AH
ME
DA
BA
D, G
UJA
RA
T, I
ND
IA
INT
AS
PH
AR
MA
CE
UT
ICA
LSLI
MIT
ED
, MA
TO
DA
, TA
LUK
A,
AH
ME
DA
BA
D, G
UJA
RA
T, I
ND
IA
INT
AS
PH
AR
MA
CE
UT
ICA
LSLI
MIT
ED
, MA
TO
DA
, TA
LUK
A,
AH
ME
DA
BA
D, G
UJA
RA
T, I
ND
IAC
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
AT
OR
IES
(P
TY
) LT
D,
AT
LAS
VIL
LE, B
OK
SB
UR
G, R
SA
AC
CO
RD
HE
ALT
HC
AR
E (
PT
Y)
LTD
, RIV
ON
IA, G
AU
TE
NG
, RS
A
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
48 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15A
RF
15
Reg
istr
atio
n nu
mbe
r:43
/21.
2/01
41R
egis
trat
ion
num
ber:
43/2
1.2/
0142
Reg
istr
atio
n nu
mbe
r:43
/20.
1.1/
0310
Nam
e of
med
icin
e:A
CC
OR
D P
IOG
LIT
AZ
ON
E 3
0 m
gN
ame
of m
edic
ine:
AC
CO
RD
PIO
GL
ITA
ZO
NE
45
mg
Nam
e of
med
icin
e:B
AC
TR
ICE
F 1
g
Dos
age
form
:T
AB
LE
TD
osag
e fo
rm:
TA
BL
ET
Dos
age
form
:P
OW
DE
R F
OR
INJE
CT
ION
Act
ive
ingr
edie
nts:
EA
CH
TA
BL
ET
CO
NT
AIN
S:A
ctiv
e in
gred
ient
s:E
AC
H T
AB
LE
T C
ON
TA
INS:
Act
ive
ingr
edie
nts:
EA
CH
VIA
L C
ON
TA
INS
:
PIO
GL
ITA
ZO
NE
PIO
GL
ITA
ZO
NE
CE
FE
PIM
E H
YD
RO
CH
LOR
IDE
EQ
UIV
ALE
NT
TO
HY
DR
OC
HL
OR
IDE
HY
DR
OC
HL
OR
IDE
CE
FE
PIM
E 1
000
,0 m
gE
QU
IVA
LE
NT
TO
EQ
UIV
AL
EN
T T
OPI
OG
LIT
AZ
ON
E 3
0,0
mg
PIO
GL
ITA
ZO
NE
45,
0 m
gC
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7, 8
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7, 8
App
lican
t:A
CC
OR
D H
EA
LT
HC
AR
E (
PTY
)A
pplic
ant:
AC
CO
RD
HE
AL
TH
CA
RE
(PT
Y)
App
lican
t:P
HA
RM
AC
AR
E L
IMIT
ED
LT
DL
TD
Man
ufac
ture
rIN
TA
S PH
AR
MA
CE
UT
ICA
LS
LIM
ITE
D, M
AT
OD
A, T
AL
UK
A,
Man
ufac
ture
rIN
TA
S PH
AR
MA
CE
UT
ICA
LS
LIM
ITE
D, M
AT
OD
A, T
AL
UK
A,
Man
ufac
ture
r:S
TR
IDE
S A
RC
OLA
B L
IMIT
ED
,A
NE
KA
L T
ALU
K, B
AN
GA
LOR
E, I
ND
IA
AH
ME
DA
BA
D, G
UJA
RA
T, I
ND
IAA
HM
ED
AB
AD
, GU
JAR
AT
,IN
DIA
Pac
ker:
INT
AS
PHA
RM
AC
EU
TIC
AL
SL
IMIT
ED
, MA
TO
DA
, TA
LU
KA
,
Pac
ker:
INT
AS
PHA
RM
AC
EU
TIC
AL
SL
IMIT
ED
, MA
TO
DA
, TA
LU
KA
,
Pac
ker:
ST
RID
ES
AR
CO
LAB
LIM
ITE
D,
AN
EK
AL
TA
LUK
, BA
NG
ALO
RE
, IN
DIA
PH
AR
MA
CA
RE
LT
D, K
OR
TS
EN
,A
HM
ED
AB
AD
, GU
JAR
AT
, IN
DIA
AH
ME
DA
BA
D, G
UJA
RA
T,
IND
IAP
OR
T E
LIZ
AB
ET
H, R
SA
AS
PE
N P
HA
RM
AC
AR
E E
AS
TLO
ND
ON
, WIL
SO
NIA
, EA
ST
LO
ND
ON
,R
SA
Labo
rato
ry: F
PR
C:
INT
AS
PHA
RM
AC
EU
TIC
AL
SL
IMIT
ED
, MA
TO
DA
, TA
LU
KA
,
Labo
rato
ry:
FP
RC
:IN
TA
S PH
AR
MA
CE
UT
ICA
LS
LIM
ITE
D, M
AT
OD
A, T
AL
UK
A,
Labo
rato
ry: F
PR
CS
TR
IDE
S A
RC
OLA
B L
IMIT
ED
,A
NE
KA
L T
ALU
K, B
AN
GA
LOR
E, I
ND
IAS
AB
S C
OM
ME
RC
IAL
(PT
Y)
LTD
,A
HM
ED
AB
AD
, GU
JAR
AT
, IN
DIA
CO
NSU
LT
ING
CH
EM
ICA
LL
AB
OR
AT
OR
IES
(PT
Y)
LT
D,
AH
ME
DA
BA
D, G
UJA
RA
T,
IND
IAC
ON
SUL
TIN
G C
HE
MIC
AL
PH
AR
MA
CE
UT
ICA
L C
HE
MIS
TR
YD
EP
AR
TM
EN
T, G
RO
EN
KLO
OF
,P
RE
TO
RIA
, RS
AR
ES
EA
RC
H IN
ST
ITU
TE
FO
RA
TL
ASV
ILL
E, B
OK
SBU
RG
, RSA
LA
BO
RA
TO
RIE
S (P
TY
) L
TD
,A
TL
ASV
ILL
E, B
OK
SBU
RG
,R
SA
IND
US
TR
IAL
PH
AR
MA
CY
, NO
RT
H-
WE
ST
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
, RS
AM
&L
LAB
OR
AT
OR
Y S
ER
VIC
ES
, (P
TY
)LT
D, L
IMB
RO
BU
SIN
ES
S P
AR
K,
SA
ND
TO
N, R
SA
FP
RR
:A
CC
OR
D H
EA
LT
HC
AR
E (
PTY
)L
TD
, RIV
ON
IA, G
AU
TE
NG
, RSA
FP
RR
:A
CC
OR
D H
EA
LT
HC
AR
E (
PTY
)L
TD
, RIV
ON
IA, G
AU
TE
NG
, RSA
FP
RC
/FP
RR
:P
HA
RM
AC
AR
E L
TD
, KO
RT
SE
N,
PO
RT
ELI
ZA
BE
TH
, RS
AA
SP
EN
PH
AR
MA
CA
RE
EA
ST
LON
DO
N, W
ILS
ON
IA, E
AS
T L
ON
DO
N,
RS
A
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)S
helf-
life:
24 m
onth
s (P
rovi
sion
al)
FP
RR
:P
HA
RM
AC
AR
E L
TD
, WO
OD
ME
AD
,S
AN
DT
ON
, RS
A
Dat
e of
reg
istr
atio
n:27
JUL
Y 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY
201
2S
helf-
life:
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 49
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:43
/20.
2.8/
0433
Reg
istr
atio
n nu
mbe
r:43
/5.1
0/05
42R
egis
trat
ion
num
ber:
43/5
.10/
0543
Nam
e of
med
icin
e:V
ALC
YT
E 5
0 m
g/m
lN
ame
of m
edic
ine:
ON
DA
NS
ET
RO
N F
RE
SE
NIU
SN
ame
of m
edic
ine:
ON
DA
NS
ET
RO
N F
RE
SE
NIU
S2
mg/
ml (
4 m
g/2
ml)
2 m
g/m
l (8
mg/
4 m
l)
Dos
age
form
:P
OW
DE
R F
OR
OR
AL
SO
LUT
ION
Dos
age
form
:S
OLU
TIO
N F
OR
INJE
CT
ION
Dos
age
form
:S
OLU
TIO
N F
OR
INJE
CT
ION
Act
ive
ingr
edie
nts:
EA
CH
1,0
ml S
OLU
TIO
N C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H A
MP
OU
LE C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H A
MP
OU
LE C
ON
TA
INS
:V
alga
ncic
lovi
r hy
droc
hlor
ide
equi
vale
nt to
Val
ganc
iclo
vir
50,0
mg
ON
DA
NS
ET
RO
NH
YD
RO
CH
LOR
IDE
DIH
YD
RA
TE
ON
DA
NS
ET
RO
NH
YD
RO
CH
LOR
IDE
DIH
YD
RA
TE
EQ
UIV
ALE
NT
TO
ON
DA
NS
EN
TR
ON
EQ
UIV
ALE
NT
TO
4,0
mg
ON
DA
NS
EN
TR
ON
8,0
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7, 8
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8
App
lican
t:R
OC
HE
PR
OD
UC
TS
(P
TY
) LT
DA
pplic
ant:
FR
ES
EN
IUS
KA
BI S
OU
TH
AF
RIC
AA
pplic
ant:
FR
ES
EN
IUS
KA
BI S
OU
TH
(PT
Y)
LTD
AF
RIC
A (
PT
Y)
LTD
Man
ufac
ture
r:P
AN
TH
EO
N IN
C, M
ISS
ISS
AU
GA
,O
NT
AR
IO, C
AN
AD
AM
anuf
actu
rer:
LAB
ES
FA
L, L
AB
OR
AT
OR
IOS
ALI
RO
S.A
, FR
ES
EN
IUS
KA
BI G
RO
UP
,S
AN
TIA
GO
DE
BE
ST
EIR
OS
,P
OR
TU
GA
L
Man
ufac
ture
r:LA
BE
SF
AL,
LA
BO
RA
TO
RIO
SA
LIR
O S
.A, F
RE
SE
NIU
S K
AB
IG
RO
UP
, SA
NT
IAG
O D
EB
ES
TE
IRO
S, P
OR
TU
GA
L
Pac
ker:
PA
TH
EO
N IN
C, M
ISS
ISS
AU
GA
,O
NT
AR
IO, C
AN
AD
AF
. HO
FF
MA
NN
-LA
RO
CH
E L
TD
,K
AIS
ER
AU
GS
T S
WIT
ZE
RLA
ND
Pac
ker:
LAB
ES
FA
L, L
AB
OR
AT
OR
IOS
ALI
RO
S.A
, FR
ES
EN
IUS
KA
BI G
RO
UP
,S
AN
TIA
GO
DE
BE
ST
EIR
OS
,P
OR
TU
GA
L
Pac
ker:
LAB
ES
FA
L, L
AB
OR
AT
OR
IOS
ALI
RO
S.A
, FR
ES
EN
IUS
KA
BI
GR
OU
P, S
AN
TIA
GO
DE
BE
ST
EIR
OS
, PO
RT
UG
AL
AK
AC
IA H
EA
LTH
CA
RE
(P
TY
) LT
D,
ISA
ND
O, J
OH
AN
NE
SB
UR
G, R
SA
Labo
rato
ry: F
PR
C:
PA
TH
EO
N IN
C, M
ISS
ISS
AU
GA
,O
NT
AR
IO, C
AN
AD
AR
OC
HE
PH
AR
MA
AG
, GR
EN
ZA
CH
-W
YH
LEN
, GE
RM
AN
Y
Labo
rato
ry:
FP
RC
:LA
BE
SF
AL,
LA
BO
RA
TO
RIO
S A
LIR
OS
.A, F
RE
SE
NIU
S K
AB
I GR
OU
P,
SA
NT
IAG
O D
E B
ES
TE
IRO
S,
PO
RT
UG
AL
Labo
rato
ry: F
PR
CLA
BE
SF
AL,
LA
BO
RA
TO
RIO
SA
LIR
O S
.A, F
RE
SE
NIU
S K
AB
IG
RO
UP
, SA
NT
IAG
O D
EB
ES
TE
IRO
S, P
OR
TU
GA
LA
KA
CIA
HE
ALT
H C
AR
E (
PT
Y)
LTD
,IS
AN
DO
, JO
HA
NN
ES
BU
RG
, RS
AS
AB
S C
OM
ME
RC
IAL
(PT
Y)
LTD
,P
HA
RM
AC
EU
TIC
AL
CH
EM
IST
RY
SA
BS
CO
MM
ER
CIA
L (P
TY
) LT
D,
PH
AR
MA
CE
UT
ICA
LD
EP
AR
TM
EN
T, G
RO
EN
KLO
OF
,P
RE
TO
RIA
, RS
AK
HU
LULE
KA
NI L
AB
OR
AT
OR
Y
CH
EM
IST
RY
DE
PA
RT
ME
NT
,G
RO
EN
KLO
OF
, PR
ET
OR
IA,
RS
AS
ER
VIC
ES
, RA
ND
JES
PA
RK
,M
IDR
AN
D, R
SA
KH
ULU
LEK
AN
I LA
BO
RA
TO
RY
SE
RV
ICE
S, R
AN
DJE
SP
AR
K,
MID
RA
ND
, RS
A
FP
RR
:R
OC
HE
PR
OD
UC
TS
(P
TY
) LT
D,
ILLO
VO
, JO
HA
NN
ES
BU
RG
, RS
AF
PR
R:
FR
ES
EN
IUS
KA
BI S
OU
TH
AF
RIC
A(P
TY
) LT
D, H
ALF
WA
Y H
OU
SE
,M
IDR
AN
D, R
SA
FP
RR
:F
RE
SE
NIU
S K
AB
I SO
UT
HA
FR
ICA
(P
TY
) LT
D, H
ALF
WA
YH
OU
SE
, MID
RA
ND
, RS
A
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)S
helf-
life:
24 m
onth
s (P
rovi
sion
al)
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
50 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15M
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:43
/5.4
.1/0
622
Reg
istr
atio
n nu
mbe
r:43
/5.4
.1/0
623
Reg
istr
atio
n nu
mbe
r:43
/5.4
.1/0
624
Nam
e of
med
icin
e:P
RA
ME
X 0
,5N
ame
of m
edic
ine:
PR
AM
EX
0,2
5N
ame
of m
edic
ine:
PR
AM
EX
0,1
25
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
,Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H T
AB
LET
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:P
RA
MIP
EX
OLE
DIH
YD
RO
CH
LOR
IDE
PR
AM
IPE
XO
LEP
RA
MIP
EX
OLE
0,5
mg
DIH
YD
RO
CH
LOR
IDE
0,2
5 m
gD
IHY
DR
OC
HLO
RID
E 0
,125
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
App
lican
t:A
KA
CIA
HE
ALT
HC
AR
E (
PT
Y)
LTD
App
lican
t:A
KA
CIA
HE
ALT
HC
AR
E (
PT
Y)
LTD
App
lican
t:A
KA
CIA
HE
ALT
HC
AR
E (
PT
Y)
LTD
Man
ufac
ture
r:P
HA
RM
AT
HE
N S
.A.,
PA
LLIN
I,A
TT
IKIS
, GR
EE
CE
Man
ufac
ture
r:P
HA
RM
AT
HE
N S
.A.,
PA
LLIN
I,A
TT
IKIS
, GR
EE
CE
Man
ufac
ture
r:P
HA
RM
AT
HE
N S
.A.,
PA
LLIN
I,A
TT
IKIS
, GR
EE
CE
Pac
ker:
PH
AR
MA
TH
EN
S.A
., P
ALL
INI,
AT
TIK
IS, G
RE
EC
EP
acke
r:P
HA
RM
AT
HE
N S
.A.,
PA
LLIN
I,A
TT
IKIS
, GR
EE
CE
Pac
ker:
PH
AR
MA
TH
EN
S.A
., P
ALL
INI,
AT
TIK
IS, G
RE
EC
EF
AM
AR
S.A
., A
NT
HO
US
A, A
TT
IKIS
,G
RE
EC
EF
AM
AR
S.A
., A
NT
HO
US
A, A
TT
IKIS
,G
RE
EC
EF
AM
AR
S.A
., A
NT
HO
US
A,
AT
TIK
IS, G
RE
EC
EP
HA
RM
AN
EL
PH
AR
MA
CE
UT
ICA
LSP
HA
RM
AN
EL
PH
AR
MA
CE
UT
ICA
LSP
HA
RM
AN
EL
S.A
., A
TH
EN
S-L
AM
IA H
IGH
WA
Y,
SC
HIM
AT
RI,
AT
HE
NS
, GR
EE
CE
S.A
., A
TH
EN
S-L
AM
IA H
IGH
WA
Y,
SC
HIM
AT
RI,
AT
HE
NS
, GR
EE
CE
PH
AR
MA
CE
UT
ICA
LS S
.A.,
AT
HE
NS
-LA
MIA
HIG
HW
AY
,S
CH
IMA
TR
I, A
TH
EN
S, G
RE
EC
E
Labo
rato
ry: F
PR
C:
PH
AR
MA
TH
EN
S.A
, P
ALL
INI,
AT
TIK
IS, G
RE
EC
ELa
bora
tory
:F
PR
C:
PH
AR
MA
TH
EN
S.A
. PA
LLIN
I,A
TT
IKIS
, GR
EE
CE
Labo
rato
ry: F
PR
CP
HA
RM
AT
HE
N S
.A.,
PA
LLIN
I,A
TT
IKIS
, GR
EE
CE
SA
BS
CO
MM
ER
CIA
L (P
TY
) LT
D,
PH
AR
MA
CE
UT
ICA
L C
HE
MIS
TR
YS
AB
S C
OM
ME
RC
IAL
(PT
Y)
LTD
,P
HA
RM
AC
EU
TIC
AL
CH
EM
IST
RY
SA
BS
CO
MM
ER
CIA
L (P
TY
) LT
D,
PH
AR
MA
CE
UT
ICA
LD
EP
AR
TM
EN
T, G
RO
EN
KLO
OF
,P
RE
TO
RIA
, RS
AR
ES
EA
RC
H IN
ST
ITU
TE
FO
R
DE
PA
RT
ME
NT
, GR
OE
NK
LOO
