JYSELECA

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

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 more about Filgotinib

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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