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STAATSKOERANT, 8 AUGUSTUS 2008 No. 31270 3
NOTICE 905 O F 2008
CONDITIONS OF REGISTRATION OF A MEDICINE IN TERMS OF THE PROVISIONS OF SECTION 15(7) OF THE MEDICINES AND RELATED SUBSTANCES ACT, 1965 . .
(ACT 101 OF 1965)
The applicant shall ensure that the medicine is manufactured and controlled in terms of the current Good Manufacturing Practices as determined by Council The manufacture of this medicine is subject to regular investigation and inspections by the inspectors appointed in terms of Section 26 of the Act, to assess compliance with current Good Manufacturing Practices. The information in the package insert shall be updated on a regular basis to conform to the package insert recently approved by Council. The applicant must comply with all the legal requirements of the Medicines and Related Substances Act, 1965 (Act 101 of 1965). The registration of this medicine shall be subject to review at intervals as determined by Council regarding its quality, safety and efficacy, and the registration of this medicine may be varied subject to issues Council may deem fit. The first two production batches must be fully validated in terms of the detailed process validation protocol submitted at the time of application for registration, and the validation report must be submitted within a month after completion of the validation. The product may be advertised to the professions only. 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 first three production batches (NCE) in accordance with the Stability Guideline. Stability testing submitted on any pilot batches must also be completed and reported on. The stability report must be submitted within six months after completion of the stability trial. However, Council has to be informed immediately if any parameter shows a significant change or out-of-specification result during the stability trial. A post-registration inspection must be conducted on the first production batch manufactured by each local manufacturer. A post-registration inspection must be conducted on the first production batch of the imported product. Marketing of the product may only commence following a satisfactory post- registration inspection report. One sample of every batch, together with four copies of the protocol for testing of the bulk lot and filling lot, and six copies of the certificate of release issued by a competent authority in the country in which the product was manufactured, must be submitted to the Council for lot release purposes. The expiry date allocated shall be modified by adding a statement that the virus strains are currently recommended for South African usage in the specific year. The strains of the master seed viruses must be approved by the Department of Health for each year.
MR
F 1
5
Reg
istr
atio
n nu
mbe
r: 36
l7.5
1028
1
Nam
e of
med
icin
e:
BE
ZA
CH
OLE
SR
Dos
age
form
: T
AB
LET
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NT
AIN
S:
BE
ZA
FIB
RA
TE
40
0,O
mg
Con
ditio
ns o
f reg
istr
atio
n:
1, 2
, 3, 4
, 5, 6
, 7
App
lican
t: P
HA
RM
AC
AR
E L
IMIT
ED
Man
ufac
ture
r:
VA
LPH
AR
MA
IN
TE
RN
AT
ION
AL S
.p.A
., P
EN
NA
BIL
LI, P
ER
SA
RO
-UR
BIN
O, I
TA
LY
Pac
ker:
A
SP
EN
PH
AR
MA
CA
RE
EA
ST
LO
ND
ON
, WIL
SO
NIA
, E
AS
T L
ON
DO
N
PH
AR
MA
CA
RE
LTD
, KO
RS
TE
N, P
OR
T E
LIZ
AB
ET
H
Labo
rato
ry:
FP
RC
: V
ALP
HA
RM
A I
NT
ER
NA
TIO
NA
L S.p
.A.,
PE
NN
AB
ILLI
, PE
RS
AR
O-U
RB
INO
, IT
ALY
S
ED
EK
AG
RIK
EM
, K
AM
EE
LDR
IFT
EA
ST
, PR
ET
OR
IA
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
L SE
RV
ICE
S.
SIL
VE
RT
ON
DA
LE, P
RE
TO
RIA
S
OU
TH
AF
RIC
AN
BU
RE
AU
OF
ST
AN
DA
RD
S.
GR
OE
NK
LOO
F, P
RE
TO
RIA
M
&L
LAB
OR
AT
OR
Y S
ER
VIC
ES
, OR
MO
ND
E,
JOH
AN
NE
SB
UR
G
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
AS
PE
N P
HA
RM
AC
AR
E E
AS
T L
ON
DO
N, W
ILS
ON
IA,
EA
ST
LO
ND
ON
FP
RC
IFP
RR
: P
HA
RM
AC
AR
E L
TD, K
OR
ST
EN
, PO
RT
ELI
ZA
BE
TH
She
lf-lif
e:
24 m
onth
s
Dat
e of
reg
istr
atio
n:
18 A
PR
IL 2
008
.
MR
F 1
5
Reg
istr
atio
n nu
mbe
r: 37
/26/
0483
Nam
e of
med
icin
e:
NE
OT
ALE
M
Dos
age
form
: IN
JEC
TIO
N
Act
ive
ingr
edie
nts:
E
AC
H 1
0.0
ml V
IAL
CO
NT
AIN
S:
MIT
OX
AN
TR
ON
E H
YD
RO
CH
LOR
IDE
E
QU
IVA
LEN
T T
O M
ITO
XA
NT
RO
NE
20
,O m
g
Con
ditio
ns o
f reg
istr
atio
n:
1, 2
, 3,4
, 5,
6, 7
App
lican
t: K
EY
ON
CO
LOG
ICS
(PT
Y) L
TD
Man
ufac
ture
r:
Pac
ker:
LEM
ER
Y S
.A. d
e C
.V,
HU
ICH
AP
AN
, XO
CH
, M
EX
ICO
LEM
ER
Y S
.A. d
e C
.V,
HU
ICH
AP
AN
, XO
CH
. M
EX
ICO
Labo
rato
ry:
FP
RC
: LE
ME
RY
S.A
. de
C.V
, HU
ICH
AP
AN
, XO
CH
, M
EX
ICO
IN
ST
ITU
TE
FO
R P
HA
RM
AC
EU
TIC
AL
SE
RV
ICE
S,
SIL
VE
RT
ON
DA
LE, P
RE
TO
RIA
FP
RR
: K
EY
ON
CO
LOG
ICS
, SA
ND
TO
N, J
OH
AN
NE
SB
UR
G
She
lf-lif
e:
24 m
onth
s
Dat
e of
reg
istr
atio
n:
18
AP
RIL
200
8
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
fonn
:
Act
ive
ingr
edie
nts:
AU
ST
ELL
-LIS
INO
PR
IL 1
0 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TAIN
S:
LlS
lNO
PR
lL D
IHY
DR
AT
E E
QU
IVA
LEN
T T
O
LlS
lNO
PR
lL
10,O
mg
Reg
istra
tion
num
ber:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
AU
ST
ELL
-LIS
INO
PR
IL 5
mg
TAB
LET
EA
CH
TA
BLE
T C
ON
TAIN
S:
LlS
lNO
PR
lL D
IHY
DR
ATE
EQ
UIV
ALE
NT
TO
LI
SIN
OP
RIL
5,
0 m
g
Con
ditio
ns o
f reg
istra
tion:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FPR
C:
FPR
R:
She
lf-lif
e:
Dat
e of
reg
istra
tion:
1,2,
3,4
, 5.6
, 7
AU
ST
ELL
LA
BO
RA
TO
RIE
S (P
TY
) LTD
IPC
A L
AB
OR
AT
OR
IES
LTD
, SIL
VA
SS
A, D
AD
RA
&
NA
GA
R H
AV
ELI
, IN
DIA
IPC
A L
AB
OR
AT
OR
IES
LT
D, S
ILV
AS
SA
, DA
DR
A &
N
AG
AR
HA
VE
LI, I
ND
IA
IPC
A L
AB
OR
AT
OR
IES
LTD
, SIL
VA
SS
A, D
AD
RA
&
NA
GA
R H
AV
ELI
, IN
DIA
S
OU
TH A
FR
ICA
N B
UR
EA
U O
F S
TA
ND
AR
DS
, G
RO
EN
KLO
OF,
PR
ET
OR
IA
AU
ST
ELL
LA
BO
RA
TO
RIE
S, S
PR
ING
FIE
LD,
JOH
AN
NE
SB
UR
G
36 m
onth
s
18 A
PR
IL 2
008
Con
ditio
ns o
f reg
istra
tion:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FPR
C:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istra
tion:
AU
ST
ELL
LA
BO
RA
TO
RIE
S (P
TY
) LT
D
IPC
A L
AB
OR
AT
OR
IES
LT
D, S
ILV
AS
SA
, D
AD
RA
& N
AG
AR
HA
VE
LI, I
ND
IA
IPC
A L
AB
OR
AT
OR
IES
LT
D, S
ILV
AS
SA
, D
AD
RA
& N
AG
AR
HA
VE
LI, I
ND
IA
IPC
A L
AB
OR
AT
OR
IES
LT
D, S
ILV
AS
SA
, D
AD
RA
& N
AG
AR
HA
VE
LI, I
ND
IA
SO
UT
H A
FR
ICA
N B
UR
EA
U O
F S
TA
ND
AR
DS
, G
RO
EN
KLO
OF
, PR
ET
OR
IA
AU
ST
ELL
LA
BO
RA
TO
RIE
S, S
PR
ING
FIE
LD.
