Agenţia Naţională a Medicamentului şi a Dispozitivelor Medicale

ROMÂNIA

Buletin informativ An 19, Nr. 3 (75), trim. III 2017

Agenţia Naţională a Medicamentului şi a Dispozitivelor Medicale Lista seriilor de medicamente retrase în trim. III 2017 Cereri de autorizare/reînnoire a autorizaţiilor de punere pe piaţă primite de ANMDM în trim. II 2017 Medicamente autorizate de punere pe piaţă de ANMDM în trim. II 2017 Medicamente autorizate prin procedura centralizată de către Agenţia Europeană a Medicamentului (EMA) pentru care s-a notificat intenţia de punere pe piaţă în România în trim. II 2017

1/27

Toate datele cuprinse în prezenta publicaţie reprezintă informaţii oficiale şi sunt sub autoritatea Agenţiei Naţionale a Medicamentului şi a Dispozitivelor Medicale. Întregul conţinut al prezentei publicaţii se află sub protecţia legislativă integrală a Agenţiei Naţionale a Medicamentului şi a Dispozitivelor Medicale. 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. Toate drepturile editoriale aparţin în exclusivitate Agenţiei Naţionale a Medicamentului şi a Dispozitivelor Medicale.

ISSN 1583-347X

2/27

CUPRINS

Lista seriilor de medicamente retrase în trim. III 2017 ...................................4 Cereri de autorizare/reînnoire a autorizaţiilor de punere pe piaţă primite de ANMDM în trim. II 2017 .................................................................................8 Medicamente autorizate de punere pe piaţă de ANMDM în trim II 2017 ......10 Medicamente autorizate prin procedura centralizată de către Agenţia Europeană a Medicamentului (EMA) pentru care s-a notificat intenţia de punere pe piaţă în România în trim. II 2017 ..................................................27

3/27

Lista seriilor de medicamente retrase în trim. III 2017 Nr crt

1

2

3

Produs retras

AUGMENTIN ES 600mg/42,9mg/5ml

SULFAT DE ATROPINA TAKEDA 1 mg/ml

LAMISIL crema 10 mg/g

Forma farmaceutica

pulbere pentru suspensie orala

solutie injectabila

crema

Conc.

600mg/ 42,9mg/ 5ml

1mg/ml

10 mg/g

DCI

Producator/DAP P

amoxicilina+ acid clavulanic

Smithkline Beecham Pharmaceuticals UK/ Smithkilne Beecham Ltd UK

sulfat de atropina

Takeda GmbH Austria/ Takeda GmbH Germania

terbinafina

Novartis Consumer Health GmbH Germania/ GSK Consumer Healthcare SRL Romania

4/27

Serie

Motivul retragerii

Actiune propusa

Data retragerii

1515, 1552

produs pentru care a expirat termenul de 2 ani (prevazut de OMS nr. 279/2005) dupa aprobarea de catre ANMDM a modificarilor la APP

Retragere voluntara si distrugere

14.07.2017

11159377

produs pentru care la finalizarea testelor de stabilitate de rutina s-a observat obtinerea unui rezultat in afara specificatiei la parametrul "acid tropic" pentru seria 11110600 (blocata in vederea distrugerii in depozitul propriu)

Retragere voluntara (ca masura de precautie a seriei 11159377) si distrugere

19.07.2017

R01610A, R02892A, R03501B

produs pentru care a expirat termenul de 2 ani (prevazut de OMS nr. 279/2005) dupa aprobarea de catre ANMDM a modificarilor la APP din 17.07.2015


10.08.2017

4

5

6

7

VENTOLIN 0,5 mg/ml

solutie injectabila

PANADOL 500 mg

comprimate filmate

TYVERB 250 mg

comprimate filmate

FENISTIL gel 1 mg/g

gel

0,5 mg/ml

500 mg

250 mg

1 mg/g

GSK Manufacturing SPA Italia/ Glaxo Wellcome UK Ltd

5505, 5502, 4513AB, 4513A, 4513, 4510C, 4510B

produs pentru care a expirat termenul de 2 ani (prevazut de OMS nr. 279/2005) dupa aprobarea de catre ANMDM a modificarilor la APP


21.08.2017

paracetamol

GSK Dungarvan Ltd Irllanda/ GSK Consumer Healthcare UK

025, 027, 028, 029, 030, 031, 032, 033, 034, 035, 036, 037, 038, 039, 040, 041, 042, 043, 044, 045, 046, 047, 048, 049, 050, 051, 052



24.08.2017

lapatinib

Glaxo Operation UK Ltd/ Novartis Europharm Ltd UK

R94G

produs pentru care a incetat valabilitatea codului CIM W533221006 incepand cu 01.07.2017


04.09.2017


R02394B, R02869A, T00538A, T00539A, T00540A, T00541A, T00734A, T01115A, T01116A, T01308B, T01309A, T01310A, T01311A, T01740A, T01741A, T01742A, T01743A,

produs pentru care a expirat termenul de 1 an (prevazut de OMS nr. 1810/2006) dupa aprobarea de catre ANMDM a modificarilor la APP din 08.09.2016


22.09.2017

salbutamol

dimetinden

5/27

T02155A, T02156A, T04244B, T04246A, T04247A, T04248A, T04249A, T04250A, T04251A.

8

9

10

VIBROCIL DUO 0,5 mg/ml+ 0,6 mg/ml

DUOFILM

PARASINUS PENTA

spray nazal solutie

solutie cutanata

comprimate

0,5 mg/ml+ 0,6 mg/ml

167 mg/g + 167 mg/g

500mg/25mg/ 5 mg/20mg/ 38 mg

R02711E, R04347A, R04353B



22.09.2017


22.09.2017


29.09.2017

xylometazolina + ipratropiu


combinatii (acid salicilic + acid lactic)

Stiefel Laboratories Ireland LTD/GSK Consumer Healthcare SRL Romania

456T, 866T, 1111T


GSK Dungarvan Ltd Irllanda/ GSK Consumer Healthcare UK

024, 025, 026, 027, 028, 029, 030, 031, 032, 033, 034, 035, 036, 037, 038, 039, 040, 041, 042, 043, 044, 045, 046, 047, 048, 049, 050, 051, 052, 5001, 5002, 6201, 6202, 6203


combinatii (paracetamol+ cofeina+ fenilefrina+ terpinhidrat+ ac. ascorbic)

