Bosulif

Medicinal product

(Invented) name

Bosulif

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

Pfizer Europe MA EEIG, Belgija

Date of authorisation

2013-03-27

Date of renewal

Documents

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 tablets	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
55844	69897	1069897	lizdinė plokštelė	N28		Receptinis	EU/1/13/818/001	Netiekiama	2025-04-14	2025-12-31	Yes	2025-07-04	2025-12-31
55845	69898	1069898	lizdinė plokštelė	N30		Receptinis	EU/1/13/818/002	Netiekiama	-	-	No	-	-
59861	74112	1074112	lizdinė plokštelė	N112		Receptinis	EU/1/13/818/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-03-27	Registruotas