Bosutinib MSN

Medicinal product

(Invented) name

Bosutinib MSN

Active substance (s)

Bozutinibas

Strength

100 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)

L01EA04, bosutinib

Marketing authorisation holder

MSN Labs Europe Limited, Malta

Date of authorisation

2025-04-24

Date of renewal

Documents

5758-5759-5760_Bosutinib MSN.docx

5758-59-60_pakuotes lapelis_2025-04-24.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

CZ/H/1293/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Bozutinibas	100 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
117270	103370	1103370	lizdinė plokštelė	N28		Receptinis	LT/1/25/5758/001	Netiekiama	-	-	No	-	-
117271	103371	1103371	lizdinė plokštelė	N30		Receptinis	LT/1/25/5758/002	Netiekiama	-	-	No	-	-
117272	103372	1103372	lizdinė plokštelė	N112		Receptinis	LT/1/25/5758/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-04-24	Registruotas