6/27

11

12

13

DRILL 3 mg+ 0,2 mg

DRILL FARA ZAHAR 3 mg+ 0,2 mg

DRILL MIERE CU AROMA DE TRANDAFIR 3 mg+ 0,2 mg

pastile

pastile

pastile

3 mg+ 0,2 mg

3 mg+ 0,2 mg

3 mg+ 0,2 mg

combinatii

Pierre Fabre Medicament Production Franta/ Pierre Fabre Medicament Franta

combinatii


combinatii


7/27

A01333, A01338, A01343, A01344



29.09.2017

A00455, A00455-A, A00456, A00457, A00459



29.09.2017

A00519, A00521, A00532, A00536



29.09.2017

Cereri de autorizare/reînnoire a autorizaţiilor de punere pe piaţă primite de ANMDM în trim. II 2017 În trimestrul II 2017 s-au primit 187 cereri de autorizare de punere pe piaţă/reînnoire a autorizaţiei pentru medicamente care corespund următoarelor grupe terapeutice: A02 - MEDICAMENTE IN TRAT. TULBURARILOR PROVOCATE DE HIPERACIDITATE A03 – MEDICAMENTE PENTRU TULBURARI GASTROINTESTINALE FUNCTIONALE A04 – ANTIEMETICE A06 – LAXATIVE A07 - ANTIDIAREICE ANTIINFLAMATOARE / ANTIINFECTIOASE INTESTINALE A10 – MEDICAMENTE UTILIZATE IN DIABET A12 - SUPLIMENTE MINERALE A16 – ALTE PRODUSE PENTRU TRACTUL DIGESTIV SI METABOLISM B01 – ANTITROMBOTICE B02 – SANGE SI ORGANE HEMATOPOETICE B03.- ANTIANEMICE C01 – TERAPIA CORDULUI C02.- ANTIHIPERTENSIVE C08 – BLOCANTE ALE CANALELOR DE CALCIU C09 – MEDICAMENTE ACTIVE PE SISTEMUL RENINA-ANGIOTENSINA D07 – CORTICOSTEROIZI DE UZ DERMATOLOGIC D10 – PRODUSE PT. TRAT. ACNEEI G03 - HORMONII SEXUALI SI MODULATORII APARATULUI GENITAL G04 - MEDICATIA APARATULUI URINAR H01 - HORMONI HIPOFIZARI, HIPOTALAMICI SI ANALOGI J01 - ANTIBIOTICE DE UZ SISTEMIC J02 - ANTIMICOTICE DE UZ SISTEMIC J05 - ANTIVIRALE DE UZ SISTEMIC L01 – ANTINEOPLAZICE L02 – TERAPIE ENDOCRINA L04- IMUNOSUPRESOARE M01 - MEDICAMENTE ANTIINFLAMATOARE SI ANTIREUMATICE M04 – SISTEMUL MUSCULO-SCHELETIC M05 - MEDICAMENTE PENTRU TRATAMENTUL AFECTIUNILOR OSOASE N01 - ANESTEZICE N02 - ANALGEZICE N03 - ANTIEPILEPTICE N04 - ANTIPARKINSONIENE N05 - PSIHOLEPTICE N06 - PSIHOANALEPTICE 8/27

N07 – ALTE MEDICAMENTE CU ACTIUNE ASUPRA SISTEMULUI NERVOS R01 – MEDICAMENTE NAZALE R03 - MEDICAMENTE PT. TRATAMENTUL BOLILOR OBSTRUCTIVE ALE CAILOR RESPIRATORII R06 – ANTIHISTAMINICE DE UZ SISTEMIC S01 – MEDICAMENTE FOLOSITE IN OFTALMOLOGIE V03 - ALTE PREPARATE TERAPEUTICE XRN - MEDICAMENTE HOMEOPATE

9/27

Medicamente autorizate de punere pe piaţă de ANMDM în trim II 2017 DCI

Denumire Comerciala

ACIDUM ACETYLSALICYLICUM+ ATORVASTATINUM+ RAMIPRILUM

TRINOMIA 100 mg/40 mg/2,5 mg


TRINOMIA 100 mg/40 mg/5 mg


Forma Farm.

Conc

Firma detinatoare

Tara Detinatoare

Nr. APP

caps.

100mg/40mg/ 2,5mg

FERRER INTERNACIONAL, S.A.

SPANIA

9972

2017

01

caps.

100mg/40mg/ 5mg


SPANIA

9973

2017

01

TRINOMIA 100 mg/40 mg/10 mg

caps.

100mg/40mg/ 10mg


SPANIA

9974

2017

01

ACIDUM ASCORBICUM

VITAMINA C SOPHARMA 100 mg/ml

sol inj./perf.

100mg/ml

SOPHARMA AD

BULGARIA

10054

2017

01

ACIDUM IBANDRONICUM

OSAGRAND 3 mg/3 ml

sol. inj.

3mg/3ml

ZENTIVA K.S.

REPUBLICA CEHA

9963

2017

01

ACIDUM IBANDRONICUM

OSAGRAND 150 mg

compr. film.

150mg

ZENTIVA K.S.

REPUBLICA CEHA

9964

2017

01

ACIDUM ZOLEDRONICUM

ACID ZOLEDRONIC CIPLA 4 mg/100 ml

sol. perf.

4mg/100ml

CIPLA (EU) LIMITED

MAREA BRITANIE

9991

2017

01

ALBENDAZOLUM

ESKAZOLE 400 mg

compr.

400mg

GLAXOSMITHKLIN E EXPORT LIMITED

MAREA BRITANIE

9938

2017

01

AMIODARONUM

AMIODARONA ARENA 200 mg

compr.

200mg

ARENA GROUP S.A.

ROMANIA

9977

2017

01

ANASTROZOLUM

ANASTELB 1 mg

compr. film.

1mg

STADA ARZNEIMITTEL AG

GERMANIA

10058

2017

01

AZATHIOPRINUM

IMURAN 50 mg

compr. film.

50mg

ASPEN PHARMA TRADING LIMITED

IRLANDA

10042

2017

01

10/27

AZITHROMYCINUM

AZIBIOT 20 mg/ml

pulb. pt. sol. perf.

20mg/ml

AZITHROMYCINUM

AZIBIOT 40 mg/ml


40mg/ml

BECLOMETASONUM

CLENIL JET 250 mcg

BENDAMUSTINUM

RIBOVACT 2,5 mg/ml

BENZYDAMINUM

BETAHISTINUM

TANTUM ROSA 500 mg BETAHISTINA ATB 8 mg BETAHISTINA ATB 24 mg

BICALUTAMIDUM

KRKA, D.D., NOVO MESTO

SLOVENIA

9933

2017

01

SLOVENIA

9934

2017

01

ITALIA

9978

2017

01

10068

2017

01

250mcg

KRKA, D.D., NOVO MESTO CHIESI FARMACEUTICI S.P.A.

