Entecavir

Hauptinformation

  • Handelsname:
  • Entecavir Glenmark 0,5 mg Filmtabletten
  • Darreichungsform:
  • Filmtablette
  • Zusammensetzung:
  • Entecavir 1 H<2>O 0.53mg
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

  • für die Allgemeinheit:
  • Das Informationsblatt für dieses Produkt ist derzeit nicht verfügbar, können Sie eine Anfrage an unseren Kundendienst zu senden und wir werden Sie benachrichtigen, sobald wir in der Lage, um es zu erhalten.


    Fordern Sie das Informationsblatt für die Öffentlichkeit.

  • Information für medizinisches Fachpersonal:
  • Das Informationsblatt für dieses Produkt ist derzeit nicht verfügbar, können Sie eine Anfrage an unseren Kundendienst zu senden und wir werden Sie benachrichtigen, sobald wir in der Lage, um es zu erhalten.


    Fordern Sie die Packungsbeilage für medizinisches Fachpersonal.

Lokalisierung

  • Erhältlich in:
  • Entecavir Glenmark 0,5 mg Filmtabletten
    Deutschland
  • Sprache:
  • Deutsch

Weitere Informationen

Status

  • Quelle:
  • BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte
  • Zulassungsnummer:
  • 98009.00.00
  • Letzte Änderung:
  • 12-02-2018

21-7-2017

Pending EC decision:  Entecavir Accord, entecavir, Opinion date: 20-Jul-2017

Pending EC decision: Entecavir Accord, entecavir, Opinion date: 20-Jul-2017

Europe - EMA - European Medicines Agency

21-7-2017

Pending EC decision:  Entecavir Mylan, entecavir, Opinion date: 20-Jul-2017

Pending EC decision: Entecavir Mylan, entecavir, Opinion date: 20-Jul-2017

Europe - EMA - European Medicines Agency

16-6-2017

 Eleven new substances on the list of euphoriant substances

Eleven new substances on the list of euphoriant substances

On 15 June 2017, 11 new substances were included in annex 1 of executive order no. 557 of 31 May 2011 on euphoriant substances issued by the Danish Ministry of Health. The information is primarily relevant to companies authorised to deal with euphoriant substances. As from 15 June 2017, the following substances are included in schedule B: 0. AB-CHMINACA (N-(1-aminocarbonyl-2-methylpropyl)-1-(cyclohexylmethyl)-1H-indazol-3-carboxamid). 15 b. AMB-FUBINACA (N-(1-methoxycarbonyl-2-methylpropyl)-1-(...

Danish Medicines Agency

3-4-2018

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (Active substance: 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) - Transfer of orphan designation - Commission Decision (2018)2056 of Tue, 03 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/124/12/T/01

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1989 (FGK Representative Service GmbH)

EU/3/18/1989 (FGK Representative Service GmbH)

EU/3/18/1989 (Active substance: (2S,4R)-1-(2-(3-acetyl-5-(2-methylpyrimidine-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromopyridine-2-yl)-4-fluoropyrrolidine-2-carboxamide) - Orphan designation - Commission Decision (2018)1878 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/208/17

Europe -DG Health and Food Safety

19-3-2018

ENTECAVIR Tablet [Breckenridge Pharmaceutical, Inc.]

ENTECAVIR Tablet [Breckenridge Pharmaceutical, Inc.]

Updated Date: Mar 19, 2018 EST

US - DailyMed

15-3-2018

EU/3/14/1362 (Inventiva)

EU/3/14/1362 (Inventiva)

EU/3/14/1362 (Active substance: 1-(6-benzothiazolylsulfonyl)-5-chloro-1H-indole-2-butanoic acid) - Corrigendum - Commission Decision (2018)1645 of Thu, 15 Mar 2018

Europe -DG Health and Food Safety

15-3-2018

EU/3/14/1361 (Inventiva)

EU/3/14/1361 (Inventiva)

EU/3/14/1361 (Active substance: 1-(6-benzothiazolylsulfonyl)-5-chloro-1H-indole-2-butanoic acid) - Corrigendum - Commission Decision (2014)1644 of Thu, 15 Mar 2018

Europe -DG Health and Food Safety

26-2-2018

EU/3/18/1974 (Takeda Pharma A/S)

EU/3/18/1974 (Takeda Pharma A/S)

EU/3/18/1974 (Active substance: 6-{[(1R,2S)-2-aminocyclohexyl]amino}-7-fluoro-4-(1-methyl-1H-pyrazol-4-yl)-1,2-dihydro-3H-pyrrolo[3,4-c]pyridin-3-one monocitrate) - Orphan designation - Commission Decision (2018)1257 of Mon, 26 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/193/17

