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

UAB AURE FARMA, Lietuva

Date of authorisation

2017-09-28

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

CR-Lygiagretus platinimas

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
97929	84025	1084025	lizdinė plokštelė	N56		Receptinis	EU/1/12/751/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-09-28	Registruotas