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ROMÂNIA
Buletin informativ An 21, Nr. 4 (84), trim. IV 2019
Agenţia Naţională a Medicamentului şi a
Dispozitivelor Medicale din România
Lista seriilor de medicamente retrase în trim. IV 2019
Cereri de autorizare/reînnoire a autorizaţiilor de punere pe piaţă primite de
ANMDMR în trim. III 2019
Medicamente autorizate de punere pe piaţă de ANMDMR în trim. III 2019
Medicamente autorizate prin procedura centralizată, efectuată la nivelul
Agenţiei Europene a Medicamentului (EMA), pentru care s-a notificat
intenţia de punere pe piaţă în România în trim. III 2019
2/31
Toate datele cuprinse în prezenta publicaţie reprezintă informaţii oficiale şi sunt
sub autoritatea Agenţiei Naţionale a Medicamentului şi a Dispozitivelor Medicale
din România.
Întregul conţinut al prezentei publicaţii se află sub protecţia legislativă integrală a
Agenţiei Naţionale a Medicamentului şi a Dispozitivelor Medicale din România.
Orice valorificare a conţinutului prezentei publicaţii în scopul obţinerii de venituri
sau comercializarea prezentei este interzisă şi pasibilă de pedeapsă fără acordul
excepţional al Agenţiei Naţionale a Medicamentului şi a Dispozitivelor Medicale
din România.
Toate drepturile editoriale aparţin în exclusivitate Agenţiei Naţionale a
Medicamentului şi a Dispozitivelor Medicale din România.
ISSN 1583-347X
3/31
CUPRINS
Lista seriilor de medicamente retrase în trim. IV 2019 .....................................4
Cereri de autorizare/reînnoire a autorizaţiilor de punere pe piaţă primite de
ANMDMR în trim. III 2019 ..................................................................................7
Medicamente autorizate de punere pe piaţă de ANMDMR în trim III 2019 ...8
Medicamente autorizate prin procedura centralizată, efectuată la nivelul
Agenţiei Europene a Medicamentului (EMA), pentru care s-a notificat
intenţia de punere pe piaţă în România în trim. III 2019
.................................................................................................................................31
4/31
Lista seriilor de medicamente retrase în trimestrul IV 2019
Nr
crt Produs retras
Forma
farmaceutica Conc. DCI Producator/DAPP Serie Motivul retragerii
Actiune propusa
Data retragerii
1
AVONEX
30µg/0,5 ml
PEN
solutie
injectabila in
stilou injector
(PEN)
preumplut
30µg/
0,5 ml
Interferon
Beta 1A
Biogen
Manufacturing
APS, Danemarca/
Biogen Netherland
BV Olanda
1423312,
1423322,
1423480
retragere voluntara de
pe piata la nivel de
farmacie/spital, ca
urmare a obtinerii unei
valori in afara
specificatiei, in cadrul
testarilor periodice,
precum si a emiterii
unei alerte rapide de
catre autoritatea din
Danemarca, referitoare
la o neconformitate de
calitate (cu afectarea
integritatii inchiderii
seringii)
Retragere
voluntare si
distrugere
23.10.2019
2
NUTRIFLEX
OMEGA
SPECIAL
emulsie
perfuzabila combinatii
B.Braun
Melsungen AG,
Germania
182828051,
174638051
retragere de pe piata,
ca urmare a primirii
unei alerte rapide din
partea autoritatii
competente din Franta,
referitoare la aparitia
unor neconformitati de
calitate (cazuri rare de
schimbare a culorii,
insotita sau nu de
separarea fazelor
emulsiei)
Retragere
si
distrugere
12.11.2019
5/31
3 NUTRIFLEX
OMEGA PLUS
emulsie
perfuzabila combinatii
B.Braun
Melsungen AG,
Germania
175158051,
180338052,
182338051,
183248051,
181028052,
182138052,
182748052
retragere de pe piata,
ca urmare a primirii
unei alerte rapide din
partea autoritatii
competente din Franta,
referitoare la aparitia
unor neconformitati de
calitate (cazuri rare de
schimbare a culorii,
insotita sau nu de
separarea fazelor
emulsiei)
Retragere
si
distrugere
12.11.2019
4 KEPPRA
100 mg/ml
conc. pt. sol.
perfuz.
100 mg/
ml levetiracetam
UCB Pharma SA,
Belgia toate seriile
retragere voluntara de
pe piata, ca urmare a
eliminarii
medicamentului din
Canamed si Catalogul
Public incepand cu
data de 07.11.2019
Retragere
voluntara
si
distrugere
28.11.2019
5 DEBRIDAT
24 mg/5ml
granule pentru
suspensie orala
24 mg/
5ml x
125 ml
trimebutina
Farmea,
Franta/Pfizer
Europe MA EEIG,
Belgia
3830, 3847,
3855, 3862,
3874
retragere de pe piata,
la nivel de farmacie,
ca urmare a unui
incident aparut pe linia
de umplere a locului
de fabricaţie (cu
posibilitatea foarte
redusa ca un corp
strain sa fi patruns
intr-un flacon din cele
92 serii destinate mai
multor tari)
Retragere
si
distrugere
28.11.2019
6/31
6 DEBRIDAT
24 mg/5ml
granule pentru
suspensie orala
24 mg/
5ml x
250 ml
trimebutina
Farmea,
Franta/Pfizer
Europe MA EEIG,
Belgia
3804, 3805,
3806, 3807,
3808, 3809,
3810, 3811,
3812, 3813,
3835, 3836,
3837, 3838,
3839, 3840,
3841, 3842,
3843, 3849,
3850, 3864,
3865, 3868,
3869, 3870,
3871, 3872,
3873, 3877
retragere de pe piata,
la nivel de farmacie,
ca urmare a unui
incident aparut pe linia
de umplere a locului
de fabricaţie (cu
posibilitatea foarte
redusa ca un corp
strain sa fi patruns
intr-un flacon din cele
92 serii destinate mai
multor tari)
Retragere
si
distrugere
28.11.2019
7/31
Cereri de autorizare/reînnoire a autorizaţiilor de punere pe piaţă primite
de ANMDMR în trim. III 2019
În trimestrul III 2019 s-au primit 22 cereri de autorizare de punere pe
piaţă/reînnoire a autorizaţiei pentru medicamentele care corespund următoarelor
grupe terapeutice:
COD ATC
R05 - MEDICAMENTE PENTRU TRATAMENTUL TUSEI ŞI RĂCELII
J02 - ANTIMICOTICE DE UZ SISTEMIC
A07 – ANTIDIAREICE ANTIINFLAMATOARE/ANTIINFECTIOASE INTESTINALE
A02 - MEDICAMENTE PENTRU TULBURĂRI DETERMINATE DE HIPERACIDITATE
J05 - ANTIVIRALE DE UZ SISTEMIC
J05 - ANTIVIRALE DE UZ SISTEMIC
N03 - ANTIEPILEPTICE
N03 - ANTIEPILEPTICE
D06 - ANTIBIOTICE ŞI CHIMIOTERAPICE DE UZ DERMATOLOGIC
J01 - ANTIBIOTICE DE UZ SISTEMIC
G01 - ANTIINFECŢIOASE ŞI ANTISEPTICE GINECOLOGICE
M02 - MEDICAMENTE TOPICE PENTRU LEZIUNI ŞI ALGII MUSCULARE
M01 - MEDICAMENTE ANTIINFLAMATOARE ŞI ANTIREUMATICE
A16 – ALTE PRODUSE PENTRU TRACTUL DIGESTIV SI METABOLISM
B01 – ANTITROMBOTICE
B01 – ANTITROMBOTICE
J01 - ANTIBIOTICE DE UZ SISTEMIC
C09 – MEDICAMENTE ACTIVE PE SISTEMUL RENINA-ANGIOTENSINA
C09 – MEDICAMENTE ACTIVE PE SISTEMUL RENINA-ANGIOTENSINA
M02 - MEDICAMENTE TOPICE PENTRU LEZIUNI ŞI ALGII MUSCULARE
A07 – ANTIDIAREICE ANTIINFLAMATOARE/ANTIINFECTIOASE INTESTINALE
M01- MEDICAMENTE ANTIINFLAMATOARE SI ANTIREUMATICE
8/31
Medicamente autorizate de punere pe piaţă de ANMDMR în trim III 2019
DCI Denumire Comerciala Forma farm. Conc. Firma detinatoare
Tara
Detinatoare
Nr. APP
ACECLOFENACUM AFLAMIL crema
15mg/g
GEDEON RICHTER
ROMANIA S.A. ROMANIA 12491 2019 01
ACECLOFENACUM AFLAMIL
pulb pt susp
orala
100mg
GEDEON RICHTER
ROMANIA S.A. ROMANIA 12490 2019 01
ACID
ACETILSALICILICUM MIO-AAS
compr.