2,5mg/ml

ASTELLAS PHARMA GMBH

GERMANIA

gran. pt. sol. vaginala

500mg

ANGELINI PHARMA ÖSTERREICH GMBH

AUSTRIA

9982

2017

01

compr.

8mg

ANTIBIOTICE S.A.

ROMANIA

9931

2017

01

compr.

24mg

ANTIBIOTICE S.A.

ROMANIA

9932

2017

01

BICALUTAMIDA KABI 50 mg

compr. film.

50 mg

FRESENIUS KABI ONCOLOGY PLC

MAREA BRITANIE

10057

2017

01

BUTYLSCOPOLAMMONII BROMIDUM

BYSIMIN 20 mg/ml

sol inj.

20mg/ml

MEDOCHEMIE LTD.

CIPRU

10063

2017

01

CANDESARTANUM CILEXETIL

CANZENO 8 mg

compr.

8mg

ZENTIVA, K.S.

REPUBLICA CEHA

10064

2017

01


CANZENO 16 mg

compr.

16mg

ZENTIVA, K.S.

REPUBLICA CEHA

10065

2017

01


CANZENO 32 mg

compr.

32mg

ZENTIVA, K.S.

REPUBLICA CEHA

10066

2017

01

CARBAMAZEPINUM

TEGRETOL 400 mg

compr.

400mg

NOVARTIS PHARMA GMBH

GERMANIA

9998

2017

01

CARBAMAZEPINUM

TEGRETOL 200 mg

compr.

200mg

NOVARTIS PHARMA GMBH

GERMANIA

9997

2017

01

BETAHISTINUM

sol. inhalat presurizata pulb. pt. conc. pt. sol. perf.

11/27

CELECOXIBUM

CELEBREX 200 mg

caps.

200mg

PFIZER EUROPE MA EEIG

MAREA BRITANIE

10008

2017

01

CELECOXIBUM

CELEBREX 100 mg

caps.

100mg

PFIZER EUROPE MA EEIG

MAREA BRITANIE

10007

2017

01

CIPROFLOXACINUM

CIPROFLOXACINA ZENTIVA 10 mg/ml

conc. pt. sol. perf.

100mg/10ml

ZENTIVA S.A.

ROMANIA

9864

2017

01

CLARITHROMYCINUM

KLERIMED 250

compr. film.

250mg

MEDOCHEMIE LTD.

CIPRU

10031

2017

01

CLARITHROMYCINUM

KLERIMED 500

compr. film.

500mg

MEDOCHEMIE LTD.

CIPRU

10032

2017

01

COMBINATII

ROCKLE`S

sol. dent.

FRANTA

9865

2017

01

COMBINATII

AMINOVEN 5%

sol. perf.

5%

SUEDIA

9943

2017

01

COMBINATII

AMINOVEN 10%

10%

SUEDIA

9944

2017

01

COMBINATII

ROWATINEX

sol. perf. caps. moi gastrorez.

SEPTODONT FRESENIUS KABI AB FRESENIUS KABI AB ROWA-WAGNER GMBH & CO. KG

10009

2017

01

COMBINATII

MACMIROR COMPLEX 100 mg+40000 UI/g

crema vag.

10g/4000000UI

POLICHEM SA

LUXEMBURG

9980

2017

01

COMBINATII

ROWACHOL

caps.

ROWA-WAGNER GMBH & CO. KG

GERMANIA

10033

2017

01

COMBINATII

ROWACHOL

pic. orale, sol.

ROWA-WAGNER GMBH & CO. KG

GERMANIA

10050

2017

01

FRESENIUS KABI DEUTSCHLAND GMBH

GERMANIA

10051

2017

01

THEA FARMA S.P.A.

ITALIA

10046

2017

01

VIFOR FRANCE S.A. FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH

FRANTA

9940

2017

01

GERMANIA

9924

2017

01

COMBINATII

NEPHROTECT

sol. perf.

COMBINATII

FLUMETOL 2 mg/1 mg/ml

pic. oft., sol

2mg/1mg/ml

COMBINATII

MALTOFER FOL 100 mg/0,35 mg

compr. mast.

100mg/ 0,35mg

COMBINATII

MULTILAC cu 2 mmol/l POTASIU

sol. pt. hemodializa/ hemofiltrare

2mmol/l

12/27

GERMANIA

COMBINATII

MULTILAC FARA POTASIU

sol. pt. hemodializa/ hemofiltrare

COMBINATII (ADAPALENUM+ BENZOYLIS PEROXIDUM)

EPIDUO 1 mg/25 mg/g

gel

COMBINATII (CARVEDILOLUM+ IVABRADINUM)

DILORYM 6,25 mg/5mg


DILORYM 6,25 mg/7,5mg


DILORYM 12,5 mg/5mg


DILORYM 12,5 mg/7,5mg

COMBINATII (CARVEDILOLUM+ IVABRADINUM) COMBINATII (CARVEDILOLUM+ IVABRADINUM) COMBINATII (DESOGESTRELUM+ ETINILESTRADIOLUM) COMBINATII (DIENOGESTUM+ ETINILESTRADIOLUM)

DILORYM 25 mg/5mg

compr. film.

compr. film.

compr. film.

compr. film.

compr. film.

FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH

GERMANIA

9923

2017

01

1mg/25mg/g

GALDERMA INTERNATIONAL

FRANTA

9950

2017

01

6,25mg/5mg

EGIS PHARMACEUTICAL S PLC

UNGARIA

9854

2017

01

6,25mg/7,5mg


UNGARIA

9855

2017

01

12,5mg/5mg


UNGARIA

9856

2017

01

12,5mg/7,5mg


UNGARIA

9857

2017

01

25mg/5mg


UNGARIA

9858

2017

01

UNGARIA

9859

2017

01

DILORYM 25 mg/7,5mg

compr. film.

25mg/7,5mg


NOVYNETTE CONTINUU 150 micrograme/ 20 micrograme

compr. film.

150micrograme/ 20micrograme

GEDEON RICHTER ROMANIA S.A.

ROMANIA

10087

2017

01

SIBILLA 2 mg/0,03 mg

compr. film.

