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Аймафикс 500 IU

Основна информация

  • Търговско наименование:
  • Аймафикс 500 IU (Aimafix 500 IU)
  • Предлага се от:
  • Kedrion S.p.A.
  • дозиране:
  • 500 IU/флакон + 10 ml x
  • Лекарствена форма:
  • прах и разтворител за инфузионен разтвор
  • Композиция:
  • прах и разтворител за инфузионен разтвор 500 IU/флакон + 10 ml x
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици
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Документи

Локализация

  • Предлага се в:
  • Аймафикс 500 IU (Aimafix 500 IU)
    България
  • Език:
  • български

Друга информация

Състояние

  • Източник:
  • Изпълнителна агенция по лекарствата - Bulgarian Drug Agency - Bulgaria
  • Последна актуализация:
  • 09-08-2016

Листовка за пациента


12-10-2017

Scientific guideline:  Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1), adopted

Scientific guideline: Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1), adopted

Revision 1 is a major revision with modifications throughout and contains the following: - Revised definition and process for emerging safety issues, previously addressed in GVP Module VI (IX.A.1.1. and IX.C.2.); - Streamlined information on scientific aspects of signal management (IX.B.2. to IX.B.4.), statistical aspects now addressed in Addendum I;

Europe - EFSA - European Food Safety Authority EFSA Journal

1-12-2017

REBINYN ((Coagulation Factor Ix (Recombinant), Glycopegylated)) Kit [Novo Nordisk]

REBINYN ((Coagulation Factor Ix (Recombinant), Glycopegylated)) Kit [Novo Nordisk]

Updated Date: Dec 1, 2017 EST

US - DailyMed

29-11-2017

RIXUBIS (Coagulation Factor Ix (Recombinant)) Kit [BAXALTA US INC.]

RIXUBIS (Coagulation Factor Ix (Recombinant)) Kit [BAXALTA US INC.]

Updated Date: Nov 29, 2017 EST

US - DailyMed

20-11-2017

KOGENATE Bayer (Bayer AG)

KOGENATE Bayer (Bayer AG)

KOGENATE Bayer (Active substance: Recombinant coagulation factor VIII (octocog alfa)) - Referral - Commission Decision (2017)7811 of Mon, 20 Nov 2017 European Medicines Agency (EMA) procedure number: EMEA/H/C/275/A31/185

Europe -DG Health and Food Safety

20-11-2017

Helixate NexGen (Bayer AG)

Helixate NexGen (Bayer AG)

Helixate NexGen (Active substance: Recombinant coagulation factor VIII (octocog alfa)) - Referral - Commission Decision (2017)7812 of Mon, 20 Nov 2017 European Medicines Agency (EMA) procedure number: EMEA/H/C/276/A31/178

Europe -DG Health and Food Safety

16-11-2017

BEBULIN (Coagulation Factor Ix Human) Kit [Baxalta Incorporated]

BEBULIN (Coagulation Factor Ix Human) Kit [Baxalta Incorporated]

Updated Date: Nov 16, 2017 EST

US - DailyMed

13-11-2017

Human coagulation factor VIII

Human coagulation factor VIII

Human coagulation factor VIII (Active substance: Human coagulation factor VIII) - Community Referrals - Art 31 - Commission Decision (2017)7630 of Mon, 13 Nov 2017 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1448

Europe -DG Health and Food Safety

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

2-10-2017

NOVOSEVEN RT (Coagulation Factor Viia (Recombinant)) Kit [Novo Nordisk]

NOVOSEVEN RT (Coagulation Factor Viia (Recombinant)) Kit [Novo Nordisk]

Updated Date: Oct 2, 2017 EST

US - DailyMed

28-7-2017

Voncento (CSL Behring GmbH)

Voncento (CSL Behring GmbH)

Voncento (Active substance: human coagulation factor VIII / human von Willebrand factor) - Centralised - 2-Monthly update - Commission Decision (2017)5354 of Fri, 28 Jul 2017 European Medicines Agency (EMA) procedure number: EMEA/H/C/2493/II/17/G

Europe -DG Health and Food Safety

22-6-2017

EU/3/17/1884 (Voisin Consulting S.A.R.L.)

EU/3/17/1884 (Voisin Consulting S.A.R.L.)

EU/3/17/1884 (Active substance: Recombinant human factor IX protein modified with three point mutations) - Orphan designation - Commission Decision (2017)4370 of Thu, 22 Jun 2017 European Medicines Agency (EMA) procedure number: EMA/OD/018/17

Europe -DG Health and Food Safety

21-6-2017

MONONINE (Coagulation Factor Ix Human) Kit [CSL Behring LLC]

MONONINE (Coagulation Factor Ix Human) Kit [CSL Behring LLC]

Updated Date: Jun 21, 2017 EST

US - DailyMed

6-6-2017

IXINITY (Coagulation Factor Ix (Recombinant)) Kit [Aptevo BioTherapeutics LLC]

IXINITY (Coagulation Factor Ix (Recombinant)) Kit [Aptevo BioTherapeutics LLC]

Updated Date: Jun 6, 2017 EST

US - DailyMed

20-2-2017

Nonafact (Sanquin Plasma Products B.V.)

Nonafact (Sanquin Plasma Products B.V.)

Nonafact (Active substance: Human coagulation factor IX) - Centralised - Yearly update - Commission Decision (2017)1259 of Mon, 20 Feb 2017

Europe -DG Health and Food Safety

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