F,
PR
ET
OR
IA, R
SA
RE
SE
AR
CH
INS
TIT
UT
E F
OR
CH
EM
IST
RY
DE
PA
RT
ME
NT
,G
RO
EN
KLO
OF
, PR
ET
OR
IA,
RS
AIN
DU
ST
RIA
L P
HA
RM
AC
Y, N
OR
TH
-W
ES
T U
NIV
ER
SIT
Y,
PO
TC
HE
FS
TR
OO
M, R
SA
M&
L LA
BO
RA
TO
RY
SE
RV
ICE
S,
(PT
Y)
LTD
, LIM
BR
O B
US
INE
SS
PA
RK
, SA
ND
TO
N, R
SA
IND
US
TR
IAL
PH
AR
MA
CY
, NO
RT
H-
WE
ST
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
, RS
AM
&L
LAB
OR
AT
OR
Y S
ER
VIC
ES
,(P
TY
) LT
D, L
IMB
RO
BU
SIN
ES
SP
AR
K, S
AN
DT
ON
, RS
A
RE
SE
AR
CH
INS
TIT
UT
E F
OR
IND
US
TR
IAL
PH
AR
MA
CY
,N
OR
TH
-WE
ST
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
, RS
AM
&L
LAB
OR
AT
OR
Y S
ER
VIC
ES
,(P
TY
) LT
D, L
IMB
RO
BU
SIN
ES
SC
ON
SU
LTIN
G C
HE
MIC
AL
CO
NS
ULT
ING
CH
EM
ICA
LP
AR
K, S
AN
DT
ON
, RS
ALA
BO
RA
TO
RIE
S, (
PT
Y)
LTD
,A
TLA
SV
ILLE
, BO
KS
BU
RG
, RS
ALA
BO
RA
TO
RIE
S, (
PT
Y)
LTD
,A
TLA
SV
ILLE
, BO
KS
BU
RG
, RS
AC
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
AT
OR
IES
, (P
TY
) LT
D,
AT
LAS
VIL
LE, B
OK
SB
UR
G, R
SA
FP
RR
:A
KA
CIA
HE
ALT
HC
AR
E (
PT
Y)
LTD
,IS
AN
DO
, JO
HA
NN
ES
BU
RG
, RS
AF
PR
R:
AK
AC
IA H
EA
LTH
CA
RE
(P
TY
) LT
D,
ISA
ND
O, J
OH
AN
NE
SB
UR
G, R
SA
FP
RC
/FP
RR
:A
KA
CIA
HE
ALT
HC
AR
E (
PT
Y)
LTD
, IS
AN
DO
,JO
HA
NN
ES
BU
RG
, RS
A
She
lf-lif
e:24
mon
ths
She
lf-lif
e:24
mon
ths
She
lf-lif
e:24
mon
ths
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 51
MR
F 1
5M
RF
151F
15
Reg
istr
atio
n nu
mbe
r:43
/5.4
.1/0
625
Reg
istr
atio
n nu
mbe
r:43
/5.4
.1/0
626
Reg
istr
atio
n nu
mbe
r:43
/7.1
.3/0
652
Nam
e of
med
icin
e:P
RA
ME
X 1
,0N
ame
of m
edic
ine:
PR
AM
EX
1,5
Nam
e of
med
icin
e:P
ER
IPR
EX
2/0
,625
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H T
AB
LET
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:P
RA
MIP
EX
OLE
DIH
YD
RO
CH
LOR
IDE
PR
AM
IPE
XO
LE D
IHY
DR
OC
HLO
RID
EP
ER
IND
OP
RIL
TE
RT
-BU
TY
LAM
INE
1,0
mg
1,5
mg
2,0
mg
IND
AP
AM
IDE
0,6
25 m
g
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8
App
lican
t:A
KA
CIA
HE
ALT
HC
AR
E (
PT
Y)
LTD
App
lican
t:A
KA
CIA
HE
ALT
HC
AR
E (
PT
Y)
LTD
App
lican
t:A
RR
OW
PH
AR
MA
SO
UT
H A
FR
ICA
(PT
Y)
LTD
Man
ufac
ture
r:P
HA
RM
AT
HE
N S
.A.,
PA
LLIN
I, A
TT
IKIS
,G
RE
EC
EM
anuf
actu
rer:
PH
AR
MA
TH
EN
S A
, P
ALL
INI,
AT
TIK
IS,
GR
EE
CE
Man
ufac
ture
r:A
RR
OW
LA
BO
RA
TO
RIE
S L
IMIT
ED
,C
RO
YD
ON
SO
UT
H, V
ICT
OR
IA,
AU
ST
RA
LIA
AR
RO
W P
HA
RM
A (
MA
LTA
) LI
MIT
ED
,H
AL
FA
R IN
DU
ST
RIA
L E
ST
AT
E,
BIR
ZE
BB
UG
IA, M
ALT
A
Pac
ker:
PH
AR
MA
TH
EN
S.A
., P
ALL
INI,
AT
TIK
IS,
GR
EE
CE
FA
MA
R S
.A.,
AN
TH
OU
SA
, AT
TIK
IS,
GR
EE
CE
PH
AR
MA
NE
L P
HA
RM
AC
EU
TIC
ALS
S.A
.,A
TH
EN
S-L
AM
IA H
IGH
WA
Y, S
CH
IMA
TR
I,A
TH
EN
S, G
RE
EC
E
Pac
ker:
PH
AR
MA
TH
EN
S.A
., P
ALL
INI,
AT
TIK
ISG
RE
EC
EF
AM
AR
S.A
., A
NT
HO
US
A, A
TT
IKIS
,G
RE
EC
EP
HA
RM
AN
EL
PH
AR
MA
CE
UT
ICA
LS S
.A.,
AT
HE
NS
-LA
MIA
HIG
HW
AY
, SC
HIM
AT
RI,
AT
HE
NS
, GR
EE
CE
Pac
ker:
AR
RO
W L
AB
OR
AT
OR
IES
LIM
ITE
D,
CR
OY
DO
N S
OU
TH
, VIC
TO
RIA
,A
US
TR
ALI
AA
RR
OW
PH
AR
MA
(M
ALT
A)
LIM
ITE
D,
HA
L F
AR
IND
US
TR
IAL
ES
TA
TE
,B
IRZ
EB
BU
GIA
, MA
LTA
DIV
PH
AR
M M
AN
UF
AC
TU
RIN
G A
ND
PA
CK
AG
ING
(P
TY
) LT
D L
ON
GD
ALE
,IN
DU
ST
RIA
, RS
AT
EC
HN
IKO
N L
AB
OR
AT
OR
IES
(P
TY
)LT
D, R
OB
ER
TV
ILLE
, FLO
RID
A, R
SA
Labo
rato
ry: F
PR
C:
PH
AR
MA
TH
EN
S.A
.. P
ALL
INI,
AT
TIK
IS,
GR
EE
CE
SA
BS
CO
MM
ER
CIA
L (P
TY
) LT
D,
PH
AR
MA
CE
UT
ICA
L C
HE
MIS
TR
YD
EP
AR
TM
EN
T, G
RO
EN
KLO
OF
,P
RE
TO
RIA
RS
A
Labo
rato
ry:
FP
RC
:P
HA
RM
AT
HE
N S
.A.,
PA
LLIN
I, A
TT
IKIS
,G
RE
EC
ES
AB
S C
OM
ME
RC
IAL
(PT
Y)
LTD
,P
HA
RM
AC
EU
TIC
AL
CH
EM
IST
RY
DE
PA
RT
ME
NT
, GR
OE
NK
LOO
F,
PR
ET
OR
IA, R
SA
Labo
rato
ry: F
PR
CA
RR
OW
LA
BO
RA
TO
RIE
S L
IMIT
ED
,C
RO
YD
ON
SO
UT
H, V
ICT
OR
IA,
AU
ST
RA
LIA
AR
RO
W P
HA
RM
A (
MA
LTA
) LI
MIT
ED
,H
AL
FA
R IN
DU
ST
RIA
L E
ST
AT
E,
BIR
ZE
BB
UG
IA, M
ALT
AR
ES
EA
RC
H IN
ST
ITU
TE
FO
R IN
DU
ST
RIA
LP
HA
RM
AC
Y, N
OR
TH
-WE
ST
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
, RS
A
RE
SE
AR
CH
INS
TIT
UT
E F
OR
IND
US
TR
IAL
PH
AR
MA
CY
, NO
RT
H-W
ES
T U
NIV
ER
SIT
Y,
PO
TC
HE
FS
TR
OO
M, R
SA
SE
DE
K A
GR
ICH
EM
,S
ILV
ER
TO
ND
ALE
, PR
ET
OR
IA, R
SA
CO
NS
ULT
ING
CH
EM
ICA
LM
81 L
AB
OR
AT
OR
Y S
ER
VIC
ES
, (P
TY
) LT
D,
LIM
BR
O B
US
INE
SS
PA
RK
, SA
ND
TO
N,
RS
A
M&
L LA
BO
RA
TO
RY
SE
RV
ICE
S, (
PT
Y)
LTD
, LIM
BR
O B
US
INE
SS
PA
RK
,S
AN
DT
ON
, RS
A
LAB
OR
AT
OR
IES
(P
TY
) LT
DA
TLA
SV
ILLE
, BO
KS
BU
RG
, RS
A
CO
NS
ULT
ING
CH
EM
ICA
LC
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
AT
OR
IES
, (P
TY
) LT
D, A
TLA
SV
ILLE
,B
OK
SB
UR
G, R
SA
LAB
OR
AT
OR
IES
, (P
TY
) LT
D,
AT
LAS
VIL
LE, B
OK
SB
UR
G, R
SA
FP
RR
AK
AC
IA H
EA
LTH
CA
RE
(P
TY
) LT
D,
ISA
ND
O, J
OH
AN
NE
SB
UR
G, R
SA
FP
RC
/ FP
RR
:A
KA
CIA
HE
ALT
HC
AR
E (
PT
Y)
LTD
,IS
AN
DO
, JO
HA
NN
ES
BU
RG
, RS
AF
PR
R:
AR
RO
W P
HA
RM
A S
OU
TH
AF
RIC
A(P
TY
) LT
D, N
OR
WIC
H C
LOS
E,
SA
ND
OW
N, R
SA
She
lf-lif
e:24
mon
ths
She
lf-lif
e:24
mon
ths
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
52 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
152F
15
Reg
istr
atio
n nu
mbe
r:43
/7.1
.3/0
653
Reg
istr
atio
n nu
mbe
r:43
/7.1
.3/0
654
Reg
istr
atio
n nu
mbe
r:43
/7.1
.3/0
655
Nam
e of
med
icin
e:P
ER
IPR
EX
4/1
,25
Nam
e of
med
icin
e:A
RIP
RE
L P
LUS
2/0
,625
Nam
e of
med
icin
e:A
RIP
RE
L P
LUS
4/1
,25
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H T
AB
LET
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:P
ER
IND
OP
RIL
TE
RT
-BU
TY
LAM
INE
4,0
mg
PE
RIN
DO
PR
IL T
ER
T-B
UT
YLA
MIN
EP
ER
IND
OP
RIL
TE
RT
-BU
TY
LAM
INE
IND
AP
AM
IDE
1,2
5 m
g2,
0 m
g4,
0 m
gIN
DA
PA
MID
E0,
625
mg
IND
AP
AM
IDE
1,2
5 m
g
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7, 8
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8
App
lican
t:A
RR
OW
PH
AR
MA
SO
UT
H A
FR
ICA
(P
TY
)A
pplic
ant
AR
RO
W P
HA
RM
A S
OU
TH
AF
RIC
A (
PT
Y)
App
lican
t:A
RR
OW
PH
AR
MA
SO
UT
H A
FR
ICA
LTD
LTD
(PT
Y)
LTD
Man
ufac
ture
r.A
RR
OW
LA
BO
RA
TO
RIE
S L
IMIT
ED
,C
RO
YD
ON
SO
UT
H, V
ICT
OR
IA,
AU
ST
RA
LIA
Man
ufac
ture
rA
RR
OW
LA
BO
RA
TO
RIE
S L
IMIT
ED
,C
RO
YD
ON
SO
UT
H, V
ICT
OR
IA,
AU
ST
RA
LIA
Man
ufac
ture
r:A
RR
OW
LA
BO
RA
TO
RIE
S L
IMIT
ED
,C
RO
YD
ON
SO
UT
H, V
ICT
OR
IA,
AU
ST
RA
LIA
AR
RO
W P
HA
RM
A (
MA
LTA
) LI
MIT
ED
, HA
LF
AR
IND
US
TR
IAL
ES
TA
TE
, BIR
ZE
BB
UG
IA,
MA
LTA
AR
RO
W P
HA
RM
A (
MA
LTA
) LI
MIT
ED
, HA
LF
AR
IND
US
TR
IAL
ES
TA
TE
,B
IRZ
EB
BU
GIA
, MA
LTA
AR
RO
W P
HA
RM
A (
MA
LTA
) LI
MIT
ED
,H
AL
FA
R IN
DU
ST
RIA
L E
ST
AT
E,
BIR
ZE
BB
UG
IA, M
ALT
A
Pac
ker:
AR
RO
W L
AB
OR
AT
OR
IES
LIM
ITE
D,
CR
OY
DO
N S
OU
TH
, VIC
TO
RIA
,A
US
TR
ALI
A
Pac
ker:
AR
RO
W L
AB
OR
AT
OR
IES
LIM
ITE
D,
CR
OY
DO
N S
OU
TH
, VIC
TO
RIA
,A
US
TR
ALI
A
Pac
ker:
AR
RO
W L
AB
OR
AT
OR
IES
LIM
ITE
D,
CR
OY
DO
N S
OU
TH
, VIC
TO
RIA
,A
US
TR
ALI
AA
RR
OW
PH
AR
MA
(M
ALT
A)
LIM
ITE
D, H
AL
FA
R IN
DU
ST
RIA
L E
ST
AT
E, B
IRZ
EB
BU
GIA
,M
ALT
A
AR
RO
W P
HA
RM
A (
MA
LTA
) LI
MIT
ED
, HA
LF
AR
IND
US
TR
IAL
ES
TA
TE
,B
IRZ
EB
BU
GIA
, MA
LTA
AR
RO
W P
HA
RM
A (
MA
LTA
) LI
MIT
ED
,H
AL
FA
R IN
DU
ST
RIA
L E
ST
AT
E,
BIR
ZE
BB
UG
IA, M
ALT
AD
IVP
HA
RM
MA
NU
FA
CT
UR
ING
AN
DD
iVP
HA
RM
MA
NU
FA
CT
UR
ING
AN
DD
IVP
HA
RM
MA
NU
FA
CT
UR
ING
AN
DP
AC
KA
GIN
G (
PT
Y)
LTD
, LO
NG
DA
LE,
IND
US
TR
IA, R
SA
PA
CK
AG
ING
(P
TY
) LT
D, L
ON
GD
ALE
,IN
DU
ST
RIA
, RS
AP
AC
KA
GIN
G (
PT
Y)
LTD
, LO
NG
DA
LE,
IND
US
TR
IA, R
SA
TE
CH
NIK
ON
LA
BO
RA
TO
RIE
S (
PT
Y)
LTD
,R
OB
ER
TV
ILLE
, FLO
RID
A, R
SA
TE
CH
NIK
ON
LA
BO
RA
TO
RIE
S (
PT
Y)
LTD
,R
OB
ER
TV
ILLE
, FLO
RID
A, R
SA
TE
CH
NIK
ON
LA
BO
RA
TO
RIE
S (
PT
Y)
LTD
, RO
BE
RT
VIL
LE, F
LOR
IDA
, RS
A
Labo
rato
ry: F
PR
C:
AR
RO
W L
AB
OR
AT
OR
IES
LIM
ITE
D,
CR
OY
DO
N S
OU
TH
, VIC
TO
RIA
,A
US
TR
ALI
A
Labo
rato
ry:
FP
RC
:A
RR
OW
LA
BO
RA
TO
RIE
S L
IMIT
ED
,C
RO
YD
ON
SO
UT
H, V
ICT
OR
IA,
AU
ST
RA
LIA
Labo
rato
ry: F
PR
CA
RR
OW
LA
BO
RA
TO
RIE
S L
IMIT
ED
,C
RO
YD
ON
SO
UT
H, V
ICT
OR
IA,
AU
ST
RA
LIA
AR
RO
W P
HA
RM
A (
MA
LTA
) LI
MIT
ED
, HA
LF
AR
IND
US
TR
IAL
ES
TA
TE
, BIR
ZE
BB
UG
IA,
MA
LTA
AR
RO
W P
HA
RM
A (
MA
LTA
) LI
MIT
ED
, HA
LF
AR
IND
US
TR
IAL
ES
TA
TE
,B
IRZ
EB
BU
GIA
, MA
LTA
AR
RO
W P
HA
RM
A (
MA
LTA
) LI
MIT
ED
,H
AL
FA
R IN
DU
ST
RIA
L E
ST
AT
E,
BIR
ZE
BB
UG
IA, M
ALT
AS
ED
EK
AG
RIC
HE
M, S
ILV
ER
TO
ND
ALE
,P
RE
TO
RIA
, RS
AS
ED
EK
AG
RIC
HE
M, S
ILV
ER
TO
ND
ALE
,P
RE
TO
RIA
, RS
AS
ED
EK
AG
RIC
HE
M,
SIL
VE
RT
ON
DA
LE, P
RE
TO
RIA
, RS
AC
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
AT
OR
IES
CO
NS
ULT
ING
CH
EM
ICA
LC
ON
SU
LTIN
G C
HE
MIC
AL
(PT
Y)
LTD
AT
LAS
VIL
LE, B
OK
SB
UR
G, R
SA
LAB
OR
AT
OR
IES
(P
TY
) LT
D A
TLA
SV
ILLE
,B
OK
SB
UR
G, R
SA
LAB
OR
AT
OR
IES
(P
TY
) LT
DA
TLA
SV
ILLE
, BO
KS
BU
RG
, RS
A
FP
RR
:A
RR
OW
PH
AR
MA
SO
UT
H A
FR
ICA
(P
TY
)F
PR
R:
AR
RO
W P
HA
RM
A S
OU
TH
AF
RIC
A (
PT
Y)
FP
RR
:A
RR
OW
PH
AR
MA
SO
UT
H A
FR
ICA
LTD
, NO
RW
ICH
CLO
SE
, SA
ND
OW
N, R
SA
LTD
, NO
RW
ICH
CLO
SE
, SA
ND
OW
N, R
SA
(PT
Y)
LTD
, NO
RW
ICH
CLO
SE
,S
AN
DO
WN
, RS
A
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)S
helf-
life:
24 m
onth
s (P
rovi
sion
al)
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 53
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:43
/32.
16/0
681
Reg
istr
atio
n nu
mbe
r:43
/30.
