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.
Extavia : EPAR - Summary for the public (PDF/143.41 KB) (updated)
First published: 05/06/2008
Last updated: 06/01/2020
Extavia : EPAR - Risk-management-plan summary (PDF/540.11 KB)
First published: 17/10/2019
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Novartis Europharm Ltd
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19/09/2019 Extavia - EMEA/H/C/000933 - II/0096/G
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.