Nonafact

Withdrawn

This medicine's authorisation has been withdrawn

human coagulation factor IX

Overview

The marketing authorisation for Nonafact has been withdrawn at the request of the marketing-authorisation holder.

Nonafact : EPAR - Summary for the public

Product information

Nonafact : EPAR - Product Information

Latest procedure affecting product information: IB/0062

24/11/2016

This medicine’s product information is available in all official EU languages.
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Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Nonafact : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Nonafact
• Active substance:
  human coagulation factor IX
• International non-proprietary name (INN) or common name:
  human coagulation factor IX
• Therapeutic area (MeSH):
  Hemophilia B
• Anatomical therapeutic chemical (ATC) code:
  B02BD04

Pharmacotherapeutic group

Antihemorrhagics

Therapeutic indication

Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).

Authorisation details

• EMA product number:
  EMEA/H/C/000348
• Marketing authorisation holder:
  Sanquin Plasma Products B.V.

  Plesmanlaan 125; NL-1066 CX Amsterdam; The Netherlands

• Marketing authorisation issued:
  03/07/2001
• Revision:
  9

Assessment history

Changes since initial authorisation of medicine

Nonafact : EPAR - Procedural steps taken and scientific information after authorisation

Nonafact : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

Nonafact : EPAR - Procedural steps taken before authorisation

Nonafact : EPAR - Scientific Discussion