IBRANCE

Medicinal product

(Invented) name

IBRANCE

Active substance (s)

Palbociklibas

Strength

100 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	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
67085	81628	1081628	lizdinė plokštelė	N21		Receptinis	EU/1/16/1147/003	Netiekiama	-	-	No	-	-
67086	81629	1081629	buteliukas	N21		Receptinis	EU/1/16/1147/004	Netiekiama	-	-	No	-	-
99231	85337	1085337	lizdinė plokštelė	N63		Receptinis	EU/1/16/1147/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-11-09	Registruotas