Stivarga

Medicinal product

(Invented) name

Stivarga

Active substance (s)

Regorafenibas

Strength

40 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)

L01EX05, regorafenib

Marketing authorisation holder

Bayer AG, Vokietija

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

Film-coated tablet	1 vnt.
Regorafenibas	40 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
57049	71161	1071161	buteliukas	N28		Receptinis	EU/1/13/858/001	Netiekiama	-	-	No	-	-
57050	71162	1071162	buteliukas	N84 (3x28)		Receptinis	EU/1/13/858/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-08-26	Registruotas