1/07
27R
egis
trat
ion
num
ber:
43/3
0.1/
0728
Nam
e of
med
icin
e:S
EQ
UE
NT
PLE
AS
EN
ame
of m
edic
ine:
ST
ELA
RA
45
mg
Nam
e of
med
icin
e:S
TE
LAR
A 9
0 m
g
Dos
age
form
:P
TC
A B
ALL
OO
N C
AT
HE
TE
RD
osag
e fo
rm:
SO
LUT
ION
FO
R IN
JEC
TIO
ND
osag
e fo
rm:
SO
LUT
ION
FO
R IN
JEC
TIO
N
Act
ive
ingr
edie
nts:
EA
CH
mm
2 S
UR
FA
CE
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
VIA
L C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H V
IAL
CO
NT
AIN
S:
PA
CLI
TA
XE
L 3,
0 pg
US
TE
KIN
UM
AB
45,0
mg
US
TE
KIN
UM
AB
90,0
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
App
lican
t:B
BR
AU
N M
ED
ICA
L (P
TY
) LT
DA
pplic
ant:
JAN
SS
EN
PH
AR
MA
CE
UT
ICA
(P
TY
)A
pplic
ant:
JAN
SS
EN
PH
AR
MA
CE
UT
ICA
LTD
(PT
Y)
LTD
Man
ufac
ture
r:B
. BR
AU
N M
ELS
UN
GE
N A
G -
VA
SC
ULA
R S
YS
TE
MS
, BE
RLI
N,
GE
RM
AN
Y
Man
ufac
ture
r:C
ILA
G A
G, S
CH
AF
FH
AU
SE
N,
SW
ITZ
ER
LAN
DB
AX
TE
R P
HA
RM
AC
EU
TIC
AL
Man
ufac
ture
r:C
ILA
G A
G, S
CH
AF
FH
AU
SE
N,
SW
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ER
LAN
DB
AX
TE
R P
HA
RM
AC
EU
TIC
AL
B. B
RA
UN
ME
LSU
NG
EN
AG
,M
ELS
UN
GE
N, G
ER
MA
NY
SO
LUT
ION
S, B
LOO
MIN
GT
ON
,IN
DIA
NA
, US
AS
OLU
TIO
NS
, BLO
OM
ING
TO
N,
IND
IAN
A, U
SA
HE
MO
TE
Q G
mbH
, WU
RS
ELE
N,
GE
RM
AN
Y
Pac
ker:
B. B
RA
UN
ME
LSU
NG
EN
AG
-V
AS
CU
LAR
SY
ST
EM
S, B
ER
LIN
,G
ER
MA
NY
Pac
ker:
CIL
AG
AG
, SC
HA
FF
HA
US
EN
,S
WIT
ZE
RLA
ND
BA
XT
ER
PH
AR
MA
CE
UT
ICA
L
Pac
ker:
CIL
AG
AG
, SC
HA
FF
HA
US
EN
,S
WIT
ZE
RLA
ND
BA
XT
ER
PH
AR
MA
CE
UT
ICA
LB
. BR
AU
N M
ELS
UN
GE
N A
G,
ME
LSU
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EN
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TIO
NS
, BLO
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TO
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IND
IAN
A, U
SA
SO
LUT
ION
S, B
LOO
MIN
GT
ON
,IN
DIA
NA
, US
AH
EM
OT
EQ
Gm
bH, W
UR
SE
LEN
,G
ER
MA
NY
Labo
rato
ry: F
PR
C:
BIO
PR
OO
F A
G, M
UN
CH
EN
,G
ER
MA
NY
Labo
rato
ry:
FP
RC
:C
ILA
G A
G, S
CH
AF
FH
AU
SE
N,
SW
ITZ
ER
LAN
DLa
bora
tory
: FP
RC
CIL
AG
AG
, SC
HA
FF
HA
US
EN
,S
WIT
ZE
RLA
ND
ME
DIC
AL
DE
VIC
E S
ER
VIC
ES
- D
rC
EN
TO
R B
.V, L
EID
EN
, TH
EC
EN
TO
R B
.V, L
EID
EN
, TH
ER
OS
SB
ER
GE
R G
mbH
, GIL
CH
ING
,G
ER
MA
NY
NE
TH
ER
LAN
DS
NE
TH
ER
LAN
DS
M &
L L
AB
OR
AT
OR
Y S
ER
VIC
ES
(PT
Y)
LTD
, LIM
BR
O B
US
INE
SS
PA
RK
, SA
ND
TO
N, R
SA
CO
NS
ULT
ING
CH
EM
ICA
LLA
BO
RA
TO
RIE
S (
PT
Y)
LTD
,A
TLA
SV
ILLE
, BO
KS
BU
RG
, RS
A
FP
RR
:B
BR
AU
N M
ED
ICA
L (P
TY
) LT
D,
FO
UR
WA
YS
, RA
ND
BU
RG
, RS
AF
PR
R:
JAN
SS
EN
PH
AR
MA
CE
UT
ICA
(P
TY
)LT
D, W
OO
DM
EA
D, R
SA
FP
RR
:JA
NS
SE
N P
HA
RM
AC
EU
TIC
A(P
TY
) LT
D, W
OO
DM
EA
D, R
SA
She
lf-lif
e:24
mon
ths
She
lf-lif
e:12
mon
ths
(Via
l)S
helf-
life:
12 m
onth
s (V
ial)
18 m
onth
s (P
re-f
illed
syr
inge
)18
mon
ths
(Pre
-fill
ed s
yrin
ge)
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
54 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
151F
15
Reg
istr
atio
n nu
mbe
r:43
/20.
1.1/
0783
Reg
istr
atio
n nu
mbe
r:43
/20.
1.1/
0784
Reg
istr
atio
n nu
mbe
r:43
/5.7
.1/0
814
Nam
e of
med
icin
e:LE
VO
TA
V IV
250
Nam
e of
med
icin
e:LE
VO
TA
V IV
500
Nam
e of
med
icin
e:C
ET
LEV
5
Dos
age
form
:IN
FU
SIO
ND
osag
e fo
rm:
INF
US
ION
Dos
age
form
:T
AB
LET
Act
ive
ingr
edie
nts:
EA
CH
50,
0 m
l SO
LUT
ION
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
50,
0 m
l SO
LUT
ION
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:LE
VO
FLO
XA
CIN
250,
0 m
gLE
VO
FLO
XA
CIN
500,
0 m
gLe
voce
tiriz
ine
dihy
droc
hlor
ide
5,0
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7, 8
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8
App
lican
t:A
DC
OC
K IN
GR
AM
LIM
ITE
DA
pplic
ant:
AD
CO
CK
ING
RA
M L
IMIT
ED
App
lican
t:D
R R
ED
DY
'S L
AB
OR
AT
OR
IES
(P
TY
)LT
D
Man
ufac
ture
r:A
CS
DO
BF
AR
INF
O S
A, C
AM
PA
SC
IO,
SW
ITZ
ER
LAN
DM
anuf
actu
rer:
AC
S D
OB
FA
R IN
FO
SA
, CA
MP
AS
CIO
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ZE
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ND
Man
ufac
ture
r:D
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'S L
AB
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UT
HU
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AN
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IA
Pac
ker:
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SA
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MP
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ZE
RLA
ND
Pac
ker:
AC
S D
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FA
R IN
FO
SA
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MP
AS
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WIT
ZE
RLA
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Pac
ker:
DR
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DD
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LA
BO
RA
TO
RIE
SLI
MIT
ED
, QU
TH
UB
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MA
ND
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RA
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DIS
TR
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ND
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NG
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LE,
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US
TR
IA, R
SA
TE
CH
NIK
ON
LA
BO
RA
TO
RIE
S (
PT
Y)
LTD
, RO
BE
RT
VIL
LE, F
LOR
IDA
, RS
A
Labo
rato
ry: F
PR
C:
AC
S D
OB
FA
R IN
FO
SA
, CA
MP
AS
CIO
,S
WIT
ZE
RLA
ND
Labo
rato
ry:
FP
RC
:A
CS
DO
BF
AR
INF
O S
A, C
AM
PA
SC
IO,
SW
ITZ
ER
LAN
DLa
bora
tory
: FP
RC
DR
RE
DD
Y'S
LA
BO
RA
TO
RIE
SLI
MIT
ED
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TH
UB
ULL
AP
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MA
ND
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RA
NG
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DY
DIS
TR
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ND
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RA
DE
SH
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UT
E F
OR
PH
AR
MA
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LS
ER
VIC
ES
, SIL
VE
RT
ON
DA
LE,
PR
ET
OR
IA, R
SA
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SE
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CH
INS
TIT
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OR
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US
TR
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PH
AR
MA
CY
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RT
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WE
ST
UN
IVE
RS
ITY
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CH
EF
ST
RO
OM
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A
FP
RC
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RR
:A
DC
OC
K IN
GR
AM
CR
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AL
CA
RE
(P
TY
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PR
C/F
PR
R:
AD
CO
CK
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RA
M C
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L C
AR
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PT
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R R
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TY
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ON
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DC
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K IN
GR
AM
LIM
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D -
RE
SE
AR
CH
LTD
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RO
TO
N, J
OH
AN
NE
SB
UR
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SA
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CK
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ES
EA
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HLT
D, S
OU
TH
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G, T
HE
PLA
CE
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AN
DT
ON
, RS
A&
DE
VE
LOP
ME
NT
, AE
RO
TO
N,
JOH
AN
NE
SB
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G, R
SA
& D
EV
ELO
PM
EN
T, A
ER
OT
ON
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HA
NN
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BU
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, RS
A
FP
RR
:A
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GR
AM
LIM
ITE
D, E
RA
ND
FP
RR
:A
DC
OC
K IN
GR
AM
LIM
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D, E
RA
ND
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)G
AR
DE
NS
, MID
RA
ND
, RS
AG
AR
DE
NS
, MID
RA
ND
, RS
A
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)S
helf-
life:
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 55
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56 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:43
/20.
1.1/
0860
Reg
istr
atio
n nu
mbe
r:43
/20.
1.1/
0955
Reg
istr
atio
n nu
mbe
r:43
/20.
1.1/
0956
Nam
e of
med
icin
e:S
AN
DO
X C
LAR
ITH
RO
MY
CIN
500
XL
Nam
e of
med
icin
e:M
YLA
N C
IPR
OF
LOX
AC
IN 2
00m
g/10
0 m
lN
ame
of m
edic
ine:
MY
LAN
CIP
RO
FLO
XA
CIN
400
mg/
200
ml
Dos
age
form
:T
AB
LET
Dos
age
form
:IN
FU
SIO
ND
osag
e fo
rm:
INF
US
ION
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H 1
00,0
ml S
OLU
TIO
NA
ctiv
e in
gred
ient
s:E
AC
H 2
00,0
ml S
OLU
TIO
NC
LAR
ITH
RO
MY
CIN
500
,0 m
gC
ON
TA
INS
:C
ON
TA
INS
:C
IPR
OF
LOX
AC
IN20
0,0
mg
CIP
RO
FLO
XA
CIN
400,
0 m
g
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
App
lican
t:S
AN
DO
Z (
PT
Y)
LTD
App
lican
t:S
CP
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
App
lican
t:S
CP
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
LTD
LTD
Man
ufac
ture
r:
Pac
ker:
LEK
PH
AR
MA
CE
UT
ICA
LS d
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LJU
BLJ
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A, S
LOV
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PH
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Man
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Pac
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Man
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MA
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S,
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NC
ET
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HN
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(P
TY
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D, R
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TV
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RID
A, R
SA
SA
ND
OZ
SA
(P
TY
) LT
D, S
PA
RT
AN
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EM
PT
ON
PA
RK
, RS
A
Labo
rato
ry: F
PR
C:
LEK
PH
AR
MA
CE
UT
ICA
LS d
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BLJ
AN
A, S
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bora
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UC
TIO
NS
SA
S,
MO
UV
AU
X, F
RA
NC
EC
ON
SU
LTIN
G C
HE
MIC
AL
ME
RC
K P
HA
RM
AC
EU
TIC
ALS
ME
RC
K P
HA
RM
AC
EU
TIC
ALS
LAB
OR
AT
OR
IES
, AT
LAS
VIL
LE,
BO
KS
BU
RG
, RS
AM
AN
UF
AC
TU
RIN
G (
PT
Y)
LTD
,W
AD
EV
ILLE
, GE
RM
IST
ON
, RS
AM
AN
UF
AC
TU
RIN
G (
PT
Y)
LTD
,W
AD
EV
ILLE
, GE
RM
IST
ON
, RS
AS
AB
S C
OM
ME
RC
IAL
(PT
Y)
LTD
RE
SE
AR
CH
INS
TIT
UT
E F
OR
RE
SE
AR
CH
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
L C
HE
MIS
TR
YD
EP
AR
TM
EN
T G
RO
EN
KLO
OF
,P
RE
TO
RIA
, RS
A
IND
US
TR
IAL
PH
AR
MA
CY
, NO
RT
HW
ES
T U
NIV
ER
SIT
Y,
PO
TC
HE
FS
TR
OO
M, R
SA
IND
US
TR
IAL
PH
AR
MA
CY
,N
OR
TH
WE
ST
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
, RS
AC
ON
SU
LTIN
G C
HE
MIC
AL
CO
NS
ULT
ING
CH
EM
ICA
LLA
BO
RA
TO
RIE
S, (
PT
Y)
LTD
,A
TLA
SV
ILLE
, BO
KS
BU
RG
, RS
ALA
BO
RA
TO
RIE
S, (
PT
Y)
LTD
,A
TLA
SV
ILLE
, BO
KS
BU
RG
, RS
AA
CO
RN
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
AC
OR
N P
HA
RM
AC
EU
TIC
ALS
LTD
, NO
RT
H R
IDIN
G,
JOH
AN
NE
SB
UR
G, R
SA
(PT
Y)
LTD
, NO
RT
H R
IDIN
G,
JOH
AN
NE
SB
UR
G, R
SA
FP
RR
:S
AN
DO
Z S
A (
PT
Y)
LTD
, SP
AR
TA
N,
KE
MP
TO
N P
AR
K, R
SA
FP
RR
:S
CP
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
LTD
, MO
DD
ER
FO
NT
EIN
,JO
HA
NN
ES
BU
RG
, RS
A
FP
RR
:S
CP
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
LTD
, MO
DD
ER
FO
NT
EIN
,JO
HA
NN
ES
BU
RG
, RS
A
She
lf-lif
e:24
mon
ths
She
lf-lif
e:24
mon
ths
She
lf-lif
e:24
mon
ths
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 57
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:43
/21.
2/10
55R
egis
trat
ion
num
ber:
43/2
1.2/
1056
Reg
istr
atio
n nu
mbe
r:43
/7.1
/112
7
Nam
e of
med
icin
e:G
ALV
US
ME
T 5
0 m
g/85
0 m
gN
ame
of m
edic
ine:
GA
LVU
S M
ET
50
mg/
1 00
0 m
gN
ame
of m
edic
ine:
TR
ITA
CE
PLU
S 2
,5/1
2,5
mg
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H T
AB
LET
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:V
ILD
AG
LIP
TIN
50,0
mg
VIL
DA
GLI
PT
IN50
,0 m
gR
AM
IPR
IL 2
,5 m
gM
ET
FO
RM
IN H
YD
RO
CH
LOR
IDE
ME
TF
OR
MIN
HY
DR
OC
HLO
RID
EH
YD
RO
CH
LOR
OT
HIA
ZID
E85
0,0
mg
1 00
0,0
mg
12,5
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7, 8
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
App
lican
t:N
OV
AR
TIS
SA
(P
TY
) LT
DA
pplic
ant:
NO
VA
RT
IS S
A (
PT
Y)
LTD
App
lican
t:S
AN
OF
I-A
VE
NT
IS S
OU
TH
AF
RIC
A (
PT
Y)
LTD
Man
ufac
ture
r:N
OV
AR
TIS
PH
AR
MA
ST
EIN
AG
,S
TE
IN, S
WIT
ZE
RLA
ND
Man
ufac
ture
r:N
OV
AR
TIS
PH
AR
MA
ST
EIN
AG
,S
TE
IN, S
WIT
ZE
RLA
ND
Man
ufac
ture
r:S
AN
OF
I-A
VE
NT
ISD
EU
TS
CH
LAN
D G
mbH
,F
RA
NK
FU
RT
, GE
RM
AN
YS
AN
OF
I-A
VE
NT
IS S
.p.A
.,S
CO
PP
ITO
, IT
ALY
Pac
ker:
NO
VA
RT
IS P
HA
RM
A S
TE
IN A
G,
ST
EIN
, SW
ITZ
ER
LAN
DP
acke
r:N
OV
AR
TIS
PH
AR
MA
ST
EIN
AG
,S
TE
IN, S
WIT
ZE
RLA
ND
Pac
ker:
SA
NO
FI-
AV
EN
TIS
S.p
.A.,
SC
OP
PIT
O, I
TA
LYA
LLP
AC
K A
G, R
EIN
AC
H,
SW
ITZ
ER
LAN
DA
LLP
AC
K A
G, R
EIN
AC
H,
SW
ITZ
ER
LAN
DW
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
KO
NA
PH
AR
MA
AG
, PR
AT
TE
LN,
SW
ITZ
ER
LAN
DK
ON
AP
HA
RM
A A
G, P
RA
TT
ELN
,S
WIT
ZE
RLA
ND
LTD
, WA
LTLO
O, P
RE
TO
RIA
,R
SA
SA
ND
OZ
SA
(P
TY
) LT
D, S
PA
RT
AN
,K
EM
PT
ON
PA
RK
, RS
AS
AN
DO
ZS
A (
PT
Y)
LTD
, SP
AR
TA
N,
KE
MP
TO
N P
AR
K, R
SA
IVE
RS
-LE
E A
G, B
UR
GD
OR
F,
SW
ITZ
ER
LAN
DIV
ER
S-L
EE
AG
, BU
RG
DO
RF
,S
WIT
ZE
RLA
