Ruxolitinib MSN

Medicinal product

(Invented) name

Ruxolitinib MSN

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

MSN Labs Europe Limited, Malta

Date of authorisation

2026-07-17

Date of renewal

Documents

6086_7_8_pakuotes lapelis_2026-07-17.docx

6086_7_8_Ruxolitinib MSN.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/6248/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

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
121653	107763	1107763	dalomoji lizdinė plokštelė	N56×1		Receptinis	LT/1/26/6086/001	Netiekiama	-	-	No	-	-
121654	107764	1107764	lizdinė plokštelė	N56 (kalendorinė)	kalendorinė pakuotė	Receptinis	LT/1/26/6086/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-07-17	Registruotas