2mg/0,03mg


ROMANIA

10067

2017

01

13/27

pic. oft., sol

20mg/ml+5mg/ ml

DR. GERHARD MANN CHEM.PHARM.FABRIK GMBH

compr. film.

60micrograme/ 15micorgrame

EXELTIS MAGYARORSZÁG KFT

COMBINATII (DORZOLAMIDUM+ TIMOLOLUM)

DORZOLAMIDA/TIMOLO L DR. GERHARD MANN 20 mg/ml+5 mg/ml

COMBINATII (GESTODENUM+ ETINILESTRADIOLUM)

VONILLE 60 micrograme/ 15 micorgrame

COMBINATII (IBUPROFENUM+ PSEUDOEFEDRINUM)

IBUVALEN FLU 200 mg/30 mg

compr. film.

200mg/30mg

ARUCOM 50 micrograme/ml + 5 mg/ml

pic. oft., sol.

50micrograme/ ml+5mg/ml

POLISANO PHARMACEUTICAL S S.R.L. DR. GERHARD MANN CHEM.PHARM. FABRIK GMBH

LEVODOPA/CARBIDOPA /ENTACAPONA MYLAN 50 mg/12,5 mg/200 mg

compr. film.

50mg/12,5mg/ 200mg


compr. film.

LEVODOPA/CARBIDOPA /ENTACAPONA MYLAN 100 mg/25 mg/200 mg

COMBINATII (LATANOPROSTUM+ TIMOLOLUM) COMBINATII (LEVODOPUM+ CARBIDOPUM+ ENTACAPONUM) COMBINATII (LEVODOPUM+ CARBIDOPUM+ ENTACAPONUM) COMBINATII (LEVODOPUM+ CARBIDOPUM+ ENTACAPONUM) COMBINATII (LEVODOPUM+ CARBIDOPUM+ ENTACAPONUM) COMBINATII (LEVODOPUM+ CARBIDOPUM+ ENTACAPONUM)

GERMANIA

9929

2017

01

UNGARIA

9965

2017

01

ROMANIA

9937

2017

01

GERMANIA

9874

2017

01

GENERICS (UK) LTD

MAREA BRITANIE

9952

2017

01

75mg/18,75mg/ 200mg

GENERICS (UK) LTD

MAREA BRITANIE

9953

2017

01

compr. film.

100mg/25mg/ 200mg

GENERICS (UK) LTD

MAREA BRITANIE

9954

2017

01


compr. film.

125mg/31,25mg /200mg

GENERICS (UK) LTD

MAREA BRITANIE

9955

2017

01


compr. film.

150mg/37,5mg/ 200mg

GENERICS (UK) LTD

MAREA BRITANIE

9956

2017

01

14/27

COMBINATII (LEVODOPUM+ CARBIDOPUM+ ENTACAPONUM) COMBINATII (PERINDOPRILUM+ AMLODIPINUM) COMBINATII (PERINDOPRILUM+ AMLODIPINUM) COMBINATII (PERINDOPRILUM+ AMLODIPINUM) COMBINATII (PERINDOPRILUM+ AMLODIPINUM) COMBINATII (RAMIPRILUM + AMLODIPINUM) COMBINATII (RAMIPRILUM + AMLODIPINUM) COMBINATII (RAMIPRILUM + AMLODIPINUM) COMBINATII (RAMIPRILUM + AMLODIPINUM)

LEVODOPA/CARBIDOPA /ENTACAPONA MYLAN 200 mg/50 mg/200 mg

compr. film.

200mg/50mg/ 200mg

GENERICS (UK) LTD

MAREA BRITANIE

9957

2017

01

BEATIL 4 mg/5 mg

compr.

4mg/5mg


ROMANIA

9968

2017

01

BEATIL 8 mg/5 mg

compr.

8mg/5mg


ROMANIA

9969

2017

01

BEATIL 4 mg/10 mg

compr.

4mg/10mg

GEDEON RICHTER ROMÂNIA S.A.

ROMANIA

9970

2017

01

BEATIL 8 mg/10 mg

compr.

8mg/10mg


ROMANIA

9971

2017

01

RAMIPRIL/AMLODIPINA KRKA 5 mg/5 mg

caps.

5mg/5mg


SLOVENIA

10071

2017

01


caps.

5mg/10mg


SLOVENIA

10072

2017

01


caps.

10mg/5mg


SLOVENIA

10073

2017

01


caps.

10mg/10mg


SLOVENIA

10074

2017

01

COMPLEX DE HIDROXID DE FER (III) POLIMALTOZAT

FERRUM HAUSMANN 10 mg/ml

sirop

10mg/ml

VIFOR FRANCE

FRANTA

10043

2017

01


FERRUM HAUSMANN 50 mg/ml

picaturi orale, sol.

50mg/ml

VIFOR FRANCE

FRANTA

10044

2017

01


MALTOFER 100 mg

compr. mast.

100mg

VIFOR FRANCE S.A.

FRANTA

9939

2017

01

15/27

CYTARABINUM

CITARABINA TEVA 100 mg/ml

DARUNAVIRUM

DARUNAVIR ALVOGEN 400 mg

DARUNAVIRUM

DARUNAVIR ALVOGEN 600 mg

sol inj./perf.

compr. film.

compr. film.

100mg/ml

TEVA PHARMACEUTICAL S S.R.L.

ROMANIA

9888

2017

01

400mg

ALVOGEN MALTA OPERATIONS (ROW) LIMITED

MALTA

9879

2017

01

600mg


MALTA

9880

2017

01

800mg


MALTA

9881

2017

01

INFOMED FLUIDS S.R.L.

ROMANIA

10052

2017

01

ROMANIA

10053

2017

01

GERMANIA

10040

2017

01

GERMANIA

10041

2017

01

POLONIA

10075

2017

01

10045

2017

01

DEXTRANUM

DARUNAVIR ALVOGEN 800 mg DEXTRAN 40 INFOMED 100 g/l in solutie de GLUCOZA 50 g/l DEXTRAN 70 INFOMED 60 g/l in solutie de GLUCOZA 50 g/l

DIAZEPAMUM

DIAZEPAM DESITIN 5 mg/2,5 ml

sol. rectala

5mg/2,5ml

DIAZEPAMUM

DIAZEPAM DESITIN 10 mg/2,5 ml

sol. rectala

10mg/2,5ml

DIOSMINUM

DIOSMINA HASCO-LEK 1000 mg

compr. film.

1000mg

INFOMED FLUIDS S.R.L. DESITIN ARZNEIMITTEL GMBH DESITIN ARZNEIMITTEL GMBH PRZEDSIEBIORSTW O PRODUKCJI FARMAC. HASCOLEK S.A.

