Tafinlar

Medicinal product

(Invented) name

Tafinlar

Active substance (s)

Dabrafenibas

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)

L01EC02, dabrafenib

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2013-08-26

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

Capsules, hard	1 vnt.
Dabrafenibas	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
57055	71167	1071167	buteliukas	N28		Receptinis	EU/1/13/865/003	Netiekiama	-	-	No	-	-
57056	71168	1071168	buteliukas	N120		Receptinis	EU/1/13/865/004	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-08-26	Registruotas