Erivedge

Medicinal product

(Invented) name

Erivedge

Active substance (s)

Vismodegibas

Strength

150 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)

L01XJ01, vismodegib

Marketing authorisation holder

Roche Registration GmbH, Vokietija

Date of authorisation

2013-07-12

Date of renewal

Documents

Erivedge mokomoji medziaga sveikatos prieziuros specialistams.pdf

Erivedge mokomoji medziaga pacientams.pdf

Erivedge mokomoji medziaga sveikatos prieziuros specialistams2.pdf

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Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Hard capsule	1 vnt.
Vismodegibas	150 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
56762	70868	1070868	buteliukas	N28		Receptinis	EU/1/13/848/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-07-12	Registruotas