Europe -DG Health and Food Safety

26-2-2018

EU/3/18/1972 (CATS Consultants GmbH)

EU/3/18/1972 (CATS Consultants GmbH)

EU/3/18/1972 (Active substance: 1-[[[4-(4-fluoro-2-methyl-1H-indol-5-yloxy)-6-methoxyquinolin-7-yl]oxy]methyl]cyclopropanamine-dihydrochloride) - Orphan designation - Commission Decision (2018)1256 of Mon, 26 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/202/17

Europe -DG Health and Food Safety

15-2-2018

ENTECAVIR Tablet, Film Coated [Accord Healthcare Inc.]

ENTECAVIR Tablet, Film Coated [Accord Healthcare Inc.]

Updated Date: Feb 15, 2018 EST

US - DailyMed

13-2-2018

EU/3/10/802 (Genkyotex S.A.)

EU/3/10/802 (Genkyotex S.A.)

EU/3/10/802 (Active substance: 2-(2-chlorophenyl)-4-[3-(dimethylamino)phenyl]-5-methyl-1H-pyrazolo[4,3-C]pyridine-3,6(2H,5H)-dione) - Transfer of orphan designation - Commission Decision (2018)939 of Tue, 13 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/079/10/T/02

Europe -DG Health and Food Safety

13-2-2018

EU/3/15/1559 (Genkyotex S.A.)

EU/3/15/1559 (Genkyotex S.A.)

EU/3/15/1559 (Active substance: 2-(2-chlorophenyl)-4-[3-(dimethylamino)phenyl]-5-methyl-1H-pyrazolo[4,3-C]pyridine-3,6(2H,5H)-dione) - Transfer of orphan designation - Commission Decision (2018)944 of Tue, 13 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/105/15/T/01

Europe -DG Health and Food Safety

19-1-2018

ENTECAVIR Tablet, Film Coated [AvKARE, Inc.]

ENTECAVIR Tablet, Film Coated [AvKARE, Inc.]

Updated Date: Jan 19, 2018 EST

US - DailyMed

20-12-2017

EU/3/09/681 (AOP Orphan Pharmaceuticals AG)

EU/3/09/681 (AOP Orphan Pharmaceuticals AG)

EU/3/09/681 (Active substance: 6-chloro-2,3,4,9-tetrahydro-1H-carbazole-1-carboxamide) - Transfer of orphan designation - Commission Decision (2017)8998 of Wed, 20 Dec 2017 European Medicines Agency (EMA) procedure number: EMA/OD/066/09/T/01

Europe -DG Health and Food Safety

14-12-2017

EU/3/17/1946 (FGK Representative Service GmbH)

EU/3/17/1946 (FGK Representative Service GmbH)

EU/3/17/1946 (Active substance: (2S,4R)-1-(2-(3-acetyl-5-(2-methylpyrimidine-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromopyridine-2-yl)-4-fluoropyrrolidine-2-carboxamide) - Orphan designation - Commission Decision (2017)8778 of Thu, 14 Dec 2017 European Medicines Agency (EMA) procedure number: EMA/OD/156/17

Europe -DG Health and Food Safety

17-11-2017

ENTECAVIR Tablet [Aurobindo Pharma Limited]

ENTECAVIR Tablet [Aurobindo Pharma Limited]

Updated Date: Nov 17, 2017 EST

US - DailyMed

10-11-2017

EU/3/17/1942 (Celleron Therapeutics Limited)

EU/3/17/1942 (Celleron Therapeutics Limited)

EU/3/17/1942 (Active substance: N-(2-aminophenyl)-4-(1-[(1,3-dimethyl-1H-pyrazol-4-yl)methyl]piperidin)benzamide) - Orphan designation - Commission Decision (2017)7564 of Fri, 10 Nov 2017 European Medicines Agency (EMA) procedure number: EMA/OD/121/17

Europe -DG Health and Food Safety

18-10-2017

EU/3/17/1916 (Voisin Consulting S.A.R.L.)

EU/3/17/1916 (Voisin Consulting S.A.R.L.)

