IBRANCE

Medicinal product

(Invented) name

IBRANCE

Active substance (s)

Palbociklibas

Strength

125 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	125 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
103334	89436	1089436	lizdinė plokštelė	N21 (PVC/OPA/alu/PVC/alu)		Receptinis	EU/1/16/1147/014	Netiekiama	-	-	No	-	-
103335	89437	1089437	lizdinė plokštelė	N63		Receptinis	EU/1/16/1147/015	Netiekiama	-	-	No	-	-
109688	95794	1095794	lizdinė plokštelė	N21 (PVC/OPA/Al/PVC/Al) dėklo kortelėje		Receptinis	EU/1/16/1147/018	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-11-09	Registruotas