ND
Labo
rato
ry: F
PR
C:
NO
VA
RT
IS P
HA
RM
A S
TE
IN A
G,
ST
EIN
, SW
ITZ
ER
LAN
DLa
bora
tory
:F
PR
C:
NO
VA
RT
IS P
HA
RM
A S
TE
IN A
G,
ST
EIN
, SW
ITZ
ER
LAN
DLa
bora
tory
: FP
RC
SA
NO
FI-
AV
EN
TIS
S.p
.A.,
SC
OP
PIT
O, I
TA
LYN
OV
AR
TIS
PH
AR
MA
NA
LYT
ICA
SA
,LO
CA
RN
O, S
WIT
ZE
RLA
ND
NO
VA
RT
IS P
HA
RM
AN
ALY
TIC
A S
A,
LOC
AR
NO
, SW
ITZ
ER
LAN
DW
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
SA
ND
OZ
SA
(P
TY
) LT
D, S
PA
RT
AN
,K
EM
PT
ON
PA
RK
, RS
AS
AN
DO
Z S
A (
PT
Y)
LTD
, SP
AR
TA
N,
KE
MP
TO
N P
AR
K, R
SA
LTD
, WA
LTLO
O, P
RE
TO
RIA
,R
SA
M&
L LA
BO
RA
TO
RY
SE
RC
ICE
SM
&L
LAB
OR
AT
OR
Y S
ER
CIC
ES
RE
SE
AR
CH
INS
TIT
UT
E F
OR
(PT
Y)
LTD
, LIM
BR
O B
US
INE
SS
PA
RK
, SA
ND
TO
N, R
SA
(PT
Y)
LTD
, LIM
BR
O B
US
INE
SS
PA
RK
, SA
ND
TO
N, R
SA
IND
US
TR
IAL
PH
AR
MA
CY
,N
OR
TH
-WE
ST
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
FP
RR
:N
OV
AR
TIS
SA
(P
TY
) LT
D,
SP
AR
TA
N, K
EM
PT
ON
PA
RK
, RS
AF
PR
R:
NO
VA
RT
IS S
A (
PT
Y)
LTD
,S
PA
RT
AN
, KE
MP
TO
N P
AR
K, R
SA
FP
RR
:S
AN
OF
I-A
VE
NT
IS S
OU
TH
AF
RIC
A (
PT
Y)
LTD
, MID
RA
ND
,R
SA
WIN
TH
RO
PP
HA
RM
AC
EU
TIC
ALS
(P
TY
)LT
D, W
ALT
LOO
, PR
ET
OR
IA,
RS
A
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)S
helf-
life:
24 m
onth
s (P
rovi
sion
al)
She
lf-lif
e:36
mon
ths
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
Jul
y 20
12
58 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:43
/7.1
/112
8R
egis
trat
ion
num
ber:
43/7
.1/1
129
Reg
istr
atio
n nu
mbe
r:43
/7.1
/113
0
Nam
e of
med
icin
e:T
RIT
AC
E P
LUS
5/1
2,5
mg
Nam
e of
med
icin
e:T
RIT
AC
E P
LUS
10/
12,5
mg
Nam
e of
med
icin
e:T
RIT
AC
E P
LUS
5/2
5 m
g
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H T
AB
LET
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:R
AM
IPR
IL 5
,0 m
gR
AM
IPR
IL 1
0,0
mg
RA
MIP
RIL
5,0
mg
HY
DR
OC
HLO
RO
TH
IAZ
IDE
12,
5 m
gH
YD
RO
CH
LOR
OT
HIA
ZID
E 1
2,5
mg
HY
DR
OC
HLO
RO
TH
IAZ
IDE
25,0
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
App
lican
t:S
AN
OF
I-A
VE
NT
IS S
OU
TH
AF
RIC
AA
pplic
ant:
SA
NO
FI-
AV
EN
TIS
SO
UT
H A
FR
ICA
App
lican
t:S
AN
OF
I-A
VE
NT
IS S
OU
TH
(PT
Y)
LTD
(PT
Y)
LTD
AF
RIC
A (
PT
Y)
LTD
Man
ufac
ture
r:S
AN
OF
I- A
VE
NT
IS D
EU
TS
CH
LAN
DM
anuf
actu
rer:
SA
NO
FI-
AV
EN
TIS
DE
UT
SC
HLA
ND
Man
ufac
ture
r:S
AN
OF
I-A
VE
NT
ISG
mbH
, FR
AN
KF
UR
T, G
ER
MA
NY
SA
NO
FI-
AV
EN
TIS
S.p
.A.,
SC
OP
PIT
O, I
TA
LY
Gm
bH, F
RA
NK
FU
RT
, GE
RM
AN
YS
AN
OF
I-A
VE
NT
IS S
.p.A
.,S
CO
PP
ITO
, IT
ALY
DE
UT
SC
HLA
ND
Gm
bH,
FR
AN
KF
UR
T, G
ER
MA
NY
SA
NO
FI-
AV
EN
TIS
S.p
.A.,
SC
OP
PIT
O, I
TA
LY
Pac
ker:
SA
NO
FI-
AV
EN
TIS
S.p
.A.,
SC
OP
PIT
O, I
TA
LYP
acke
r:S
AN
OF
I-A
VE
NT
IS S
.p.A
.,S
CO
PP
ITO
, IT
ALY
Pac
ker:
SA
NO
FI-
AV
EN
TIS
S.p
.A.,
SC
OP
PIT
O, I
TA
LYW
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LSW
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LSW
INT
HR
OP
(PT
Y)
LTD
, WA
LTLO
O, P
RE
TO
RIA
,R
SA
(PT
Y)
LTD
, WA
LTLO
O, P
RE
TO
RIA
,R
SA
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
LTD
, WA
LTLO
O, P
RE
TO
RIA
,R
SA
Labo
rato
ry: F
PR
C:
SA
NO
FI-
AV
EN
TIS
S.p
.A.,
SC
OP
PIT
O, I
TA
LYLa
bora
tory
:F
PR
C:
SA
NO
FI-
AV
EN
TIS
S.p
.A.,
SC
OP
PIT
O, I
TA
LYLa
bora
tory
: FP
RC
SA
NO
FI-
AV
EN
TIS
S.p
.A.,
SC
OP
PIT
O, I
TA
LYW
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LSW
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LSW
INT
HR
OP
(PT
Y)
LTD
, WA
LTLO
O, P
RE
TO
RIA
,R
SA
RE
SE
AR
CH
INS
TIT
UT
E F
OR
(PT
Y)
LTD
, WA
LTLO
O, P
RE
TO
RIA
,R
SA
RE
SE
AR
CH
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
LTD
, WA
LTLO
O, P
RE
TO
RIA
,R
SA
IND
US
TR
IAL
PH
AR
MA
CY
, NO
RT
H-
WE
ST
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
IND
US
TR
IAL
PH
AR
MA
CY
, NO
RT
H-
WE
ST
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
RE
SE
AR
CH
INS
TIT
UT
E F
OR
IND
US
TR
IAL
PH
AR
MA
CY
,N
OR
TH
-WE
ST
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
FP
RR
:S
AN
OF
I-A
VE
NT
IS S
OU
TH
AF
RIC
AF
PR
R:
SA
NO
FI-
AV
EN
TIS
SO
UT
H A
FR
ICA
FP
RR
:S
AN
OF
I-A
VE
NT
IS S
OU
TH
(PT
Y)
LTD
, MID
RA
ND
, RS
AW
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LS(P
TY
) LT
D, M
IDR
AN
D, R
SA
WIN
TH
RO
P P
HA
RM
AC
EU
TIC
ALS
AF
RIC
A (
PT
Y)
LTD
, MID
RA
ND
,R
SA
(PT
Y)
LTD
, WA
LTLO
O, P
RE
TO
RIA
,R
SA
(PT
Y)
LTD
, WA
LTLO
O, P
RE
TO
RIA
,R
SA
WIN
TH
RO
PP
HA
RM
AC
EU
TIC
ALS
(P
TY
)LT
D, W
ALT
LOO
, PR
ET
OR
IA,
RS
A
She
lf-lif
e:36
mon
ths
She
lf-lif
e:36
mon
ths
She
lf-lif
e:36
mon
ths
Dat
e of
reg
istr
atio
n:27
Jul
y 20
12D
ate
of r
egis
trat
ion:
27 J
uly
2012
Dat
e of
reg
istr
atio
n:27
Jul
y 20
12
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 59
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:43
/7.1
/113
1R
egis
trat
ion
num
ber:
44/7
.1.3
/007
5R
egis
trat
ion
num
ber:
44/7
.1.3
/007
6
Nam
e of
med
icin
e:T
RIT
AC
E P
LUS
10/
25 m
gN
ame
of m
edic
ine:
CO
EX
FO
RG
E 5
mg/
160
mg/
12,5
mg
Nam
e of
med
icin
e:C
O E
XF
OR
GE
5 m
g/16
0 m
g/25
mg
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H T
AB
LET
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:R
AM
IPR
IL 1
0,0
mg
Am
lodi
pine
bes
ylat
e eq
uiva
lent
toA
mlo
dipi
ne b
esyl
ate
equi
vale
nt to
HY
DR
OC
HLO
RO
TH
IAZ
IDE
25,
0 m
gA
mlo
dipi
ne 5
,0 m
gA
mlo
dipi
ne 5
,0 m
gV
alsa
rtan
160,
0 m
gV
alsa
rtan
160,
0 m
gH
ydro
chlo
roth
iazi
de12
,5 m
gH
ydro
chlo
roth
iazi
de25
,0 m
g
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
App
lican
t:S
AN
OF
I-A
VE
NT
IS S
OU
TH
AF
RIC
AA
pplic
ant:
NO
VA
RT
IS S
A (
PT
Y)
LTD
App
lican
t:N
OV
AR
TIS
SA
(P
TY
) LT
D(P
TY
) LT
D
Man
ufac
ture
r:S
AN
OF
I-A
VE
NT
IS D
EU
TS
CH
LAN
DG
mbH
, FR
AN
KF
UR
T. G
ER
MA
NY
Man
ufac
ture
r:N
OV
AR
TIS
PH
AR
MA
ST
EIN
AG
,S
TE
IN, S
WIT
ZE
RLA
ND
Man
ufac
ture
r:N
OV
AR
TIS
PH
AR
MA
ST
EIN
AG
,S
TE
IN, S
WIT
ZE
RLA
ND
SA
NO
FI-
AV
EN
TIS
S.p
.A.,
SC
OP
PIT
O, I
TA
LY
Pac
ker:
SA
NO
FI-
AV
EN
TIS
S.p
.A.,
SC
OP
PIT
O, I
TA
LYP
acke
r:N
OV
AR
TIS
PH
AR
MA
ST
EIN
AG
,S
TE
IN, S
WIT
ZE
RLA
ND
Pac
ker:
NO
VA
RT
IS P
HA
RM
A S
TE
IN A
G,
ST
EIN
, SW
ITZ
ER
LAN
DW
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LS(P
TY
) LT
D, W
ALT
LOO
, PR
ET
OR
IA,
RS
A
ALL
PA
CK
AG
, RE
INA
CH
,S
WIT
ZE
RLA
ND
KO
NA
PH
AR
MA
AG
, PR
AT
TE
LN,
SW
ITZ
ER
LAN
D
ALL
PA
CK
AG
, RE
INA
CH
,S
WIT
ZE
RLA
ND
KO
NA
PH
AR
MA
AG
, PR
AT
TE
LN,
SW
ITZ
ER
LAN
DS
AN
DO
Z S
A (
PT
Y)
LTD
, SP
AR
TA
N,
KE
MP
TO
N P
AR
K, R
SA
IVE
RS
-LE
E A
G, B
UR
GD
OR
F,
SW
ITZ
ER
LAN
D
SA
ND
OZ
SA
(P
TY
) LT
D,
SP
AR
TA
N, K
EM
PT
ON
PA
RK
,R
SA
IVE
RS
-LE
E A
G, B
UR
GD
OR
F,
SW
ITZ
ER
LAN
D
Labo
rato
ry: F
PR
C:
SA
NO
FI-
AV
EN
TIS
S.p
.A.,
SC
OP
PIT
O, I
TA
LYLa
bora
tory
:F
PR
C:
NO
VA
RT
IS P
HA
RM
A S
TE
IN A
G,
ST
EIN
, SW
ITZ
ER
LAN
DLa
bora
tory
: FP
RC
NO
VA
RT
IS P
HA
RM
A S
TE
IN A
G,
ST
EIN
, SW
ITZ
ER
LAN
DW
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LS(P
TY
) LT
D, W
ALT
LOO
, PR
ET
OR
IA,
RS
AR
ES
EA
RC
H IN
ST
ITU
TE
FO
RIN
DU
ST
RIA
L P
HA
RM
AC
Y, N
OR
TH
-W
ES
T U
NIV
ER
SIT
Y,
PO
TC
HE
FS
TR
OO
M
NO
VA
RT
IS P
HA
RM
AN
ALY
TIC
A S
A,
LOC
AR
NO
, SW
ITZ
ER
LAN
DS
AN
DO
Z S
A (
PT
Y)
LTD
, SP
AR
TA
N,
KE
MP
TO
N P
AR
K, R
SA
M&
L LA
BO
RA
TO
RY
SE
RC
ICE
S(P
TY
) LT
D, L
IMB
RO
BU
SIN
ES
SP
AR
K, S
AN
DT
ON
, RS
A
NO
VA
RT
IS P
HA
RM
AN
ALY
TIC
AS
A, L
OC
AR
NO
, SW
ITZ
ER
LAN
DS
AN
DO
Z S
A (
PT
Y)
LTD
,S
PA
RT
AN
, KE
MP
TO
N P
AR
K,
RS
AM
&L
LAB
OR
AT
OR
Y S
ER
CIC
ES
(PT
Y)
LTD
, LIM
BR
O B
US
INE
SS
PA
RK
, SA
ND
TO
N, R
SA
FP
RR
:S
AN
OF
I-A
VE
NT
IS S
OU
TH
AF
RIC
A(P
TY
) LT
D, M
IDR
AN
D, R
SA
WIN
TH
RO
P P
HA
RM
AC
EU
TIC
ALS
FP
RR
:N
OV
AR
TIS
SA
(P
TY
) LT
D,
SP
AR
TA
N, K
EM
PT
ON
PA
RK
, RS
AF
PR
R:
NO
VA
RT
IS S
A (
PT
Y)
LTD
,S
PA
RT
AN
, KE
MP
TO
N P
AR
K,
RS
A(P
TY
) LT
D, W
ALT
LOO
, PR
ET
OR
IA,
RS
A
She
lf-lif
e:36
mon
ths
She
lf-lif
e:24
mon
ths
She
lf-lif
e:24
mon
ths
Dat
e of
reg
istr
atio
n:27
Jul
y 20
12D
ate
of r
egis
trat
ion:
27 J
ULY
201
2D
ate
of r
egis
trat
ion:
27 J
ULY
201
2
60 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
44/7
.1.3
/007
7
CO
EX
FO
RG
E 1
0 m
g/16
0 m
g/12
,5 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:A
mlo
dipi
ne b
esyl
ate
equi
vale
nt to
Am
lodi
pine
10,0
mg
Val
sart
an16
0,0
mg
Hyd
roch
loro
thia
zide
12,5
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C:
FP
RR
:
She
lf-lif
e:
NO
VA
RT
IS S
A (
PT
Y)
LTD
NO
VA
RT
IS P
HA
RM
A S
TE
IN A
G,
ST
EIN
, SW
ITZ
ER
LAN
D
NO
VA
RT
IS P
HA
RM
A S
TE
IN A
G,
ST
EIN
, SW
ITZ
ER
LAN
DA
LLP
AC
KA
G, R
EIN
AC
H,
SW
ITZ
ER
LAN
DK
ON
AP
HA
RM
A A
G, P
RA
TT
ELN
,S
WIT
ZE
RLA
ND
SA
ND
OZ
SA
(P
TY
) LT
D, S
PA
RT
AN
,K
EM
PT
ON
PA
RK
, RS
AIV
ER
S-L
EE
AG
, BU
RG
DO
RF
,S
WIT
ZE
RLA
ND
NO
VA
RT
IS P
HA
RM
A S
TE
IN A
G,
ST
EIN
, SW
ITZ
ER
LAN
DN
OV
AR
TIS
PH
AR
MA
NA
LYT
ICA
SA
,LO
CA
RN
O, S
WIT
ZE
RLA
ND
SA
ND
OZ
SA
(P
TY
) LT
D, S
PA
RT
AN
,K
EM
PT
ON
PA
RK
, RS
AM
&L
LAB
OR
AT
OR
Y S
ER
CIC
ES
(PT
Y)
LTD
, LIM
BR
O B
US
INE
SS
PA
RK
, SA
ND
TO
N, R
SA
NO
VA
RT
IS S
A (
PT
Y)
LTD
,S
PA
RT
AN
, KE
MP
TO
N P
AR
K, R
SA
24 m
onth
s
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
MR
F15
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
44/7
.1.3
/007
8
CO
EX
FO
RG
E 1
0 m
g/16
0 m
g/25
mg
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:A
mlo
dipi
ne b
esyl
ate
equi
vale
nt to
Am
lodi
pine
10,0
mg
Val
sart
an16
0,0
mg
Hyd
roch
loro
thia
zide
25 m
g
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
NO
VA
RT
IS S
A (
PT
Y)
LTD
NO
VA
RT
IS P
HA
RM
A S
TE
IN A
G,
ST
EIN
, SW
ITZ
ER
LAN
D
NO
VA
RT
IS P
HA
RM
A S
TE
IN A
G,
ST
EIN
, SW
ITZ
ER
LAN
DA
LLP
AC
KA
G, R
EIN
AC
H,
SW
ITZ
ER
LAN
DK
ON
AP
HA
RM
A A
G, P
RA
TT
ELN
,S
WIT
ZE
RLA
ND
SA
ND
OZ
SA
(P
TY
) LT
D, S
PA
RT
AN
,K
EM
PT
ON
PA
RK
, RS
AIV
ER
S-L
EE
AG
, BU
RG
DO
RF
,S
WIT
ZE
RLA
ND
NO
VA
RT
IS P
HA
RM
A S
TE
IN A
G,
ST
EIN
, SW
ITZ
ER
LAN
DN
OV
AR
TIS
PH
AR
MA
NA
LYT
ICA
SA
,LO
CA
RN
O, S
WIT
ZE
RLA
ND
SA
ND
OZ
SA
(P
TY
) LT
D, S
PA
RT
AN
,K
EM
PT
ON
PA
RK
, RS
AM
&L
LAB
OR
AT
OR
Y S
ER
CIC
ES
(PT
Y)
LTD
, LIM
BR
O B
US
INE
SS
PA
RK
, SA
ND
TO
N, R
SA
NO
VA
RT
IS S
A (
PT
Y)
LTD
,S
PA
RT
AN
, KE
MP
TO
N P
AR
K, R
SA
24 m
onth
s
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
MR
F 1
5 Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
fre
gist
ratio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
44/7
.1.3
/007
9
CO
EX
FO
RG
E 1
0 m
g/32
0 m
g/25
mg
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:A
mlo
dipi
ne b
esyl
ate
equi
vale
nt to
Am
lodi
pine
10,
0 m
gV
alsa
rtan
320,
0 m
gH
ydro
chlo
roth
iazi
de25
mg
1, 2
, 3, 4
, 5, 6
, 7
NO
VA
RT
IS S
A (
PT
Y)
LTD
NO
VA
RT
IS P
HA
RM
A S
TE
IN A
G,
ST
EIN
, SW
ITZ
ER
LAN
D
NO
VA
RT
IS P
HA
RM
A S
TE
IN A
G,
ST
EIN
, SW
ITZ
ER
LAN
DA
LLP
AC
KA
G, R
EIN
AC
H,
SW
ITZ
ER
LAN
DK
ON
AP
HA
RM
A A
G, P
RA
TT
ELN
,S
WIT
ZE
RLA
ND
SA
ND
OZ
SA
(P
TY
) LT
D, S
PA
RT
AN
,K
EM
PT
ON
PA
RK
, RS
AIV
ER
S-L
EE
AG
, BU
RG
DO
RF
,S
WIT
ZE
RLA
ND
NO
VA
RT
IS P
HA
RM
A S
TE
IN A
G,
ST
EIN
, SW
ITZ
ER
LAN
DN
OV
AR
TIS
PH
AR
MA
NA
LYT
ICA
SA
,LO
CA
RN
O, S
WIT
ZE
RLA
ND
SA
ND
OZ
SA
(P
TY
) LT
D, S
PA
RT
AN
,K
EM
PT
ON
PA
RK
, RS
AM
&L
LAB
OR
AT
OR
Y S
ER
CIC
ES
(P
TY
)LT
D, L
IMB
RO
BU
SIN
ES
S P
AR
K,
SA
ND
TO
N, R
SA
NO
VA
RT
IS S
A (
PT
Y)
LTD
, SP
AR
TA
N,
KE
MP
TO
N P
AR
K, R
SA
24 m
onth
s
27 J
ULY
201
2
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 61
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:44
/10.
2.2/
0200
Reg
istr
atio
n nu
mbe
r:44
/10.
2.2/
0201
Reg
istr
atio
n nu
mbe
r:44
/20.
1.1/
0220
Nam
e of
med
icin
e:M
ON
TE
WIN
5 m
gN
ame
of m
edic
ine:
MO
NT
EW
IN 1
0 m
gN
ame
of m
edic
ine:
PR
OP
AN
LE
VO
FLO
XA
CIN
IV25
0
Dos
age
form
:C
HE
WA
BLE
TA
BLE
TS
Dos
age
form
:T
AB
LET
SD
osag
e fo
rm:
INF
US
ION
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H T
AB
LET
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
50,
0 m
l SO
LUT
ION
MO
NT
ELU
KA
ST
SO
DIU
MM
ON
TE
LUK
AS
T S
OD
IUM
CO
NT
AIN
S:
EQ
UIV
ALE
NT
TO
MO
NT
ELU
KA
ST
EQ
UIV
ALE
NT
TO
MO
NT
ELU
KA
ST
LEV
OF
LOX
AC
IN25
0,0
mg
5,0
mg
10,0
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7, 8
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8
App
lican
t:W
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LSA
pplic
ant:
WIN
TH
RO
P P
HA
RM
AC
EU
TIC
ALS
App
lican
t:A
DC
OC
K IN
GR
AM
LIM
ITE
D(P
TY
) LT
D(P
TY
) LT
D
Man
ufac
ture
r:N
YC
OM
ED
, LY
SZ
KO
WIC
E, P
OLA
ND
Man
ufac
ture
r:N
YC
OM
ED
, LY
SZ
KO
WIC
E,
PO
LAN
DM
anuf
actu
rer:
AC
S D
OB
FA
R IN
FO
SA
,C
AM
PA
SC
IO, S
WIT
ZE
RLA
ND
Pac
ker:
NY
CO
ME
D, L
YS
ZK
OW
ICE
, PO
LAN
DW
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LSP
acke
r:N
YC
OM
ED
, LY
SZ
KO
WIC
E,
PO
LAN
DP
acke
r:A
CS
DO
BF
AR
INF
O S
A,
CA
MP
AS
CIO
, SW
ITZ
ER
LAN
D(P
TY
) LT
D, W
ALT
LOO
, PR
ET
OR
IA,
RS
AW
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LS(P
TY
) LT
D, W
ALT
LOO
, PR
ET
OR
IA,
RS
A
Labo
rato
ry: F
PR
C:
NY
CO
ME
D, L
YS
ZK
OW
ICE
, PO
LAN
DR
ES
EA
RC
H IN
ST
ITU
TE
FO
RLa
bora
tory
: FP
RC
:N
YC
OM
ED
, LY
SZ
KO
WIC
E,
PO
LAN
DLa
bora
tory
: FP
RC
AC
S D
OB
FA
R IN
FO
SA
,C
AM
PA
SC
IO, S
WIT
ZE
RLA
ND
IND
US
TR
IAL
PH
AR
MA
CY
NO
RT
H-
RE
SE
AR
CH
INS
TIT
UT
E F
OR
WE
ST
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
, RS
AIN
DU
ST
RIA
L P
HA
RM
AC
Y N
OR
TH
-W
ES
T U
NIV
ER
SIT
Y,
PO
TC
HE
FS
TR
OO
M, R
SA
FP
RC
/FP
RR
:W
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LSF
PR
C/F
PR
R:
WIN
TH
RO
P P
HA
RM
AC
EU
TIC
ALS
FP
RC
/FP
RR
:A
DC
OC
K IN
GR
AM
CR
ITIC
AL
(PT
Y)
LTD
, WA
LTLO
O, P
RE
TO
RIA
,R
SA
(PT
Y)
LTD
, WA
LTLO
O, P
RE
TO
RIA
,R
SA
CA
RE
(P
TY
) LT
D, A
ER
OT
ON
,JO
HA
NN
ES
BU
RG
, RS
AA
DC
OC
K IN
GR
AM
LIM
ITE
D -
RE
SE
AR
CH
& D
EV
ELO
PM
EN
T,
AE
RO
TO
N, J
OH
AN
NE
SB
UR
G,
RS
A
FP
RR
:W
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LS(P
TY
) LT
D, M
IDR
AN
D, R
SA
FP
RR
:W
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LS(P
TY
) LT
D, M
IDR
AN
D, R
SA
FP
RR
:A
DC
OC
K IN
GR
AM
LIM
ITE
D,
ER
AN
D G
AR
DE
NS
, MID
RA
ND
,R
SA
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)S
helf-
life:
24 m
onth
s (P
rovi
sion
al)
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
62 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:44
/20.
