JYSELECA Film-coated tablet Ref.[11006] Active ingredients: Filgotinib

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Galapagos NV, Generaal De Wittelaan L11 A3, 2800 Mechelen, Belgium

Product name and form

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.

Qualitative and quantitative composition

Jyseleca 100 mg film-coated tablets

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).

Jyseleca 200 mg film-coated tablets

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
Lactose monohydrate
Pregelatinised starch
Colloidal silicon dioxide
Fumaric acid
Magnesium stearate

Film-coating:

Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol
Talc
Iron oxide yellow (E172)
Iron oxide red (E172)

Pack sizes and marketing

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.

Marketing authorization holder

Galapagos NV, Generaal De Wittelaan L11 A3, 2800 Mechelen, Belgium

Marketing authorization dates and numbers

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

Drugs

Drug Countries
JYSELECA Austria, Estonia, Finland, France, Ireland, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom

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