JOH
AN
NE
SB
UR
G
36 m
onth
s
18 A
PR
IL 2
008
MR
F I
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
38/2
6/00
57
LIT
AK
10
INJE
CT
ION
EA
CH
5.0
ml V
lAL
CO
NT
AIN
S:
CLA
DR
lBlN
E
10,O
mg
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
CE
FU
RO
XIM
E-S
AF
ELI
NE
1,5
g
INJE
CT
ION
EA
CH
VlA
L C
ON
TA
INS
: C
EF
UR
OX
IME
SO
DIU
M E
QU
IVA
LEN
T T
O
CE
FUR
OX
IME
1,
5 g
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
regi
stra
tion:
KE
Y O
NC
OLO
GIC
S (P
TY
) LT
D
HA
UP
T P
HA
RM
A G
mbH
, WO
LFR
AT
SH
AU
SE
N,
GE
RM
AN
Y
HA
UP
T P
HA
RM
A G
mbH
, WO
LFR
AT
SH
AU
SE
N,
GE
RM
AN
Y
HA
UP
T P
HA
RM
A G
mbH
, WO
LFR
AT
SH
AU
SE
N,
GE
RM
AN
Y
LIP
OM
ED
AG
, AR
LES
HE
IM,
SW
ITZ
ER
LAN
D
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
KE
Y O
NC
OLO
GIC
S, S
AN
DT
ON
, JO
HA
NN
ES
BU
RG
24 m
onth
s
18 A
PR
IL 2
008
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
regi
stra
tion:
SA
FE
LIN
E P
HA
RM
AC
EU
TIC
ALS
(PTY
) LT
D
DE
MO
S.A
. PH
AR
MA
CE
UT
ICA
L, K
RY
ON
ER
I, A
TH
EN
S, G
RE
EC
E
DE
MO
S.A
. P
HA
RM
AC
EU
TIC
AL.
KR
YO
NE
RI,
AT
HE
NS
, G
RE
EC
E
DE
MO
S.A
. P
HA
RM
AC
EU
TIC
AL,
KR
YO
NE
RI,
AT
HE
NS
, GR
EE
CE
IN
ST
ITU
TE
FO
R P
HA
RM
AC
EU
TIC
AL
SE
RV
ICE
S,
SIL
VE
RT
ON
DA
LE. P
RE
TO
RIA
SA
FE
LIN
E P
HA
RM
AC
EU
TIC
ALS
, FLO
RID
A,
JOH
AN
NE
SB
UR
G
24
mon
ths
18 A
PR
IL 2
008
(I, 2 3 (I, 8 rn n P
Z
-4
0,
P
C
G) C Y C (I, IU 0
0
0,
Z
P ??
IU
-4 0
4
MR
F 1
5
Reg
istr
atio
n nu
mbe
r: 38
120.
1.11
0205
Nam
e of
med
icin
e:
CE
FU
RO
XIM
E-S
AF
ELI
NE
750
mg
Dos
age
form
: IN
JEC
TIO
N
Act
ive
ingr
edie
nts:
E
AC
H V
IAL
CO
NT
AIN
S:
CE
FU
RO
XIM
E S
OD
IUM
EQ
UIV
ALE
NT
TO
C
EF
UR
OX
IME
75
0 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:
She
lf-lif
e:
SA
FE
LIN
E P
HA
RM
AC
EU
TIC
ALS
(PTY
) LT
D
DE
MO
S.A
. P
HA
RM
AC
EU
TIC
AL,
KR
YO
NE
RI,
AT
HE
NS
, G
RE
EC
E
DE
MO
S.A
. PH
AR
MA
CE
UT
ICA
L, K
RY
ON
ER
I, A
TH
EN
S,
GR
EE
CE
FP
RC
: D
EM
O S
.A. P
HA
RM
AC
EU
TIC
AL,
KR
YO
NE
RI,
AT
HE
NS
, GR
EE
CE
IN
ST
ITU
TE
FO
R P
HA
RM
AC
EU
TIC
AL
SE
RV
ICE
S,
SIL
VE
RT
ON
DA
LE, P
RE
TO
RIA
FP
RR
: S
AF
ELI
NE
PH
AR
MA
CE
UT
ICA
LS, F
LOR
IDA
, JO
HA
NN
ES
BU
RG
24 m
onth
s
Dat
e of
reg
istr
atio
n:
18 A
PR
IL 2
008
MR
F 15
Reg
istr
atio
n nu
mbe
r: A
0413
.1.5
108
Nam
e of
med
icin
e:
TIL
DR
EN
Dos
age
form
: IN
JEC
TIO
N
Act
ive
ingr
edie
nts:
E
AC
H V
IAL
CO
NT
AIN
S:
TIL
UD
RO
NIC
AC
ID
50,O
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:
She
lf-lif
e:
CE
VA
AN
CH
OR
PH
AR
M A
NIM
AL
HE
ALT
H
S.A
(P
TY)
LTD
CE
VA
SA
NT
E A
NIM
ALE
SA
, CE
DE
X,
FR
AN
CE
C
EV
A L
AB
OR
AT
OIR
ES
ST
ER
ILY
O, S
AN
T A
MA
ND
LE
S E
AU
X, F
RA
NC
E
CE
VA
SA
NT
E A
NIM
ALE
SA
, CE
DE
X,
FR
AN
CE
FP
RC
: C
EV
A S
AN
TE
AN
IMA
LE S
A.
CE
DE
X,
FR
AN
CE
C
EV
A L
AB
OR
AT
OIR
ES
ST
ER
ILY
O, S
AN
T
AM
AN
D L
ES
EA
UX
, FR
AN
CE
C
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
AT
OR
IES
, A
TLA
SV
ILLE
, BO
KS
BU
RG
FP
RR
: C
EV
A A
NC
HO
RP
HA
RM
AN
IMA
L H
EA
LTH
, B
RA
MLE
Y, J
OH
AN
NE
SB
UR
G
36 m
onth
s
Dat
e of
reg
istr
atio
n:
18 A
PR
l L 2
008
Reg
istra
tion
num
ber:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istra
tion:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FPR
C: FP
RR
She
lf-lif
e:
Dat
e of
reg
istra
tion:
A05
122.
6.2/
10
ALl
ZlN
E
INJE
CT
ION
EA
CH
1,O
ml S
OLU
TIO
N C
ON
TAIN
S:
AG
LEP
RIS
TO
NE
30
,O m
g
1,2
, 3,4
,5,
6, 7
VIR
BA
C R
SA
(PTY
) LT
D
VIR
BA
C S
A, C
ED
EX
, F
RA
NC
E
VIR
BA
C S
A, C
ED
EX
, FR
AN
CE
V
IRB
AC
RS
A, C
EN
TUR
ION
, RS
A
VIR
BA
C S
A, C
ED
EX
, F
RA
NC
E
M&
L LA
BO
RA
TO
RY
SE
RV
ICE
S, O
RM
ON
DE
, JO
HA
NN
ES
BU
RG
VIR
BA
C R
SA
, CE
NT
UR
ION
, RS
A
36 m
onth
s
18 A
PR
IL 2
008
MR
F 15
Reg
istr
atio
n nu
mbe
r: A
3813
.210
381
Nam
e of
med
icin
e:
BO
ND
RO
NA
T 6
mg1
6 m
i
Dos
age
form
: IN
JEC
TIO
N
Act
ive
ingr
edie
nts:
E
AC
H V
IAL
CO
NTA
INS
: IB
AN
DR
ON
IC A
CID
6
0 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:
RO
CH
E P
RO
DU
CT
S (P
TY)
LTD
RO
CH
E D
IAG
NO
ST
IC G
mbH
, MA
NN
HE
IM,
GE
RM
AN
Y
RO
CH
E D
IAG
NO
ST
IC G
mbH
, MA
NN
HE
IM.
GE
RM
AN
Y
RO
CH
E P
RO
DU
CTS
. IS
AN
DO
, RS
A
FPR
C:
RO
CH
E D
IAG
NO
ST
IC G
mbH
, MA
NN
HE
IM,
GE
RM
AN
Y
FP
RC
IFP
RR
: R
OC
HE
PR
OD
UC
TS
, IS
AN
DO
, RS
A
She
lf-lif
e:
60 m
onth
s
Dat
e of
regi
stra
tion:
18
AP
RIL
200
8
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:
FPR
C:
A39
R1 .I 2100
64
CE
TR
OT
IDE
0.2
5 m
g
INJE
CT
ION
EA
CH
VlA
L C
ON
TA
INS
: C
ET
RO
RE
LIX
AC
ET
AT
E E
QU
IVA
LEN
T T
O
CE
TR
OR
ELI
X
0,25
mg
1, 2
, 3,4
, 5
,6,7
ME
RC
K (P
TY
) LT
D
BA
XT
ER
ON
CO
LOG
Y G
mbH
, HA
LLE
, GE
RM
AN
Y
BA
XT
ER
ON
CO
LOG
Y G
mbH
, HA
LLE
, GE
RM
AN
Y
SO
LVA
Y P
HA
RM
AC
EU
TIC
ALS
BV
, OLS
T, T
HE
N
ET
HE
RLA
ND
S
BA
XT
ER
ON
CO
LOG
Y G
mbH
, HA
LLE
, GE
RM
AN
Y
SO
UT
H A
FR
ICA
N B
UR
EA
U O
F S
TA
ND
AR
DS
, G
RO
EN
KLO
OF
, PR
ET
OR
IA
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
A39
/21.