1.1/
0221
Reg
istr
atio
n nu
mbe
r:44
/20.
1.1/
0222
Reg
istr
atio
n nu
mbe
r:44
/20.
1.1/
0223
Nam
e of
med
icin
e:P
RO
PA
N L
EV
OF
LOX
AC
IN IV
Nam
e of
med
icin
e:R
ES
TA
N L
EV
OF
LOX
AC
IN IV
Nam
e of
med
icin
e:R
ES
TA
N L
EV
OF
LOX
AC
IN IV
500
250
500
Dos
age
form
:IN
FU
SIO
ND
osag
e fo
rm:
INF
US
ION
Dos
age
form
:IN
FU
SIO
N
Act
ive
ingr
edie
nts:
EA
CH
100
,0 m
l SO
LUT
ION
Act
ive
ingr
edie
nts:
EA
CH
50,
0 m
l SO
LUT
ION
Act
ive
ingr
edie
nts:
EA
CH
100
,0 m
l SO
LUT
ION
CO
NT
AIN
S:
CO
NT
AIN
S:
CO
NT
AIN
S:
LEV
OF
LOX
AC
IN50
0,0
mg
LEV
OF
LOX
AC
IN25
0,0
mg
LEV
OF
LOX
AC
IN50
0,0
mg
Con
ditio
ns o
fre
gist
ratio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of
regi
stra
tion:
1, 2
, 3, 4
, 5, 6
, 7, 8
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8
App
lican
t:A
DC
OC
K IN
GR
AM
LIM
ITE
DA
pplic
ant:
AD
CO
CK
ING
RA
M L
IMIT
ED
App
lican
t:A
DC
OC
K IN
GR
AM
LIM
ITE
D
Man
ufac
ture
r:A
CS
DO
BF
AR
INF
O S
A,
CA
MP
AS
CIO
, SW
ITZ
ER
LAN
DM
anuf
actu
rer:
AC
S D
OB
FA
R IN
FO
SA
,C
AM
PA
SC
IO, S
WIT
ZE
RLA
ND
Man
ufac
ture
r:A
CS
DO
BF
AR
INF
O S
A,
CA
MP
AS
CIO
,S
WIT
ZE
RLA
ND
Pac
ker:
AC
S D
OB
FA
R IN
FO
SA
,C
AM
PA
SC
IO. S
WIT
ZE
RLA
ND
Pac
ker:
AC
S D
OB
FA
R IN
FO
SA
,C
AM
PA
SC
IO, S
WIT
ZE
RLA
ND
Pac
ker:
AC
S D
OB
FA
R IN
FO
SA
,C
AM
PA
SC
IO,
SW
ITZ
ER
LAN
D
Labo
rato
ry: F
PR
C:
AC
S D
OB
FA
R IN
FO
SA
,C
AM
PA
SC
IO, S
WIT
ZE
RLA
ND
Labo
rato
ry: F
PR
C:
AC
S D
OB
FA
R IN
FO
SA
,C
AM
PA
SC
IO, S
WIT
ZE
RLA
ND
Labo
rato
ry: F
PR
CA
CS
DO
BF
AR
INF
O S
A,
CA
MP
AS
CIO
,S
WIT
ZE
RLA
ND
FP
RC
/FP
RR
:A
DC
OC
K IN
GR
AM
CR
ITIC
AL
FP
RC
/FP
RR
:A
DC
OC
K IN
GR
AM
CR
ITIC
AL
FP
RC
/FP
RR
:A
DC
OC
K IN
GR
AM
CA
RE
(P
TY
) LT
D, A
ER
OT
ON
,JO
HA
NN
ES
BU
RG
, RS
AA
DC
OC
K IN
GR
AM
LIM
ITE
D -
CA
RE
(P
TY
) LT
D, A
ER
OT
ON
,JO
HA
NN
ES
BU
RG
, RS
AA
DC
OC
K IN
GR
AM
LIM
ITE
D -
CR
ITIC
AL
CA
RE
(P
TY
) LT
D,
AE
RO
TO
N,
JOH
AN
NE
SB
UR
G, R
SA
RE
SE
AR
CH
& D
EV
ELO
PM
EN
T,
AE
RO
TO
N, J
OH
AN
NE
SB
UR
G,
RS
A
RE
SE
AR
CH
& D
EV
ELO
PM
EN
T,
AE
RO
TO
N, J
OH
AN
NE
SB
UR
G,
RS
A
AD
CO
CK
ING
RA
M L
IMIT
ED
- R
ES
EA
RC
H &
DE
VE
LOP
ME
NT
,A
ER
OT
ON
,JO
HA
NN
ES
BU
RG
, RS
A
FP
RR
:A
DC
OC
K IN
GR
AM
LIM
ITE
D,
ER
AN
D G
AR
DE
NS
, MID
RA
ND
,R
SA
FP
RR
:A
DC
OC
K IN
GR
AM
LIM
ITE
D,
ER
AN
D G
AR
DE
NS
, MID
RA
ND
,R
SA
FP
RR
:A
DC
OC
K IN
GR
AM
LIM
ITE
D,
ER
AN
D G
AR
DE
NS
,M
IDR
AN
D, R
SA
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)S
helf-
life:
24 m
onth
s (P
rovi
sion
al)
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 63
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:44
/20.
1.1/
0224
Reg
istr
atio
n nu
mbe
r:44
/20.
1.1/
0225
Reg
istr
atio
n nu
mbe
r:44
/10.
2.2/
0257
Nam
e of
med
icin
e:C
OV
AN
LE
VO
FLO
XA
CIN
IV 2
50N
ame
of m
edic
ine:
CO
VA
N L
EV
OF
LOX
AC
IN IV
500
Nam
e of
med
icin
e:M
ON
TE
FLO
4
Dos
age
form
:IN
FU
SIO
ND
osag
e fo
rm:
INF
US
ION
Dos
age
form
:C
HE
WA
BLE
TA
BLE
T
Act
ive
ingr
edie
nts:
EA
CH
50,
0 m
l SO
LUT
ION
Act
ive
ingr
edie
nts:
EA
CH
100
,0 m
l SO
LUT
ION
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:C
ON
TA
INS
:C
ON
TA
INS
:M
ON
TE
LUK
AS
T S
OD
IUM
LEV
OF
LOX
AC
IN25
0,0
mg
LEV
OF
LOX
AC
IN50
0,0
mg
EQ
UIV
ALE
NT
TO
MO
NT
ELU
KA
ST
4,0
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7, 8
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8
App
lican
t:A
DC
OC
K IN
GR
AM
LIM
ITE
DA
pplic
ant:
AD
CO
CK
ING
RA
M L
IMIT
ED
App
lican
t:T
RIN
ITY
PH
AR
MA
SA
(P
TY
)LT
D
Man
ufac
ture
r:A
CS
DO
BF
AR
INF
O S
A,
CA
MP
AS
CIO
, SW
ITZ
ER
LAN
DM
anuf
actu
rer:
AC
S D
OB
FA
R IN
FO
SA
,C
AM
PA
SC
IO, S
WIT
ZE
RLA
ND
Man
ufac
ture
r:T
OR
RE
NT
PH
AR
MA
CE
UT
ICA
LS L
TD
,M
EH
SA
NA
, IN
DIA
Pac
ker:
AC
S D
OB
FA
R IN
FO
SA
,C
AM
PA
SC
IO, S
WIT
ZE
RLA
ND
Pac
ker:
AC
S D
OB
FA
R IN
FO
SA
,C
AM
PA
SC
IO, S
WIT
ZE
RLA
ND
Pac
ker:
TO
RR
EN
TP
HA
RM
AC
EU
TIC
ALS
LT
D,
ME
HS
AN
A, I
ND
IA
Labo
rato
ry: F
PR
C:
AC
S D
OB
FA
R IN
FO
SA
,C
AM
PA
SC
IO, S
WIT
ZE
RLA
ND
Labo
rato
ry:
FP
RC
:A
CS
DO
BF
AR
INF
O S
A,
CA
MP
AS
CIO
, SW
ITZ
ER
LAN
DLa
bora
tory
: FP
RC
TO
RR
EN
TP
HA
RM
AC
EU
TIC
ALS
LT
D,
ME
HS
AN
A, I
ND
IAIN
ST
ITU
TE
FO
RP
HA
RM
AC
EU
TIC
AL
SE
RV
ICE
S,
SIL
VE
RT
ON
DA
LE,
PR
ET
OR
IA, R
SA
RE
SE
AR
CH
INS
TIT
UT
EF
OR
IND
US
TR
IAL
PH
AR
MA
CY
, NO
RT
H-W
ES
TU
NIV
ER
SIT
Y,
PO
TC
HE
FS
TR
OO
M, R
SA
FP
RC
/FP
RR
:A
DC
OC
K IN
GR
AM
CR
ITIC
AL
FP
RC
/FP
RR
:A
DC
OC
K IN
GR
AM
CR
ITIC
AL
FP
RR
:T
RIN
ITY
PH
AR
MA
SA
(P
TY
)C
AR
E (
PT
Y)
LTD
, AE
RO
TO
N,
JOH
AN
NE
SB
UR
G, R
SA
CA
RE
(P
TY
) LT
D, A
ER
OT
ON
,JO
HA
NN
ES
BU
RG
, RS
ALT
D, M
UR
RA
YF
IELD
,P
RE
TO
RIA
, RS
AA
DC
OC
K IN
GR
AM
LIM
ITE
D -
AD
CO
CK
ING
RA
M L
IMIT
ED
-R
ES
EA
RC
H &
DE
VE
LOP
ME
NT
,A
ER
OT
ON
, JO
HA
NN
ES
BU
RG
,R
SA
RE
SE
AR
CH
& D
EV
ELO
PM
EN
T,
AE
RO
TO
N, J
OH
AN
NE
SB
UR
G,
RS
A
FP
RR
:A
DC
OC
K IN
GR
AM
LIM
ITE
D,
ER
AN
D G
AR
DE
NS
, MID
RA
ND
,R
SA
FP
RR
:A
DC
OC
K IN
GR
AM
LIM
ITE
D,
ER
AN
D G
AR
DE
NS
, MID
RA
ND
,R
SA
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)S
helf-
life:
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
64 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:44
/10.
2.2/
0262
Reg
istr
atio
n nu
mbe
r:44
/10.
2.2/
0286
Reg
istr
atio
n nu
mbe
r:44
/1.3
.2/0
339
Nam
e of
med
icin
e:M
ON
TE
FLO
5N
ame
of m
edic
ine:
MO
NT
EF
LO 1
0N
ame
of m
edic
ine:
ALT
RE
X
Dos
age
form
:C
HE
WA
BLE
TA
BLE
TD
osag
e fo
rm:
TA
BLE
TD
osag
e fo
rm:
TA
BLE
T
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H T
AB
LET
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:M
ON
TE
LUK
AS
T S
OD
IUM
MO
NT
ELU
KA
ST
SO
DIU
MN
ALT
RE
XO
NE
EQ
UIV
ALE
NT
TO
EQ
UIV
ALE
NT
TO
HY
DR
OC
HLO
RID
E 5
0,0
mg
MO
NT
ELU
KA
ST
5,0
mg
MO
NT
ELU
KA
ST
10,0
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7, 8
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8
App
lican
t:T
RIN
ITY
PH
AR
MA
SA
(P
TY
) LT
DA
pplic
ant:
TR
INIT
Y P
HA
RM
A S
A (
PT
Y)
App
lican
t:P
HA
RM
AP
LAN
(P
TY
) LT
DLT
D
Man
ufac
ture
r:T
OR
RE
NT
PH
AR
MA
CE
UT
ICA
LSLT
D, M
EH
SA
NA
, IN
DIA
Man
ufac
ture
r:T
OR
RE
NT
PH
AR
MA
CE
UT
ICA
LS L
TD
,M
EH
SA
NA
, IN
DIA
Man
ufac
ture
r:M
ALL
INC
KR
OD
T IN
C,
HO
BA
RT
, NE
W Y
OR
K, U
SA
Pac
ker:
TO
RR
EN
T P
HA
RM
AC
EU
TIC
ALS
LTD
, ME
HS
AN
A, I
ND
IAP
acke
r:T
OR
RE
NT
PH
AR
MA
CE
UT
ICA
LS L
TD
,M
EH
SA
NA
, IN
DIA
Pac
ker:
MA
LLIN
CK
RO
DT
INC
,H
OB
AR
T, N
EW
YO
RK
, US
A
Labo
rato
ry: F
PR
C:
TO
RR
EN
T P
HA
RM
AC
EU
TIC
ALS
LTD
, ME
HS
AN
A, I
ND
IAIN
ST
ITU
TE
FO
R
Labo
rato
ry:
FP
RC
:T
OR
RE
NT
PH
AR
MA
CE
UT
ICA
LS L
TD
,M
EH
SA
NA
, IN
DIA
Labo
rato
ry: F
PR
CM
ALL
INC
KR
OD
T IN
C,
HO
BA
RT
, NE
W Y
OR
K, U
SA
CO
NS
ULT
ING
CH
EM
ICA
LP
HA
RM
AC
EU
TIC
AL
SE
RV
ICE
S,
SIL
VE
RT
ON
DA
LE, P
RE
TO
RIA
,R
SA
RE
SE
AR
CH
INS
TIT
UT
E F
OR
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
LS
ER
VIC
ES
, SIL
VE
RT
ON
DA
LE,
PR
ET
OR
IA, R
SA
LAB
OR
AT
OR
IES
(P
TY
) LT
D,
AT
LAS
VIL
LE, B
OK
SB
UR
G,
RS
A
IND
US
TR
IAL
PH
AR
MA
CY
,N
OR
TH
-WE
ST
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
, RS
A
RE
SE
AR
CH
INS
TIT
UT
E F
OR
IND
US
TR
IAL
PH
AR
MA
CY
,N
OR
TH
-WE
ST
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
, RS
A
FP
RR
:T
RIN
ITY
PH
AR
MA
SA
(P
TY
)LT
D, M
UR
RA
YF
IELD
,P
RE
TO
RIA
, RS
A
FP
RR
:T
RIN
ITY
PH
AR
MA
SA
(P
TY
)LT
D, M
UR
RA
YF
IELD
,P
RE
TO
RIA
, RS
A
FP
RR
:P
HA
RM
AP
LAN
(P
TY
) LT
D,
MID
RA
ND
, RS
A
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)S
helf-
life:
24 m
onth
s (P
rovi
sion
al)
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 65
MR
F 1
5M
RF
152.
F 1
5
Reg
istr
atio
n nu
mbe
r:44
/10.
2.2/
0384
Reg
istr
atio
n nu
mbe
r:44
/10.
2.2/
0431
Reg
istr
atio
n nu
mbe
r:44
/10.
