Source: European Medicines Agency (EU) Revision Year: 2020 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: White, film-coated, round, biconvex tablet with a diameter of approximately 6.8 mm. Skilarence 120 mg: Blue, film-coated, round, biconvex tablet with a diameter of approximately 11.6 mm. |
Skilarence 30 mg: Each gastro-resistant tablet contains 30 mg dimethyl fumarate.
Skilarence 120 mg: Each gastro-resistant tablet contains 120 mg dimethyl fumarate.
Excipient with known effect:
Skilarence 30 mg: Each gastro-resistant tablet contains 34.2 mg lactose (as monohydrate).
Skilarence 120 mg: Each gastro-resistant tablet contains 136.8 mg lactose (as monohydrate).
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 |
|---|
|
Core: Lactose monohydrate Coating: Skilarence 30 mg: Methacrylic acid-ethyl acrylate copolymer (1:1) Skilarence 120 mg: Methacrylic acid-ethyl acrylate copolymer (1:1) |
Skilarence 30 mg: 42, 70 and 210 gastro-resistant tablets in PVC/PVDC-aluminium blister packs.
Skilarence 120 mg: 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
| Drug | Countries | |
|---|---|---|
| SKILARENCE | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, United Kingdom |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