12/0
065
CE
TR
OT
IDE
3 m
g
INJE
CT
ION
EA
CH
VlA
L C
ON
TA
INS
: C
ET
RO
RE
LIX
AC
ET
AT
E E
QU
IVA
LEN
T T
O
CE
TR
OR
ELI
X
3,0
mg
1, 2
, 3,4
,5,6
, 7
ME
RC
K (
PT
Y) L
TD
BA
XT
ER
ON
CO
LOG
Y G
mbH
, HA
LLE
, GE
RM
AN
Y
BA
XT
ER
ON
CO
LOG
Y G
mbH
, H
ALL
E, G
ER
MA
NY
S
OLV
AY
PH
AR
MA
CE
UT
ICA
LS B
V, O
LST
, TH
E
NE
TH
ER
LAN
DS
BA
XT
ER
ON
CO
LOG
Y G
mbH
, HA
LLE
. GE
RM
AN
Y
SO
UT
H A
FR
ICA
N B
UR
EA
U O
F S
TA
ND
AR
DS
, G
RO
EN
KLO
OF
, PR
ET
OR
IA
FP
RR
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
ME
RC
K, M
OD
DE
RF
ON
TE
IN, R
SA
24 m
onth
s
18
AP
RIL
200
8
FP
RR
She
lf-lif
e:
Dat
e of
regi
stra
tion:
ME
RC
K, M
OD
DE
RF
ON
TE
IN, R
SA
24 m
onth
s
18 A
PR
IL 2
008
MR
F I5
M
RF
I5
Reg
istr
atio
n nu
mbe
r: A
3912
.110
077
Reg
istr
atio
n nu
mbe
r: A
3913
0.41
0417
Nam
e of
med
icin
e:
B. B
RA
UN
PR
OP
OF
OL
1 %
(10
mgl
ml)
Nam
e of
med
icin
e:
CE
PR
OT
IN 5
00 iu
Dos
age
form
: E
MU
LSIO
N
Dos
age
form
: IN
JEC
TIO
N
Act
ive
ingr
edie
nts:
E
AC
H 1
,O m
l EM
ULS
ION
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
E
AC
H V
IAL
CO
NT
AIN
S:
PR
OP
OF
OL
10,O
mg
PR
OT
EIN
C
500,
O i
u
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:
Man
ufac
ture
r:
B B
RA
UN
ME
DIC
AL
(PT
Y) L
TD
A
pplic
ant:
B B
RA
UN
ME
LSU
NG
EN
AG
, B
ER
LIN
, GE
RM
AN
Y
Man
ufac
ture
r:
Pac
ker:
B
BR
AU
N M
ELS
UN
GE
N A
G,
BE
RLI
N, G
ER
MA
NY
Labo
rato
ry:
FP
RC
: B
BR
AU
N M
ELS
UN
GE
N A
G,
BE
RLI
N, G
ER
MA
NY
C
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
AT
OR
IES
, A
TLA
SV
ILLE
, BO
KS
BU
RG
Pac
ker:
Labo
rato
ry:
AD
CO
CK
IN
GR
AM
CR
ITIC
AL
CA
RE
(PTY
) LT
D
BA
XT
ER
AG
, IN
DU
ST
RIE
ST
RA
SS
E, V
IEN
NA
, A
US
TR
IA
BA
XT
ER
AG
, BE
NA
TZ
KY
GA
SS
E, V
IEN
NA
, A
US
TR
IA
BA
XTE
R S
.p.A
., R
UF
INA
, IT
ALY
BA
XT
ER
AG
, IN
DU
ST
RIE
ST
RA
SS
E, V
IEN
NA
, A
US
TR
IA
AD
CO
CK
ING
RA
M C
RIT
ICA
L C
AR
E,
AE
RO
TO
N,J
OH
AN
NE
SB
UR
G
FPR
C:
BA
XTE
R A
G,
SM
OLA
GA
SS
E, V
IEN
NA
, A
US
TR
IA
FP
RR
: B
BR
AU
N M
ED
ICA
L, H
ON
EY
DE
W, R
AN
DB
UR
G
FP
RC
IFP
RR
: A
DC
OC
K I
NG
RA
M C
RIT
ICA
L C
AR
E,
AE
RO
TO
N, J
OH
AN
NE
SB
UR
G
She
lf-lif
e:
24 m
onth
s S
helf-
life:
24
mon
ths
Dat
e of
regi
stra
tion:
18
AP
RIL
200
8 D
ate
of re
gist
ratio
n:
18 A
PR
IL 2
008
MR
F 1
5
Reg
istr
atio
n nu
mbe
r: A
3913
0.41
0418
Nam
e of
med
icin
e:
CE
PR
OT
IN 1
000
iu
Dos
age
form
: IN
JEC
TIO
N
Act
ive
ingr
edie
nts:
E
AC
H V
IAL
CO
NT
AIN
S:
PR
OT
EIN
C
1000
,O i
u
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:
AD
CO
CK
ING
RA
M C
RIT
ICA
L C
AR
E (P
TY
) LT
D
BA
XT
ER
AG
, IN
DU
ST
RIE
ST
RA
SS
E, V
IEN
NA
, A
US
TR
IA
BA
XT
ER
AG
, B
EN
AT
ZK
YG
AS
SE
, VIE
NN
A,
AU
ST
RIA
B
AX
TE
R S
.p.A
., R
UF
INA
, IT
ALY
BA
XT
ER
AG
, IN
DU
ST
RIE
ST
RA
SS
E, V
IEN
NA
, A
US
TR
IA
AD
CO
CK
ING
RA
M C
RIT
ICA
L C
AR
E, A
ER
OTO
N,
JOH
AN
NE
SB
UR
G
FPR
C:
BA
XT
ER
AG
, S
MO
LAG
AS
SE
, VIE
NN
A, A
US
TR
IA
FP
RC
IFP
RR
: A
DC
OC
K I
NG
R
ul C
RIT
ICA
L C
AR
E,
JOH
AN
NE
SB
UR
G
She
lf-lif
e:
24 m
onth
s
Dat
e of
regi
stra
tion:
1
8 A
PR
IL 2
008
MR
F 1
5
Reg
istr
atio
n nu
mbe
r: A
3911
.2/0
500
Nam
e of
med
icin
e:
TA
ZE
RO
N 1
5 m
g
Dos
age
form
: T
AB
LET
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NT
AIN
S:
MIR
TA
ZA
PIN
E
15,O
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:
PH
AR
MA
PLA
N (P
TY)
LTD
KE
RN
PH
AR
MA
S.L
., T
ER
RA
SS
A,
BA
RC
ELO
NA
, SP
AIN
KE
RN
PH
AR
MA
S.L
., T
ER
RA
SS
A,
BA
RC
ELO
NA
, SP
AIN
FPR
C:
CO
MB
INO
PH
AR
M S
.L.,
SA
NT
JO
AN
DE
SP
I. B
AC
ELO
NA
, SP
AIN
C
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
AT
OR
IES
, A
TLA
SV
ILLE
, BO
KS
BU
RG
FPR
R:
PH
AR
MA
PLA
N. M
IDR
AN
D, R
SA
24
mon
ths
Dat
e of
reg
istr
atio
n:
18
AP
RIL
200
8
MR
F I
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:
Dat
e of
reg
istr
atio
n:
A39
11 2
1050
1
TA
ZE
RO
N 3
0 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: M
IRT
AZ
AP
INE
30
,O m
g
1,2
,3,4
,5,6
, 7
PH
AR
MA
PLA
N (P
TY)
LTD
KE
RN
PH
AR
MA
S.L
., T
ER
RA
SS
A, B
AR
CE
LON
A,
SP
AIN
KE
RN
PH
AR
MA
S.L
., T
ER
RA
SS
A, B
AR
CE
LON
A,
SP
AIN
CO
MB
INO
PH
AR
M S
.L.,
SA
NT
JO
AN
DE
SP
I, B
AC
ELO
NA
, SP
AIN
C
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
AT
OR
IES
, A
TLA
SV
ILLE
, B
OK
SB
UR
G
PH
AR
MA
PLA
N, M
IDR
AN
D, R
SA
24 m
onth
s
18 A
PR
IL 2
008
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
SA
ND
OZ
BE
CLO
ME
TH
AS
ON
E
DIP
RO
PIO
NA
TE
AQ
100
Dos
age
form
:
Act
ive
ingr
edie
nts:
SU
SP
EN
SIO
N
EA
CH
ME
TE
RE
DN
AS
ALS
PR
AY
DO
SE
C
ON
TA
INS
: B
EC
LOM
ET
HA
SO
NE
DIP
