Ponvory

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ponesimod

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

Overview

Ponvory is a medicine for treating adults with relapsing active forms of multiple sclerosis. 

Multiple sclerosis is a disease of the brain and spinal cord in which inflammation attacks the protective covering (sheath) around nerves and damages the nerves themselves.

Ponvory contains the active substance ponesimod.

This EPAR was last updated on 31/05/2022

Authorisation details

Product details
Name
Ponvory
Agency product number
EMEA/H/C/005163
Active substance
ponesimod
International non-proprietary name (INN) or common name
ponesimod
Therapeutic area (MeSH)
Multiple Sclerosis, Relapsing-Remitting
Anatomical therapeutic chemical (ATC) code
L04AA
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Janssen-Cilag International N.V.   
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
19/05/2021
Contact address

Turnhoutseweg 30
BE-2340 Beerse
Belgium

Product information

30/05/2022 Ponvory - EMEA/H/C/005163 - IB/0006

Other EU languages available icon 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:

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

Immunosuppressants

Therapeutic indication

Ponvory is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.

Assessment history

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