EU/3/17/1916 (Active substance: 5-amino-1-(2-methyl-1H-benzo[d]imidazol-5-yl)-1H-pyrazol-4-yl 1H-indol-2-yl ketone mono[(S)-2-hydroxysuccinate]) - Orphan designation - Commission Decision (2017)7049 of Wed, 18 Oct 2017 European Medicines Agency (EMA) procedure number: EMA/OD/124/17

Europe -DG Health and Food Safety

28-9-2017

Entecavir Accord (Accord Healthcare Limited)

Entecavir Accord (Accord Healthcare Limited)

Entecavir Accord (Active substance: entecavir) - Centralised - Authorisation - Commission Decision (2017)6645 of Thu, 28 Sep 2017 European Medicines Agency (EMA) procedure number: EMEA/H/C/004458/0000

Europe -DG Health and Food Safety

22-9-2017

ENTECAVIR Tablet [American Health Packaging]

ENTECAVIR Tablet [American Health Packaging]

Updated Date: Sep 22, 2017 EST

US - DailyMed

22-9-2017

ENTECAVIR Tablet, Film Coated [Teva Pharmaceuticals USA, Inc.]

ENTECAVIR Tablet, Film Coated [Teva Pharmaceuticals USA, Inc.]

Updated Date: Sep 22, 2017 EST

US - DailyMed

20-9-2017

Entecavir Mylan (Mylan S.A.S.)

Entecavir Mylan (Mylan S.A.S.)

Entecavir Mylan (Active substance: entecavir) - Centralised - Authorisation - Commission Decision (2017)6407 of Wed, 20 Sep 2017 European Medicines Agency (EMA) procedure number: EMEA/H/C/004377/0000

Europe -DG Health and Food Safety

7-9-2017

EU/3/03/182 (Idorsia Pharmaceuticals Deutschland GmbH)

EU/3/03/182 (Idorsia Pharmaceuticals Deutschland GmbH)

EU/3/03/182 (Active substance: 5-methyl-pyridine-2-sulfonic acid {6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-2-[2-(1H-tetrazol-5-yl)-pyridin-4-yl]-pyrimidin-4-yl}-amide sodium salt) - Transfer of orphan designation - Commission Decision (2017)6106 of Thu, 07 Sep 2017 European Medicines Agency (EMA) procedure number: EMEA/OD/057/03/T/02

Europe -DG Health and Food Safety

30-8-2017

EU/3/07/518 (Bayer AG)

EU/3/07/518 (Bayer AG)

EU/3/07/518 (Active substance: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carbamate) - Transfer of orphan designation - Commission Decision (2017)5980 of Wed, 30 Aug 2017 European Medicines Agency (EMA) procedure number: EMEA/OD/088/07/T/02

Europe -DG Health and Food Safety

18-8-2017

Entecavir Heumann Filmtabletten

Rote - Liste

10-8-2017

ENTECAVIR Tablet, Film Coated [Cadila Healthcare Limited]

ENTECAVIR Tablet, Film Coated [Cadila Healthcare Limited]

Updated Date: Aug 10, 2017 EST

US - DailyMed

10-8-2017

ENTECAVIR Tablet, Film Coated [Zydus Pharmaceuticals (USA) Inc.]

ENTECAVIR Tablet, Film Coated [Zydus Pharmaceuticals (USA) Inc.]

Updated Date: Aug 10, 2017 EST

US - DailyMed

19-7-2017

EU/3/17/1889 (PhaRA bvba)

EU/3/17/1889 (PhaRA bvba)

EU/3/17/1889 (Active substance: (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4-yl)piperazin-yl)pyrimidin-5-yl)ethan-1-amine) - Orphan designation - Commission Decision (2017)5153 of Wed, 19 Jul 2017 European Medicines Agency (EMA) procedure number: EMA/OD/037/17

Europe -DG Health and Food Safety

7-7-2017

ENTECAVIR Tablet [Camber Pharmaceuticals, Inc.]

ENTECAVIR Tablet [Camber Pharmaceuticals, Inc.]

Updated Date: Jul 7, 2017 EST

US - DailyMed

23-6-2017

ENTECAVIR Tablet, Coated [Par Pharmaceutical Inc.]

ENTECAVIR Tablet, Coated [Par Pharmaceutical Inc.]

Updated Date: Jun 23, 2017 EST

US - DailyMed

21-6-2017

ENTECAVIR Tablet, Film Coated [Par Pharmaceutical Inc.]

ENTECAVIR Tablet, Film Coated [Par Pharmaceutical Inc.]

Updated Date: Jun 21, 2017 EST

US - DailyMed

15-6-2017

ENTECAVIR Tablet, Film Coated [NorthStar RxLLC]

ENTECAVIR Tablet, Film Coated [NorthStar RxLLC]

Updated Date: Jun 15, 2017 EST

US - DailyMed

30-5-2017

Entecavir Klinge 1,0 mg Filmtabletten

Rote - Liste

30-5-2017

Entecavir Klinge 0,5 mg Filmtabletten

Rote - Liste