Vumerity

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diroximel fumarate

Authorised
This medicine is authorised for use in the European Union.

Overview

Vumerity is a medicine used to treat adults with a type of multiple sclerosis (MS) known as relapsing-remitting MS. MS is a disease in which the immune system (the body’s natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and the optic nerve of the eye), causing inflammation that damages the nerves and the insulation around them. In relapsing-remitting MS, the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).


Vumerity contains the active substance diroximel fumarate.

This EPAR was last updated on 23/11/2022

Authorisation details

Product details
Name
Vumerity
Agency product number
EMEA/H/C/005437
Active substance
Diroximel fumarate (BIIB098)
International non-proprietary name (INN) or common name
diroximel fumarate
Therapeutic area (MeSH)
Multiple Sclerosis, Relapsing-Remitting
Anatomical therapeutic chemical (ATC) code
L04AX07
Publication details
Marketing-authorisation holder
Biogen Netherlands B.V.
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
15/11/2021
Contact address

Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands

Product information

27/10/2022 Vumerity - EMEA/H/C/005437 - II/0005

This medicine’s product information is available in all official EU languages.
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Product information documents contain:

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

dimethyl fumarate

Therapeutic indication

Vumerity is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see Section 5.1 for important information on the populations for which efficacy has been established).

Assessment history

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