JYSELECA

This brand name is authorized in Austria, Estonia, Finland, France, Croatia, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom

Active ingredients

The drug JYSELECA contains one active pharmaceutical ingredient (API):

1 Filgotinib UNII JG8OB4UL9Y - FILGOTINIB MALEATE

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. Read about Filgotinib

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
JYSELECA Film-coated tablet	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
L04AF04		L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AF Janus-associated kinase (JAK) inhibitors
Discover more medicines within L04AF04

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: EE	Ravimiamet	Identifier(s): 1828649, 1828650, 1828661, 1828672
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 456041, 563137
Country: FR	Base de données publique des médicaments	Identifier(s): 61867201, 69858631
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 390431, 390436
Country: IE	Health Products Regulatory Authority	Identifier(s): 89059, 89060
Country: IT	Agenzia del Farmaco	Identifier(s): 049054012, 049054024, 049054036, 049054048
Country: JP	医薬品医療機器総合機構	Identifier(s): 3999053F1023, 3999053F2020
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1091250, 1091251, 1091252, 1091253
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 204951, 204978
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100441818, 100441824
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W68379001, W68379002, W68380001, W68380002