Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Galapagos NV, Generaal De Wittelaan L11 A3, 2800 Mechelen, Belgium
Jyseleca 100 mg film-coated tablets.
Jyseleca 200 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Jyseleca 100 mg film-coated tablets: Beige 12 × 7 mm, capsule-shaped, film-coated tablet debossed with “GSI” on one side and “100” on the other side. Jyseleca 200 mg film-coated tablets: Beige 17 × 8 mm, capsule-shaped, film-coated tablet debossed with “GSI” on one side and “200” on the other side. |
Each film-coated tablet contains filgotinib maleate equivalent to 100 mg of filgotinib.
Excipient with known effect: Each 100 mg film-coated tablet contains 76 mg of lactose (as monohydrate).
Each film-coated tablet contains filgotinib maleate equivalent to 200 mg of filgotinib.
Excipient with known effect: Each 200 mg film-coated tablet contains 152 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Filgotinib |
Filgotinib is an adenosine triphosphate (ATP)-competitive and reversible inhibitor of the JAK family. Within the signalling pathway, JAKs phosphorylate and activate signal transducers and activators of transcription (STATs) which modulate intracellular activity including gene expression. Filgotinib modulates these signalling pathways by preventing the phosphorylation and activation of STATs. Filgotinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose Film-coating: Polyvinyl alcohol |
White, high-density polyethylene (HDPE) bottles, enclosed with a child-resistant polypropylene (PP) screw cap lined with an induction-sealed aluminium foil liner. Each bottle contains either a canister or sachet containing silica gel desiccant and polyester coil.
The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 (3 bottles of 30) film-coated tablets.
Not all pack sizes may be marketed.
Galapagos NV, Generaal De Wittelaan L11 A3, 2800 Mechelen, Belgium
Jyseleca 100 mg film-coated tablets:
EU/1/20/1480/001
EU/1/20/1480/002
Jyseleca 200 mg film-coated tablets:
EU/1/20/1480/003
EU/1/20/1480/004
Date of first authorisation: 24 September 2020
| Drug | Countries | |
|---|---|---|
| JYSELECA | Austria, Estonia, Finland, France, Croatia, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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