Overview
This marketing authorisation has been revoked by the European Commission in order to implement the judgment of the Court of Justice of 16 March 2023 in Commission and Others v Pharmaceutical Works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.
Dimethyl fumarate Mylan : EPAR - Medicine Overview
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Dimethyl fumarate Mylan : EPAR - Risk management plan summary
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Product information
Dimethyl fumarate Mylan : EPAR - Product Information
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13/12/2023
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).
Dimethyl fumarate Mylan : EPAR - All authorised presentations
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eesti keel (ET) (127.08 KB - PDF)
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italiano (IT) (132.43 KB - PDF)
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lietuvių kalba (LT) (127.96 KB - PDF)
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română (RO) (126.05 KB - PDF)
slovenčina (SK) (135.46 KB - PDF)
slovenščina (SL) (131.65 KB - PDF)
Suomi (FI) (126.81 KB - PDF)
svenska (SV) (125.26 KB - PDF)
Product details
- Name of medicine
- Dimethyl fumarate Mylan
- 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 Mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.
Authorisation details
- EMA product number
- EMEA/H/C/005956
Generic
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.
- Marketing authorisation holder
- Mylan Ireland Limited
Unit 35/36
Grange Parade
Baldoye
Industrial Estate
Dublin 13
Ireland - Opinion adopted
- 24/02/2022
- Marketing authorisation issued
- 13/05/2022
- Revocation of marketing authorisation
- 13/12/2023
- Revision
- 5
Assessment history
Dimethyl fumarate Mylan : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (235.66 KB - PDF)
News on Dimethyl fumarate Mylan
More information on Dimethyl fumarate Mylan
Public statement on Dimethyl fumarate Mylan : Revocation of the marketing authorisation in the European Union
English (EN) (117.74 KB - PDF)