Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Biogen Netherlands B.V., Prins Mauritslaan 13, 1171 LP Badhoevedorp, The Netherlands
Tecfidera 120 mg gastro-resistant hard capsules.
Tecfidera 240 mg gastro-resistant hard capsules.
| Pharmaceutical Form |
|---|
|
Gastro-resistant hard capsule. Tecfidera 120 mg gastro-resistant hard capsules: Green and white gastro-resistant hard capsules, size 0, printed with ‘BG-12 120 mg’ containing microtablets. Tecfidera 240 mg gastro-resistant hard capsules: Green gastro-resistant hard capsules, size 0, printed with ‘BG-12 240 mg’ containing microtablets. |
Tecfidera 120 mg gastro-resistant hard capsules: Each gastro-resistant hard capsule contains 120 mg dimethyl fumarate.
Tecfidera 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 microtablets): Microcrystalline cellulose Capsule shell: Gelatin Capsule print (black ink): Shellac |
120 mg capsules: 14 capsules in PVC/PE/PVDC-PVC aluminium blister packs.
240 mg capsules: 56 or 168 capsules in PVC/PE/PVDC-PVC aluminium blister packs.
Not all pack sizes may be marketed.
Biogen Netherlands B.V., Prins Mauritslaan 13, 1171 LP Badhoevedorp, The Netherlands
EU/1/13/837/001
EU/1/13/837/002
EU/1/13/837/003
Date of first authorisation: 30 January 2014
Date of latest renewal: 20 September 2018
| Drug | Countries | |
|---|---|---|
| TECFIDERA | Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States |
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