Extavia
interferon beta-1b
Table of contents
Overview
Extavia is a medicine used to treat adults who have multiple sclerosis (MS). MS is a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves. Extavia is used in patients:
- who have experienced the signs of MS for the first time, and these are severe enough to justify treatment with injected corticosteroids (anti‑inflammatory medicines). It is used when the patient is considered to be at high risk of developing MS. Before using Extavia, doctors need to exclude other causes for the symptoms;
- who have MS of the type known as ‘relapsing-remitting’, when the patient has attacks (relapses) between periods with no symptoms (remissions), and with at least two relapses within the last two years;
- who have secondary progressive MS (the type of MS that comes after relapsing-remitting MS), when their disease is active.
Extavia contains the active substance interferon beta-1b. This medicine is the same as Betaferon, which is already authorised in the EU. The company that makes Betaferon has agreed that its scientific data can be used for Extavia.
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List item
Extavia : EPAR - Summary for the public (PDF/143.41 KB)
First published: 05/06/2008
Last updated: 06/01/2020
EMA/307167/2012 -
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List item
Extavia : EPAR - Risk-management-plan summary (PDF/540.11 KB)
First published: 17/10/2019
Authorisation details
Product details | |
---|---|
Name |
Extavia
|
Agency product number |
EMEA/H/C/000933
|
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
|
Publication details | |
---|---|
Marketing-authorisation holder |
Novartis Europharm Limited
|
Revision |
25
|
Date of issue of marketing authorisation valid throughout the European Union |
20/05/2008
|
Contact address |
Vista Building |
Product information
08/12/2022 Extavia - EMEA/H/C/000933 - II/0116/G
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.