IBRANCE

Medicinal product

(Invented) name

IBRANCE

Active substance (s)

Palbociklibas

Strength

75 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01EF01, palbociclib

Marketing authorisation holder

Pfizer Europe MA EEIG, Belgija

Date of authorisation

2016-11-09

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

Capsule, hard	1 vnt.
Palbociklibas	75 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
67083	81626	1081626	lizdinė plokštelė	N21		Receptinis	EU/1/16/1147/001	Netiekiama	-	-	No	-	-
67084	81627	1081627	buteliukas	N21		Receptinis	EU/1/16/1147/002	Netiekiama	-	-	No	-	-
99230	85336	1085336	lizdinė plokštelė	N63		Receptinis	EU/1/16/1147/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-11-09	Registruotas