gastrorez. 75mg
POLISANO
PHARMACEUTICALS ROMANIA 12352 2019 01
ACIDUM
ACETYLSALICYLICUM ALUPIRIN
compr.
gastrorez. 75mg
LABORMED PHARMA
S.A. ROMANIA 12477 2019 01
ACIDUM ASCORBICUM VITAMINA C ARENA sol. inj. 750 mg ARENA GROUP S.A. ROMANIA 12518 2019 01
ACIDUM ASCORBICUM VITAMEDI-C sol. inj.
750 mg/
5 ml
PASCOE
PHARMAZEUTISCHE
PRAEPARATE GMBH GERMANIA 12480 2019 01
ALBUMINUM HUMANUM
TECHNESCAN LYO
MAA
trusa kit
pentru
preparate
radiofarmaceu-
tice 2,0 mg
MALLINCKRODT
MEDIC. BV OLANDA 12386 2019 01
ALFACALCIDOLUM ALPHA D 3 0,5 µg caps. moi 0,5µg
TEVA
PHARMACEUTICALS
S.R.L. ROMANIA 12482 2019 01
ALFACALCIDOLUM ALPHA D3 caps. moi 0,25 mcg
TEVA
PHARMACEUTICALS
S.R.L. ROMANIA 12481 2019 01
ALFACALCIDOLUM ALPHA D3 caps. moi 1 mcg
TEVA
PHARMACEUTICALS ROMANIA 12483 2019 01
9/31
S.R.L.
AMANTADINI
HYDROCHLORIDUM VIREGYT-K caps. 100 mg
EGIS
PHARMACEUTICALS
PLC UNGARIA 12264 2019 01
AMBAZONUM
MONOHYDRATE
FARINGOSEPT
SCORTISOARA compr. pt. supt 10mg TERAPIA S.A. ROMANIA 12236 2019 01
AMBAZONUM
MONOHYDRATE FARINGOSEPT ROM compr. pt. supt 10mg TERAPIA S.A. ROMANIA 12237 2019 01
AMBAZONUM
MONOHYDRATE FARINGOSEPT MENTA compr. pt. supt 10mg TERAPIA S.A. ROMANIA 12238 2019 01
AMBROXOLUM
HYDROCHLORIDE
AMBROXOL
LAROPHARM sol. orala 15mg/5ml LAROPHARM S.R.L. ROMANIA 12308 2019 01
AMBROXOLUM
HYDROCHLORIDE AMBROSPRAY spray oral , sol. 10mg
CYATHUS
EXQUIRERE AUSTRIA 12350 2019 01
AMPICILLINUM
TRIHIDRATE AMPICILINA ARENA caps. 250 mg ARENA GROUP S.A. ROMANIA 12244 2019 01
AMPICILLINUM
TRIHIDRATE AMPICILINA ARENA caps. 500 mg ARENA GROUP S.A. ROMANIA 12245 2019 01
ATAZANAVIRUM
SULFATE ATANAZAVIR STADA caps. 150mg STADA M&D SRL GERMANIA 12456 2019 01
ATAZANAVIRUM
SULFATE ATANAZAVIR STADA caps. 300mg STADA M&D SRL ROMANIA 12457 2019 01
ATORVASTATINUM
CALCICUM TORVAZIN PLUS caps.
10mg/
10mg
EGIS
PHARMACEUTICALS
PLC UNGARIA 12434 2019 01
ATORVASTATINUM
CALCICUM TORVAZIN PLUS caps.
20mg/
10mg
EGIS
PHARMACEUTICALS
PLC UNGARIA 12435 2019 01
ATORVASTATINUM
CALCICUM TORVAZIN PLUS caps.
40/mg/
10mg
EGIS
PHARMACEUTICALS UNGARIA 12436 2019 01
10/31
PLC
ATORVASTATINUM
CALCIUM/EZETINIBUM ZETOVAR compr.
10mg/
10mg ZENTIVA k.s. CEHIA 12430 2019 01
ATORVASTATINUM
CALCIUM/EZETINIBUM ZETOVAR compr.
20mg/
10mg ZENTIVA k.s. CEHIA 12431 2019 01
ATORVASTATINUM
CALCIUM/EZETINIBUM ZETOVAR compr.
40mg/
10mg ZENTIVA k.s. CEHIA 12432 2019 01
ATORVASTATINUM
CALCIUM/EZETINIBUM ZETOVAR compr.
80mg/
10mg ZENTIVA k.s. CEHIA 12433 2019 01
AZELASTINUM ALLERGODIL S spray nazal 1,5 mg/ml
MEDA PHARMA
GmbH GERMANIA 12511 2019 01
BENDAMUSTINUM
BENDAMUSTINA
ACTAVIS
pulb. conc. sol.
perf. 2.5mg/ml
ACTAVIS GROUP PTC
EHF ISLANDA 12303 2019 01
BENFOTIAMINUM NEUROSSEN compr. film. 300mg AAA PHARMA GMBH GERMANIA 12208 2019 01
BENZIDAMINI
HYDROCHLORIDUM TANTUM ROSA sol. vaginala 1 mg/ml
CSC
PHARMACEUTICALS
HANDELS GmbH AUSTRIA 12512 2019 01
BENZOAT DE BENZIL
BENZOAT DE BENZIL
FITERMAN crema 250 mg/g
FITERMAN PHARMA
SRL ROMANIA 12415 2019 01
BETAMETHASONE +
CLORAMPHENICOL BETABIOPTAL pic. oft., susp.
2 mg/
5 mg/ml THEA FARMA ITALIA 12319 2019 01
BETULLA VERUCOSA ITUZALAX liof. oral 12 SQ-BET ALK - ABELLO A/S DANEMARCA 12455 2019 01
BIFONAZOLUM BIAZOL crema 10 mg/g
GEDEON RICHTER
ROMANIA S.A. ROMANIA 12498 2019 01
BISACODILUM DULCOLAX 10 mg supoz. 10 mg
SANOFI - AVENTIS
ROMANIA S.R.L. ROMANIA 12285 2019 01
11/31
BISOPROLOLUM/
AMLOPIDINUM ALOTENDIN compr. 5mg/5mg EGIS PHARMA. PLC UNGARIA 12279 2019 01
BISOPROLOLUM/
AMLOPIDINUM ALOTENDIN compr. 5mg/10mg EGIS PHARMA. PLC UNGARIA 12280 2019 01
BISOPROLOLUM/
AMLOPIDINUM ALOTENDIN compr. 10mg/5mg EGIS PHARMA. PLC UNGARIA 12281 2019 01
BISOPROLOLUM/
AMLOPIDINUM ALOTENDIN compr.
