Ponvory
ponesimod
Table of contents
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.
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Ponvory : EPAR - Medicine overview (PDF/99.04 KB)
First published: 02/06/2021
EMA/251618/2021 -
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Ponvory : EPAR - Risk-management-plan summary (PDF/147.69 KB)
First published: 02/06/2021
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 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 | |
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Marketing-authorisation holder |
Janssen-Cilag International N.V.
|
Revision |
2
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Date of issue of marketing authorisation valid throughout the European Union |
19/05/2021
|
Contact address |
Turnhoutseweg 30 |
Product information
30/05/2022 Ponvory - EMEA/H/C/005163 - IB/0006
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
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.