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Dimethyl Fumarate Mylan



Mylan IRE Healthcare LimitedEU/1/22/1634/001-0004

Main Information

Trade NameDimethyl Fumarate Mylan
Active SubstancesDimethyl Fumarate
Dosage FormGastro-resistant capsule, hard
Licence HolderMylan IRE Healthcare Limited
Licence NumberEU/1/22/1634/001-0004

Group Information

ATC CodeL04AX07 dimethyl fumarate

Status

License statusAuthorised
Licence Issued13/05/2022
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
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