RO
PIO
NA
TE
10
0,o
ug
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
SA
ND
OZ
S.A
. (P
TY
) LT
D
CH
lES
l FA
RM
AC
EU
TIC
I SpA
, LE
ON
AR
DO
, P
AR
MA
, IT
ALY
CH
lES
l FA
RM
AC
EU
TIC
I SpA
, LE
ON
AR
DO
. P
AR
MA
, IT
ALY
C
HlE
Sl F
AR
MA
CE
UT
ICI S
pA, P
ALE
RM
O,
PA
RM
A, I
TA
LY
NO
VA
RT
IS S
.A.,
SP
AR
TA
N, K
EM
PT
ON
P
AR
K
MR
F 1
5
Labo
rato
ry:
FP
RC
: C
HlE
Sl F
AR
MA
CE
UT
ICI S
pA, L
EO
NA
RD
O,
PA
RM
A, I
TA
LY
SO
UT
H A
FR
ICA
N B
UR
EA
U O
F S
TA
ND
AR
DS
, G
RO
EN
KLO
OF
, PR
ET
OR
IA
NO
VA
RT
IS S
.A.,
SP
AR
TA
N, K
EM
PT
ON
P
AR
K
FPR
R:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
SA
ND
OZ
S.A
., S
PA
RT
AN
, KE
MP
TO
N P
AR
K
36 m
onth
s
18 A
PR
IL 2
008
MR
F 1
5
Reg
istr
atio
n nu
mbe
r: A
4011
3.4
.1 10
035
Nam
e of
med
icin
e:
CLO
BE
X S
HA
MP
OO
Dos
age
form
: S
HA
MP
OO
Act
ive
ingr
edie
nts:
E
AC
H 1
,O g
SH
AM
PO
O C
ON
TA
INS
: C
LOB
ETA
SO
L P
RO
PIO
NA
TE
03
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:
She
lf-lif
e:
GA
LDE
RM
A L
AB
OR
AT
OR
IES
S.A
. (P
TY
) LT
D
LAB
OR
AT
OIR
ES
GA
LDE
RM
A, M
ON
TD
ES
IR, A
LBY
- S
UR
-CH
ER
AN
, FR
AN
CE
LAB
OR
AT
OIR
ES
GA
LDE
RM
A, M
ON
TD
ES
IR, A
LBY
- S
UR
-CH
ER
AN
, FR
AN
CE
FPR
C:
LAB
OR
AT
OIR
ES
GA
LDE
RM
A, M
ON
TD
ES
IR, A
LBY
- S
UR
-CH
ER
AN
, FR
AN
CE
FPR
R:
GA
LDE
RM
A L
AB
OR
AT
OR
IES
S.A
., B
RY
AN
ST
ON
, JO
HA
NN
ES
BU
RG
36 m
onth
s
Dat
e of
regi
stra
tion:
18
AP
RIL
200
8
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
She
lf-lif
e:
MR
F 1
5
Reg
istr
atio
n nu
mbe
r: A
4013
4100
45
Nam
e of
med
icin
e:
CIP
LA-T
AM
SU
LOS
IN H
YD
RO
CH
LOR
IDE
Dos
age
form
: C
AP
SU
LE
Act
ive
ingr
edie
nts:
E
AC
H C
AP
SU
LE C
ON
TA
INS
: T
AM
SU
LOS
IN H
YD
RO
CH
LOR
IDE
40
0,O
ug
Con
ditio
ns o
f reg
istr
atio
n:
1,2
, 3,4
,5,6
,7
ClP
LA L
IFE
SC
IEN
CE
S (P
TY
) LT
D
ClP
LA L
TD, V
IRG
ON
AG
AR
, BA
NG
ALO
RE
, IN
DIA
ClP
LA L
TD
, VIR
GO
NA
GA
R, B
AN
GA
LOR
E, I
ND
IA
FPR
C:
ClP
LA L
TD
, VIR
GO
NA
GA
R, B
AN
GA
LOR
E, I
ND
IA
FPR
R:
ClP
LA L
IFE
SC
IEN
CE
S, R
OS
EN
PA
RK
, BE
LLV
ILLE
24 m
onth
s
Dat
e of
regi
stra
tion:
18
AP
RIL
200
8
MR
F 15
Reg
istr
atio
n nu
mbe
r: A
4013
4100
46
Nam
e of
med
icin
e:
UR
OM
AX
Dos
age
form
: C
AP
SU
LE
Act
ive
ingr
edie
nts:
E
AC
H C
AP
SU
LE C
ON
TAIN
S:
TA
MS
ULO
SIN
HY
DR
OC
HLO
RID
E
400,
O u
g
Con
ditio
ns o
f reg
istra
tion:
1
,2,
3,4
, 5, 6
, 7
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
She
lf-lif
e:
ClP
lA M
ED
PR
O (
PlY
) LT
D
ClP
LA L
TD, V
IRG
ON
AG
AR
, BA
NG
ALO
RE
, IN
DIA
ClP
LA L
TD, V
IRG
ON
AG
AR
, BA
NG
ALO
RE
, IN
DIA
FPR
C:
ClP
LA L
TD, V
IRG
ON
AG
AR
, BA
NG
ALO
RE
, IN
DIA
FPR
R:
ClP
LA M
ED
PR
O, R
OS
EN
PA
RK
, BE
LLV
ILLE
24 m
onth
s
Dat
e of
regi
stra
tion:
18
AP
RIL
200
8
MR
F 15
Reg
istr
atio
n nu
mbe
r: A
4012
0.1
.I101
02
Nam
e of
med
icin
e:
ZITH
RO
MA
X O
NE
Dos
age
form
: G
RA
NU
LES
Act
ive
ingr
edie
nts:
E
AC
H B
OlT
LE
CO
NTA
INS
: A
ZIT
HR
OM
YC
IN D
IHY
DR
AT
E E
QU
IVA
LEN
T TO
A
ZIT
HR
OM
YC
IN
2,o
g
Con
ditio
ns o
f reg
istra
tion:
1
,2,3
,45
6,7
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
PF
IZE
R L
AB
OR
AT
OR
IES
(PlY
) LT
D
PF
IZE
R P
HA
RM
AC
EU
TIC
ALS
LLC
. VE
GA
B
AJA
, PU
ER
TO R
lCO
PFI
ZER
PH
AR
MA
CE
UT
ICA
LS LL
C, V
EG
A
BA
JA. P
UE
RT
O R
lCO
P
FIZ
ER
ITA
LIA
s.r.
l., LA
TIN
A, I
TA
LY
PF
IZE
R G
LOB
AL
MA
NU
FA
CT
UR
ING
, R
ETR
EA
T, C
AP
E T
OW
N
FPR
C:
PFI
ZER
PH
AR
MA
CE
UT
ICA
LS L
LC, V
EG
A
BA
JA, P
UE
RTO
RlC
O
PFI
ZER
ITA
LIA
s.r.
l., LA
TIN
A, I
TA
LY
FPR
CIF
PR
R:
PFI
ZER
GLO
BA
L M
AN
UF
AC
TU
RIN
G,
RE
TRE
AT,
CA
PE
TO
WN
FPR
R
PFI
ZER
LA
BO
RA
TO
RIE
S, S
AN
DTO
N,
JOH
AN
NE
SB
UR
G
She
lf-lif
e:
24 m
onth
s
Dat
e of
regi
stra
tion:
18
AP
RIL
200
8
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:
Dat
e of
regi
stra
tion:
A40
121 2
/01
32
GLl
MP
lD 1
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: G
LlM
EP
lRlD
E
1.0
mg
1, 2
,3,4
,5,6
,7,8
RA
NB
AX
Y (S
A)
(PT
Y) L
TD
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LTD
, PA
ON
TA S
AH
IB,
HIM
AC
HA
L P
RA
DE
SH
, IN
DIA
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D. P
AO
NTA
SA
HIB
, H
IMA
CH
AL
PR
AD
ES
H, I
ND
IA
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, P
AO
NTA
SA
HIB
, H
IMA
CH
AL
PR
AD
ES
H, I
ND
IA
CO
NS
ULT
ING
CH
EM
ICA
L LA
BO
RA
TO
RIE
S,
AT
LAS
VIL
LE,
BO
KS
BU
RG
, RS
A
RA
NB
AX
Y (S
A),
CE
NT
UR
ION
, RS
A
24 m
onth
s (P
rovi
sion
al)
18
AP
RIL
200
8
MRF 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
:
FPR
R:
She
lf-lif
e:
Dat
e of
regi
stra
tion:
A40
121.