10mg/
10 mg EGIS PHARMA. PLC UNGARIA 12282 2019 01
BROMHEXINUM
HYDROCHLORIDE BROMHEXIN BIOFARM compr. 8 mg BIOFARM S.A. ROMANIA 12232 2019 01
BROMHEXINUM
HYDROCHLORIDE BROMHEXIN BIOFARM compr. 12 mg BIOFARM S.A. ROMANIA 12233 2019 01
BROMHEXINUM
HYDROCHLORIDE BRONHOSOLV sol. orala 10mg/5ml LAROPHARM S.R.L. ROMANIA 12307 2019 01
BROMHEXINUM
HYDROCHLORIDE BROMHEXIN 8 mg compr. 8mg FARMACOM S.A. ROMANIA 12315 2019 01
BROMHEXINUM
HYDROCHLORIDE BRONHOSOLV compr. 8 mg LAROPHARM S.R.L. ROMANIA 12364 2019 01
BROMHEXINUM
HYDROCHLORIDE
BROMHEXIN HELCOR
8 mg compr. 8mg
AC HELCOR
PHARMA SRL ROMANIA 12440 2019 01
BUDESONIDUM RINOCLENIL
spray nazal ,
susp. 100 µg/doza
CHIESI
FARMACEUTICI SPA ITALIA 12365 2019 01
BUPROPIONUM
HYDROCHLORIDE ZYBAN
compr. elib.
prel. 150mg
GLAXO OPERATIONS
UK LIMITED
MAREA
BRITANIE 12478 2019 01
CALCIUM +
CHOLECALCIFEROLUM CALCIVID compr. film.
BERES
PHARMACEUTICALS
Co. Ltd. UNGARIA 12489 2019 01
12/31
CALCIUM
CARBONATE/CALCIUM
LACTATE GLUCONATE
CALCIU-SANDOZ +
VIT. C compr. eff. 1000 mg SANDOZ S.R.L. ROMANIA 12330 2019 01
CALCIUM GLUCONATE
GLUCONAT DE
CALCIU S.MED sol. inj. 95mg/ml S.MED GERMANIA 12468 2019 01
CANDESARTANUM
CILEXETIL/
AMLOPIDINUM
BESILATE CARAMLO compr. 8mg/5mg ZENTIVA k.s. CEHIA 12225 2019 01
CANDESARTANUM
CILEXETIL/
AMLOPIDINUM
BESILATE CARAMLO compr.
16mg/
10mg ZENTIVA k.s. CEHIA 12226 2019 01
CAPTOPRILUM CAPTOPRIL MCC compr. 25mg MAGISTRA C&C SRL ROMANIA 12321 2019 01
CAPTOPRILUM CAPTOPRIL MCC compr. 50mg MAGISTRA C&C SRL ROMANIA 12322 2019 01
CAPTOPRILUM
CAPTOPRIL
SINTOFARM compr. 25 mg SINTOFARM S.A. ROMANIA 12397 2019 01
CAPTOPRILUM CAPTOPRIL LPH compr. 25 mg
LABORMED PHARMA
S.A. ROMANIA 12399 2019 01
CAPTOPRILUM CAPTOPRIL LPH compr. 50mg
LABORMED PHARMA
S.A. ROMANIA 12400 2019 01
CARBAMAZEPINUM
CARBAMAZEPIN
BIOEEL compr 200 mg BIO EEL SRL ROMANIA 12234 2019 01
CARBOCISTEINUM FLUIDOL sirop
250 mg/
5 ml
TIS FARMACEUTIC
S.A. ROMANIA 12525 2019 01
CARBOCISTEINUM FLUIDOL sirop
100 mg/
5 ml
TIS FARMACEUTIC
S.A. ROMANIA 12524 2019 01
CARVEDILOLUM
CARVEDILOL VIM
SPECTRUM caps. vag. 12,5 mg VIM SPECTRUM S.R.L. ROMANIA 12230 2019 01
CARVEDILOLUM
CARVEDILOL VIM
SPECTRUM caps. vag. 6,25 mg VIM SPECTRUM S.R.L. ROMANIA 12229 2019 01
13/31
CEFACLORUM CEFACLOR TERAPIA
gran. pt.
susp.orala
125 mg/
5 ml TERAPIA S.A. ROMANIA 12286 2019 01
CEFACLORUM CEFACLOR TERAPIA
gran. pt.
susp.orala
250mg/
5 ml TERAPIA S.A. ROMANIA 12287 2019 01
CEFACLORUM CEFACLOR TERAPIA caps. 250 mg TERAPIA S.A. ROMANIA 12311 2019 01
CEFACLORUM CEFACLOR ARENA caps. 500mg ARENA GROUP S.A. ROMANIA 12393 2019 01
CEFIXIMUM XIFIA
gran. pt.
sol.orala
100mg/
5ml INN-FARM d.o.o. SLOVENIA 12473 2019 01
CEFTRIAXONUM
SODIUM CEFTRIAXONA MIP
pulb. pt. sol.
inj./perf. 1g MIP PHARMA GmbH GERMANIA 12267 2019 01
CEFTRIAXONUM
SODIUM CEFTRIAXONA MIP
pulb. pt. sol.
inj./perf. 2g MIP PHARMA GmbH GERMANIA 12268 2019 01
CIMETIDINUM CIMETIDINA ARENA caps. 200mg ARENA GROUP S.A. ROMANIA 12371 2019 01
CINACALCETUM CINACALCET ARISTO compr. film. 30mg ARISTO PHARMA GERMANIA 12216 2019 01
CINACALCETUM CINACALCET ARISTO compr. film. 60mg ARISTO PHARMA GERMANIA 12217 2019 01
CINACALCETUM CINACALCET ARISTO compr. film. 90mg ARISTO PHARMA GERMANIA 12218 2019 01
CIPROFLOXACINUM CIPROCIN compr. film. 500mg E.I.P.I.C.O. MED S.R.L. ROMANIA 12332 2019 01
CIPROFLOXACINUM CIPROQUIN compr. film. 500 mg ANTIBIOTICE S.A. ROMANIA 12354 2019 01
CIPROFLOXACINUM
HYDROCHLORIDE CIPROCIN compr. film. 250mg E.I.P.I.C.O. MED S.R.L. ROMANIA 12331 2019 01
CIPROFLOXACINUM/
FLUOCINOLONUM
ACETONIDE OTOTIS
pic. auriculare,
sol
3mg/ml+
0,5 mg/ml
TIS FARMACEUTIC
S.A. ROMANIA 12438 2019 01
CIPROHEPTADINUM
HYDROCHLORIDE
CIPROHEPTADINA
ARENA compr. 4mg ARENA GROUP S.A. ROMANIA 12363 2019 01
CISPLATINUM SINPLATIN
conc. pt. sol
perf. 1mg/ml ACTAVIS SRL ROMANIA 12451 2019 01
14/31
CLARITHROMYCINUM KLABAX
gran. pt.
susp.orala
125mg/
5ml TERAPIA S.A ROMANIA 12297 2019
01
CLARITHROMYCINUM KLABAX
gran. pt.
susp.orala
250mg/
5ml TERAPIA S.A ROMANIA 12298 2019 01
CLOMIFENUM CLOSTILBEGYT compr 50 mg
EGIS
PHARMACEUTICALS
PLC UNGARIA 12316 2019 01
CLOPIDOGRELUM CLOPIDOGREL EIPICO compr. film. 75 mg E.I.P.I.C.O. MED S.R.L. ROMANIA 12506 2019 01
CLORCHINALDOLUM SAPROSAN draj. 100mg SINTOFARM S.A. ROMANIA 12517 2019 01
CLORHIDRAT DE
CIPROFLOXACINA
CIPROFLOXACIN
ROMPHARM
pic. oft.
auriculare 3 mg/ml
ROMPHARM
COMPANY S.R.L. ROMANIA 12383 2019 01
CLORHIDRAT DE
LIDOCAINA XILINA sol. inj. 20 mg/ml ZENTIVA S.A. ROMANIA 12270 2019 01
CLORHIDRAT DE
LIDOCAINA XILINA sol. inj. 10 mg/ml ZENTIVA S.A. ROMANIA 12269 2019 01
CLORHIDRAT DE
LIDOCAINA XILINA sol. inj. 40 mg/ml ZENTIVA S.A. ROMANIA 12271 2019 01
CLORHIDRAT DE
TERBINAFINA FUNGISIL crema 10 mg/g
FITERMAN PHARMA
SRL ROMANIA 12515 2019 01
CLORHIDRATUM
PROPANOLOLUM
PROPRANOLOL
BIOEEL compr. 40mg BIO EEL SRL ROMANIA 12487 2019 01
CLORHIRAT DE
EFEDRINUM EFEDRINA ZENTIVA sol. inj. 50 mg/ml ZENTIVA S.A. ROMANIA 12497 2019 01
CODEINI PHOSPHAS
FOSFAT DE CODEINA
EEL compr. 15 mg BIO EEL SRL ROMANIA 12523 2019 01
COMBINATII CITROLIN apa de gura
PHARCO IMPEX 93
S.R.L. ROMANIA 12248 2019 01
COMBINATII PANANGIN compr. film.
