IBRANCE

Medicinal product

(Invented) name

IBRANCE

Active substance (s)

Palbociklibas

Strength

75 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)

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

Film-coated tablet	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
103336	89438	1089438	lizdinė plokštelė	N21 (PVC/OPA/alu/PVC/alu)		Receptinis	EU/1/16/1147/010	Netiekiama	-	-	No	-	-
103337	89439	1089439	lizdinė plokštelė	N63		Receptinis	EU/1/16/1147/011	Netiekiama	-	-	No	-	-
109686	95792	1095792	lizdinė plokštelė	N21 (PVC/OPA/Al/PVC/Al) dėklo kortelėje		Receptinis	EU/1/16/1147/016	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-11-09	Registruotas