Հեմատ

main_info

  • trade_name:
  • Հեմատ Պ 1000
  • dosage:
  • 1000ՄՄՄ+2400ՄՄ(1) ապակե սրվակ, 15մլ ապակե սրվակ լուծչով, (1)ֆիլտրող/փոխանցող մ
  • pharmaceutical_form:
  • դեղափոշի և լուծիչ ներարկման /կաթիլաներարկման լուծույթի
  • prescription_type:
  • Դեղատոմսով
  • medicine_domain:
  • Human
  • medicine_type:
  • Allopathic

documents

localization

  • country:
  • Հեմատ Պ 1000
    አርሜኒያ
  • language:
  • አማርኛ

other_info

status

  • source:
  • Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում - Armenia
  • last_update:
  • 31-05-2018

30-11-2018


Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products - Revision 3

Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products - Revision 3

Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products - Revision 3

Europe - EMA - European Medicines Agency

9-4-2019


Orphan designation: Lentiviral vector encoding human coagulation factor IX, Treatment of haemophilia B, 26/02/2019, Positive

Orphan designation: Lentiviral vector encoding human coagulation factor IX, Treatment of haemophilia B, 26/02/2019, Positive

Orphan designation: Lentiviral vector encoding human coagulation factor IX, Treatment of haemophilia B, 26/02/2019, Positive

Europe - EMA - European Medicines Agency

29-3-2019

Coagadex (BPL Bioproducts Laboratory GmbH)

Coagadex (BPL Bioproducts Laboratory GmbH)

Coagadex (Active substance: human coagulation factor X) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2577 of Fri, 29 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3855/T/14

Europe -DG Health and Food Safety

26-3-2019


Orphan designation: Human coagulation factor X, Treatment of hereditary factor X deficiency, 14/09/2007, Positive

Orphan designation: Human coagulation factor X, Treatment of hereditary factor X deficiency, 14/09/2007, Positive

Orphan designation: Human coagulation factor X, Treatment of hereditary factor X deficiency, 14/09/2007, Positive

Europe - EMA - European Medicines Agency

18-3-2019

EU/3/07/471 (BPL Bioproducts Laboratory GmbH)

EU/3/07/471 (BPL Bioproducts Laboratory GmbH)

EU/3/07/471 (Active substance: Human coagulation factor X) - Transfer of orphan designation - Commission Decision (2019)2158 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004129

Europe -DG Health and Food Safety

28-2-2019

EU/3/19/2141 (Fondazione Telethon)

EU/3/19/2141 (Fondazione Telethon)

EU/3/19/2141 (Active substance: Lentiviral vector encoding human coagulation factor IX) - Orphan designation - Commission Decision (2019)1733 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002293

Europe -DG Health and Food Safety

11-1-2019


Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia A, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

30-10-2018

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Active substance: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant) - Orphan designation - Commission Decision (2018)7281 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/127/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Active substance: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII) - Orphan designation - Commission Decision (2018)7280 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/104/18

Europe -DG Health and Food Safety

29-8-2018

Coagadex (Bio Products Laboratory Ltd)

Coagadex (Bio Products Laboratory Ltd)

Coagadex (Active substance: human coagulation factor X) - Centralised - 2-Monthly update - Commission Decision (2018)5772 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3855/II/07

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2015 (Baxalta Innovations GmbH)

EU/3/18/2015 (Baxalta Innovations GmbH)

EU/3/18/2015 (Active substance: Adeno-associated viral vector serotype 8 containing a functional copy of the codon-optimised F8 cDNA encoding the B-domain deleted human coagulation factor VIII) - Orphan designation - Commission Decision (2018)3382 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/18

Europe -DG Health and Food Safety