ERYPRO SAFE ,000 IU

Main information

  • Trade name:
  • ERYPRO SAFE ,000 IU 1ML INJ
  • Dosage:
  • 10000IU.
  • Pharmaceutical form:
  • INJ
  • Composition:
  • 1ML
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ERYPRO SAFE ,000 IU 1ML INJ
    India
  • Language:
  • English

Other information

Status

  • Source:
  • Central Drugs Standard Control Organization
  • Last update:
  • 09-08-2016

28-3-2018

Orphan designation:  Recombinant fusion protein linking human coagulation factor VIIa with human albumin,  for the: Treatment of haemophilia B

Orphan designation: Recombinant fusion protein linking human coagulation factor VIIa with human albumin, for the: Treatment of haemophilia B

On 13 May 2011, orphan designation (EU/3/11/863) was granted by the European Commission to CSL Behring GmbH, Germany, for recombinant fusion protein linking human coagulation factor VIIa with human albumin for the treatment of haemophilia B.

Europe - EMA - European Medicines Agency

11-10-2017

Medical Imaging Drugs Advisory Committee Charter

Medical Imaging Drugs Advisory Committee Charter

The Medical Imaging Drugs Advisory Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which the Food and Drug Administration has regulatory responsibility.

FDA - U.S. Food and Drug Administration

10-10-2017

Nonprescription Drugs Advisory Committee

Nonprescription Drugs Advisory Committee

he Nonprescription Drugs Advisory Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which the Food and Drug Administration has regulatory responsibility.

FDA - U.S. Food and Drug Administration

23-3-2018

EU/3/18/2000 (Amicus Therapeutics UK Ltd)

EU/3/18/2000 (Amicus Therapeutics UK Ltd)

EU/3/18/2000 (Active substance: Recombinant human acid alpha-glucosidase) - Orphan designation - Commission Decision (2018)1877 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/230/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1999 (uniQure Biopharma B.V.)

EU/3/18/1999 (uniQure Biopharma B.V.)

EU/3/18/1999 (Active substance: Recombinant adeno-associated viral vector containing a codon-optimized Padua derivative of human coagulation factor IX cDNA) - Orphan designation - Commission Decision (2018)1888 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/232/17

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1727 (Quintiles Ireland Limited)

EU/3/16/1727 (Quintiles Ireland Limited)

EU/3/16/1727 (Active substance: Recombinant human interleukin-12) - Transfer of orphan designation - Commission Decision (2018)1824 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/116/16/T/01

Europe -DG Health and Food Safety

21-3-2018

Silgard (Merck Sharp and Dohme Limited)

Silgard (Merck Sharp and Dohme Limited)

Silgard (Active substance: Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)) - Centralised - Yearly update - Commission Decision (2018)1745 of Wed, 21 Mar 2018

Europe -DG Health and Food Safety

26-2-2018

EU/3/18/1984 (Omeros London Limited)

EU/3/18/1984 (Omeros London Limited)

EU/3/18/1984 (Active substance: Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2) - Orphan designation - Commission Decision (2018)1251 of Mon, 26 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/200/17

Europe -DG Health and Food Safety

21-2-2018

Gardasil 9 (MSD VACCINS)

Gardasil 9 (MSD VACCINS)

Gardasil 9 (Active substance: human papillomavirus 9-valent vaccine (recombinant, adsorbed)) - Centralised - Yearly update - Commission Decision (2018) 1135 of Wed, 21 Feb 2018

Europe -DG Health and Food Safety

29-1-2018

EU/3/09/709 (Apogenix AG)

EU/3/09/709 (Apogenix AG)

EU/3/09/709 (Active substance: Recombinant fusion protein consisting of the extracellular portion of CD95 fused to the Fc part of a human IgG1 molecule) - Transfer of orphan designation - Commission Decision (2018)556 of Mon, 29 Jan 2018 European Medicines Agency (EMA) procedure number: EMA/OD/098/09/T/01

Europe -DG Health and Food Safety

29-1-2018

EU/3/06/411 (Apogenix AG)

EU/3/06/411 (Apogenix AG)

EU/3/06/411 (Active substance: Recombinant fusion protein consisting of the extracellular portion of CD95 fused to the Fc part of a human IgG1 molecule) - Transfer of orphan designation - Commission Decision (2018)565 of Mon, 29 Jan 2018 European Medicines Agency (EMA) procedure number: EMA/OD/054/06/T/01

Europe -DG Health and Food Safety

24-1-2018

ADVATE (Antihemophilic Factor, Human Recombinant) Kit [Baxalta US Inc.]

ADVATE (Antihemophilic Factor, Human Recombinant) Kit [Baxalta US Inc.]

Updated Date: Jan 24, 2018 EST

US - DailyMed

19-1-2018

EU/3/14/1272 (Voisin Consulting S.A.R.L.)

EU/3/14/1272 (Voisin Consulting S.A.R.L.)

