Cotellic

Medicinal product

(Invented) name

Cotellic

Active substance (s)

Kobimetinibas

Strength

20 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)

L01EE02, cobimetinib

Marketing authorisation holder

Roche Registration GmbH, Vokietija

Date of authorisation

2015-11-20

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.
Kobimetinibas	20 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
64386	78869	1078869	lizdinė plokštelė	N63 (3x21)		Receptinis	EU/1/15/1048/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-11-20	Registruotas