Zelboraf

Medicinal product

(Invented) name

Zelboraf

Active substance (s)

Vemurafenibas

Strength

240 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)

L01EC01, vemurafenib

Marketing authorisation holder

Roche Registration GmbH, Vokietija

Date of authorisation

2012-02-17

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.
Vemurafenibas	240 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
51247	65140	1065140	lizdinė plokštelė	N56		Receptinis	EU/1/12/751/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-02-17	Registruotas