Ruxolitinib Viatris

Medicinal product

(Invented) name

Ruxolitinib Viatris

Active substance (s)

Ruksolitinibas

Strength

5 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01EJ01, ruxolitinib

Marketing authorisation holder

Viatris Limited, Airija

Date of authorisation

2026-09-18

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Ruksolitinibas	5 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
122424	108536	1108536	lizdinė plokštelė	N56		Receptinis	EU/1/26/2064/001	Netiekiama	-	-	No	-	-
122425	108537	1108537	lizdinė plokštelė	N56 (kalendorinė)	kalendorinė pakuotė	Receptinis	EU/1/26/2064/002	Netiekiama	-	-	No	-	-
122426	108538	1108538	dalomoji lizdinė plokštelė	N56×1		Receptinis	EU/1/26/2064/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-09-18	Registruotas