158mg/
140mg
GEDEON RICHTER
PLC UNGARIA 12235 2019 01
COMBINATII FARINGO HOT DRINK gran. pt. 500mg/ TERAPIA SA ROMANIA 12239 2019 01
15/31
susp.orala 200mg/
4mg
COMBINATII KANAMICINA H ATB ung. oftalmic
5 mg/
10 mg/g ANTIBIOTICE S.A. ROMANIA 12272 2019 01
COMBINATII
CATHEJELL CU
LIDOCAINA gel uretral
PHARMAZEUTISCHE
FABRIK MONTAVIT
Ges.m.B.H AUSTRIA 12295 2019 01
COMBINATII SPERSALLERG pic. oft., sol
0,5 mg/
0,4 mg/ml
NOVARTIS PHARMA
GmbH GERMANIA 12320 2019 01
COMBINATII DENTINOX-GEL gel
DENTINOX
GESELLSCHAFT GERMANIA 12309 2019 01
COMBINATII VI-SOL CALCIUM sirop FELSIN FARM. S.R.L. ROMANIA 12317 2019 01
COMBINATII TRIAMCINOLON S ATB crema
1 mg/
30 mg/g ANTIBIOTICE S.A. ROMANIA 12345 2019 01
COMBINATII SALIFORM FORTE crema
150 mg/
100 mg/g ANTIBIOTICE S.A. ROMANIA 12382 2019 01
COMBINATII CAL C VITA compr. eff. BAYER S.R.L. ROMANIA 12329 2019 01
COMBINATII ALGIFEN compr.
500 mg/
5 mg/
0,1 mg ZENTIVA S.A. ROMANIA 12374 2019 01
COMBINATII
ALGIFEN SOLUTIE
INJECTABILA sol. inj.
500 mg/
2 mg/
0,02mg/ml ZENTIVA S.A. ROMANIA 12373 2019 01
COMBINATII RIBOMUNYL
gran. pt.
sol.orala
PIERRE FABRE
MEDICAMENT FRANTA 12362 2019 01
COMBINATII TUSOCALM compr.
7,5mg/
120mg ARENA GROUP S.A. ROMANIA 12372 2019 01
COMBINATII IBALGIN SPORT crema ZENTIVA k.s. CEHIA 12403 2019 01
COMBINATII DEEP HEAT RUB crema
COLEP LAUPHEIM
Gm GERMANIA 12344 2019 01
16/31
COMBINATII STREPSILS MENTA pastile
RECKITT BENCKISER
HEALTHCARE
INTERNAIONAL
MAREA
BRITANIE 12339 2019 01
COMBINATII CALGEL gel gingival
GLAXO WELLCOME
UK LTD.
MAREA
BRITANIE 12409 2019 01
COMBINATII SAL-EKARZIN ung.
0,50 mg/
30mg/g ANTIBIOTICE S.A. ROMANIA 12410 2019 01
COMBINATII GENTOS pic. orale, sol.
RICHARD BITTNER
AG AUSTRIA 12419 2019 01
COMBINATII N-ANTIGRIPAL compr. ARENA GROUP S.A. ROMANIA 12520 2019 01
DEFERAXIROSUM
DEFERASIROX MSN
LABORATORIES compr. film. 90mg
VIVANTA GENERICS
sro CEHIA 12276 2019 01
DEFERAXIROSUM
DEFERASIROX MSN
LABORATORIES compr. film. 180mg
VIVANTA GENERICS
sro CEHIA 12277 2019 01
DEFERAXIROSUM
DEFERASIROX MSN
LABORATORIES compr. film. 360mg
VIVANTA GENERICS
sro CEHIA 12278 2019 01
DEXTROMETHORPHANUM HYDROBROMIDE
ROBITUSIN
ANTITUSSICUM sol. orala 7,5mg/5ml
PFIZER
CORPORATION AUSTRIA 12446 2019 01
DEXTROMETHORPHANUM HYDROBROMIDE ROBITUSIN JUNIOR sol. orala 3,75mg/5ml
PFIZER
CORPORATION AUSTRIA 12447 2019 01
DICLOFENACUM
SODIUM GLIMBAX apa de gura
0,074g/
100ml ANGELINI PHARMA AUSTRIA 12212 2019 01
DICLOFENACUM
SODIUM DICLOFENAC MCC gel 10 mg/g MAGISTRA C&C ROMANIA 12288 2019 01
DICLOFENACUM
SODIUM DICLOFENAC MCC gel 50 mg/g MAGISTRA C&C ROMANIA 12289 2019 01
DICLOFENACUM
SODIUM
DICLOFENAC
FITERMAN ung. 10 mg/g
FITERMAN PHARMA
SRL ROMANIA 12314 2019 01
DICLOFENACUM
SODIUM DIFLEX gel 50mg/g
FITERMAN PHARMA
SRL ROMANIA 12313 2019 01
17/31
DICLOFENACUM
SODIUM
DICLOFENAC
SINTOFARM supoz. 12.5mg SINTOFARM S.A. ROMANIA 12334 2019 01
DICLOFENACUM
SODIUM + MISOPROSTOL ARTHROTEC
compr.
gastrorez.
75mg/
0,20mg
PFIZER EUROPE MA
EEIG
MAREA
BRITANIE 12398 2019 01
DICLOFENACUM
SODIUM/OMEORAZOLUM DICLOPRAM caps.
75mg/
20mg
PHARMASWISS
CESKA REPUBLIKA
s.r.o. CEHIA 12300 2019 01
DIMENTHYDRINATUM ORIENS compr. 50mg GALENICA S.A. GRECIA 12467 2019 01
DIMETICONUM/
GUAIAZULENUM PEPSANE caps. moi
300 mg/
4 mg
LABORATOIRES
ROSA-
PHYTOPHARMA FRANTA 12327 2019 01
DIMETICONUM/
GUAIAZULENUM PEPSANE gel oral 3g/0,004 g
LABORATOIRES
ROSA-
PHYTOPHARMA FRANTA 12328 2019 01
DONEPEZILUM
HYDROCHLORIDE TUADIN compr. film. 10 mg ANTIBIOTICE S.A. ROMANIA 12385 2019 01
DORZOLAMIDUM
DORZOLAMIDA
ARENA sol. oft. 20mg/ml ARENA GROUP S.A. ROMANIA 12262 2019 01
DROTAVERINUM
HYDROCHLORIDE SPAVERIN caps. 40 mg ANTIBIOTICE S.A. ROMANIA 12521 2019 01
DROTAVERINUM
HYDROCHLORIDE SPAVERIN caps. 80 mg ANTIBIOTICE S.A. ROMANIA 12522 2019 01
DUTASTERIDUM/
TAMSULOSIN
DUTASTERIDA/
TAMSULOSIN
AUROBINDO caps.
0,5 mg/
0,4 mg
AUROBINDO
PHARMA LIMITED ROMANIA 12228 2019 01
DUTASTERIDUM/
TAMSULOSINUM DUTAZEN caps.
