Iblias
Withdrawn
This medicine's authorisation has been withdrawn
octocog alfa
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 3 September 2019, the European Commission withdrew the marketing authorisation for Iblias (octocog alfa) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Bayer AG, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Iblias was granted marketing authorisation in the EU on 18 February 2016 for treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). The marketing authorisation was initially valid for a 5-year period. The product had not been marketed in the EU since 2018.
The European Public Assessment Report (EPAR) for Iblias is updated to indicate that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
A31/0002
10/11/2017
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
- Iblias
- Active substance
- Octocog alfa
- International non-proprietary name (INN) or common name
- octocog alfa
- Therapeutic area (MeSH)
- Hemophilia A
- Anatomical therapeutic chemical (ATC) code
- B02BD02
Pharmacotherapeutic group
AntihemorrhagicsTherapeutic indication
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Iblias can be used for all age groups.
News on Iblias
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