Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Mylan Ireland Limited, Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
Dimethyl fumarate Mylan 120 mg gastro-resistant hard capsules.
Dimethyl fumarate Mylan 240 mg gastro-resistant hard capsules.
| Pharmaceutical Form |
|---|
|
Gastro-resistant hard capsule (gastro-resistant capsule). Dimethyl fumarate Mylan 120 mg gastro-resistant hard capsules: Blue-green and white gastro-resistant hard capsules, 21.7 mm in length, printed with ‘MYLAN’ over ‘DF-120’ containing white to off-white enteric coated pellets. Dimethyl fumarate Mylan 240 mg gastro-resistant hard capsules: Blue-green gastro-resistant hard capsules, 21.7 mm in length, printed with ‘MYLAN’ over ‘DF-240’ containing white to off-white enteric coated pellets. |
Dimethyl fumarate Mylan 120 mg gastro-resistant hard capsules: Each gastro-resistant hard capsule contains 120 mg dimethyl fumarate.
Dimethyl fumarate Mylan 240 mg gastro-resistant hard capsules: Each gastro-resistant hard capsule contains 240 mg dimethyl fumarate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dimethyl fumarate |
The anti-inflammatory and immunomodulating effects of dimethyl fumarate and its metabolite monomethyl fumarate are not fully elucidated but are thought to be mainly due to the interaction with the intracellular reduced glutathione of cells directly involved in the pathogenesis of psoriasis. Their main activity is considered to be immunomodulatory, resulting in a shift in T helper cells (Th) from the Th1 and Th17 profile to a Th2 phenotype. |
| List of Excipients |
|---|
|
Capsule contents (enteric-coated pellets): Microcrystalline cellulose Capsule shell: Gelatin Capsule print (black ink): Shellac |
120 mg gastro-resistant hardcapsules: 14 gastro-resistant hard capsules in PVC/PE/PVdC aluminium blister packs and unit dose blister packs and white High density polyethylene (HDPE) bottles with a white opaque polypropylene screw cap with aluminium induction seal liner wad containing 14 or 60 gastro-resistant hard capsules.
240 mg gastro-resistant hard capsules 56 or 168 gastro-resistant hard capsules in PVC/PE/PVdC aluminium blister packs and unit dose blister packs and white High density polyethylene (HDPE) bottles with a white opaque polypropylene screw cap with aluminium induction seal liner wad containing 56 or 168 gastro-resistant hard capsules.
Not all pack sizes may be marketed.
Mylan Ireland Limited, Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
Dimethyl fumarate Mylan 120 mg gastro-resistant hard capsules:
EU/1/22/1634/001
EU/1/22/1634/002
EU/1/22/1634/003
EU/1/22/1634/004
Dimethyl fumarate Mylan 240 mg gastro-resistant hard capsules:
EU/1/22/1634/005
EU/1/22/1634/006
EU/1/22/1634/007
EU/1/22/1634/008
EU/1/22/1634/009
EU/1/22/1634/010
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