0.5mg/
0.4mg ZENTIVA k.s. CEHIA 12462 2019 01
ECONAZOLUM
NITRATUM ECONAZOL ROMINKO ovule 150 mg ROMINKO SA ROMANIA 12488 2019 01
ENALAPRILUM ENALAPRIL VIM compr. 10 mg VIM SPECTRUM S.R.L. ROMANIA 12405 2019 01
18/31
(MALEATE) SPECTRUM
ENALAPRILUM
MALEATE ENALAPRIL ARENA compr. 5mg ARENA GROUP S.A. ROMANIA 12357 2019 01
ENALAPRILUM
MALEATE ENALAPRIL ARENA compr. 10mg ARENA GROUP S.A. ROMANIA 12358 2019 01
ENALAPRILUM
MALEATE ENALAPRIL ARENA compr. 20mg ARENA GROUP S.A. ROMANIA 12359 2019 01
EPOETINUM ALFA EPREX 40000 UI
sol. inj.
(seringi
preumplute) 40000 UI/ml
JOHNSON &
JOHNSON d.o.o. SLOVENIA 12445 2019 01
ERTAPENEMUM SODIUM
ERTAPENEM
VILLERTON
pulb. conc. sol.
perf. 1g
VILLERTON INVEST
S.A. LUXEMBURG 12224 2019 01
ERYTHROMYCINUM ERYFLUID sol. cut. 40 mg/ml
PIRRE FABRE
DERMATOLOGIE FRANTA 12441 2019 01
ETAMSILATUM ETAMSILAT ZENTIVA sol. inj. 250mg ZENTIVA S.A. ROMANIA 12401 2019 01
ETHINYLESTRADIOL,
GESTODENE MILLIGEST draj.
GEDEON RICHTER
PLC UNGARIA 12442 2019 01
ETIONAMIDA ETIONAMIDA ATB compr. film. 250mg ANTIBIOTICE S.A. ROMANIA 12392 2019 01
ETOPOSIDUM ETOPOZIDA KABI
conc. pt. sol.
perf. 20mg/ml
FRESENIUS KABI
ONCOLOGY PLC UK 12301 2019 01
EXEMESTANUM XANEPRA compr. film. 25mg NEOLA PHARMA SRL ROMANIA 12495 2019 01
FEBUXOSTATUM FEBUXOSTAT MSN compr. film. 80mg VIVANTA GENERICS CEHIA 12425 2019 01
FEBUXOSTATUM FEBUXOSTAT MSN compr. film. 120mg VIVANTA GENERICS CEHIA 12426 2019 01
FENAZONUM/
CLORHIDRATUL DE
LIDOCAINUM OTILERIN
pic. auriculare,
sol
47,2 mg/
11,8 mg/ml BIOFARM S.A. ROMANIA 12507 2019 01
FLUCONAZOLUM
FLUCONAZOL
ROMPHARM caps. 150mg
ROMPHARM
COMPANY S.R.L. ROMANIA 12423 2019 01
FUROSEMIDUM FUROSEMID LPH compr. 40 mg
LABORMED PHARMA
S.A. ROMANIA 12326 2019 01
19/31
GADOBUTROLUM MEMOVIST sol. inj. 1.0 mmol/ml BAYER AG GERMANIA 12219 2019 01
GADOBUTROLUM MEMOVIST
sol. inj.
(seringi
preumplute) 1.0 mmol/ml BAYER AG GERMANIA 12220 2019 01
GESTODENUM+
ETINILESTRADIOLUM MARYNARKA compr.
0.075mg/
0.02mg
EXELTIS
HEALTHCARE S.L SPANIA 12302 2019 01
GINKGO BILOBA TANAKAN pic. orale, sol. 40 mg/ml IPSEN PHARMA GmbH FRANTA 12367 2019 01
GINKGO BILOBA
FRUNZA DE GINKGO
TEVA compr. film. 120mg TEVA PHARMA B.V. OLANDA 12429 2019 01
GINKGO BILOBA
FRUNZA DE GINKGO
TEVA compr. film. 80mg TEVA PHARMA B.V. OLANDA 12428 2019 01
GINKGO BILOBA
FRUNZA DE GINKGO
TEVA compr. film. 40mg TEVA PHARMA B.V. OLANDA 12427 2019 01
GINKGO BILOBA BILOBIL FORTE caps. 80 mg
KRKA D.D. NOVO
MESTO SLOVENIA 12492 2019 01
GLIBENCLAMIDUM
GLIBENCLAMID
ARENA compr. 5 mg ARENA GROUP S.A. ROMANIA 12404 2019 01
GLICERINUM TRINITRAT NITROMINT
spray
sublingual 0,4mg
EGIS
PHARMACEUTICALS
PLC UNGARIA 12439 2019 01
GLYCERYL TRINITRATE NITROMINT
compr. film.
elib. prel. 2,6mg
EGIS
PHARMACEUTICALS
PLC UNGARIA 12351 2019 01
GUAIFENESIUM
ROBITUSIN
EXPECTORANS sol. orala 100mg/5 ml
PFIZER
CORPORATION AUSTRIA 12448 2019 01
HEXOPRENALINUM GYNIPRAL sol. inj. 10mcg/2 ml NYCOMED AUSTRIA AUSTRIA 12414 2019 01
HOMEOPATE GASTROCYNESINE compr. BOIRON S.A. FRANTA 12306 2019
01
HOMEOPATE TONSILOTREN compr.
DEUTSCHE
HOMEOOPATHIE-
UNION GERMANIA 12336 2019 01
20/31
HOMEOPATE TONSIPRET compr. BIONORICA AG GERMANIA 12424 2019 01
IBUPROFENUM
LAROFEN PENTRU
COPII susp. orala 100mg/5 ml LAROPHARM S.R.L. ROMANIA 12395 2019 01
IBUPROFENUM PADUDEN caps. 200mg TERAPIA SA ROMANIA 12443 2019 01
IBUPROFENUM PADUDEN FORTE compr 400 mg TERAPIA S.A. ROMANIA 12444 2019 01
IBUPROFENUM ALGIN JUNIOR susp. orala 100mg/5 ml ZENTIVA k.s. CEHIA 12503 2019 01
IBUPROFENUM
NUROFEN IMMEDIA
ULTRA draj. 400mg
RECKITT BENCKISER
HEALTHCARE
INTERNAIONAL ROMANIA 12516 2019 01
INDAPAMIDUM
INDAPAMIDA SR
TORRENT
compr. elib.
prel. 1,5mg
TORRENT PHARMA
S.R.L. ROMANIA 12412 2019 01
ISOFLURANUM ANESTERAN
lichid pt. vap.
de inhalat
ROMPHARM
COMPANY S.R.L. ROMANIA 12454 2019 01
ISOSORBIDI DINITRAS
ISOSORBID DINITRAT
EIPICO compr. 10mg E.I.P.I.C.O. MED S.R.L. ROMANIA 12368 2019 01
ITRACONAZOLUM
ITRACONAZOL
SLAVIA caps. 100 mg SLAVIA PHARM S.R.L. ROMANIA 12422 2019 01
KETOPROFENUM
KETOPROFEN
TERAPIA sol. inj./perf.