2101
33
GLl
MP
lD 2
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: G
LlM
EP
lRlD
E
2,0
mg
1, 2
, 3
,4,5
,6,7
,8
RA
NB
AX
Y (S
A)
(PT
Y)
LTD
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, P
AO
NTA
S
AH
IB, H
IMA
CH
AL
PR
AD
ES
H, I
ND
IA
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LTD
, P
AO
NTA
S
AH
IB, H
IMA
CH
AL
PR
AD
ES
H, I
ND
IA
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, P
AO
NTA
S
AH
IB, H
IMA
CH
AL
PR
AD
ES
H, I
ND
IA
CO
NS
ULT
ING
CH
EM
ICA
L LA
BO
RA
TO
RIE
S,
AT
LAS
VIL
LE, B
OK
SB
UR
G, R
SA
RA
NB
AX
Y (S
A),
CE
NT
UR
ION
, RS
A
24 m
onth
s (P
rovi
sion
al)
18
AP
RIL
200
8
MR
F 15
Reg
istr
atio
n nu
mbe
r: A
4012
1 21
0 1 3
4
Nam
e of
med
icin
e:
GLl
MP
lD 4
Dos
age
form
: T
AB
LET
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NTA
INS
: G
LlM
EP
lRlD
E
4.0
mg
Con
ditio
ns o
f reg
istra
tion:
1
,2,3
,4,5
,6,7
,8
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
She
lf-lif
e:
RA
NB
AX
Y (S
A)
(PTY
) LT
D
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LTD
, PA
ON
TA S
AH
IB,
HIM
AC
HA
L P
RA
DE
SH
, IN
DIA
RA
NB
AX
Y L
AB
OR
ATO
RIE
S L
TD, P
AO
NTA
SA
HIB
, H
IMA
CH
AL
PR
AD
ES
H, I
ND
IA
FPR
C:
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LTD
, PA
ON
TA S
AH
IB,
HIM
AC
HA
L P
RA
DE
SH
, IN
DIA
C
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
ATO
RIE
S,
AT
LAS
VIL
LE, B
OK
SB
UR
G, R
SA
FPR
R:
RA
NB
AX
Y (S
A),
CE
NTU
RIO
N, R
SA
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istra
tion:
18
AP
RIL
200
8
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
istra
tion:
App
lican
t:
Man
ufac
ture
r:
A40
/2.5
/016
6
DY
NA
-LA
MO
TR
IGIN
E 1
00 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TAIN
S:
LAM
OT
RlG
lNE
10
0,O
mg
1,2
,3,4
,5,6
,7
PH
AR
MA
DY
NA
MIC
S (P
TY)
LTD
ME
DO
CH
EM
IE L
TD, L
IMA
SS
OL,
CY
PR
US
Pac
ker:
Labo
rato
ry:
FPR
C:
FPR
R:
Sh
elf
-li:
Dat
e of
regi
stra
tion:
ME
DO
CH
EM
IE L
TD, L
IMA
SS
OL,
CY
PR
US
D
IVP
HA
RM
MA
NU
FA
CT
UR
ING
&
PA
CK
AG
ING
, LO
NG
DA
LE, J
OH
AN
NE
SB
UR
G
TE
CH
NIK
ON
LA
BO
RA
TOR
IES
, FLO
RID
A,
RS
A
PH
AR
MA
CE
UT
ICA
L E
NT
ER
PR
ISE
S,
N'D
AB
EN
I, K
ZN
IM
PIL
O D
RU
GS
, IS
ITH
EB
E, K
ZN
ME
DO
CH
EM
IE L
TD, L
IMA
SS
OL,
CY
PR
US
C
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
ATO
RIE
S,
AT
LAS
VIL
LE, B
OK
SB
UR
G, R
SA
T
EC
HN
IKO
N L
AB
OR
ATO
RIE
S, F
LOR
IDA
, R
SA
PH
AR
MA
DY
NA
MIC
S, S
ILV
ER
WO
OD
, W
ES
TLA
KE
, R
SA
24 m
onth
s
18 A
PR
IL 2
008
MR
F 1
5
MR
F 1
5
Reg
istr
atio
n nu
mbe
r: A
40/2
.5/0
167
Nam
e of
med
icin
e:
DY
NA
-LA
MO
TR
IGIN
E 2
00 m
g
Dos
age
form
: TA
BLE
T
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NTA
INS
: LA
MO
TR
lGlN
E
200,
O m
g
Con
ditio
ns o
f reg
istra
tion:
1
,2, 3
, 4, 5
, 6,7
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
S he
lf-lif
e:
PH
AR
MA
DY
NA
MIC
S (P
TY)
LTD
ME
DO
CH
EM
IE L
TD, L
IMA
SS
OL,
CY
PR
US
ME
DO
CH
EM
IE L
TD, L
IMA
SS
OL.
CY
PR
US
D
IVP
HA
RM
MA
NU
FA
CT
UR
ING
& P
AC
KA
GIN
G,
LON
GD
ALE
, JO
HA
NN
ES
BU
RG
T
EC
HN
IKO
N L
AB
OR
AT
OR
IES
, FLO
RID
A, R
SA
P
HA
RM
AC
EU
TIC
AL
EN
TE
RP
RIS
ES
, N'D
AB
EN
I, K
ZN
FP
RC
: M
ED
OC
HE
MIE
LTD
, LIM
AS
SO
L, C
YP
RU
S
CO
NS
ULT
ING
CH
EM
ICA
L LA
BO
RA
TO
RIE
S,
AT
LAS
VIL
LE, B
OK
SB
UR
G, R
SA
T
EC
HN
IKO
N L
AB
OR
AT
OR
IES
, FLO
RID
A, R
SA
FPR
R:
PH
AR
MA
DY
NA
MIC
S, S
ILV
ER
WO
OD
, WE
ST
LAK
E,
RS
A
24 m
onth
s
Dat
e of
reg
istra
tion:
18
AP
RIL
200
8
MR
F 1
5
Reg
istra
tion
num
ber:
A40
/2.5
/016
9
Nam
e of
med
icin
e:
DY
NA
-LA
MO
TR
IGIN
E 5
0 m
g
Dos
age
form
: T
AB
LET
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NTA
INS
: LA
MO
TR
lGlN
E
50,O
mg
Con
ditio
ns o
f reg
istra
tion:
1,
2,3
,4,5
, 6,7
App
lican
t: P
HA
RM
A D
YN
AM
ICS
(PTY
) LT
D
Man
ufac
ture
r: M
ED
OC
HE
MIE
LTD
, LIM
AS
SO
L, C
YP
RU
S
Pac
ker:
ME
DO
CH
EM
IE L
TD, L
IMA
SS
OL,
CY
PR
US
D
IVP
HA
RM
MA
NU
FA
CT
UR
ING
&
PA
CK
AG
ING
, LO
NG
DA
LE, J
OH
AN
NE
SB
UR
G
TE
CH
NIK
ON
LA
BO
RA
TOR
IES
, FLO
RID
A,
RS
A
PH
AR
MA
CE
UT
ICA
L E
NT
ER
PR
ISE
S,
N'D
AB
EN
I, K
ZN
Labo
rato
ry:
FP
RC
: M
ED
OC
HE
MIE
LTD
, LIM
AS
SO
L, C
YP
RU
S
CO
NS
ULT
ING
CH
EM
ICA
L LA
BO
RA
TO
RIE
S,
AT
LAS
VIL
LE, B
OK
SB
UR
G, R
SA
T
EC
HN
IKO
N L
AB
OR
AT
OR
IES
, FLO
RID
A,
RS
A
FP
RR
: P
HA
RM
A D
YN
AM
ICS
, SIL
VE
RW
OO
D,
WE
ST
LAK
E, R
SA
She
lf-lif
e:
24 m
onth
s
Dat
e of
reg
istra
tion:
18
AP
RIL
200
8
MR
F 1
5
Reg
istr
atio
n nu
mbe
r: A
4012
.510
173
Nam
e of
med
icin
e:
DY
NA
-LA
MO
TR
IGIN
E 2
5 m
g
Dos
age
form
: T
AB
LET
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NT
AIN
S:
LAM
OT
RlG
lNE
2
50
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:
She
lf-lif
e:
PH
AR
MA
DY
NA
MIC
S (P
TY
) LT
D
ME
DO
CH
EM
IE L
TD, L
IMA
SS
OL,
CY
PR
US
ME
DO
CH
EM
IE L
TD, L
IMA
SS
OL,
CY
PR
US
D
IVP
HA
RM
MA
NU
FA
CT
UR
ING
& P
AC
KA
GIN
G,
LON
GD
ALE
, JO
HA
NN
ES
BU
RG
T
EC
HN
IKO
N L
AB
OR
AT
OR
IES
, FLO
RID
A, R
SA
P
HA
RM
AC
EU
TIC
AL
EN
TE
RP
RIS
ES
, N'D
AB
EN
I, K
ZN
FPR
C:
ME
DO
CH
EM
IE L
TD
, LIM
AS
SO
L, C
YP
RU
S
CO
NS
ULT
ING
CH
EM
ICA
L LA
BO
RA
TO
RIE
S,
AT
LAS
VIL
LE, B
OK
SB
UR
G,
RS
A
TE
CH
NIK
ON
LA
BO
RA
TO
RIE
S, F
LOR
IDA
, RS
A
FP
RR
: P
HA
RM
A D
