Extavia
Withdrawn
This medicine's authorisation has been withdrawn
interferon beta-1b
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 25 November 2024, the European Commission withdrew the marketing authorisation for Extavia (interferon beta-1B) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Novartis Europharm Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Extavia was granted marketing authorisation in the EU on 20 May 2008 for the treatment of single demyelinating events with an active inflammatory process and multiple sclerosis. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2012.
Extavia is identical to Betaferon which is authorised in the EU with the same indication as Extavia.
Product information
Latest procedure affecting product information:II/0116/G
08/12/2022
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
- Extavia
- Active substance
- interferon beta-1b
- International non-proprietary name (INN) or common name
- interferon beta-1b
- Therapeutic area (MeSH)
- Multiple Sclerosis
- Anatomical therapeutic chemical (ATC) code
- L03AB08
Pharmacotherapeutic group
ImmunostimulantsTherapeutic indication
Extavia is indicated for the treatment of:
- patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis;
- patients with relapsing-remitting multiple sclerosis and two or more relapses within the last two years;
- patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.
Assessment history
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