100 mg/
2 ml TERAPIA S.A. ROMANIA 12375 2019 01
KETOPROFENUM KETOPROXIN compr. film. 50mg
AC HELCOR
PHARMA SRL ROMANIA 12389 2019 01
KETOPROFENUM KETOPROXIN compr. film. 100mg
AC HELCOR
PHARMA SRL ROMANIA 12390 2019 01
KETOPROFENUM
KETOPROFEN
ROMPHARM sol. inj. 100mg/2 ml
ROMPHARM
COMPANY S.R.L. ROMANIA 12411 2019 01
LACTULOSUM LACTULOSE EIPICO sirop 65% E.I.P.I.C.O. MED S.R.L. ROMANIA 12355 2019 01
LATANOPROSTUM MONOPOST sol. oft. 50mcg/ml
LABORATOIRES
THEA FRANTA 12283 2019 01
LERCANIDIPINUM
HYDROCHLORIDE
LERCANIDIPINA
SANDOZ compr. film. 10mg SANDOZ S.R.L. ROMANIA 12221 2019 01
21/31
LERCANIDIPINUM
HYDROCHLORIDE
LERCANIDIPINA
SANDOZ compr. film. 20mg SANDOZ S.R.L. ROMANIA 12222 2019 01
LERCANIDIPINUM
HYDROCHLORIDE LERIDIP compr. film. 20 mg
RECORDATI
INDUSTRIA CHIMICA
E FARMACEUTICA
S.p.A. ITALIA 12291 2019 01
LERCANIDIPINUM
HYDROCHLORIDE LERIDIP compr. film. 10mg BERLIN CHEMIE AG GERMANIA 12290 2019 01
LEVODROPROPIZINUM LEVOPRONT sirop 30 mg/ 5 ml
DOMPE
FARMACEUTICI SPA ITALIA 12209 2019 01
LEVODROPROPIZINUM LEVOPRONT pic. orale, sol. 60 mg/ml
DOMPE
FARMACEUTICI SPA ITALIA 12210 2019 01
LEVOFLOXACINUM L-OPTIC pic. oft., sol 5mg/ml
ROMPHARM
COMPANY S.R.L. ROMANIA 12211 2019 01
LIDOCAINUM
HYDROCHLORIDE OTIRELAX
pic. auriculare,
sol
45,5 mg/ml+
11,4 mg/ml
ROMPHARM
COMPANY S.R.L. ROMANIA 12384 2019 01
LOPERAMIDUM
LOPERAMID
LAROPHARM sol. orala 1mg/5ml LAROPHARM S.R.L. ROMANIA 12496 2019 01
LOPERAMIDUM
CLORHIDRATUM NEO-ENTEROSEPTOL caps. 2mg SPECIFAR S.A. GRECIA 12250 2019 01
LOPERAMIDUM
CLORHIDRATUM LOPERAMID TERAPIA caps. 2mg TERAPIA S.A. ROMANIA 12294 2019 01
LOPERAMIDUM
HYDROCHLORIDE LOPERAMID SLAVIA caps. 2mg SLAVIA PHARM S.R.L. ROMANIA 12293 2019 01
LORATADINUM LORATADINA ARENA compr 10 mg ARENA GROUP S.A. ROMANIA 12346 2019 01
LORAZEPANUM TEMELOR sol. inj. 4mg/ml
MEDOCHEMIE
IBERICA S.A. PORTUGALIA 12223 2019 01
MELOXICAMUM MELOXICAM sol. inj. 15mg/1.5ml ROMPHARM ROMANIA 12519 2019 01
22/31
ROMPHARM COMPANY S.R.L.
MEMANTINUM
HYDROCHLORIDE MANTOMED compr. film. 10 mg MEDOCHEMIE LTD CIPRU 12458 2019 01
MEMANTINUM
HYDROCHLORIDE MANTOMED compr. film. 20 mg MEDOCHEMIE LTD CIPRU 12459 2019 01
MEMANTINUM
HYDROCHLORIDE
MEMANTINA
AUROBINDO 10 mg compr. film. 10mg
AUROBINDO
PHARMA LIMITED ROMANIA 12471 2019 01
MENOTROPHINUM HP MENOPUR
pulb. si solv.
pt. sol. inj. 600UI FERRING GmbH GERMANIA 12265 2019 01
MENOTROPHINUM HP MENOPUR
pulb. si solv.
pt. sol. inj. 1200UI FERRING GmbH GERMANIA 12266 2019 01
MEROPENEMUM ARCHIFAR
pulb. pt. sol.
inj./perf. 500mg
MEDOCHEMIE
ROMANIA S.R.L. ROMANIA 12484 2019 01
MEROPENEMUM ARCHIFAR
pulb. pt. sol.
inj./perf. 1000mg
MEDOCHEMIE
ROMANIA S.R.L. ROMANIA 12485 2019 01
MESALAZINUM
MESALAZINA
SOFARFARM
compr.
gastrorez. 400mg SOFARFARM ROMANIA 12452 2019 01
MESALAZINUM
MESALAZINA
SOFARFARM
compr.
gastrorez. 800mg SOFARFARM ROMANIA 12453 2019 01
MESALAZINUM PENTASA
compr. elib.
prel. 1g FERRING GmbH AUSTRIA 12513 2019 01
MESALAZINUM PENTASA
compr. elib.
prel. 2g FERRING GmbH GERMANIA 12514 2019 01
METADONUM
HYDROCHLORIDE METADONA BIOEEL compr. 10mg BIO EEL SRL ROMANIA 12406 2019 01
METADONUM
HYDROCHLORIDE METADONA BIOEEL compr. 40mg BIO EEL SRL ROMANIA 12407 2019 01
METHOTREXATUM
DISODIUM ALDESTA sol. inj. 2.5mg
ADDENDA PHARMA
S.R.L. ITALIA 12251 2019 01
METHOTREXATUM ALDESTA sol. inj. 7.5mg ADDENDA PHARMA ITALIA 12252 2019 01
23/31
DISODIUM S.R.L.
METHOTREXATUM
DISODIUM ALDESTA sol. inj. 10mg
ADDENDA PHARMA
S.R.L. ITALIA 12253 2019 01
METHOTREXATUM
DISODIUM ALDESTA sol. inj. 12,5mg
ADDENDA PHARMA
S.R.L. ITALIA 12254 2019 01
METHOTREXATUM
DISODIUM ALDESTA sol. inj. 15mg
ADDENDA PHARMA
S.R.L. ITALIA 12255 2019 01
METHOTREXATUM
DISODIUM ALDESTA sol. inj. 17.5mg
ADDENDA PHARMA
S.R.L. ITALIA 12256 2019 01
METHOTREXATUM
DISODIUM ALDESTA sol. inj. 20mg
ADDENDA PHARMA
S.R.L. ITALIA 12257 2019 01
METHOTREXATUM
DISODIUM ALDESTA sol. inj. 22,5mg
ADDENDA PHARMA
S.R.L. ITALIA 12258 2019 01
METHOTREXATUM
DISODIUM ALDESTA sol. inj. 25mg
ADDENDA PHARMA
S.R.L. ITALIA 12259 2019 01
METHOTREXATUM
DISODIUM ALDESTA sol. inj. 30mg
ADDENDA PHARMA
S.R.L. ITALIA 12261 2019 01
METHOTREXATUM
DISODIUM ALDESTA sol. inj. 27,5mg
ADDENDA PHARMA
S.R.L. ITALIA 12260 2019 01
METOPROLOLUM
TARTRATE BETAPROL compr. 50 mg
AC HELCOR
PHARMA SRL ROMANIA 12449 2019 01
METOPROLOLUM
TARTRATE BETAPROL compr. 100 mg
AC HELCOR
PHARMA SRL ROMANIA 12450 2019 01
METRONIDAZOLUM METRONIDAZOL ovule vag. 500mg IRCON SRL ROMANIA 12510 2019 01
MORPHYNUM
HYDROCHLORIDE VENDAL RETARD compr. film. 60mg
LANNACHER
HEILMITTEL AUSTRIA 12206 2019 01
24/31
Ges.m.b.H
MORPHYNUM
HYDROCHLORIDE VENDAL RETARD compr. film. 30mg
LANNACHER
HEILMITTEL
Ges.m.b.H AUSTRIA 12205 2019 01
MORPHYNUM
HYDROCHLORIDE VENDAL RETARD compr. film. 10mg
LANNACHER
HEILMITTEL
Ges.m.b.H AUSTRIA 12204 2019 01
MORPHYNUM
HYDROCHLORIDE VENDAL RETARD compr. film. 100mg
LANNACHER
HEILMITTEL
Ges.m.b.H AUSTRIA 12207 2019 01
NEBIVOLOLUM
HYDROCHLORIDE NEBIVOLOL TORRENT compr. 5mg
TORRENT PHARMA
S.R.L. ROMANIA 12356 2019 01
NICERGOLINUM OXIFLUX
compr. film.
