Nonafact
Withdrawn
This medicine's authorisation has been withdrawn
human coagulation factor IX
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
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The European Public Assessment Report (EPAR) for Nonafact is updated to indicate that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:IB/0062
24/11/2016
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
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).
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
AntihemorrhagicsTherapeutic indication
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
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