Jyseleca

Medicinal product

(Invented) name

Jyseleca

Active substance (s)

Filgotinibas

Strength

200 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AF04, filgotinib

Marketing authorisation holder

Alfasigma S.p.A., Italija

Date of authorisation

2020-09-24

Date of renewal

Documents

Jyseleca mokomoji medziaga sveikatos prieziuros specialistams.pdf

Jyseleca paciento kortele.pdf

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Filgotinibas	200 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
105150	91252	1091252	buteliukas	N30		Receptinis	EU/1/20/1480/003	Netiekiama	-	-	No	-	-
105151	91253	1091253	buteliukas	N90 (3x30)		Receptinis	EU/1/20/1480/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-09-24	Registruotas