2.2/
0493
Nam
e of
med
icin
e:M
ON
TE
WIN
4 m
gN
ame
of m
edic
ine:
LEU
KO
BLO
C 1
0 m
gN
ame
of m
edic
ine:
MIN
AIR
4
Dos
age
form
:C
HE
WA
BLE
TA
BLE
TS
Dos
age
form
:T
AB
LET
Dos
age
form
:C
HE
WA
BLE
TA
BLE
T
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H T
AB
LET
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:M
ON
TE
LUK
AS
T S
OD
IUM
EQ
UIV
ALE
NT
TO
MO
NT
ELU
KA
ST
SO
DIU
M E
QU
IVA
LEN
TM
onte
luka
st s
odiu
m e
quiv
alen
t to
MO
NT
ELU
KA
ST
4,0
mg
TO
MO
NT
ELU
KA
ST
10,0
mg
Mon
telu
kast
4,0
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7, 8
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
App
lican
t:W
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
App
lican
tP
HA
RM
AC
AR
E L
IMIT
ED
App
lican
t:A
KA
CIA
HE
ALT
HC
AR
E (
PT
Y)
LTD
LTD
Man
ufac
ture
r:N
YC
OM
ED
, LY
SZ
KO
WIC
E, P
OLA
ND
Man
ufac
ture
r:A
BD
I IB
RA
HIM
ILA
SA
N, V
E T
IC. A
S,
HA
DIM
KO
Y/ I
ST
AN
BU
L, T
UR
KE
YM
anuf
actu
rer:
PH
AR
MA
TH
EN
S.A
, PA
LLIN
I,A
TT
IKIS
, GR
EE
CE
PH
AR
MA
CA
RE
LIM
ITE
D, K
OR
ST
EN
,P
OR
T E
LIZ
AB
ET
H, R
SA
AS
PE
N P
HA
RM
AC
AR
E E
AS
T L
ON
DO
N,
WIL
SO
NIA
, EA
ST
LO
ND
ON
, RS
A
Pac
ker:
NY
CO
ME
D, L
YS
ZK
OW
ICE
, PO
LAN
DW
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
Pac
ker:
AB
DI I
BR
AH
IM IL
Ac
SA
N, V
E T
IC. A
S,
HA
DIM
KO
Y/ I
ST
AN
BU
L, T
UR
KE
YP
acke
r:P
HA
RM
AT
HE
N S
.A, P
ALL
INI,
AT
TIK
IS, G
RE
EC
ELT
D, W
ALT
LOO
, PR
ET
OR
IA, R
SA
PH
AR
MA
CA
RE
LIM
ITE
D, K
OR
ST
EN
,P
OR
T E
LIZ
AB
ET
H, R
SA
FA
MA
R S
.A, A
NT
HO
US
A, A
TT
IKIS
,G
RE
EC
EA
SP
EN
PH
AR
MA
CA
RE
EA
ST
LO
ND
ON
,W
ILS
ON
IA, E
AS
T L
ON
DO
N, R
SA
PH
AR
MA
NE
L P
HA
RM
AC
EU
TIC
ALS
S.A
, AT
HE
NS
-LA
MIA
HIG
HW
AY
,S
CH
IMA
TR
I, A
TH
EN
S, G
RE
EC
E
Labo
rato
ry: F
PR
C:
NY
CO
ME
D, L
YS
ZK
OW
ICE
, PO
LAN
DR
ES
EA
RC
H IN
ST
ITU
TE
FO
R IN
DU
ST
RIA
LLa
bora
tory
:F
PR
C:
SA
BS
CO
MM
ER
CIA
L (P
TY
) LT
D,
PH
AR
MA
CE
UT
ICA
L C
HE
MIS
TR
YLa
bora
tory
: FP
RC
PH
AR
MA
TH
EN
S.A
, PA
LLIN
I,A
TT
IKIS
, GR
EE
CE
PH
AR
MA
CY
NO
RT
H-W
ES
T U
NIV
ER
SIT
Y,
PO
TC
HE
FS
TR
OO
M, R
SA
DE
PA
RT
ME
NT
, GR
OE
NK
LOO
F,
PR
ET
OR
IA, R
SA
SA
BS
CO
MM
ER
CIA
L (P
TY
) LT
D,
PH
AR
MA
CE
UT
ICA
L C
HE
MIS
TR
YM
& L
LA
BO
RA
TO
RY
SE
RV
ICE
S (
PT
Y)
LTD
, LIM
BR
O B
US
INE
SS
PA
RK
,S
AN
DT
ON
, RS
A
DE
PA
RT
ME
NT
, GR
OE
NK
LOO
F,
PR
ET
OR
IA, R
SA
CO
NS
ULT
ING
CH
EM
ICA
LR
ES
EA
RC
H IN
ST
ITU
TE
FO
R IN
DU
ST
RIA
LP
HA
RM
AC
Y,N
OR
TH
-WE
ST
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
, RS
A
LAB
OR
AT
OR
IES
(P
TY
) LT
D,
AT
LAS
VIL
LE, B
OK
SB
UR
G, R
SA
M&
L LA
BO
RA
TO
RY
SE
RV
ICE
S, (
PT
Y)
LTD
, LIM
BR
O B
US
INE
SS
PA
RK
,S
AN
DT
ON
, RS
AR
ES
EA
RC
H IN
ST
ITU
TE
FO
RIN
DU
ST
RIA
L P
HA
RM
AC
Y, N
OR
TH
-W
ES
T U
NIV
ER
SIT
Y,
PO
TC
HE
FS
TR
OO
M, R
SA
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
LS
ER
VIC
ES
, SIL
VE
RT
ON
DA
LE,
PR
ET
OR
IA, R
SA
CO
NS
ULT
ING
MIC
RO
BIO
LOG
ICA
LLA
BO
RA
TO
RY
(P
TY
) LT
D,
MO
RE
HIL
L, B
EN
ON
I, R
SA
PH
AR
MA
SP
EC
CO
NS
ULT
ING
LAB
OR
AT
OR
IES
, FE
RN
DA
LE,
RA
ND
BU
RG
, RS
A
FP
RR
:W
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
LTD
, WA
LTLO
O, P
RE
TO
RIA
, RS
AF
PR
C/F
PR
R:
PH
AR
MA
CA
RE
LIM
ITE
D, K
OR
ST
EN
,P
OR
T E
LIZ
AB
ET
H, R
SA
FP
RR
:A
KA
CIA
HE
ALT
HC
AR
E (
PT
Y)
LTD
,IS
AN
DO
, JO
HA
NN
ES
BU
RG
, RS
AA
SP
EN
PH
AR
MA
CA
RE
EA
ST
LO
ND
ON
,W
ILS
ON
IA, E
AS
T L
ON
DO
N, R
SA
She
lf-lif
e:W
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
LTD
, MID
RA
ND
, RS
AF
PR
R:
PH
AR
MA
CA
RE
LIM
ITE
D,
WO
OD
ME
AD
, SA
ND
TO
N, R
SA
She
lf-lif
e:24
mon
ths
Dat
e of
reg
istr
atio
n:24
mon
ths
(Pro
visi
onal
)S
helf-
life:
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
27 J
ULY
201
2D
ate
of r
egis
trat
ion:
27 J
ULY
201
2
66 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15IF
15
Reg
istr
atio
n nu
mbe
r:44
/10.
2.2/
0494
Reg
istr
atio
n nu
mbe
r:44
/10.
2.2/
0495
Reg
istr
atio
n nu
mbe
r:44
/20
1 1/
0582
Nam
e of
med
icin
e:M
INA
IR 5
Nam
e of
med
icin
e:M
INA
IR 1
0N
ame
of m
edic
ine:
ZO
CE
F 2
50 m
g
Dos
age
form
:C
HE
WA
BLE
TA
BLE
TD
osag
e fo
rm:
TA
BLE
TD
osag
e fo
rm:
TA
BLE
T
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H T
AB
LET
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:M
onte
luka
st s
odiu
m e
quiv
alen
t to
Mon
telu
kast
sod
ium
equ
ival
ent t
oC
EF
UR
OX
IME
AX
ET
IL E
QU
IVA
LEN
TM
onte
luka
st 5
,0 m
gM
onte
luka
st 1
0,0
mg
TO
CE
FU
RO
XIM
E25
0,0
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
App
lican
t:A
KA
CIA
HE
ALT
HC
AR
E (
PT
Y)
LTD
App
lican
t:A
KA
CIA
HE
ALT
HC
AR
E (
PT
Y)
LTD
App
lican
t:A
LKE
M L
AB
OR
AT
OR
IES
(P
TY
) LT
D
Man
ufac
ture
r:P
HA
RM
AT
HE
N S
.A, P
ALL
INI,
AT
TIK
IS,
GR
EE
CE
Man
ufac
ture
r:P
HA
RM
AT
HE
N S
.A, P
ALL
INI.
AT
TIK
IS,
GR
EE
CE
Man
ufac
ture
r:A
LKE
M L
AB
OR
AT
OR
IES
LIM
ITE
D,
AM
ALI
YA
, DA
MA
N, I
ND
IA
Pac
ker:
PH
AR
MA
TH
EN
S.A
, PA
LLIN
I, A
TT
IKIS
,G
RE
EC
EP
acke
r:P
HA
RM
AT
HE
N S
.A, P
ALL
INI,
AT
TIK
IS,
GR
EE
CE
Pac
ker:
ALK
EM
LA
BO
RA
TO
RIE
S L
IMIT
ED
,A
MA
LIY
A, D
AM
AN
, IN
DIA
FA
MA
R S
.A, A
NT
HO
US
A, A
TT
IKIS
,G
RE
EC
EF
AM
AR
S.A
, AN
TH
OU
SA
, AT
TIK
IS,
GR
EE
CE
PH
AR
MA
NE
L P
HA
RM
AC
EU
TIC
ALS
S.A
,A
TH
EN
S-L
AM
IA H
IGH
WA
Y, S
CH
IMA
TR
I,A
TH
EN
S, G
RE
EC
E
PH
AR
MA
NE
L P
HA
RM
AC
EU
TIC
ALS
S.A
,A
TH
EN
S-L
AM
IA H
IGH
WA
Y, S
CH
IMA
TR
I,A
TH
EN
S, G
RE
EC
E
Labo
rato
ry: F
PR
C:
PH
AR
MA
TH
EN
S.A
, PA
LLIN
I, A
TT
IKIS
,G
RE
EC
ELa
bora
tory
:F
PR
C:
PH
AR
MA
TH
EN
S.A
, PA
LLIN
I, A
TT
IKIS
,G
RE
EC
ELa
bora
tory
: FP
RC
ALK
EM
LA
BO
RA
TO
RIE
S L
IMIT
ED
,A
MA
LIY
A, D
AM
AN
, IN
DIA
SA
BS
CO
MM
ER
CIA
L (P
TY
) LT
D,
PH
AR
MA
CE
UT
ICA
L C
HE
MIS
TR
YD
EP
AR
TM
EN
T, G
RO
EN
KLO
OF
,P
RE
TO
RIA
, RS
A
SA
BS
CO
MM
ER
CIA
L (P
TY
) LT
D,
PH
AR
MA
CE
UT
ICA
L C
HE
MIS
TR
YD
EP
AR
TM
EN
T, G
RO
EN
KLO
OF
,P
RE
TO
RIA
, RS
A
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
LS
ER
VIC
ES
, SIL
VE
RT
ON
DA
LE,
PR
ET
OR
IA, R
SA
RE
SE
AR
CH
INS
TIT
UT
E F
OR
CO
NS
ULT
ING
CH
EM
ICA
L LA
BO
RA
TO
RIE
S(P
TY
) LT
D, A
TLA
SV
ILLE
, BO
KS
BU
RG
, RS
AM
&L
LAB
OR
AT
OR
Y S
ER
VIC
ES
, (P
TY
) LT
D,
LIM
BR
O B
US
INE
SS
PA
RK
, SA
ND
TO
N,
RS
AR
ES
EA
RC
H IN
ST
ITU
TE
FO
R IN
DU
ST
RIA
L
CO
NS
ULT
ING
CH
EM
ICA
LLA
BO
RA
TO
RIE
S (
PT
Y)
LTD
, AT
LAS
VIL
LE,
BO
KS
BU
RG
, RS
AM
&L
LAB
OR
AT
OR
Y S
ER
VIC
ES
, (P
TY
)LT
D, L
IMB
RO
BU
SIN
ES
S P
AR
K,
SA
ND
TO
N, R
SA
IND
US
TR
IAL
PH
AR
MA
CY
, NO
RT
H-
WE
ST
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
, RS
AC
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
AT
OR
IES
, AT
LAS
VIL
LE,
BO
KS
BU
RG
, RS
AP
HA
RM
AC
Y, N
OR
TH
-WE
ST
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
, RS
AIN
ST
ITU
TE
FO
R P
HA
RM
AC
EU
TIC
AL
RE
SE
AR
CH
INS
TIT
UT
E F
OR
IND
US
TR
IAL
PH
AR
MA
CY
, NO
RT
H-W
ES
T U
NIV
ER
SIT
Y,
PO
TC
HE
FS
TR
OO
M, R
SA
SE
RV
ICE
S, S
ILV
ER
TO
ND
ALE
, PR
ET
OR
IA,
RS
AC
ON
SU
LTIN
G M
ICR
OB
IOLO
GIC
AL
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
LS
ER
VIC
ES
, SIL
VE
RT
ON
DA
LE,
PR
ET
OR
IA, R
SA
LAB
OR
AT
OR
Y (
PT
Y)
LTD
, MO
RE
HIL
L,B
EN
ON
I, R
SA
PH
AR
MA
SP
EC
CO
NS
ULT
ING
CO
NS
ULT
ING
MIC
RO
BIO
LOG
ICA
LLA
BO
RA
TO
RY
(P
TY
) LT
D, M
OR
EH
ILL,
BE
NO
NI,
RS
ALA
BO
RA
TO
RIE
S, F
ER
ND
ALE
,R
AN
DB
UR
G, R
SA
PH
AR
MA
SP
EC
CO
NS
ULT
ING
LAB
OR
AT
OR
IES
, FE
RN
DA
LE,
RA
ND
BU
RG
, RS
A
FP
RR
:A
KA
CIA
HE
ALT
HC
AR
E (
PT
Y)
LTD
,IS
AN
DO
, JO
HA
NN
ES
BU
RG
, RS
AF
PR
R:
AK
AC
IA H
EA
LTH
CA
RE
(P
TY
) LT
D,
ISA
ND
O, J
OH
AN
NE
SB
UR
G, R
SA
FP
RR
:A
LKE
M L
AB
OR
AT
OR
IES
(P
TY
) LT
D,
PO
TC
HE
FS
TR
OO
M, R
SA
She
lf-lif
e:24
mon
ths
She
lf-lif
e:24
mon
ths
She
lf-lif
e:24
mon
ths
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 67
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:44
/20.
1.1/
0583
Reg
istr
atio
n nu
mbe
r:44
/10.
2.2/
0666
Reg
istr
atio
n nu
mbe
r:44
/10.
2.2/
0667
Nam
e of
med
icin
e:Z
OC
EF
500
mg
Nam
e of
med
icin
e:M
SD
MO
NT
ELU
KA
ST
4 m
gN
ame
of m
edic
ine:
MS
D M
ON
TE
LUK
AS
T 5
mg
Dos
age
form
:T
AB
LET
Dos
age
form
:C
HE
WA
BLE
TA
BLE
TD
osag
e fo
rm:
CH
EW
AB
LE T
AB
LET
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H T
AB
LET
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:C
EF
UR
OX
IME
AX
ET
IL E
QU
IVA
LEN
TM
ON
TE
LUK
AS
T S
OD
IUM
MO
NT
ELU
KA
ST
SO
DIU
MT
O C
EF
UR
OX
IME
500,
0 m
gE
QU
IVA
LEN
T T
OE
QU
IVA
LEN
T T
OM
ON
TE
LUK
AS
T4,
0 m
gM
ON
TE
LUK
AS
T5,
0 m
g
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
App
lican
t:A
LKE
M L
AB
OR
AT
OR
IES
(P
TY
) LT
DA
pplic
ant:
MS
D (
PT
Y)
LTD
App
lican
t:M
SD
(P
TY
) LT
D
Man
ufac
ture
r:A
LKE
M L
AB
OR
AT
OR
IES
LIM
ITE
D,
AM
ALI
YA
, DA
MA
N, I
ND
IA.
Man
ufac
ture
r:M
ER
CK
SH
AR
P &
DO
HM
E,
CR
AM
LIN
GT
ON
,N
OR
TH
UM
BE
RLA
ND
, UK
Man
ufac
ture
r:M
ER
CK
SH
AR
P &
DO
HM
E,
CR
AM
LIN
GT
ON
,N
OR
TH
UM
BE
RLA
ND
, UK
Pac
ker:
ALK
EM
LA
BO
RA
TO
RIE
S L
IMIT
ED
,A
MA
LIY
A, D
AM
AN
, IN
DIA
Pac
ker:
ME
RC
K S
HA
RP
& D
OH
ME
,C
RA
MLI
NG
TO
N,
NO
RT
HU
MB
ER
LAN
D, U
K
Pac
ker:
ME
RC
K S
HA
RP
& D
OH
ME
,C
RA
MLI
NG
TO
N,
NO
RT
HU
MB
ER
LAN
D, U
KM
MD
HA
AR
LEM
, PC
HA
AR
LEM
,T
HE
NE
TH
ER
LAN
DS
MM
D H
AA
RLE
M, P
C H
AA
RLE
M,
TH
E N
ET
HE
RLA
ND
SM
SD
(P
TY
) LT
D, H
ALF
WA
Y H
OU
SE
,R
SA
MS
D (
PT
Y)
LTD
, HA
LFW
AY
HO
US
E, R
SA
Labo
rato
ry: F
PR
C:
ALK
EM
LA
BO
RA
TO
RIE
S L
IMIT
ED
,A
MA
LIY
A, D
AM
AN
, IN
DIA
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
L
Labo
rato
ry:
FP
RC
:M
ER
CK
SH
AR
P &
DO
HM
E,
CR
AM
LIN
GT
ON
,N
OR
TH
UM
BE
RLA
ND
, UK
Labo
rato
ry: F
PR
CM
ER
CK
SH
AR
P &
DO
HM
E,
CR
AM
LIN
GT
ON
,N
OR
TH
UM
BE
RLA
ND
, UK
SE
RV
ICE
S, S
ILV
ER
TO
ND
ALE
,P
RE
TO
RIA
, RS
AM
MD
HA
AR
LEM
, PC
HA
AR
LEM
,T
HE
NE
TH
ER
LAN
DS
MM
D H
AA
RLE
M, P
C H
AA
RLE
M,
TH
E N
ET
HE
RLA
ND
SR
ES
EA
RC
H IN
ST
ITU
TE
FO
RIN
DU
ST
RIA
L P
HA
RM
AC
Y, N
OR
TH
-W
ES
T U
NIV
ER
SIT
Y,
PO
TC
HE
FS
TR
OO
M, R
SA
CO
NS
ULT
ING
CH
EM
ICA
LLA
BO
RA
TO
RIE
S, A
TLA
SV
ILLE
,B
OK
SB
UR
G, R
SA
FP
RR
:A
LKE
M L
AB
OR
AT
OR
IES
(P
TY
) LT
D,
PO
TC
HE
FS
TR
OO
M, R
SA
FP
RR
:M
SD
(P
TY
) LT
D, H
ALF
WA
Y H
OU
SE
,R
SA
FP
RR
:M
SD
(P
TY
) LT
D, H
ALF
WA
YH
OU
SE
, RS
A
She
lf-lif
e:24
mon
ths
She
lf-lif
e:24
mon
ths
She
lf-lif
e:24
mon
ths
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
68 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:44
/10.
2.2/
0668
Reg
istr
atio
n nu
mbe
r:44
/10.
2.2/
0669
Reg
istr
atio
n nu
mbe
r:44
/10.
2.2/
0844
Nam
e of
med
icin
e:M
SD
MO
NT
ELU
KA
ST
10
mg
Nam
e of
med
icin
e:M
SD
MO
NT
ELU
KA
ST
SP
RIN
KLE
SN
ame
of m
edic
ine:
MO
NT
ELU
KA
ST
BR
IMP
HA
RM
4
Dos
age
form
:T
AB
LET
Dos
age
form
:G
RA
NU
LES
Dos
age
form
:C
HE
WA
BLE
TA
BLE
T
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H P
AC
KE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H T
AB
LET
CO
NT
AIN
S:
MO
NT
ELU
KA
ST
SO
DIU
MM
ON
TE
LUK
AS
T S
OD
IUM
MO
NT
ELU
KA
ST
SO
DIU
ME
QU
IVA
LEN
T T
OE
QU
IVA
LEN
T T
OE
QU
IVA
LEN
T T
OM
ON
TE
LUK
AS
T10
,0 m
gM
ON
TE
LUK
AS
T4,
0 m
gM
ON
TE
LUK
AS
T4,
0 m
g
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8
App
lican
t:M
SD
(P
TY
) LT
DA
pplic
ant:
MS
D (
PT
Y)
LTD
App
lican
t:B
RIM
PH
AR
M S
A (
PT
Y)
LTD
Man
ufac
ture
r:M
ER
CK
SH
AR
P &
DO
HM
E,
CR
AM
LIN
GT
ON
,N
OR
TH
UM
BE
RLA
ND
, UK
Man
ufac
ture
r:M
ER
CK
MA
NU
FA
CT
UR
ING
DIV
ISIO
N, W
ES
T P
OIN
T,
PE
NN
SY
LVA
NIA
, US
A
Man
ufac
ture
r:S
IEG
FR
IED
LT
D, Z
OF
ING
EN
,S
WIT
ZE
RLA
ND
SIE
GF
RIE
D G
EN
ER
ICS
(M
ALT
A)
LTD
, HA
L F
AR
, MA
LTA
Pac
ker:
ME
RC
K S
HA
RP
& D
OH
ME
,C
RA
MLI
NG
TO
N,
NO
RT
HU
MB
ER
LAN
D, U
K
Pac
ker:
ME
RC
K M
AN
UF
AC
TU
RIN
GD
IVIS
ION
, WIL
SO
N, N
OR
TH
CA
RO
LIN
A, U
SA
Pac
ker:
SIE
GF
RIE
D L
TD
, ZO
FIN
GE
N,
SW
ITZ
ER
LAN
DS
IEG
FR
IED
GE
NE
RIC
S (
MA
LTA
)M
MD
HA
AR
LEM
, PC
HA
AR
LEM
, TH
EN
ET
HE
RLA
ND
SM
MD
HA
AR
LEM
, PC
HA
AR
LEM
,T
HE
NE
TH
ER
LAN
DS
LTD
, HA
L F
AR
,MA
LTA
DIV
PH
AR
M M
AN
UF
AC
TU
RIN
GM
SD
(P
TY
) LT
D, H
ALF
WA
Y H
OU
SE
,R
SA
MS
D (
PT
Y)
LTD
, HA
LFW
AY
HO
US
E,
RS
A&
PA
CK
AG
ING
, LO
NG
DA
LE,
IND
US
TR
IA, J
OH
AN
NE
SB
UR
G,
RS
A
Labo
rato
ry: F
PR
C:
ME
RC
K S
HA
RP
& D
OH
ME
,C
RA
MLI
NG
TO
N,
NO
RT
HU
MB
ER
LAN
D, U
K
Labo
rato
ry:
FP
RC
:M
ER
CK
MA
NU
FA
CT
UR
ING
DIV
ISIO
N, W
ES
T P
OIN
T,
PE
NN
SY
LVA
NIA
, US
A
Labo
rato
ry: F
PR
CS
IEG
FR
IED
LT
D, Z
OF
ING
EN
,S
WIT
ZE
RLA
ND
SIE
GF
RIE
D G
EN
ER
ICS
(M
ALT
A)
MM
D H
AA
RLE
M, P
C H
AA
RLE
M, T
HE
ME
RC
K M
AN
UF
AC
TU
RIN
GLT
D, H
AL
FA
R, M
ALT
AN
ET
HE
RLA
ND
SD
IVIS
ION
, WIL
SO
N, N
OR
TH
CA
RO
LIN
A, U
SA
CO
NF
AR
MA
FR
AN
CE
S.A
.R.L
.,H
OM
BO
UR
G, F
RA
NC
EM
MD
HA
AR
LEM
, PC
HA
AR
LEM
,T
HE
NE
TH
ER
LAN
DS
CO
NS
ULT
ING
CH
EM
ICA
LLA
BO
RA
TO
RIE
S, A
TLA
SV
ILLE
,B
OK
SB
UR
G, R
SA
FP
RR
:M
SD
(P
TY
) LT
D, H
ALF
WA
Y H
OU
SE
,R
SA
FP
RC
/FP
RR
:M
SD
(P
TY
) LT
D, H
ALF
WA
Y H
OU
SE
,R
SA
FP
RR
:B
RIM
PH
AR
M S
A (
PT
Y)
LTD
,C
LAR
EM
ON
T, C
AP
E T
OW
N,
RS
A
She
lf-lif
e:24
mon
ths
She
lf-lif
e:24
mon
ths
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 69
MR
F 1
5M
RF
15
Reg
istr
atio
n nu
mbe
r:44
/10.
