Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Almirall, S.A., Ronda General Mitre, 151, 08022, Barcelona, Spain
Skilarence 30 mg gastro-resistant tablets.
Skilarence 120 mg gastro-resistant tablets.
| Pharmaceutical Form |
|---|
|
Gastro-resistant tablet. Skilarence 30 mg gastro-resistant tablets: White, film-coated, round, biconvex tablet with a diameter of approximately 6.8 mm. Skilarence 120 mg gastro-resistant tablets: Blue, film-coated, round, biconvex tablet with a diameter of approximately 11.6 mm. |
Each gastro-resistant tablet contains 30 mg dimethyl fumarate.
Excipient with known effect: Each gastro-resistant tablet contains 34.2 mg lactose (as monohydrate).
Each gastro-resistant tablet contains 120 mg dimethyl fumarate.
Excipient with known effect: Each gastro-resistant tablet contains 136.8 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
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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. The mechanism by which dimethyl fumarate exerts therapeutic effects in multiple sclerosis is not fully understood. |
| List of Excipients |
|---|
|
Skilarence 30 mg and 120 mg gastro-resistant tablets: Core Lactose monohydrate Skilarence 30 mg gastro-resistant tablets: Coating Methacrylic acid-ethyl acrylate copolymer (1:1) Skilarence 120 mg gastro-resistant tablets: Coating Methacrylic acid-ethyl acrylate copolymer (1:1) |
Skilarence 30 mg gastro-resistant tablets: 42, 70 and 210 gastro-resistant tablets in PVC/PVDC-aluminium blister packs.
Skilarence 120 mg gastro-resistant tablets: 40, 70, 90, 100, 120, 180, 200, 240, 300, 360 and 400 gastro-resistant tablets in PVC/PVDC-aluminium blister packs.
Not all pack sizes may be marketed.
Almirall, S.A., Ronda General Mitre, 151, 08022, Barcelona, Spain
EU/1/17/1201/001
EU/1/17/1201/002
EU/1/17/1201/003
EU/1/17/1201/004
EU/1/17/1201/005
EU/1/17/1201/006
EU/1/17/1201/007
EU/1/17/1201/008
EU/1/17/1201/009
EU/1/17/1201/010
EU/1/17/1201/011
EU/1/17/1201/012
EU/1/17/1201/013
EU/1/17/1201/014
Date of first authorisation: 23 June 2017
Date of latest renewal: 21 February 2022
| Drug | Countries | |
|---|---|---|
| SKILARENCE | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, United Kingdom |
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