DIVERSE

OSTEOGENON 830 mg

compr. film.

830mg

PIERRE FABRE MEDICAMENT

FRANTA

DONEPEZILUM

ZILDON 5 mg

compr. film.

5mg

SANDOZ S.R.L.

ROMANIA

9907

2017

01

DONEPEZILUM

ZILDON 10 mg

compr. film.

10mg

ROMANIA

9908

2017

01

ENALAPRILUM

ENALAPRIL LPH 5 mg

compr.

5mg

SANDOZ S.R.L. LABORMED PHARMA S.A.

ROMANIA

9984

2017

01

DARUNAVIRUM

DEXTRANUM

compr. film.

sol. perf.

sol. perf.

16/27

ENALAPRILUM

ENALAPRIL LPH 10 mg

compr.

10mg

ENALAPRILUM

ENALAPRIL LPH 20 mg

compr.

20mg

LABORMED PHARMA S.A. LABORMED PHARMA S.A.

ENTECAVIRUM

ENTECAVIR TEVA 0,5 mg

ENTECAVIRUM

ENTECAVIR TEVA 1 mg

ENTECAVIRUM

ENTECAVIR GLENMARK 0,5 mg

ENTECAVIRUM

ENTECAVIR GLENMARK 1 mg

EPIRUBICINUM

EPISINDAN 10 mg

EPIRUBICINUM

EPISINDAN 50 mg

compr. film.

compr. film.

ROMANIA

9985

2017

01

ROMANIA

9986

2017

01

0,5mg


ROMANIA

10021

2017

01

1mg


ROMANIA

10022

2017

01

REPUBLICA CEHA

10024

2017

01

REPUBLICA CEHA

10025

2017

01

compr. film.

0,5mg

compr. film. pulb. pt. sol. inj. pulb. pt. sol. inj.

1mg

GLENMARK PHARMACEUTICAL S S.R.O. GLENMARK PHARMACEUTICAL S S.R.O.

10mg

ACTAVIS S.R.L.

ROMANIA

10048

2017

01

50mg

ACTAVIS S.R.L.

ROMANIA

10049

2017

01

100mg

GLENMARK PHARMACEUTICAL S S.R.O.

REPUBLICA CEHA

10083

2017

01

REPUBLICA CEHA

10084

2017

01

GERMANIA

10017

2017

01

GERMANIA

10016

2017

01

9895

2017

01

ERLOTINIBUM

ERLOTINIB GLENMARK 100 mg

ERLOTINIBUM

ERLOTINIB GLENMARK 150 mg

compr. film.

150mg

ETOFENAMATUM

RHEUMON 1 g/2 ml

sol. inj.

1g/2ml

ETOFENAMATUM

RHEUMON 100 mg/g

crema

100mg/g

ETORICOXIBUM

ETORICOXIB AUROBINDO 30 mg

compr. film.

30mg

compr. film.

17/27

GLENMARK PHARMACEUTICAL S S.R.O. MEDA MANUFACTURING GMBH MEDA MANUFACTURING GMBH AUROBINDO PHARMA ROMANIA S.R.L.

ROMANIA

ETORICOXIBUM


compr. film.

60mg

ETORICOXIBUM


compr. film.

90mg

ETORICOXIBUM


compr. film.

120mg

ETORICOXIBUM

ETORICOXIB TERAPIA 30 mg

compr. film.

30mg

ETORICOXIBUM


compr. film.

60mg

ETORICOXIBUM


compr. film.

90mg

compr. film.

120mg

compr. film.

160mg

AUROBINDO PHARMA ROMANIA S.R.L. AUROBINDO PHARMA ROMANIA S.R.L. AUROBINDO PHARMA ROMANIA S.R.L. SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V. SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V. SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V. SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V. TORRENT PHARMA S.R.L.

sol. inj.

0,05mg/ml

CHIESI PHARMACEUTICAL S GMBH

unguent pic. oft., susp.

0,25mg/g

pastile

ETORICOXIBUM FENOFIBRATUM

FENTANYLUM FLUOCINOLONI ACETONIDUM FLUOROMETHOLONUM FLURBIPROFEN

ETORICOXIB TERAPIA 120 mg FENOFIBRAT TORRENT 160 mg FENTANYL TORREX 0,05 mg/ml FLUOCINOLON ACETONID LAROPHARM 0,25 mg/g FLUMETOL S 2 mg/ml FARINGO INTENSIV 8,75 mg

ROMANIA

9896

2017

01

ROMANIA

9897

2017

01

ROMANIA

9898

2017

01

OLANDA

9916

2017

01

OLANDA

9917

2017

01

OLANDA

9918

2017

01

OLANDA

9919

2017

01

ROMANIA

10056

2017

01

AUSTRIA

10001

2017

01

LAROPHARM S.R.L.

ROMANIA

10010

2017

01

2mg/ml

THEA FARMA S.P.A.

ITALIA

10047

2017

01

8,75mg

TERAPIA S.A.

ROMANIA

9891

2017

01

18/27

GINKGO BILOBA

GINKGO BILOBA BIOFARM 40 mg (vezi N06DX02) GINKGO BILOBA BIOFARM 40 mg (vezi C04AXN1)

GLIBENCLAMIDUM

MANINIL 1,75 mg

compr.

1,75mg

BERLIN-CHEMIE AG (MENARINI GROUP)

GERMANIA

10005

2017

01

GLIBENCLAMIDUM

MANINIL 3,5 mg

compr.

3,5mg

BERLIN-CHEMIE AG (MENARINI GROUP)

GERMANIA

10006

2017

01

HYDROCORTISONUM

SOFTACORT 3,35 mg/ml

pic. oft., sol. in recipient unidoza

3,35mg/ml

FRANTA

10015

2017

01

IBUPROFENUM

MASIPREN 20 mg/ml

susp. orala

20mg/ml

LABORATOIRES THEA PHARMASWISS CESKÁ REPUBLIKA S.R.O

9928

2017

01

IBUPROFENUM

IBUPROFEN B. BRAUN 400 mg

sol. perf.

400mg

B. BRAUN MELSUNGEN AG

GERMANIA

10023

2017

01

IBUPROFENUM

IBUPROFEN B. BRAUN 600 mg

sol. perf.