YN
AM
ICS
, SIL
VE
RW
OO
D, W
ES
TLA
KE
, R
SA
24 m
onth
s
Dat
e of
regi
stra
tion:
1
8 A
PR
IL 2
008
MR
F 1
5
Reg
istr
atio
n nu
mbe
r: A
4013
.1 1
0240
Nam
e of
med
icin
e:
CA
TA
FA
ST
-D T
AB
LET
S
Dos
age
form
: T
AB
LET
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NT
AIN
S:
DIC
LOF
EN
AC
SO
DIU
M
50,O
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:
NO
VA
RT
IS S
OU
TH
AF
RIC
A (
PTY
) LT
D
NO
VA
RT
lS P
HA
RM
A G
mbH
, WE
HR
, G
ER
MA
NY
NO
VA
RT
IS P
HA
RM
A G
mbH
, WE
HR
, G
ER
MA
NY
N
OV
AR
TIS
S.A
., S
PA
RT
AN
, KE
MP
TO
N
PA
RK
FP
RC
: N
OV
AR
TIS
PH
AR
MA
Gm
bH, W
EH
R,
GE
RM
AN
Y
M&
L LA
BO
RA
TO
RY
SE
RV
ICE
S, O
RM
ON
DE
, JO
HA
NN
ES
BU
RG
FP
RC
IFP
RR
: N
OV
AR
TIS
S.A
., S
PA
RT
AN
, KE
MP
TO
N
PA
RK
She
lf-lif
e:
24 m
onth
s
Dat
e of
reg
istr
atio
n:
18 A
PR
IL 2
008
MR
F 1
5
Reg
istr
atio
n nu
mbe
r: A
4Oi7
.1.3
1028
7
Nam
e of
med
icin
e:
CO
IRB
ES
AR
TA
N W
INT
HR
OP
300
/12,
5
Dos
age
form
: T
AB
LET
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NT
AIN
S:
IRB
ES
AR
TA
N
300,
O m
g H
YD
RO
CH
LOR
OT
HIA
ZID
E
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:
SA
NO
FI-S
YN
TH
ELA
BO
(PTY
) LT
D
BR
IST
OL-
MY
ER
S S
QU
IBB
CO
., E
VA
NS
VIL
LE
IND
IAN
A, U
SA
S
AN
OF
I WIN
TH
RO
P IN
DU
ST
RIE
, AM
BA
RE
S, F
RA
NC
E
SA
NO
FI W
INT
HR
OP
IND
US
TR
IE, A
MB
AR
ES
, FR
AN
CE
A
VE
NT
IS P
HA
RM
A, W
ALT
LOO
, P
RE
TO
RIA
P
HA
RM
AC
EU
TIC
AL
CO
NT
RA
CT
OR
S, I
SA
ND
O
FPR
C:
SA
NO
FI W
INT
HR
OP
IND
US
TR
IE, A
MB
AR
ES
, F
RA
NC
E
M&
L LA
BO
RA
TO
RY
SE
RV
ICE
S, O
RM
ON
DE
, JO
HA
NN
ES
BU
RG
FP
RC
IFP
RR
: A
VE
NT
IS P
HA
RM
A, W
ALT
LOO
, PR
ET
OR
IA
FP
RR
: S
AN
OF
I-SY
NT
HE
LAB
O, M
IDR
AN
D, R
SA
She
lf-lif
e:
36 m
onth
s
Dat
e of
regi
stra
tion:
18
AP
RIL
200
8
MR
F I
5
Reg
istr
atio
n nu
mbe
r: A
4Oi7
.1.3
1029
0
Nam
e of
med
icin
e:
CO
IRB
ES
AR
TA
N W
INT
HR
OP
150
112,
5
Dos
age
form
: T
AB
LET
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NT
AIN
S:
IRB
ES
AR
TA
N
150,
O m
g H
YD
RO
CH
LOR
OT
HIA
ZID
E
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:
She
lf-lif
e:
SA
NO
FI-S
YN
TH
ELA
BO
(PT
Y)
LTD
BR
IST
OL-
MY
ER
S S
QU
IB6
CO
., E
VA
NS
VIL
LE
IND
IAN
A, U
SA
S
AN
OF
I WIN
TH
RO
P IN
DU
ST
RIE
, AM
BA
RE
S,
FR
AN
CE
SA
NO
FI W
INT
HR
OP
IND
US
TR
IE, A
MB
AR
ES
, F
RA
NC
E
AV
EN
TIS
PH
AR
MA
, WA
LTLO
O,
PR
ET
OR
IA
PH
AR
MA
CE
UT
ICA
L C
ON
TR
AC
TO
RS
, IS
AN
DO
FP
RC
: S
AN
OF
I WIN
TH
RO
P IN
DU
ST
RIE
, AM
BA
RE
S,
FR
AN
CE
M
&L
LAB
OR
AT
OR
Y S
ER
VIC
ES
, OR
MO
ND
E,
JOH
AN
NE
SB
UR
G
FP
RR
: A
VE
NT
IS P
HA
RM
A, W
ALT
LOO
, PR
ET
OR
IA
SA
NO
FI-S
YN
TH
ELA
BO
, MID
RA
ND
, RS
A
Dat
e of
reg
istr
atio
n:
36 m
onth
s
18 A
PR
IL 2
008
MR
F I
S
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
istra
tion:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istra
tion:
-
A40
1341
0299
CY
CLE
AN
SO
LUT
ION
EA
CH
1,O
ml S
OLU
TIO
N C
ON
TA
INS
: P
OLY
HE
XA
NID
E
0,l
lJg
1,2
, 3,4
, 5,
6, 8
RE
VIS
ION
S.A
. (P
TY
) LT
D
SA
UF
LON
PH
AR
MA
CE
UT
ICA
LS L
TD
, TW
ICK
EN
HA
M,
MID
DLE
SE
X, U
.K.
SA
UF
LON
PH
AR
MA
CE
UT
ICA
LS L
TD
, TW
ICK
EN
HA
M,
MID
DLE
SE
X, U
.K
SA
UF
LON
PH
AR
MA
CE
UT
ICA
LS L
TD. T
WIC
KE
NH
AM
, M
IDD
LES
EX
, U.K
T
EC
HN
IKO
N L
AB
OR
AT
OR
IES
. RO
BE
RT
VIL
LE,
FLO
RID
A, R
SA
RE
VIS
ION
S.A
., B
ED
FO
RD
VIE
W, J
OH
AN
NE
SB
UR
G,
RS
A
24 m
onth
s (P
rovi
sion
al)
18 A
PR
IL 2
008
MR
F 1
5
Reg
istra
tion
num
ber:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istra
tion:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FPR
C:
FP
RR
:
She
lf-lif
e:
Dat
e of
regi
stra
tion:
A40
120.
1.1
I030
9
LEV
OF
LOX
AC
IN-W
INT
HR
OP
250
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: LE
VO
FLO
XA
CIN
HE
MIH
YD
RA
TE
E
QU
IVA
LEN
T T
O
LEV
OF
LOX
AC
IN
250,
O m
g
1, 2
, 3,
4, 5
6, 7
AV
EN
TIS
PH
AR
MA
(PT
Y) L
TD
AV
EN
TIS
PH
AR
MA
SP
EC
IALI
TE
S,
CO
MP
EIG
NE
, FR
AN
CE
AV
EN
TIS
PH
AR
MA
DE
UT
SC
HLA
ND
Gm
bH,
FR
AN
KF
UR
T, G
ER
MA
NY
AV
EN
TIS
PH
AR
MA
SP
EC
IALI
TE
S,
CO
MP
EIG
NE
, F
RA
NC
E
AV
EN
TIS
PH
AR
MA
DE
UT
SC
HLA
ND
Gm
bH.
FR
AN
KF
UR
T, G
ER
MA
NY
WIN
TH
RO
P P
HA
RM
AC
EU
TIC
ALS
, W
ALT
LOO
, PR
ET
OR
IA
AV
EN
TIS
PH
AR
MA
, MID
RA
ND
, RS
A
24 m
onth
s
18 A
PR
IL 2
008
MR
F 1
5
Reg
istra
tion
num
ber:
A40
/20.
1.1/
0310
Nam
e of
med
icin
e:
LEV
OFL
OX
AC
IN-W
INTH
RO
P 50
0
Dos
age
form
: TA
BLE
T
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NTA
INS
: LE
VO
FLO
XA
CIN
HE
MIH
YD
RA
TE E
QU
IVA
LEN
T TO
LE
VO
FLO
XA
CIN
50
0,O
mg
Con
ditio
ns o
f reg
istra
tion:
1
,2,3
,4, 5
6, 7
App
lican
t: A
VE
NTI
S P
HA
RM
A (PTY) LT
D
Man
ufac
ture
r:
Pac
ker:
AV
EN
TIS
PH
AR
MA
SP
EC
IALI
TES
, CO
MP
EIG
NE
. FR
AN
CE
AV
EN
TlS
PH
AR
MA
DE
UTS
CH
LAN
D G
mbH
. FR
AN
KFU
RT,
G
ER
MA
NY
Labo
rato
ry:
FPR
C:
AV
EN
TIS
PH
AR
MA
SP
EC
IALI
TES
. CO
MP
EIG
NE
, FR
AN
CE
A
VE
NTl
S P
HA
RM
A D
EU
TSC
HLA
ND
Gm
bH, F
RA
NK
FUR
T.
GE
RM
AN
Y
FPR
CIF
PR
R:
WlN
WR
OP
PH
AR
MA
CE
UTI
CA
LS. W
ALT
LOO
, P
RE
TOR
IA
FPR
R:
AV
EN
TIS
PH
AR
MA
. MID
RA
ND
. RS
A
She
lf-lii
: 60
mon
ths
Dat
e of
regi
stra
tion:
18
AP
RIL
200
8
MR
F 1
5
Reg
istra
tion
num
ber:
A40
/34/
03 1
4
Nam
e of
med
icin
e:
OC
TRE
OTI
DE
HE
XA
L 0.
