Erbitux

Medicinal product

(Invented) name

Erbitux

Active substance (s)

Cetuksimabas

Strength

5 mg/ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01FE01, cetuximab

Marketing authorisation holder

Merck Europe B.V., Nyderlandai

Date of authorisation

2007-02-20

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

Solution for infusion	1 ml
Cetuksimabas	5 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
25438	28046	1028046	flakonas	20 ml, N1		Receptinis	EU/1/04/281/003	Tiekiama	-	-	No	-	-
25440	28048	1028048	flakonas	100 ml, N1		Receptinis	EU/1/04/281/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-02-20	Registruotas