600mg

B. BRAUN MELSUNGEN A.G.

GERMANIA

10070

2017

01

IMATINIBUM

IMATINIB AUROBINDO 100 mg

MALTA

9975

2017

01

MALTA

9976

2017

01

ROMANIA

9911

2017

01

9966

2017

01

10080

2017

01

GINKGO BILOBA

compr. film.

40mg

BIOFARM S.A.

ROMANIA

10039

2017

01

compr. film.

40mg

BIOFARM S.A.

ROMANIA

10039

2017

01

compr. film.

100mg

compr. film.

400mg


500mg/500mg

AUROBINDO PHARMA (MALTA) LIMITED AUROBINDO PHARMA (MALTA) LIMITED AUROBINDO PHARMA ROMANIA S.R.L.

REPUBLICA CEHA

IMIPENEMUM + CILASTATINUM

IMATINIB AUROBINDO 400 mg IMIPENEM/CILASTATIN AUROBINDO 500 mg/500 mg

IMUNOGLOBULINA ANTI-D

RHOPHYLAC 300 micrograme/2 ml

sol inj. in seringa preumpluta

300micrograme/ 2ml

CSL BEHRING GMBH

GERMANIA

INSULINE UMANE

HUMULIN R 100 UI/ml

sol. inj.

100UI/ml

LILLY FRANCE

FRANTA

IMATINIBUM

19/27

S.A.S. INSULINE UMANE

HUMULIN N 100 UI/ml

susp. inj.

100UI/ml

INSULINE UMANE

HUMULIN M3 100 UI/ml

susp. inj.

100UI/ml

IOMEPROLUM

IOMERON 300 mg/ml

sol. inj.

612,4mg/ml

IOMEPROLUM

IOMERON 350 mg/ml

sol. inj.

714,4mg/ml

IOMEPROLUM

IOMERON 400 mg/ml

sol. inj.

816,5mg/ml

LILLY FRANCE S.A.S. LILLY FRANCE S.A.S. BRACCO IMAGING SpA BRACCO IMAGING SpA BRACCO IMAGING SpA

IRINOTECANUM

IRINOTECAN HAMELN 20 mg/ml


20mg/ml

HAMELN RDS GMBH

IVABRADINUM

IVABRADINA TEVA 5 mg

IVABRADINUM

IVABRADINA TEVA 7,5 mg

FRANTA

10081

2017

01

FRANTA

10082

2017

01

ITALIA

10035

2017

01

ITALIA

10036

2017

01

ITALIA

10037

2017

01

GERMANIA

9893

2017

01

5mg


ROMANIA

9889

2017

01

compr. film.

7,5mg


ROMANIA

9890

2017

01

compr. film.

5mg

MYLAN S.A.S.

FRANTA

10085

2017

01

compr. film.

7,5mg

MYLAN S.A.S.

FRANTA

10086

2017

01

ROMANIA

10004

2017

01

FRANTA

9909

2017

01

ITALIA

9882

2017

01

ROMANIA

10014

2017

01

SLOVENIA

10165

2017

01

compr. film.

IVABRADINUM

IVABRADINA MYLAN 5 mg IVABRADINA MYLAN 7,5 mg

KALII CHLORIDUM

CLORURA DE POTASIU INFOMED 149 mg/ml


149mg/ml

KETOTIFENUM

ZABAK 0,25 mg/ml

pic. oft., sol.

0.25mg/ml

LATANOPROSTUM

SIFITAN 50 micrograme/ml

pic. oft., sol

50micrograme/ ml

LEVOFLOXACINUM

LEVOFLOXACINA AUROBINDO 5 mg/ml

sol. perf.

5mg/ml

LORATADINUM

FLONIDAN 10 mg

compr.

10mg

IVABRADINUM

20/27

INFOMED FLUIDS S.R.L. LABORATOIRES THEA NTC S.R.L. AUROBINDO PHARMA ROMANIA S.R.L. LEK PHARMACEUTICAL S D.D.

MELOXICAMUM

MELOX 7,5 mg

compr.

7,5 mg

MEDOCHEMIE LTD.

CIPRU

10019

2017

01

MELOXICAMUM

MELOX 15 mg

compr.

15mg

MEDOCHEMIE LTD.

CIPRU

10020

2017

01

MEPIVACAINUM

SCANDONEST 3% PLAIN

sol. inj.

3%

LABORATOIRES SEPTODONT

FRANTA

9866

2017

01

MESALAZINUM

PENTASA 500 mg

compr. elib. prel.

500mg

GERMANIA

9996

2017

01

METFORMINUM

METFORMIN ACCORD 500 mg

compr. elib. prel.

500mg

FERRING GMBH ACCORD HEALTHCARE LIMITED

10069

2017

01

METOPROLOLUM

METOPROLOL SUCCINAT TEVA 23,75 mg

compr. elib. prel.

23,75mg


ROMANIA

9870

2017

01

METOPROLOLUM

METOPROLOL SUCCINAT TEVA 47,5 mg

compr. elib. prel.

47,5mg

ROMANIA

9871

2017

01

METOPROLOLUM

METOPROLOL SUCCINAT TEVA 95 mg

compr. elib. prel.

95mg

ROMANIA

9872

2017

01

METOPROLOLUM

METOPROLOL SUCCINAT TEVA 190 mg

compr. elib. prel.

190mg

ROMANIA

9873

2017

01

METRONIDAZOLUM

METRONIDAZOL A 5 g/l

sol. perf.

5g/l

TEVA PHARMACEUTICAL S S.R.L. TEVA PHARMACEUTICAL S S.R.L. TEVA PHARMACEUTICAL S S.R.L. INFOMED FLUIDS S.R.L.

ROMANIA

10038

2017

01

METRONIDAZOLUM

METRONIDAZOL VVB 500 mg/100 ml

sol. perf.

500mg/100ml

UAB "VVB"

LITUANIA

9892

2017

01

MINOXIDILUM

HAIRGROW 20 mg/ml

spray cutanat sol.

20mg/ml

DAR AL DAWA PHARMA S.R.L.

ROMANIA

10002

2017

01

MINOXIDILUM

HAIRGROW 50 mg/ml

spray cut. sol.

50 mg/ml

DAR AL DAWA PHARMA S.R.L.

ROMANIA

10003

2017

01

MINOXIDILUM

ALOPEXY 50 mg/ml MORFINA ZENTIVA 20 mg/ml

sol. cut.

50mg/ml

PIERRE FABRE DERMATOLOGIE

FRANTA

9951

2017

01

sol. inj.

20mg/ml

ZENTIVA S.A.

