- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 13 December 2023, the European Commission revoked the marketing authorisation for Dimethyl fumarate Polpharma (dimethyl fumarate) in the European Union (EU). Dimethyl fumarate Polpharma was a generic medicine of Tecfidera. The marketing authorisation holder for the medicine was Zakłady Farmaceutyczne Polpharma S.A.
The revocation of the marketing authorisation was necessary in order to implement the judgment of the Court of Justice of 16 March 2023 in Commission and Others v Pharmaceutical Works Polpharma, Cases C-438/21 P to C-440/21 P. It follows from that judgment that the marketing authorisation for Dimethyl fumarate Polpharma was submitted at a point in time when the regulatory data protection period of the reference product (Tecfidera) had not expired.
Further information in relation to the revocation of Dimethyl fumarate Polpharma may be found in the Commission Implementing Decision revoking the marketing authorisation, which is available on the Union Register of medicinal products for human use. Dimethyl fumarate Polpharma was granted marketing authorisation in the EU on 13 May 2022 for treatment of relapsing remitting multiple sclerosis (RRMS).
The European Public Assessment Report (EPAR) for Dimethyl fumarate Polpharma is updated to indicate that the marketing authorisation is no longer valid.
Product information
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).
Product details
- Name of medicine
- Dimethyl fumarate Polpharma
- Active substance
- dimethyl fumarate
- International non-proprietary name (INN) or common name
- dimethyl fumarate
- Therapeutic area (MeSH)
- Multiple Sclerosis, Relapsing-Remitting
- Anatomical therapeutic chemical (ATC) code
- L04AX07
Pharmacotherapeutic group
ImmunosuppressantsTherapeutic indication
Dimethyl fumarate Polpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.