2.2/
0845
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C:
FP
RR
:
She
lf-lif
e:
MO
NT
ELU
KA
ST
BR
IMP
HA
RM
5
CH
EW
AB
LE T
AB
LET
EA
CH
TA
BLE
T C
ON
TA
INS
:M
ON
TE
LUK
AS
T S
OD
IUM
EQ
UIV
ALE
NT
TO
MO
NT
ELU
KA
ST
5,0
mg
1, 2
, 3, 4
, 5, 6
, 7, 8
BR
IMP
HA
RM
SA
(P
TY
) LT
D
SIE
GF
RIE
D L
TD
, ZO
FIN
GE
N,
SW
ITZ
ER
LAN
DS
IEG
FR
IED
GE
NE
RIC
S (
MA
LTA
)LT
D, H
AL
FA
R, M
ALT
A
SIE
GF
RIE
D L
TD
, ZO
FIN
GE
N,
SW
ITZ
ER
LAN
DS
IEG
FR
IED
GE
NE
RIC
S (
MA
LTA
)LT
D, H
AL
FA
R,M
ALT
AD
IVP
HA
RM
MA
NU
FA
CT
UR
ING
&P
AC
KA
GIN
G, L
ON
GD
ALE
,IN
DU
ST
RIA
, JO
HA
NN
ES
BU
RG
, RS
A
SIE
GF
RIE
D L
TD
, ZO
FIN
GE
N,
SW
ITZ
ER
LAN
DS
IEG
FR
IED
GE
NE
RIC
S (
MA
LTA
)LT
D, H
AL
FA
R, M
ALT
AC
ON
FA
RM
A F
RA
NC
E S
.A.R
.L.,
HO
MB
OU
RG
, FR
AN
CE
CO
NS
ULT
ING
CH
EM
ICA
LLA
BO
RA
TO
RIE
S, A
TLA
SV
ILLE
,B
OK
SB
UR
G, R
SA
BR
IMP
HA
RM
SA
(P
TY
) LT
D,
CLA
RE
MO
NT
, CA
PE
TO
WN
, RS
A
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
44/1
0.2.
2/08
46
MO
NT
ELU
KA
ST
BR
IMP
HA
RM
10
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:M
ON
TE
LUK
AS
T S
OD
IUM
EQ
UIV
ALE
NT
TO
MO
NT
ELU
KA
ST
10,0
mg
1, 2
, 3, 4
, 5, 6
, 7, 8
BR
IMP
HA
RM
SA
(P
TY
) LT
D
SIE
GF
RIE
D L
TD
, ZO
FIN
GE
N,
SW
ITZ
ER
LAN
DS
IEG
FR
IED
GE
NE
RIC
S (
MA
LTA
)LT
D, H
AL
FA
R, M
ALT
A
SIE
GF
RIE
D L
TD
, ZO
FIN
GE
N,
SW
ITZ
ER
LAN
DS
IEG
FR
IED
GE
NE
RIC
S (
MA
LTA
)LT
D, H
AL
FA
R,M
ALT
AD
IVP
HA
RM
MA
NU
FA
CT
UR
ING
&P
AC
KA
GIN
G, L
ON
GD
ALE
,IN
DU
ST
RIA
, JO
HA
NN
ES
BU
RG
,R
SA
SIE
GF
RIE
D L
TD
, ZO
FIN
GE
N,
SW
ITZ
ER
LAN
DS
IEG
FR
IED
GE
NE
RIC
S (
MA
LTA
)LT
D, H
AL
FA
R, M
ALT
AC
ON
FA
RM
A F
RA
NC
E S
.A.R
.L.,
HO
MB
OU
RG
, FR
AN
CE
CO
NS
ULT
ING
CH
EM
ICA
LLA
BO
RA
TO
RIE
S, A
TLA
SV
ILLE
,B
OK
SB
UR
G, R
SA
BR
IMP
HA
RM
SA
(P
TY
) LT
D,
CLA
RE
MO
NT
, CA
PE
TO
WN
, RS
A
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C
FP
RR
:
She
lf-lif
e:
44/1
0.2.
2/08
89
MO
NT
ELU
KA
ST
SP
EC
PH
AR
M 4
CH
EW
AB
LE T
AB
LET
EA
CH
TA
BLE
T C
ON
TA
INS
:M
ON
TE
LUK
AS
T S
OD
IUM
EQ
UIV
ALE
NT
TO
MO
NT
ELU
KA
ST
4,0
mg
1, 2
, 3, 4
, 5, 6
, 7, 8
SP
EC
PH
AR
M (
PT
Y)
LTD
PH
AR
MA
TH
EN
S.A
.,P
ALL
INI,
AT
TIK
IS, G
RE
EC
E
PH
AR
MA
TH
EN
S.A
.,P
ALL
INI,
AT
TIK
IS, G
RE
EC
EF
AM
AR
S.A
., A
NT
HO
US
A,
AT
TIK
IS, G
RE
EC
EP
HA
RM
AN
EL
PH
AR
MA
CE
UT
ICA
LS S
.A.,
LAM
IA H
IGH
WA
Y, G
RE
EC
ES
PE
CP
HA
RM
HO
LDIN
GS
(PT
Y)
LTD
, HA
LFW
AY
HO
US
E, M
IDR
AN
D, R
SA
PH
AR
MA
TH
EN
S.A
.,P
ALL
INI,
AT
TIK
IS, G
RE
EC
ES
PE
CP
HA
RM
HO
LDIN
GS
(PT
Y)
LTD
, HA
LFW
AY
HO
US
E, M
IDR
AN
D, R
SA
CO
NS
ULT
ING
CH
EM
ICA
LLA
BO
RA
TO
RIE
S, (
PT
Y)
LTD
, AT
LAS
VIL
LE,
BO
KS
BU
RG
, RS
A
SP
EC
PH
AR
M (
PT
Y)
LTD
,H
ALF
WA
Y H
OU
SE
,M
IDR
AN
D, R
SA
24 m
onth
s(P
rovi
sion
al)
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
70 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
152F
15
Reg
istr
atio
n nu
mbe
r44
/10.
2.2/
0890
Reg
istr
atio
n nu
mbe
r:44
/10.
2.2/
0891
Reg
istr
atio
n nu
mbe
r.44
/2.5
/092
4
Nam
e of
med
icin
e:M
ON
TE
LUK
AS
T S
PE
CP
HA
RM
5N
ame
of m
edic
ine:
MO
NT
ELU
KA
ST
SP
EC
PH
AR
M 1
0N
ame
of m
edic
ine:
GD
C C
AR
BA
MA
ZE
PIN
E 2
00
Dos
age
form
:C
HE
WA
BLE
TA
BLE
TD
osag
e fo
rm:
TA
BLE
TD
osag
e fo
rm:
TA
BLE
T
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H T
AB
LET
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:M
ON
TE
LUK
AS
T S
OD
IUM
EQ
UIV
ALE
NT
TO
MO
NT
ELU
KA
ST
SO
DIU
M E
QU
IVA
LEN
TC
AR
BA
MA
ZE
PIN
E20
0,0
mg
MO
NT
ELU
KA
ST
5,0
mg
TO
MO
NT
ELU
KA
ST
10,0
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of r
egis
trat
ion.
1, 2
, 3, 4
, 5, 6
, 7, 8
Con
ditio
ns o
f reg
istr
atio
n.1,
2, 3
, 4, 5
, 6, 7
, 8
App
lican
t:S
PE
CP
HA
RM
(P
TY
) LT
DA
pplic
ant:
SP
EC
PH
AR
M (
PT
Y)
LTD
App
lican
t:G
ULF
DR
UG
CO
MP
AN
Y (
PT
Y)
LTD
Man
ufac
ture
r:P
HA
RM
AT
HE
N S
.A.,
PA
LLIN
I, A
TT
IKIS
,G
RE
EC
EM
anuf
actu
rer:
PH
AR
MA
TH
EN
S.A
., P
ALL
INI,
AT
TIK
IS,
GR
EE
CE
Man
ufac
ture
rA
LEM
BIC
LIM
ITE
D (
FO
RM
ULA
TIO
ND
IVIS
ION
), T
AL-
HA
LOL,
DIS
TR
ICT
PA
NC
MA
HA
LS, G
UJA
RA
T, I
ND
IA
Pac
ker:
PH
AR
MA
TH
EN
S.A
., P
ALL
INI,
AT
TIK
IS,
GR
EE
CE
Pac
ker
PH
AR
MA
TH
EN
S.A
., P
ALL
INI,
AT
TIK
IS,
GR
EE
CE
Pac
ker:
ALE
MB
IC L
IMIT
ED
(F
OR
MU
LAT
ION
DIV
ISIO
N),
TA
L-H
ALO
L, D
IST
RIC
TF
AM
AR
S.A
., A
NT
HO
US
A, A
TT
IKIS
,G
RE
EC
EF
AM
AR
S.A
., A
NT
HO
US
A, A
TT
IKIS
,G
RE
EC
EP
AN
CM
AH
ALS
, GU
JAR
AT
, IN
DIA
PH
AR
MA
NE
L P
HA
RM
AC
EU
TIC
ALS
S.A
.,LA
MIA
HIG
HW
AY
, GR
EE
CE
PH
AR
MA
NE
L P
HA
RM
AC
EU
TIC
ALS
S.A
.,LA
MIA
HIG
HW
AY
, GR
EE
CE
SP
EC
PH
AR
M H
OLD
ING
S (
PT
Y)
LTD
,H
ALF
WA
Y H
OU
SE
, MID
RA
ND
, RS
AS
PE
CP
HA
RM
HO
LDIN
GS
(P
TY
) LT
D,
HA
LFW
AY
HO
US
E, M
IDR
AN
D, R
SA
Labo
rato
ry: F
PR
C:
PH
AR
MA
TH
EN
S.A
., P
ALL
INI,
AT
TIK
IS,
GR
EE
CE
Labo
rato
ry:
FP
RC
:P
HA
RM
AT
HE
N S
.A.,
PA
LLIN
I, A
TT
IKIS
,G
RE
EC
ELa
bora
tory
: FP
RC
ALE
MB
IC L
IMIT
ED
(F
OR
MU
LAT
ION
DIV
ISIO
N),
TA
L-H
ALO
L, D
IST
RIC
TS
PE
CP
HA
RM
HO
LDIN
GS
(P
TY
) LT
D,
HA
LFW
AY
HO
US
E, M
IDR
AN
D, R
SA
SP
EC
PH
AR
M H
OLD
ING
S (
PT
Y)
LTD
,H
ALF
WA
Y H
OU
SE
, MID
RA
ND
, RS
AP
AN
CM
AH
ALS
, GU
JAR
AT
, IN
DIA
SA
BS
CO
MM
ER
CIA
L (P
TY
) LT
DC
ON
SU
LTIN
G C
HE
MIC
AL
CO
NS
ULT
ING
CH
EM
ICA
LP
HA
RM
AC
EU
TIC
AL
CH
EM
IST
RY
LAB
OR
AT
OR
IES
, (P
TY
) LT
D, A
TLA
SV
ILLE
,B
OK
SB
UR
G, R
SA
LAB
OR
AT
OR
IES
, (P
TY
) LT
D,
AT
LAS
VIL
LE, B
OK
SB
UR
G, R
SA
DE
PA
RT
ME
NT
GR
OE
NK
LOO
F,
PR
ET
OR
IA, R
SA
SW
IFT
MIC
RO
LA
BO
RA
TO
RIE
S (
PT
Y)
LTD
, CO
NS
TA
NT
IA, M
IDR
AN
D, R
SA
CO
NS
ULT
ING
CH
EM
ICA
LLA
BO
RA
TO
RIE
S (
PT
Y)
LTD
,A
TLA
SV
ILLE
, BO
KS
BU
RG
, RS
AIN
ST
ITU
TE
FO
R P
HA
RM
AC
EU
TIC
AL
SE
RV
ICE
S, S
ILV
ER
TO
ND
ALE
,P
RE
TO
RIA
, RS
AC
ON
SU
LTIN
G M
ICR
OB
IOLO
GIC
AL
LAB
OR
AT
OR
Y (
PT
Y)
LTD
,M
OR
EH
ILL,
BE
NO
NI,
RS
A
FP
RR
:S
PE
CP
HA
RM
(P
TY
) LT
D, H
ALF
WA
YH
OU
SE
, MID
RA
ND
, RS
AF
PR
R:
SP
EC
PH
AR
M (
PT
Y)
LTD
, HA
LFW
AY
HO
US
E, M
IDR
AN
D, R
SA
FP
RR
:G
ULF
DR
UG
CO
MP
AN
Y (
PT
Y)
LTD
,M
OU
NT
ED
GE
CO
MB
E, R
SA
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)S
helf-
life:
24 m
onth
s (P
rovi
sion
al)
She
lf -li
fe:
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 71
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
45/1
0.2.
2/00
58
DIL
AIR
4
CH
EW
AB
LE T
AB
LET
EA
CH
TA
BLE
T C
ON
TA
INS
:M
ON
TE
LUK
AS
T S
OD
IUM
EQ
UIV
ALE
NT
TO
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
45/1
0.2.
2/00
59
DIL
AIR
5
CH
EW
AB
LE T
AB
LET
EA
CH
TA
BLE
T C
ON
TA
INS
:M
ON
TE
LUK
AS
T S
OD
IUM
EQ
UIV
ALE
NT
TO
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
45/1
0.2.
2/00
60
DIL
AIR
10
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:M
ON
TE
LUK
AS
T S
OD
IUM
EQ
UIV
ALE
NT
TO
MO
NT
ELU
KA
ST
4,0
mg
MO
NT
ELU
KA
ST
5,0
mg
MO
NT
ELU
KA
ST
10,0
mg
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
App
lican
t:R
AN
BA
XY
(S
.A.)
(P
TY
) LT
DA
pplic
ant:
RA
NB
AX
Y (
S.A
.) (
PT
Y)
LTD
App
lican
t:R
AN
BA
XY
(S
.A.)
(P
TY
) LT
D
Man
ufac
ture
r:T
OR
RE
NT
PH
AR
MA
CE
UT
ICA
LSM
anuf
actu
rer:
TO
RR
EN
TM
anuf
actu
rer:
TO
RR
EN
TLT
D, I
ND
RA
D, M
EH
SA
NA
, IN
DIA
PH
AR
MA
CE
UT
ICA
LS L
TD
,IN
DR
AD
, ME
HS
AN
A, I
ND
IAP
HA
RM
AC
EU
TIC
ALS
LT
D,
IND
RA
D, M
EH
SA
NA
, IN
DIA
Pac
ker:
TO
RR
EN
T P
HA
RM
AC
EU
TIC
ALS
Pac
ker:
TO
RR
EN
TP
acke
r:T
OR
RE
NT
LTD
, IN
DR
AD
, ME
HS
AN
A, I
ND
IAP
HA
RM
AC
EU
TIC
ALS
LT
D,
IND
RA
D, M
EH
SA
NA
, IN
DIA
PH
AR
MA
CE
UT
ICA
LS L
TD
,IN
DR
AD
, ME
HS
AN
A, I
ND
IA
Labo
rato
ry: F
PR
C:
TO
RR
EN
T P
HA
RM
AC
EU
TIC
ALS
Labo
rato
ry:
TO
RR
EN
TLa
bora
tory
: FP
RC
TO
RR
EN
TLT
D, I
ND
RA
D, M
EH
SA
NA
, IN
DIA
CO
NS
ULT
ING
CH
EM
ICA
LF
PR
C:
PH
AR
MA
CE
UT
ICA
LS L
TD
,IN
DR
AD
, ME
HS
AN
A, I
ND
IAP
HA
RM
AC
EU
TIC
ALS
LT
D,
IND
RA
D, M
EH
SA
NA
, IN
DIA
LAB
OR
AT
OR
IES
, (P
TY
) LT
D,
AT
LAS
VIL
LE, B
OK
SB
UR
G, R
SA
KH
ULU
LEK
AN
I LA
BO
RA
TO
RY
SE
RV
ICE
S, C
OV
EN
TR
Y P
AR
K,
MID
RA
ND
, RS
A
CO
NS
ULT
ING
CH
EM
ICA
LLA
BO
RA
TO
RIE
S, (
PT
Y)
LTD
,A
TLA
SV
ILLE
, BO
KS
BU
RG
,R
SA
KH
ULU
LEK
AN
I LA
BO
RA
TO
RY
CO
NS
ULT
ING
CH
EM
ICA
LLA
BO
RA
TO
RIE
S, (
PT
Y)
LTD
, AT
LAS
VIL
LE,
BO
KS
BU
RG
, RS
AK
HU
LULE
KA
NI
SE
RV
ICE
S, C
OV
EN
TR
Y P
AR
K,
MID
RA
ND
, RS
ALA
BO
RA
TO
RY
SE
RV
ICE
S,
CO
VE
NT
RY
PA
RK
,M
IDR
AN
D, R
SA
FP
RR
:R
AN
BA
XY
(S
.A.)
(P
TY
) LT
D,
CE
NT
UR
ION
, RS
AF
PR
R:
RA
NB
AX
Y (
S.A
.) (
PT
Y)
LTD
,C
EN
TU
RIO
N, R
SA
FP
RR
:R
AN
BA
XY
(S
A.)