ROMANIA

9983

2017

01

MORPHYNUM

21/27

MAREA BRITANIE

NAFTIDROFURYLUM

DUSODRIL 200 mg

compr. elib. prel.

200 mg

MERCK SANTE S.A.S.

NAFTIDROFURYLUM

DUSODRIL 100 mg

caps.

100 mg

NATRII TETRADECYL SULPHAT

FIBROVEIN 0,2%

sol inj.

0,2%


FIBROVEIN 0,5%

sol inj.

0,5%


FIBROVEIN 1%

sol inj.

1%


FIBROVEIN 3%

sol inj.

3%

NEVIRAPINUM

NEVIRAPINA ACCORD 400 mg

compr. elib. prel.

400mg

MERCK SANTE S.A.S. STD PHARMACEUTICAL PRODUCTS LIMITED STD PHARMACEUTICAL PRODUCTS LIMITED STD PHARMACEUTICAL PRODUCTS LIMITED STD PHARMACEUTICAL PRODUCTS LIMITED ACCORD HEALTHCARE LIMITED, UK

NICERGOLINUM

SINERGOLIN 30

draj.

30mg

SINTOFARM S.A.

ROMANIA

NIFURATELUM

MACMIROR 200 mg

draj.

200mg

POLICHEM SA

ONDANSETRONUM

ZONDARON 2 mg/ml

2mg/ml

OXIGENUM

OXIGEN LINDE 100% (v/v)

sol inj./perf. gaz medicinal, comprimat

100%(v/v)

OXYBUTYNINUM

DRIPTANE 5 mg

compr.

PALONOSETRONUM

PALONOSETRON SANDOZ 250 micrograme

PARACETAMOLUM

GRIPPOSTAD HOT 600 mg/plic

FRANTA

10000

2017

01

FRANTA

9999

2017

01

MAREA BRITANIE

9903

2017

01

MAREA BRITANIE

9904

2017

01

MAREA BRITANIE

9905

2017

01

MAREA BRITANIE

9906

2017

01

MAREA BRITANIE

9992

2017

01

10018

2017

01

LUXEMBURG

9979

2017

01

SOPHARMA AD

BULGARIA

9994

2017

01

ROMANIA

9910

2017

01

5mg

LINDE GAZ A.S. MYLAN MEDICAL S.A.S.

FRANTA

9945

2017

01

sol inj.

250micrograme

SANDOZ S.R.L.

ROMANIA

10028

2017

01

pulb. pt. sol. orala

600mg/plic

STADA ARZNEIMITTEL AG

GERMANIA

9941

2017

01

22/27

PEFLOXACINUM

PEFLOXACIN LAROPHARM 400 mg

compr. film.

400mg

LAROPHARM S.R.L.

ROMANIA

9995

2017

01

PHYTOMENADIONUM

FITOMENADION TERAPIA 10 mg/ml

sol. inj.

10mg/ml

TERAPIA S.A.

ROMANIA

9981

2017

01

PLANTE

SINUPRET

picaturi orale-sol.

GERMANIA

9942

2017

01

PLANTE (CIMBRU)

BRONCHOSTOP

guma orala

BIONORICA SE KWIZDA PHARMA GMBH

AUSTRIA

9899

2017

01

PROGESTERONUM

PROGESTERON ACTAVIS 400 mg

ovule

400mg

ISLANDA

10055

2017

01

QUETIAPINUM

QUETIAPINA ACCORD 200 mg

compr. cu elib. prel.

200mg

MAREA BRITANIE

9925

2017

01

QUETIAPINUM



300mg

MAREA BRITANIE

9926

2017

01

QUETIAPINUM



400mg

ACTAVIS GROUP PTC EHF. ACCORD HEALTHCARE LIMITED ACCORD HEALTHCARE LIMITED ACCORD HEALTHCARE LIMITED

MAREA BRITANIE

9927

2017

01

RAMIPRILUM

RAMIPRIL-AC 2,5 mg

compr.

2,5mg

AC HELCOR PHARMA S.R.L.

ROMANIA

9867

2017

01

RAMIPRILUM

RAMIPRIL-AC 5 mg

compr.

5mg


ROMANIA

9868

2017

01

RAMIPRILUM

compr.

10mg


ROMANIA

9869

2017

01

caps.

75mg

ARENA GROUP S.A.

ROMANIA

10029

2017

01

RANITIDINUM

RAMIPRIL-AC 10 mg RANITIDINA ARENA 75 mg RANITIDINA ARENA 300 mg

caps.

300mg

ARENA GROUP S.A.

ROMANIA

10030

2017

01

RILUZOLUM

RILUZOL PMCS 50 mg

compr. film.

50 mg

REPUBLICA CEHA

9930

2017

01

ROSUVASTATINUM

ASTRIUM 5 mg

compr. film.

5mg

MAREA BRITANIE

9875

2017

01

RANITIDINUM

23/27

PRO. MED. CS PRAHA A.S. ACCORD HEALTHCARE LIMITED

ROSUVASTATINUM

ASTRIUM 10 mg

compr. film.

10mg

ROSUVASTATINUM

ASTRIUM 20 mg

compr. film.

20mg

ROSUVASTATINUM

ASTRIUM 40 mg

compr. film.

40mg

ACCORD HEALTHCARE LIMITED ACCORD HEALTHCARE LIMITED ACCORD HEALTHCARE LIMITED

SALMETEROLUM+ FLUTICASONUM

AIRFLUSAL 25 micrograme/ 125 micrograme

susp. de inhalat presurizata


SANDOZ S.R.L.

SALMETEROLUM+ FLUTICASONUM

AIRFLUSAL 25 micrograme/ 250micrograme

susp. de inhalat presurizata


MAREA BRITANIE

9876

2017

01

MAREA BRITANIE

9877

2017

01

MAREA BRITANIE

9878

2017

01

ROMANIA

10026

2017

01

SANDOZ S.R.L.

ROMANIA

10027

2017

01

ROMANIA

9894

2017

01

SILDENAFILUM SOLIFENACINUM SUCCINATE SOLIFENACINUM SUCCINATE

SILDENAFIL TEVA 20 mg

compr. film.

20mg


VEZIMED 5 mg

compr. film.

5mg

MEDOCHEMIE LTD.

CIPRU

9935

2017

01

VEZIMED 10 mg

compr. film.

10mg

CIPRU

9936

2017

01

SPIRAMYCINUM

ROVAMYCINE 1,5 Mil. UI

compr. film.

1,5 Mil.U.I.

