Nonafact

Withdrawn

This medicine's authorisation has been withdrawn

human coagulation factor IX

Overview

On 13 May 2019, the European Commission withdrew the marketing authorisation for Nonafact (human coagulation factor IX) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Sanquin Plasma Products B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Nonafact was granted marketing authorisation in the EU on 3 July 2001 for treatment of haemophilia B. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2006. 

The European Public Assessment Report (EPAR) for Nonafact is updated to indicate that the marketing authorisation is no longer valid.

Nonafact : EPAR - Summary for the public

Product information

Nonafact : EPAR - Product Information

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