elib. prel. 400 mg
LABORMED PHARMA
S.A. ROMANIA 12387 2019 01
NICOTINUM NIQUITIN CLEAR
plasture
transdermic 7 mg
HIPOCRATE 2000
S.R.L. ROMANIA 12416 2019 01
NICOTINUM NIQUITIN CLEAR
plasture
transdermic 14 mg
HIPOCRATE 2000
S.R.L. ROMANIA 12417 2019 01
NICOTINUM NIQUITIN CLEAR
plasture
transdermic
21 mg
114mg
HIPOCRATE 2000
S.R.L. ROMANIA 12418 2019 01
NIMESULIDUM NIMESULID ARENA compr 100 mg ARENA GROUP S.A. ROMANIA 12408 2019 01
NIMESULIDUM NIMELID
gran. pt.
susp.orala 100mg
ROMPHARM
COMPANY S.R.L. ROMANIA 12527 2019 01
NISTATINA
NISTATINA Atb
500000UI compr. film. 500000UI ANTIBIOTICE S.A. ROMANIA 12486 2019 01
OMEPRAZOLUM ULTOP pulb. pt. sol. 40mg KRKA D.D. NOVO SLOVENIA 12526 2019 01
25/31
inj. MESTO
OTILONIUM BROMIDE SPASMOMEN compr. film. 40mg
A.MENARINI
INDUSTRIE
FARMACEUTICHE
RIUNITE SRL ITALIA 12378 2019 01
PANTOPRAZOLE SODIUM
PANTOPRAZOL
ROMPHARM pulb pt sol inj 40mg
ROMPHARM
COMPANY S.R.L. ROMANIA 12299 2019 01
PANTOPRAZOLUM NEDIS
compr.
gastrorez. 20 mg
DR. REDDY'S
LABORATORIES
ROMANIA ROMANIA 12337 2019 01
PANTOPRAZOLUM SELTRAZ
compr.
gastrorez. 40 mg
DR. REDDY'S
LABORATORIES
ROMANIA ROMANIA 12338 2019 01
PANTOPRAZOLUM
SODIUM NOLPAZA
compr.
gastrorez. 40 mg
KRKA D.D. NOVO
MESTO SLOVENIA 12369 2019 01
PARACETAMOLUM
SANADOR PENTRU
COPII sol. orala 150mg/5 ml LAROPHARM S.R.L. ROMANIA 12213 2019 01
PARACETAMOLUM
PARACETAMOL
ARENA PENTRU COPII sol. orala 120mg/5 ml ARENA GROUP S.A. ROMANIA 12231 2019 01
PARACETAMOLUM PARACETAMOL MCC supoz. 125 mg
MAGISTRA C&C
S.R.L. ROMANIA 12420 2019 01
PARACETAMOLUM PARACETAMOL MCC supoz. 250 mg
MAGISTRA C&C
S.R.L. ROMANIA 12421 2019 01
PARACETAMOLUM
PARACETAMOL
ARENA compr. 500 mg ARENA GROUP S.A. ROMANIA 12528 2019 01
PAROXETINUM PAROXETINA ATB compr. film. 20mg ANTIBIOTICE S.A. ROMANIA 12388 2019 01
26/31
PELARGONIUM ROOT
DRY EXTRACT PELAFEN sirop 20mg/2.5ml
PHYTOPHARM
KLEKA POLONIA 12227 2019 01
PHENYLEPHRINUM
HYDROCHLORIDE BIOFLU NAZAL
spray nazal ,
sol. 5mg/ml BIOFARM S.A. ROMANIA 12247 2019 01
PHENYLEPHRINUM
HYDROCHLORIDE BIOFLU NAZAL pic. nazale, sol 2,5mg/ml BIOFARM S.A. ROMANIA 12246 2019 01
PIRACETAMUM PIRACETAM compr. 400mg ARENA GROUP S.A. ROMANIA 12305 2019 01
PIRACETAMUM PIRACETAM SLAVIA compr 400 mg SLAVIA PHARM S.R.L. ROMANIA 12318 2019 01
PIRIDOXINUM
HYDROCHLORIDE VITAMINA B6 ARENA compr. 250mg ARENA GROUP S.A. ROMANIA 12394 2019 01
PIROXICAMUM
PIROXICAM
FITERMAN crema 30 mg/g
FITERMAN PHARMA
SRL ROMANIA 12310 2019 01
PLANTE HERBION IEDERA pastile 35mg
KRKA D.D. NOVO
MESTO SLOVENIA 12215 2019 01
PLANTE ISOREL A sol. inj. 60 mg/ml
NOVAPHARM
Ges.m.b.H. AUSTRIA 12391 2019 01
PLANTE BRONCHICUM ELIXIR S sol. orala
SANOFI ROMANIA
SRL ROMANIA 12366 2019 01
PLANTE IMUPRET draj. BIONORICA AG GERMANIA 12508 2019 01
PLANTE PROSPAN
guma
medicamen-
toasa mast. 26 mg
ENGELHARD
ARZNEIMITTEL
GmbH&Co.KG GERMANIA 12476 2019 01
PLANTE BILOBIL INTENS caps. 120 mg
KRKA D.D. NOVO
MESTO SLOVENIA 12493 2019 01
PLANTE GRANU FINK FEMINA caps. PROMAROM S.R.L ROMANIA 12509 2019 01
PLANTE TUSSIPLANT sirop 30 mg/ml
PHYTOPHARM
KLEKA POLONIA 12469 2019 01
PLANTE HEDUSSIN sirop 8.25mg/ml
PHYTOPHARM
KLENKA POLONIA 12470 2019 01
27/31
POTASIUM
ASPARTATUM +
MAGNESIUM
ASPARTATUM PANANGIN FORTE compr. film.
316 mg/
280 mg
GEDEON RICHTER
ROMANIA S.A. ROMANIA 12502 2019 01
POTASSIUM CHLORIDE
CLORURA DE POTASIU
74,56 mg/ml BRAUN sol perf
B. BRAUN
MELSUNGEN AG GERMANIA 12379 2019 01
POTASSIUM IODIDE
IODURA DE POTASIU
Atb compr. 65mg ANTIBIOTICE S.A. ROMANIA 12347 2019
01
PRODUSE BIOLOGICE XEOMIN
pulb. pt. sol.
inj. 50UI
MERZ
PHARMACEUTICALS
GMBH GERMANIA 12273 2019 01
PRODUSE BIOLOGICE XEOMIN
pulb. pt. sol.
inj. 100UI
MERZ
PHARMACEUTICALS
GMBH GERMANIA 12274 2019 01
PRODUSE BIOLOGICE XEOMIN
pulb. pt. sol.
inj. 200UI
MERZ
PHARMACEUTICALS
GMBH GERMANIA 12275 2019 01
PRODUSE BIOLOGICE ALYOSTAL PRICK sol. sublinguala 100IR/ml STALLERGENES SA FRANTA 12304 2019 01
PROMETHAZINUM ROMERGAN sirop 5mg/5ml BIOFARM S.A. ROMANIA 12360 2019 01
PROPAFENONUM
CLORHIDRATUM
PROPAFENONA
ARENA 150 mg compr. 150 mg ARENA GROUP S.A. ROMANIA 12263 2019 01
RADIOFARMACEUTICE TECHNESCAN HDP
pulb. pt. sol.
inj.
3,0 mg trusa
(kit)
MALLINCKRODT
MEDIC. BV OLANDA 12214 2019 01
RADIOFARMACEUTICE TECHNESCAN DTPA
pulb. pt. sol.
perf.