05 m
g
Dos
age
form
: IN
JEC
TIO
N
Adi
ve in
gred
ient
s:
EA
CH
1.0
ml S
OLU
TIO
N C
ON
TAIN
S:
OC
TRE
OTI
DE
0,
05 m
g
Con
ditio
ns o
f reg
istra
tion:
1
.2,3
.4, 5
67
App
lican
t: H
EX
AL
PH
AR
MA
(SA
) (P
TY
Man
ufac
ture
r: W
AS
SE
RB
UR
GE
R A
RZ
NE
lMllT
ELW
ER
K G
mbH
, W
AS
SE
RB
UR
G A
M IN
N. G
ER
MA
NY
Pac
ker:
WA
SS
ER
BU
RG
ER
AR
ZN
ElM
llTE
LWE
RK
Gm
bH,
WA
SS
ER
BU
RG
AM
IN
N. G
ER
MA
NY
S
ALU
TAS
PH
AR
MA
Gm
bH, B
AR
LEB
EN
. G
ER
MA
NY
-
.
DIV
PH
AR
M M
AN
UFA
CTU
RIN
G 8
PA
CK
AG
ING
. LO
NG
DA
LE. J
OH
AN
NE
SB
UR
G
TEC
HN
IKO
N L
AB
OR
ATO
RIE
S. R
OB
ER
TVIL
LE,
FLO
RID
A
PH
AR
MA
G.
IND
US
TRIA
, JO
HA
NN
ES
BU
RG
Labo
rato
ry:
FPR
C:
WA
SS
ER
BU
RG
ER
AR
ZN
ElM
llTE
LWE
RK
Gm
bH,
WA
SS
ER
BU
RG
AM
INN
. GE
RM
AN
Y
SA
LUTA
S P
HA
RM
A G
mbH
. BA
RLE
BE
N.
GE
RM
AN
Y
LAB
OR
L+S
AG
. B
AD
BO
CK
LET
GR
OS
SE
NB
AC
H.
GE
RM
AN
Y
CO
NS
ULT
ING
CH
EM
ICA
L LA
BO
RA
TOR
IES
, A
TLA
SV
ILLE
. BO
KS
BU
RG
A
NA
LYTI
CO
N. T
ER
EN
UR
E. K
EM
PTO
N P
AR
K
. FP
RR
: H
EX
AL
PH
AR
MA
. PIN
ETO
WN
. KZN
She
lf-lii
: 24
mon
ths
Dat
e of
regi
stra
tion:
18
AP
RIL
200
8
MR
F 1
5
Reg
istr
atio
n nu
mbe
r A
40/3
4/03
15
Nam
e of
med
icin
e:
OC
TR
EO
TID
E H
EX
AL
0.1
mg
Dos
age
form
: IN
JEC
TIO
N
Act
ive
ingr
edie
nts:
E
AC
H 1
,O m
l SO
LUT
ION
CO
NTA
INS
: O
CT
RE
OT
IDE
0,
1 m
g
Con
ditio
ns o
f reg
istra
tion:
1,
2,
3, 4
, 5, 6
, 7
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
She
lf-lif
e:
HE
XA
L P
HA
RM
A (S
A) (
PT
Y
WA
SS
ER
BU
RG
ER
AR
ZN
EIM
ITT
ELW
ER
K G
mbH
, W
AS
SE
RB
UR
G A
M I
NN
, GE
RM
AN
Y
WA
SS
ER
BU
RG
ER
AR
ZN
EIM
ITT
ELW
ER
K G
mbH
, W
AS
SE
RB
UR
G A
M IN
N. G
ER
MA
NY
S
ALU
TAS
PH
AR
MA
Gm
bH, B
AR
LEB
EN
, GE
RM
AN
Y
DIV
PH
AR
M M
AN
UFA
CTU
RIN
G &
PA
CK
AG
ING
, LO
NG
DA
LE, J
OH
AN
NE
SB
UR
G
TE
CH
NIK
ON
LA
BO
RA
TOR
IES
, RO
BE
RT
VIL
LE,
FLO
RID
A
PH
AR
MA
-Q, I
ND
US
TR
IA, J
OH
AN
NE
SB
UR
G
FPR
C:
WA
SS
ER
BU
RG
ER
AR
ZN
EIM
ITT
ELW
ER
K G
mbH
, W
AS
SE
RB
UR
G A
M IN
N, G
ER
MA
NY
S
ALU
TAS
PH
AR
MA
Gm
bH, B
AR
LEB
EN
, GE
RM
AN
Y
LAB
OR
L+S
AG
, B
AD
BO
CK
LET-
GR
OS
SE
NB
AC
H,
GE
RM
AN
Y
CO
NS
ULT
ING
CH
EM
ICA
L LA
BO
RA
TO
RIE
S,
ATL
AS
VIL
LE,
BO
KS
BU
RG
A
NA
LYTI
CO
N, T
ER
EN
UR
E, K
EM
PT
ON
PA
RK
FPR
R:
HE
XA
L P
HA
RM
A, P
INE
TOW
N, K
ZN
24 m
onth
s
Dat
e of
reg
istra
tion:
18
AP
RIL
200
8
MR
F 1
5
Reg
istr
atio
n nu
mbe
r: A
4012
0.1.
1105
22
Nam
e of
med
icin
e:
TO
Bl3
00 m
gI5
ml
Dos
age
form
: S
OLU
TIO
N
Act
ive
ingr
edie
nts:
E
AC
H 5
.0 m
l SO
LUT
ION
CO
NT
AIN
S:
TO
BR
AM
YC
IN
300,
O m
g
Con
ditio
ns o
f reg
istr
atio
n:
1.Z
3.4
, 5
,6,7
App
lican
t: N
OV
AR
TlS
SA
(P
TY
) LT
D
Man
ufac
ture
r: C
AR
DIN
AL
HE
ALT
H IN
C, W
OO
DS
TOC
K.
ILLI
NO
IS,
US
A
Pac
ker:
Labo
rato
ry:
FPR
C:
CA
RD
INA
L H
EA
LTH
INC
, WO
OD
STO
CK
, IL
LIN
OIS
. U
SA
C
AR
DIN
AL
HE
ALT
H L
TD
, BO
LTO
N, L
AN
CA
SH
IRE
, U
K
CA
RD
INA
L H
EA
LTH
LTD
, BO
LTO
N, L
AN
CA
SH
IRE
. U
K
CH
IRO
N C
OR
PO
RA
TIO
N. A
NN
AN
DA
LE. N
EW
JE
RS
EY
, US
A
TE
PN
EL
LIF
E S
CIE
NC
ES
. ED
INB
UR
GH
. UK
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
FPR
R:
NO
VA
RT
IS S
A, S
PA
RT
AN
, KE
MP
TO
N P
AR
K
She
lf-lif
e:
36 m
onth
s
Dat
e of
regi
stra
tion:
18
AP
RIL
200
8
MR
F 1
5
Reg
istr
atio
n nu
mbe
r: A
4012
1.5.
1105
24
Nam
e of
med
icin
e:
AP
ME
TH
YLP
RE
D
Dos
age
form
: IN
JEC
TIO
N
Act
ive
ingr
edie
nts:
E
AC
H 8
,O m
l SO
LUT
ION
CO
NTA
INS
: M
ETH
YLP
RE
DN
ISO
LON
E S
OD
IUM
SU
CC
INA
TE
EQ
UIV
ALE
NT
TO
M
ET
HY
LPR
ED
NIS
OLO
NE
50
0,O
mg
Con
ditio
ns o
f reg
istra
tion:
1,
2,
3, 4
, 5,
6, 7
, 8
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
PH
AR
MA
CA
RE
LIM
ITE
D
STR
IDE
S A
RC
OLA
B, A
NE
KA
L TA
LUK
, B
AN
GA
LOR
E, I
ND
IA
STR
IDE
S A
RC
OLA
B, A
NE
KA
L TA
LUK
, B
AN
GA
LOR
E, I
ND
IA
AS
PE
N P
HA
RM
AC
AR
E E
AS
T L
ON
DO
N,
WIL
SO
NIA
, EA
ST
LO
ND
ON
P
HA
RM
AC
AR
E L
TD, K
OR
STE
N, P
OR
T E
LIZ
AB
ET
H
FPR
C:
STR
IDE
S A
RC
OLA
B, A
NE
KA
L TA
LUK
, B
AN
GA
LOR
E, I
ND
IA
M&
L LA
BO
RA
TO
RY
SE
RV
ICE
S, O
RM
ON
DE
, JO
HA
NN
ES
BU
RG
S
OU
TH A
FRIC
AN
BU
RE
AU
OF
STA
ND
AR
DS
, G
RO
EN
KLO
OF,
PR
ETO
RIA
R
ES
EA
RC
H IN
ST
ITU
TE
FO
R IN
DU
ST
RIA
L P
HA
RM
AC
Y, N
OR
TH-W
ES
T U
NIV
ER
SIT
Y,
PO
TCH
EFS
TRO
OM
FPR
CIF
PR
R:
AS
PE
N P
HA
RM
AC
AR
E E
AS
T L
ON
DO
N,
WIL
SO
NIA
, EA
ST
LO
ND
ON
P
HA
RM
AC
AR
E L
TD, K
OR
STE
N, P
OR
T E
LIZ
AB
ET
H
She
lf-lif
e:
24 m
onth
s (P
rovi
sion
al)
Dat
e of
regi
stra
tion:
18
AP
RIL
200
8
MR
F 15
Reg
istr
atio
n nu
mbe
r: A
40/2
0.2.
