COMETRIQ

Medicinal product

(Invented) name

COMETRIQ

Active substance (s)

Kabozantinibas

Strength

20 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)

L01EX07, cabozantinib

Marketing authorisation holder

Ipsen Pharma, Prancūzija

Date of authorisation

2014-03-21

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

Hard capsules	1 vnt.
Kabozantinibas	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
58870	73087	1073087	lizdinė plokštelė	N21x20 mg (60 mg/d dozė, kiekis 7 dienoms)		Receptinis	EU/1/13/890/001	Netiekiama	-	-	No	-	-
63278	77694	1077694	lizdinė plokštelė	N84		Receptinis	EU/1/13/890/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-03-21	Registruotas