MALLINCKRODT
MEDIC. BV OLANDA 12380 2019 01
RIFAXIMINA NORMIX compr. film. 200mg
ALFA WASSERMANN
S.p.A. ITALIA 12333 2019 01
RILMENIDINUM DIHYDROGENPHOSPHATE TENAXUM compr. 1 mg LES LAB. SERVIER FRANTA 12296 2019 01
28/31
RISPERIDONUM RISPEN compr. film. 4 mg ZENTIVA k.s. CEHIA 12243 2019 01
RISPERIDONUM RISPEN compr. film. 3 mg ZENTIVA k.s. CEHIA 12242 2019 01
RISPERIDONUM RISPEN compr. film. 2 mg ZENTIVA k.s. CEHIA 12241 2019 01
RISPERIDONUM RISPEN compr. film. 1 mg ZENTIVA k.s. CEHIA 12240 2019 01
SALICILATUM METILUM SALMET-T sol. cut. 20 mg/ml
TIS FARMACEUTIC
S.A. ROMANIA 12499 2019 01
SERTRALINUM ADJUVIN compr. film. 50mg
LANNACHER
HEILMITTEL
Ges.m.b.H AUSTRIA 12348
.201
9 01
SERTRALINUM ADJUVIN compr. film. 100mg
LANNACHER
HEILMITTEL
Ges.m.b.H AUSTRIA 12349 2019 01
SEVELAMERUM
CARBONATE
CARBONAT DE
SEVELAMER HEATON compr. film. 800mg HEATON K.S CEHIA 12437 2019 01
SODIUM CHLORIDE CLORURA DE SODIU sol. inj. 9mg/ml
B. BRAUN
MELSUNGEN AG GERMANIA 12361 2019 01
SULFADIAZINUM SILVER CICATROL pasta cutanata 10mg/g ANTIBIOTICE S.A. ROMANIA 12353 2019 01
SULFAMETHOXAZOLUM
+ TRIMETHOPRIMUM TAGREMIN compr. 400 mg/mg ZENTIVA S.A. ROMANIA 12479 2019 01
SULODEXIDUM VESEL DUE F sol. inj.
600 ULS/
2 ml
ALFA WASSERMANN
S.p.A. ITALIA 12335 2019 01
SUXAMETHONII
CHLORIDUM
SUXAMETHONIUM
CLORURA
AGUETTANT
sol. inj. in
seringa
preumpluta 10mg/ml
LABORATOIRE
AGUETTANT FRANTA 12474 2019 01
TERBINAFINUM
HYDROCHLORIDE
TERBINAFINA
ROMPHARM
spray cutanat,
sol. 10,1mg/ml
ROMPHARM
COMPANY S.R.L. ROMANIA 12249 2019 01
THEOPHYLLINUM
ETILENDIAMINUM MIOFILIN sol. inj. 24mg/ml ZENTIVA S.A. ROMANIA 12370 2019 01
THIAMINUM
VITAMINA B1
ZENTIVA sol. inj. 100 mg/2ml ZENTIVA S.A. ROMANIA 12402 2019 01
29/31
TRAMADOLUM
HYDROCHLORIDE TRAMAL RETARD
compr. elib.
prel. 150mg GRUNENTHAL GmbH GERMANIA 12324 2019 01
TRAMADOLUM
HYDROCHLORIDE TRAMAL RETARD
compr. elib.
prel. 100mg GRUNENTHAL GmbH GERMANIA 12323 2019 01
TRAMADOLUM
HYDROCHLORIDE TRAMAL RETARD
compr. elib.
prel. 200mg GRUNENTHAL GmbH GERMANIA 12325 2019 01
TRAMADOLUM
HYDROCHLORIDE MABRON sol. inj. 100mg/2ml MEDOCHEMIE LTD CIPRU 12343 2019 01
TRAMADOLUM
HYDROCHLORIDE MABRON RETARD compr. 100mg MEDOCHEMIE LTD CIPRU 12340 2019 01
TRAMADOLUM
HYDROCHLORIDE MABRON RETARD compr. 150mg MEDOCHEMIE LTD CIPRU 12341 2019 01
TRAMADOLUM
HYDROCHLORIDE MABRON RETARD compr. 200mg MEDOCHEMIE LTD CIPRU 12342 2019 01
TRAZODONUM
HYDROCHLORIDE TRITTICO XR 150 mg
compr. film.
elib. prel. 150 mg
A.C.R. ANGELINI
FRANCESCO S.p.A ITALIA 12504 2019 01
TRAZODONUM
HYDROCHLORIDE TRITTICO XR 300 mg
compr. film.
elib. prel. 300 mg
A.C.R. ANGELINI
FRANCESCO S.p.A ITALIA 12505 2019 01
TRIMEBUTINUM
MALEATE IBUTIN
compr. elib.
prel. 300 mg ZENTIVA S.A. ROMANIA 12413 2019 01
TRIMETAZIDINUM
DIHYDROCHLORIDUM DILATAN MR
compr. film.
elib. modif. 35 mg TERAPIA S.A. ROMANIA 12284 2019 01
VALACICLOVIRUM
HYDROCHLORIDE
VALGANCICLOVIR
AUROBINDO compr. film. 450mg
AUROBINDO
PHARMA LIMITED MALTA 12475 2019 01
VALGANCICLOVIRUM VALDAMIN compr. film. 450mg
EGIS
PHARMACEUTICALS
PLC UNGARIA 12472 2019 01
VALPROATUM SODIUM
VALPROAT DE SODIU
AUROBINDO
compr. elib.
prel, 300mg
AUROBINDO
PHARMA LTD ROMANIA 12460 2019 01
30/31
VALPROATUM SODIUM
VALPROAT DE SODIU
AUROBINDO
compr. elib.
prel, 500mg
AUROBINDO
PHARMA LTD ROMANIA 12461 2019 01
VENLAFAXINUM
VENLAFAXINA
AUROBINDO caps. elib. prel. 37,5mg
AUROBINDO
PHARMA LIMITED GERMANIA 12464 2019 01
VENLAFAXINUM
VENLAFAXINA
AUROBINDO caps. elib. prel. 75mg
AUROBINDO
PHARMA LIMITED GERMANIA 12465 2019 01
VENLAFAXINUM
VENLAFAXINA
AUROBINDO caps. elib. prel. 150mg
AUROBINDO
PHARMA LIMITED GERMANIA 12466 2019 01
VINCRISTINUM SINDOVIN
pulb. pt. sol.
inj./perf. 1mg ACTAVIS SRL ROMANIA 12494 2019 01
XILOMETAZOLINUM
HYDROCHLORIDE VIBROCIL ACTILONG spray nazal 1 mg/1 ml
GLAXOSMITHKLINE
PHARMACEUTICALS
S.A. ROMANIA 12376 2019 01
XILOMETAZOLINUM
HYDROCHLORIDE
VIBROCIL ACTILONG
MENTOL
spray nazal ,
sol. 1 mg/ml
GLAXOSMITHKLINE
PHARMACEUTICALS
S.A. ROMANIA 12377 2019 01
XILOMETAZOLINUM
HYDROCHLORIDE ORINOX spray nazal 1mg/ml DR MAX PHARMA CEHIA 12463 2019 01
ZOLPIDEMUM
TARTRATE ZOLPIDEM Atb compr. film. 10mg ANTIBIOTICE S.A. ROMANIA 12396 2019 01
31/31
Medicamente autorizate prin procedura centralizată, efectuată la nivelul Agenţiei Europene a Medicamentului (EMA),
pentru care s-a notificat intenţia de punere pe piaţă în România în trim. III 2019
DCI Denumire Comerciala Forma farm. Conc. Firma detinatoare Tara
detinatoare Nr. APP
COMBINATII
(DOLUTEGRAVIRUM +
LAMIVUDINUM) DOVATO 50 mg/300 mg compr. film. 50mg/300mg VIIV HEALTHCARE BV OLANDA 1370 2019 01
POSACONAZOLUM
POSACONAZOLE AHCL
40 mg/ml susp. orala 40mg/ml
ACCORD
HEALTHCARE S.L.U. SPANIA 1380 2019 01
POSACONAZOLUM
POSACONAZOLE
ACCORD 100 mg
compr.
gastrorez. 100mg
ACCORD
HEALTHCARE S.L.U. SPANIA 1379 2019 01