EU/3/14/1272 (Active substance: Recombinant human alpha 1 chain homotrimer of type VII collagen) - Transfer of orphan designation - Commission Decision (2018)394 of Fri, 19 Jan 2018 European Medicines Agency (EMA) procedure number: EMA/OD/201/13/T/01

Europe -DG Health and Food Safety

19-1-2018

EU/3/17/1969 (University of Cambridge)

EU/3/17/1969 (University of Cambridge)

EU/3/17/1969 (Active substance: Recombinant adeno-associated viral vector serotype 2/1 encoding human beta-hexosaminidase alpha and beta subunits) - Orphan designation - Commission Decision (2018)391 of Fri, 19 Jan 2018 European Medicines Agency (EMA) procedure number: EMA/OD/182/17

Europe -DG Health and Food Safety

22-12-2017

Gardasil (MSD VACCINS)

Gardasil (MSD VACCINS)

Gardasil (Active substance: Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)) - Centralised - Yearly update - Commission Decision (2017)9095 of Fri, 22 Dec 2017

Europe -DG Health and Food Safety

22-11-2017

EU/3/16/1806 (Abeona Therapeutics Europe SL)

EU/3/16/1806 (Abeona Therapeutics Europe SL)

EU/3/16/1806 (Active substance: Recombinant self-complementary adeno-associated viral vector serotype 9 containing the human CLN3 gene) - Transfer of orphan designation - Commission Decision (2017)7864 of Wed, 22 Nov 2017 European Medicines Agency (EMA) procedure number: EMA/OD/195/16/T/01

Europe -DG Health and Food Safety

20-11-2017

EU/3/15/1551 (Shire Pharmaceuticals Ireland Limited)

EU/3/15/1551 (Shire Pharmaceuticals Ireland Limited)

EU/3/15/1551 (Active substance: Recombinant human IgG1 kappa light chain monoclonal antibody targeting plasma kallikrein) - Transfer of orphan designation - Commission Decision (2017)7800 of Mon, 20 Nov 2017 European Medicines Agency (EMA) procedure number: EMA/OD/075/15/T/01

Europe -DG Health and Food Safety

14-11-2017

EU/3/16/1825 (Abeona Therapeutics Europe SL)

EU/3/16/1825 (Abeona Therapeutics Europe SL)

EU/3/16/1825 (Active substance: Recombinant adeno-associated viral vector serotype 9 containing the human N-alpha-acetylglucosaminidase gene) - Transfer of orphan designation - Commission Decision (2017)7629 of Tue, 14 Nov 2017 European Medicines Agency (EMA) procedure number: EMA/OD/226/16/T/01

Europe -DG Health and Food Safety

14-11-2017

EU/3/15/1536 (Enzyvant Farber Ireland Limited)

EU/3/15/1536 (Enzyvant Farber Ireland Limited)

EU/3/15/1536 (Active substance: Recombinant human acid ceramidase) - Transfer of orphan designation - Commission Decision (2017)7625 of Tue, 14 Nov 2017 European Medicines Agency (EMA) procedure number: EMA/OD/061/15/T/01

Europe -DG Health and Food Safety

10-11-2017

EU/3/17/1943 (REGENXBIO EU Limited)

EU/3/17/1943 (REGENXBIO EU Limited)

EU/3/17/1943 (Active substance: Recombinant adeno-associated viral vector serotype 9 containing human iduronate-2-sulfatase gene) - Orphan designation - Commission Decision (2017)7565 of Fri, 10 Nov 2017 European Medicines Agency (EMA) procedure number: EMA/OD/134/17

Europe -DG Health and Food Safety

30-10-2017

Scientific guideline:  Draft guideline on clinical investigation of recombinant and 4 human plasma-derived factor VIII products, draft: consultation open

Scientific guideline: Draft guideline on clinical investigation of recombinant and 4 human plasma-derived factor VIII products, draft: consultation open

This guideline describes the information to be documented when an application for a marketing authorisation for recombinant or human plasma-derived factor VIII products is made for use in treatment and prevention of bleeding in patients with haemophilia A. The guidance covers clinical investigations to be conducted pre- and post-marketing authorisation. Guidance is also provided for authorised products where a significant change in the manufacturing process has been made.

Europe - EMA - European Medicines Agency

30-10-2017

Scientific guideline:  Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products, draft: consultation open

Scientific guideline: Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products, draft: consultation open

This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for human plasma derived and recombinant coagulation factor VIII products, which are indicated for use in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). In case of an indication claim in von Willebrand’s disease, see also core SmPC for von Willebrand factor products (CPMP/BPWG/278/02).

Europe - EMA - European Medicines Agency

23-10-2017

EU/3/16/1786 (Diamond BioPharm Limited)

EU/3/16/1786 (Diamond BioPharm Limited)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2017)7164 of Mon, 23 Oct 2017 European Medicines Agency (EMA) procedure number: EMA/OD/183/16/T/01

Europe -DG Health and Food Safety