COMETRIQ

Medicinal product

(Invented) name

COMETRIQ

Active substance (s)

Kabozantinibas+Kabozantinibas

Strength

20 mg + 80 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 (20 mg)	1 vnt.
Kabozantinibas	20 mg
Hard capsules (80 mg)	1 vnt.
Kabozantinibas	80 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
58871	73088	1073088	lizdinė plokštelė	N7x20 mg; N7x80 mg (100 mg/d dozė, 7 dienoms)		Receptinis	EU/1/13/890/002	Netiekiama	-	-	No	-	-
58872	73089	1073089	lizdinė plokštelė	N21x20 mg; N7x80 mg (140 mg/d dozė, 7 dienoms)		Receptinis	EU/1/13/890/003	Netiekiama	-	-	No	-	-
63279	77695	1077695	lizdinė plokštelė	N28x20 mg + N28x80 mg		Receptinis	EU/1/13/890/005	Netiekiama	-	-	No	-	-
63280	77696	1077696	lizdinė plokštelė	N84x20 mg + N28x80 mg		Receptinis	EU/1/13/890/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-03-21	Registruotas