Extavia

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Withdrawn

This medicine's authorisation has been withdrawn

interferon beta-1b
MedicineHumanWithdrawn
  • 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.

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Product information

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Latest procedure affecting product information: II/0116/G
08/12/2022
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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).

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čeština (CS) (229.01 KB - PDF)

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dansk (DA) (169.94 KB - PDF)

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Deutsch (DE) (178.47 KB - PDF)

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eesti keel (ET) (177.6 KB - PDF)

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français (FR) (184.89 KB - PDF)

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hrvatski (HR) (219.37 KB - PDF)

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íslenska (IS) (172.35 KB - PDF)

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italiano (IT) (210.06 KB - PDF)

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latviešu valoda (LV) (182.29 KB - PDF)

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lietuvių kalba (LT) (182.42 KB - PDF)

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magyar (HU) (178.94 KB - PDF)

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norsk (NO) (166.49 KB - PDF)

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polski (PL) (175.55 KB - PDF)

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português (PT) (170.27 KB - PDF)

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română (RO) (221.28 KB - PDF)

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slovenčina (SK) (192.26 KB - PDF)

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slovenščina (SL) (221.05 KB - PDF)

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Suomi (FI) (181.49 KB - PDF)

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svenska (SV) (169.55 KB - PDF)

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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

Immunostimulants

Therapeutic 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.

Authorisation details

EMA product number
EMEA/H/C/000933
Marketing authorisation holder
Novartis Europharm Limited

Vista Building
Elm Park
Merrion Road
Dublin 4
Ireland

Opinion adopted
19/03/2008
Marketing authorisation issued
20/05/2008
Withdrawal of marketing authorisation
25/04/2025
Revision
26

Assessment history

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