(P
TY
) LT
D,
CE
NT
UR
ION
, RS
A
She
lf-lif
e:24
mon
ths
She
lf-lif
e:24
mon
ths
She
lf-lif
e:24
mon
ths
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
72 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:45
/20.
2.8/
0082
Reg
istr
atio
n nu
mbe
r:45
/20.
2.8/
0083
Reg
istr
atio
n nu
mbe
r:45
/20.
1.1/
0216
Nam
e of
med
icin
e:C
OT
IRA
L 10
0/25
mg
Nam
e of
med
icin
e:C
OT
IRA
L 20
0/50
mg
Nam
e of
med
icin
e:C
EF
UR
OX
IME
ALK
EM
250
mg
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Dos
age
form
:T
AB
LET
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:A
ctiv
e in
gred
ient
s:E
AC
H T
AB
LET
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
EA
CH
TA
BLE
T C
ON
TA
INS
:LO
PIN
AV
IR 1
00,0
mg
LOP
INA
VIR
200
,0 m
gC
EF
UR
OX
IME
AX
ET
ILR
ITO
NA
VIR
25,
0 m
gR
ITO
NA
VIR
50,
0 m
gE
QU
IVA
LEN
T T
OC
EF
UR
OX
IME
250
,0 m
g
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7, 8
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
App
lican
t:A
UR
OB
IND
O P
HA
RM
A (
PT
Y)
LTD
App
lican
t:A
UR
OB
IND
O P
HA
RM
A (
PT
Y)
LTD
App
lican
t:A
LKE
M L
AB
OR
AT
OR
IES
(P
TY
)LT
D
Man
ufac
ture
r:A
UR
OB
IND
O P
HA
RM
A L
IMIT
ED
,U
NIT
111
, QU
TH
UB
ULL
AP
UR
MA
ND
AL,
RA
NG
A R
AD
DY
DIS
TR
ICT
,H
YD
ER
AB
AD
, AN
DH
RA
PR
AD
ES
H,
IND
IA
Man
ufac
ture
r:A
UR
OB
IND
O P
HA
RM
A L
IMIT
ED
,U
NIT
111
, QU
TH
UB
ULL
AP
UR
MA
ND
AL,
RA
NG
A R
AD
DY
DIS
TR
ICT
, HY
DE
RA
BA
D, A
ND
HR
AP
RA
DE
SH
, IN
DIA
Man
ufac
ture
r:A
LKE
M L
AB
OR
AT
OR
IES
LIM
ITE
D, A
MA
LIY
A, D
AM
AN
,IN
DIA
Pac
ker:
AU
RO
BIN
DO
PH
AR
MA
LIM
ITE
D,
UN
IT 1
11, Q
UT
HU
BU
LLA
PU
RM
AN
DA
L, R
AN
GA
RA
DD
Y D
IST
RIC
T,
HY
DE
RA
BA
D, A
ND
HR
A P
RA
DE
SH
,IN
DIA
Pac
ker:
AU
RO
BIN
DO
PH
AR
MA
LIM
ITE
D,
UN
IT 1
11, Q
UT
HU
BU
LLA
PU
RM
AN
DA
L, R
AN
GA
RA
DD
YD
IST
RIC
T, H
YD
ER
AB
AD
, AN
DH
RA
PR
AD
ES
H, I
ND
IA
Pac
ker:
ALK
EM
LA
BO
RA
TO
RIE
SLI
MIT
ED
, AM
ALI
YA
, DA
MA
N,
IND
IA
Labo
rato
ry: F
PR
C:
AU
RO
BIN
DO
PH
AR
MA
LIM
ITE
D,
UN
IT 1
11, Q
UT
HU
BU
LLA
PU
RM
AN
DA
L, R
AN
GA
RA
DD
Y D
IST
RIC
T,
HY
DE
RA
BA
D, A
ND
HR
A P
RA
DE
SH
,IN
DIA
M&
L LA
BO
RA
TO
RY
SE
RV
ICE
S (
PT
Y)
LTD
, LIM
BR
O B
US
INE
SS
PA
RK
,S
AN
DT
ON
, RS
A
Labo
rato
ry:
FP
RC
:A
UR
OB
IND
O P
HA
RM
A L
IMIT
ED
,U
NIT
111
, QU
TH
UB
ULL
AP
UR
MA
ND
AL,
RA
NG
A R
AD
DY
DIS
TR
ICT
, HY
DE
RA
BA
D, A
ND
HR
AP
RA
DE
SH
, IN
DIA
M&
L LA
BO
RA
TO
RY
SE
RV
ICE
S(P
TY
) LT
D, L
IMB
RO
BU
SIN
ES
SP
AR
K, S
AN
DT
ON
, RS
A
Labo
rato
ry: F
PR
CA
LKE
M L
AB
OR
AT
OR
IES
LIM
ITE
D, A
MA
LIY
A, D
AM
AN
,IN
DIA
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
L S
ER
VIC
ES
,S
ILV
ER
TO
ND
ALE
, PR
ET
OR
IA,
RS
AR
ES
EA
RC
H IN
ST
ITU
TE
FO
RK
HU
LULE
KA
NI L
AB
OR
AT
OR
YS
ER
VIC
ES
, CO
VE
NT
RY
PA
RK
,M
IDR
AN
D, R
SA
KH
ULU
LEK
AN
I LA
BO
RA
TO
RY
SE
RV
ICE
S, C
OV
EN
TR
Y P
AR
K,
MID
RA
ND
, RS
A
IND
US
TR
IAL
PH
AR
MA
CY
,N
OR
TH
-WE
ST
UN
IVE
RS
ITY
,P
OT
CH
EF
ST
RO
OM
, RS
AC
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
AT
OR
IES
, AT
LAS
VIL
LE,
BO
KS
BU
RG
, RS
A
FP
RR
:A
UR
OB
IND
O P
HA
RM
A (
PT
Y)
LTD
,M
EY
ER
SD
AL,
JO
HA
NN
ES
BU
RG
, RS
AF
PR
R:
AU
RO
BIN
DO
PH
AR
MA
(P
TY
) LT
D,
ME
YE
RS
DA
L, J
OH
AN
NE
SB
UR
G,
RS
A
FP
RR
:A
LKE
M L
AB
OR
AT
OR
IES
(P
TY
)LT
D, P
OT
CH
EF
ST
RO
OM
, RS
A
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)S
helf-
life:
24 m
onth
s (P
rovi
sion
al)
She
lf-lif
e:24
mon
ths
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 73
MR
F 1
5M
RF
15
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
45/2
0.1.
1/02
17
CE
FU
RO
XIM
E A
LKE
M 5
00 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:C
EF
UR
OX
IME
AX
ET
IL E
QU
IVA
LEN
T T
OC
EF
UR
OX
IME
500
,0 m
g
1, 2
, 3, 4
, 5, 6
, 7
ALK
EM
LA
BO
RA
TO
RIE
S (
PT
Y)
LTD
ALK
EM
LA
BO
RA
TO
RIE
S L
IMIT
ED
,A
MA
LIY
A, D
AM
AN
, IN
DIA
ALK
EM
LA
BO
RA
TO
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S L
IMIT
ED
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MA
LIY
A, D
AM
AN
, IN
DIA
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EM
LA
BO
RA
TO
RIE
S L
IMIT
ED
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MA
LIY
A, D
AM
AN
, IN
DIA
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
LS
ER
VIC
ES
, SIL
VE
RT
ON
DA
LE, P
RE
TO
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SA
RE
SE
AR
CH
INS
TIT
UT
E F
OR
IND
US
TR
IAL
PH
AR
MA
CY
, NO
RT
H-W
ES
T U
NIV
ER
SIT
Y,
PO
TC
HE
FS
TR
OO
M, R
SA
CO
NS
ULT
ING
CH
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ICA
LLA
BO
RA
TO
RIE
S, A
TLA
SV
ILLE
,B
OK
SB
UR
G, R
SA
ALK
EM
LA
BO
RA
TO
RIE
S (
PT
Y)
LTD
,P
OT
CH
EF
ST
RO
OM
, RS
A
24 m
onth
s
27 J
ULY
201
2
IF 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RC
/FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
45/3
0.2/
0431
GS
K P
NE
UM
OC
OC
CA
L V
AC
CIN
E
SU
SP
EN
SIO
N F
OR
INJE
CT
ION
EA
CH
0,5
ml D
OS
E C
ON
TA
INS
:P
olys
acch
arid
e fo
r S
erot
ype
11,
0 pg
Pol
ysac
char
ide
for
Ser
otyp
e 5
1,0
pgP
olys
acch
arid
e fo
r S
erot
ype
68 1
,0 p
gP
olys
acch
arid
e fo
r S
erot
ype
7F1,
0 pg
Pol
ysac
char
ide
for
Ser
otyp
e 9V
1,0
pgP
olys
acch
arid
e fo
r S
erot
ype
141,
0 pg
Pol
ysac
char
ide
for
Ser
otyp
e 23
F 1
,0 p
gP
olys
acch
arid
e fo
r S
erot
ype
43,
0 pg
Pol
ysac
char
ide
for
Ser
otyp
e 18
C 3
,0 p
gP
olys
acch
arid
e fo
r S
erot
ype
19F
3,0
pg
1, 2
, 3, 4
, 5, 6
, 7
GLA
XO
SM
ITH
KLI
NE
SO
UT
H A
FR
ICA
(PT
Y)
LTD
GLA
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SM
ITH
KLI
NE
BIO
LOG
ICA
LS S
.A,
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EN
SA
RT
, BE
LGIU
MG
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LIN
E B
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ALS
S.A
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, BE
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M
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IUM
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SO
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ICA
(PT
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, EP
PIN
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N, R
SA
GLA
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KLI
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BIO
LOG
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LAX
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MIT
HK
LIN
E B
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ALS
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RE
, BE
LGIU
M
GLA
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SM
ITH
KLI
NE
SO
UT
H A
FR
ICA
(PT
Y)
LTD
, EP
PIN
G, C
AP
E T
OW
N, R
SA
36 m
onth
s st
ored
at 2
-8
°C
27 J
ULY
201
2
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C
FP
RR
:
She
lf -li
fe:
Dat
e of
reg
istr
atio
n:
45/2
0.2.
8/05
37
MA
CLE
OD
S E
FA
VIR
EN
Z 6
00 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:E
FA
VIR
EN
Z 6
00,0
mg
1, 2
, 3, 4
, 5, 6
, 7, 8
MA
CLE
OD
S P
HA
RM
AC
EU
TIC
ALS
SA
(PT
Y)
LTD
MA
CLE
OD
S P
HA
RM
AC
EU
TIC
ALS
LTD
, KA
CH
IGA
M, D
AM
AN
, IN
DIA
MA
CLE
OD
S P
HA
RM
AC
EU
TIC
ALS
LTD
, KA
CH
IGA
M, D
AM
AN
, IN
DIA
MA
CLE
OD
S P
HA
RM
AC
EU
TIC
ALS
LTD
, KA
CH
IGA
M, D
AM
AN
, IN
DIA
CO
NS
ULT
ING
CH
EM
ICA
LLA
BO
RA
TO
RIE
S, A
TLA
SV
ILLE
,B
OK
SB
UR
G, R
SA
SA
BS
CO
MM
ER
CIA
L (P
TY
) LT
DP
HA
RM
AC
EU
TIC
AL
CH
EM
IST
RY
DE
PA
RT
ME
NT
GR
OE
NK
LOO
F,
PR
ET
OR
IA, R
SA
MA
CLE
OD
S P
HA
RM
AC
EU
TIC
ALS
SA
(PT
Y)
LTD
, WO
OD
ME
AD
,JO
HA
NN
ES
BU
RG
, RS
A
24 m
onth
s (P
rovi
sion
al)
27 J
ULY
201
2
74 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
45/2
0.2.
8/07
66
CIP
LA L
AM
IVU
DIN
E 3
0 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
45/2
0.2.
8/07
67
ME
DP
RO
LA
MIV
UD
INE
30
mg
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
45/2
0.2.
8/08
15
NE
VIR
AP
INE
ME
DP
RO
50
mg
TA
BLE
TS
FO
R O
RA
LS
US
PE
NS
ION
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:LA
MIV
UD
INE
30,0
mg
LAM
IVU
DIN
E30
,0 m
gN
EV
IRA
PIN
E50
,0 m
g
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7, 8
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8
App
lican
t:C
IPLA
ME
DP
RO
(P
TY
) LT
DA
pplic
ant:
ME
DP
RO
PH
AR
MA
CE
UT
ICA
App
lican
t:C
IPLA
ME
DP
RO
(P
TY
) LT
D(P
TY
) LT
D
Man
ufac
ture
r:C
IPLA
LT
D, U
NIT
IV, V
ER
NA
,G
OA
, IN
DIA
Man
ufac
ture
r:C
IPLA
LT
D, U
NIT
IV, V
ER
NA
,G
OA
, IN
DIA
Man
ufac
ture
r:C
IPLA
LT
D, U
NIT
II,
PA
TA
LGA
NG
A D
IST
RIC
TR
AIG
AD
, MA
HA
RA
SH
TR
A,
IND
IA
Pac
ker:
CIP
LA L
TD
, UN
IT IV
, VE
RN
A,
GO
A, I
ND
IAP
acke
r:C
IPLA
LT
D, U
NIT
IV, V
ER
NA
,G
OA
, IN
DIA
Pac
ker:
CIP
LA L
TD
, UN
IT II
,P
AT
ALG
AN
GA
DIS
TR
ICT
RA
IGA
D, M
AH
AR
AS
HT
RA
,IN
DIA
Labo
rato
ry: F
PR
C:
CIP
LA L
TD
, UN
IT IV
, VE
RN
A,
GO
A, I
ND
IALa
bora
tory
:F
PR
C:
CIP
LA L
TD
, UN
IT IV
, VE
RN
A,
GO
A, I
ND
IALa
bora
tory
: FP
RC
CIP
LA L
TD
, UN
IT II
,P
AT
ALG
AN
GA
DIS
TR
ICT
RA
IGA
D, M
AH
AR
AS
HT
RA
,IN
DIA
FP
RR
:C
IPLA
ME
DP
RO
(P
TY
) LT
D,
RO
SE
NP
AR
K, B
ELL
VIL
LE, R
SA
FP
RR
:M
ED
PR
O P
HA
RM
AC
EU
TIC
A(P
TY
) LT
D, R
OS
EN
PA
RK
.B
ELL
VIL
LE, R
SA
FP
RR
:C
IPLA
ME
DP
RO
(P
TY
) LT
D,
RO
SE
NP
AR
K, B
ELL
VIL
LE,
RS
A
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)S
helf-
life:
24 m
onth
s (P
rovi
sion
al)
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 75
MR
F 1
5M
RF
15M
RF
15
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
45/2
0.2.
8/08
16
NE
VIR
AP
INE
ME
DP
RO
100
mg
TA
BLE
TS
FO
R O
RA
LS
US
PE
NS
ION
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
45/2
0.2.
8/08
17
NE
VIM
UN
E 5
0 m
g T
AB
LET
SF
OR
OR
AL
SU
SP
EN
SIO
N
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
45/2
0.2.
8/08
18
NE
VIM
UN
E 1
00 m
gT
AB
LET
S F
OR
OR
AL
SU
SP
EN
SIO
N
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:N
EV
IRA
PIN
E10
0,0
mg
NE
VIR
AP
INE
50,0
mg
NE
VIR
AP
INE
100,
0 m
g
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8C
ondi
tions
of r
egis
trat
ion:
1, 2
, 3, 4
, 5, 6
, 7, 8
Con
ditio
ns o
f reg
istr
atio
n:1,
2, 3
, 4, 5
, 6, 7
, 8
App
lican
t:CIPLA
ME
DP
RO
(P
TY
) LT
DA
pplic
ant
CIP
LA M
ED
PR
O (
PT
Y)
LTD
App
lican
tC
IPLA
ME
DP
RO
(P
TY
) LT
D
Man
ufac
ture
r:CIPLA
LTD
, UN
IT II
,P
AT
ALG
AN
GA
DIS
TR
ICT
Man
ufac
ture
r:C
IPLA
LT
D, U
NIT
II,
PA
TA
LGA
NG
A D
IST
RIC
TM
anuf
actu
rer:
CIPLA
LTD
, UN
IT II
,P
AT
ALG
AN
GA
DIS
TR
ICT
RA
IGA
D, M
AH
AR
AS
HT
RA
,IN
DIA
RA
IGA
D, M
AH
AR
AS
HT
RA
,IN
DIA
RA
IGA
D, M
AH
AR
AS
HT
RA
,IN
DIA
Pac
ker:
CIPLA
LTD
, UN
IT II
,P
AT
ALG
AN
GA
DIS
TR
ICT
Pac
ker:
CIP
LA L
TD
, UN
IT II
,P
AT
ALG
AN
GA
DIS
TR
ICT
Pac
ker:
CIPLA
LTD
, UN
IT II
,P
AT
ALG
AN
GA
DIS
TR
ICT
RA
IGA
D, M
AH
AR
AS
HT
RA
,IN
DIA
RA
IGA
D, M
AH
AR
AS
HT
RA
,IN
DIA
RA
IGA
D, M
AH
AR
AS
HT
RA
,IN
DIA
Labo
rato
ry: F
PR
C:
CIPLA
LTD
, UN
IT II
,P
AT
ALG
AN
GA
DIS
TR
ICT
Labo
rato
ry:
FP
RC
:CIPLA
LTD
, UN
IT II
,P
AT
ALG
AN
GA
DIS
TR
ICT
Labo
rato
ry: F
PR
CCIPLA
LTD
, UN
IT II
,P
AT
ALG
AN
GA
DIS
TR
ICT
RA
IGA
D, M
AH
AR
AS
HT
RA
,IN
DIA
RA
IGA
D, M
AH
AR
AS
HT
RA
,IN
DIA
RA
IGA
D, M
AH
AR
AS
HT
RA
,IN
DIA
FP
RR
:CIPLA
ME
DP
RO
(P
TY
) LT
D,
RO
SE
NP
AR
K, B
ELL
VIL
LE, R
SA
FP
RR
:CIPLA
ME
DP
RO
(P
TY
) LT
D,
RO
SE
NP
AR
K, B
ELL
VIL
LE, R
SA
FP
RR
:C
IPLA
ME
DP
RO
(P
TY
) LT
D,
RO
SE
NP
AR
K, B
ELL
VIL
LE,
RS
A
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)S
helf-
life:
24 m
onth
s (P
rovi
sion
al)
She
lf-lif
e:24
mon
ths
(Pro
visi
onal
)
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
Dat
e of
reg
istr
atio
n:27
JU
LY 2
012
76 No. 35845 GOVERNMENT GAZETTE, 9 NOVEMBER 2012
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
C:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
46/2
0.2.
8/00
39
EF
AV
IRE
NZ
WIN
TH
RO
P
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
:E
FA
VIR
EN
Z 6
00,0
mg
1, 2
, 3, 4
, 5, 6
, 7
WIN
TH
RO
PP
HA
RM
AC
EU
TIC
ALS
(P
TY
) LT
D
HE
TE
RO
DR
UG
S L
IMIT
ED
,U
NIT
III,
JEE
DIM
ET
LA,
HY
DE
RA
BA
D, I
ND
IAW
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
LTD
, WA
LTLO
O, P
RE
TO
RIA
,R
SA
HE
TE
RO
DR
UG
S L
IMIT
ED
,U
NIT
III,
JEE
DIM
ET
LA,
HY
DE
RA
BA
D, I
ND
IAW
INT
HR
OP
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2
STAATSKOERANT, 9 NOVEMBER 2012 No. 35845 77