10034

2017

01

TADALAFILUM

TADALAFIL ACCORD 2,5 mg

compr. film.

2,5mg

MAREA BRITANIE

9987

2017

01

TADALAFILUM

TADALAFIL ACCORD 5 mg

compr. film.

5mg

MAREA BRITANIE

9988

2017

01

TADALAFILUM


compr. film.

10mg

MAREA BRITANIE

9989

2017

01

TADALAFILUM


compr. film.

20mg

MEDOCHEMIE LTD. SANOFI ROMANIA S.R.L. ACCORD HEALTHCARE LIMITED ACCORD HEALTHCARE LIMITED ACCORD HEALTHCARE LIMITED ACCORD HEALTHCARE LIMITED

MAREA BRITANIE

9990

2017

01

24/27

ROMANIA

TADALAFILUM

TADALAFIL SANDOZ 2,5 mg TADALAFIL SANDOZ 5 mg TADALAFIL SANDOZ 10 mg TADALAFIL SANDOZ 20 mg

TADALAFILUM

TADILECTO 2,5 mg

compr. film.

2,5mg


SLOVENIA

10076

2017

01

TADALAFILUM

TADILECTO 5 mg

compr. film.

5mg


SLOVENIA

10077

2017

01

TADALAFILUM

TADILECTO 10 mg

compr. film.

10mg


SLOVENIA

10078

2017

01

TADALAFILUM

compr. film.

20mg

10079

2017

01

compr. film.

245mg

KRKA, D.D., NOVO MESTO ACCORD HEALTHCARE LIMITED

SLOVENIA

TENOFOVIRUM DISOPROXIL

TADILECTO 20 mg TENOFOVIR DISOPROXIL ACCORD 245 mg

MAREA BRITANIE

9967

2017

01

TIMOLOLUM

TIMOLOL EIPICO 5 mg/ml

picaturi oft., sol.

5mg/ml

E.I.P.I.CO. MED S.R.L.

ROMANIA

9947

2017

01

TIMOLOLUM

TIMOLOL EIPICO 2,5 mg/ml

picaturi oft., sol.

2,5mg/ml

E.I.P.I.CO. MED S.R.L.

ROMANIA

9946

2017

01

TOBRAMYCINUM

TOBRAMICINA SUN 300 mg

sol. pt. nebulizator

300mg

9993

2017

01

VALSARTANUM

VAPRESS 40 mg

compr. film.

40mg

MEDOCHEMIE LTD.

CIPRU

9900

2017

01

VALSARTANUM

VAPRESS 80 mg

compr. film.

80mg

MEDOCHEMIE LTD.

CIPRU

9901

2017

01

VALSARTANUM

VAPRESS 160 mg

160mg

MEDOCHEMIE LTD.

CIPRU

9902

2017

01

VANCOMYCINUM

VANCOMICINA MYLAN 500mg

compr. film. pulb. pt. conc. pt. sol. perf.

500mg

MYLAN S.A.S.

NORVEGIA

9920

2017

01

TADALAFILUM TADALAFILUM TADALAFILUM

compr. film.

2,5mg

SANDOZ S.R.L.

ROMANIA

9860

2017

01

compr. film.

5mg

SANDOZ S.R.L.

ROMANIA

9861

2017

01

compr. film.

10mg

SANDOZ S.R.L.

ROMANIA

9862

2017

01

compr. film.

20mg

SANDOZ S.R.L.

ROMANIA

9863

2017

01

25/27

VANCOMYCINUM

VANCOMICINA MYLAN 1000 mg

pulb. pt. conc. pt. sol. perf.

1000mg

MYLAN S.A.S.

NORVEGIA

9921

2017

01

VARDENAFILUM

VIAVARDIS 5 mg

compr. film.

5mg


SLOVENIA

10011

2017

01

VARDENAFILUM

VIAVARDIS 10 mg

compr. film.

10mg


SLOVENIA

10012

2017

01

VARDENAFILUM

VIAVARDIS 20 mg

compr. film.

20mg


SLOVENIA

10013

2017

01

VORICONAZOLUM

VORICONAZOL MEDOCHEMIE 50 mg

compr. film.

50mg

MEDOCHEMIE LTD.

CIPRU

9948

2017

01

VORICONAZOLUM

VORICONAZOL MEDOCHEMIE 200 mg

200mg

MEDOCHEMIE LTD.

CIPRU

9949

2017

01

XYLOMETAZOLINUM

SNUP 0,5 mg/ml

0,5mg/ml

STADA M&D SRL

ROMANIA

9883

2017

01

XYLOMETAZOLINUM

SNUP 1mg/ml

compr. film. spray naz.,sol. spray naz.,sol.

1mg/ml

STADA M&D SRL

ROMANIA

9884

2017

01

26/27

Medicamente autorizate prin procedura centralizată de către Agenţia Europeană a Medicamentului (EMA) pentru care s-a notificat intenţia de punere pe piaţă în România în trim. II 2017

DCI

Denumire Comerciala

Forma Farm.

Conc

Firma Detinatoare

Tara Detinatoare

Nr. APP

COMBINATII (TRIFLURIDINUM+ TIPIRACILUM)

LONSURF 20 mg/8,19 mg

compr. film.

20 mg/8,19 mg

LES LABORATOIRES SERVIER

FRANTA

1096

2017

06

COMBINATII (TRIFLURIDINUM+ TIPIRACILUM)

LONSURF 15 mg/6,14 mg

compr. film.

15 mg/6,14 mg

LES LABORATOIRES SERVIER

FRANTA

1096

2017

03

ETANERCEPTUM

ERELZI 50 mg

sol inj.

50mg

SANDOZ GMBH

AUSTRIA

1195

2017

011

ETANERCEPTUM

ERELZI 50 mg

sol inj.

50mg

SANDOZ GMBH

AUSTRIA

1195

2017

007

INOTUZUMAB OZOGAMICIN

BESPONSA 1 mg

pulb. pt. conc. pt.sol. perf.

1mg

PFIZER LIMITED

MAREA BRITANIE

1200

2017

01

5mg

ACCORD HEALTHCARE LIMITED

MAREA BRITANIE

1190

2017

03

7,5mg

ACCORD HEALTHCARE LIMITED

MAREA BRITANIE

1190

2017

10

IVABRADINUM

IVABRADINA ACCORD 5 mg

IVABRADINUM

IVABRADINA ACCORD 7,5 mg

compr. film.

compr. film.

27/27

Agenţia Naţională a Medicamentului şi a Dispozitivelor Medicale

Recommend Documents