8/06
19
Nam
e of
med
icin
e:
SO
NK
E-L
AS
TAD
30
Dos
age
form
: T
AB
LET
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NTA
INS
: LA
MlV
UD
lNE
15
0,O
mg
STA
VU
DIN
E
30,O
mg
Con
ditio
ns o
f reg
istr
atio
n:
1, 2
, 3,
4, 5
, 6
7,
8
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
She
lf-lif
e:
RA
NB
PX
Y (S
.A.)
(PT
Y) L
TD
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, P
AO
NTA
S
AH
IB, D
IST
RIC
T S
IRM
OU
R, H
IMA
CH
AL
PR
AD
ES
H, I
ND
IA
RA
NB
PX
Y L
AB
OR
ATO
RIE
S L
TD, P
AO
NTA
S
AH
IB,
DIS
TR
ICT
SIR
MO
UR
, HIM
AC
HA
L P
RA
DE
SH
, IN
DIA
FPR
C:
RA
NB
AX
Y L
AB
OR
ATO
RIE
S L
TD, P
AO
NTA
S
AH
IB, D
IST
RIC
T S
IRM
OU
R, H
IMA
CH
AL
PR
AD
ES
H, I
ND
IA
CO
NS
ULT
ING
CH
EM
ICA
L LA
BO
RA
TOR
IES
, A
TLA
SV
ILLE
, BO
KS
BU
RG
FPR
R:
RA
NB
PX
Y, C
EN
TUR
ION
, RS
A
24 m
onth
s (p
rovi
sion
al)
Dat
e of
regi
stra
tion:
18
AP
RIL
200
8
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
istra
tion:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FPR
C:
FPR
R:
She
lf-lif
e:
Dat
e of
reg
istra
tion:
A40
/20.
2.81
0620
SO
NK
E-L
AS
TA
D 4
0
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TAIN
S:
LAM
lVU
DlN
E
150,
O m
g S
TAV
UD
INE
40
.0 m
g
1, 2
, 3,
4,
5, 6
, 7, 8
RA
NB
AX
Y (S
.A.)
(PT
Y) L
TD
RA
NB
AX
Y L
AB
OR
ATO
RIE
S L
TD, P
AO
NT
A S
AH
IB,
DIS
TR
ICT
SIR
MO
UR
, HIM
AC
HA
L P
RA
DE
SH
, IN
DIA
RA
NB
AX
Y L
AB
OR
ATO
RIE
S L
TD, P
AO
NT
A S
AH
IB,
DIS
TR
ICT
SIR
MO
UR
, HIM
AC
HA
L P
RA
DE
SH
, IN
DIA
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LTD
, PA
ON
TA
SA
HIB
, D
IST
RIC
T S
IRM
OU
R, H
IMA
CH
AL
PR
AD
ES
H, I
ND
IA
CO
NS
ULT
ING
CH
EM
ICA
L LA
BO
RA
TOR
IES
, A
TLA
SV
ILLE
, BO
SK
BU
RG
RA
NB
AX
Y, C
EN
TUR
ION
, RS
A
24 m
onth
s (p
rovi
sion
al)
18 A
PR
IL 2
008
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
istra
tion:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FPR
C:
FPR
R:
She
lf-lif
e:
Dat
e of
regi
stra
tion:
AR
RO
W M
ELO
XIC
AM
73
TAB
LET
EA
CH
TA
BLE
T C
ON
TA
INS
: M
ELO
XIC
AM
7
5 m
g
AR
RO
W P
HA
RM
A S
OU
TH A
FRIC
A (
PT
Y)
LTD
RX
MA
NU
FA
CT
UR
ING
INC
, MIS
SIS
SA
UG
A.
ON
TA
RIO
, CA
NA
DA
RX
MA
NU
FAC
TUR
ING
INC
, MIS
SIS
SA
UG
A,
ON
TAR
IO, C
AN
AD
A
DIV
PH
AR
M M
AN
UFA
CTU
RIN
G 8
P
AC
KA
GIN
G, L
ON
GD
ALE
, JO
HA
NN
ES
BU
RG
RX
MA
NU
FA
CT
UR
ING
INC
, MIS
SIS
SA
UG
A,
ON
TAR
IO, C
AN
AD
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
TCH
EFS
TRO
OM
S
ED
EK
AG
RIK
EM
CC
, KA
ME
ELD
RIF
T,
PR
ET
OR
IA
AR
RO
W P
HA
RM
A S
A. W
OO
DM
EA
D,
JOH
AN
NE
SB
UR
G
24 m
onth
s
18 A
PR
IL 2
008
MR
F I5
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
istra
tion:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FPR
C:
FPR
R:
She
lf-lif
e:
Dat
e of
regi
stra
tion:
AR
RO
W M
ELO
XIC
AM
15
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TAIN
S:
ME
LOX
ICA
M
15,O
mg
AR
RO
W P
HA
RM
A S
OU
TH A
FRIC
A (
PTY
) LT
D
RX
MA
NU
FA
CT
UR
ING
INC
, MIS
SIS
SA
UG
A.
ON
TAR
IO, C
AN
AD
A
RX
MA
NU
FAC
TUR
ING
INC
, MIS
SIS
SA
UG
A,
ON
TAR
IO, C
AN
AD
A
DIV
PH
AR
M M
AN
UFA
CTU
RIN
G &
PA
CK
AG
ING
, LO
NG
DA
LE, J
OH
AN
NE
SB
UR
G
RX
MA
NU
FA
CT
UR
ING
INC
, MIS
SIS
SA
UG
A,
ON
TAR
IO, C
AN
AD
A
RE
SE
AR
CH
INS
TIT
UT
E F
OR
IND
US
TR
IAL
PH
AR
MA
CY
, NO
RTH
-WE
ST
UN
IVE
RS
ITY
, P
OT
CH
EF
ST
RO
OM
S
ED
EK
AG
RIK
EM
CC
. K
AM
EE
LDR
IFT,
PR
ETO
RIA
AR
RO
W P
HA
RM
A S
A, W
OO
DM
EA
D,
JOH
AN
NE
SB
UR
G
24 m
onth
s
18 A
PR
IL 2
008
MR
F 15
Reg
istra
tion
num
ber:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istra
tion:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FPR
C:
FPR
R:
FPR
CIF
PR
R:
She
lf-lif
e:
Dat
e of
regi
stra
tion:
AS
PE
N C
AR
VE
DIL
OL
25 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TAIN
S:
CA
RV
ED
ILO
L 25
.0 m
g
1.2
, 3.4
, 5.6
.7
PH
AR
MA
CA
RE
LIM
ITE
D
PH
AR
kMS
ClE
NC
E IN
C, M
ON
TRE
AL,
CA
NA
DA
P
HA
RM
AC
AR
E L
TD. K
OR
STE
N, P
OR
T E
LIZ
AB
ET
H
AS
PE
N P
HA
RM
AC
AR
E E
AS
T L
ON
DO
N.
WIL
SO
NIA
. E
AS
T LO
ND
ON
PH
AR
MA
SC
IEN
CE
INC
, MO
NTR
EA
L. C
AN
AD
A
PH
AR
MA
CA
RE
LTD
, KO
RS
TEN
. PO
RT
ELI
ZA
BE
TH
A
SP
EN
PH
AR
MA
CA
RE
EA
ST
LO
ND
ON
, W
ILS
ON
IA, E
AS
T L
ON
DO
N
PH
AR
MA
SC
IEN
CE
INC
, MO
NTR
EA
L, C
AN
AD
A
SO
UTH
AF
RIC
AN
BU
RE
AU
OF
STA
ND
AR
DS
, G
RO
EN
KLO
OF.
PR
ETO
RIA
R
ES
EA
RC
H IN
ST
ITU
TE
FO
R IN
DU
ST
RIA
L P
HA
RM
AC
Y. N
OR
TH-W
ES
T U
NIV
ER
SIT
Y,
PO
TCH
EFS
TRO
OM
M
&L
LAB
OR
ATO
RY
SE
RV
ICE
S. O
RM
ON
DE
. JO
HA
NN
ES
BU
RG
PH
AR
MA
CA
RE
LTD
. WO
OD
ME
AD
. JO
HA
NN
ES
BU
RG
PH
AR
MA
CA
RE
LTD
. KO
RS
TEN
. PO
RT
ELI
ZA
BE
TH
A
SP
EN
PH
AR
MA
CA
RE
EA
ST
LO
ND
ON
, W
ILS
ON
IA, E
AS
T L
ON
DO
N
36 m
onth
s
18 A
PR
IL 2
008
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