Temodal

Medicinal product

(Invented) name

Temodal

Active substance (s)

Temozolomidas

Strength

2,5 mg/ml

Pharmaceutical form

milteliai infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01AX03, Temozolomide

Marketing authorisation holder

Merck Sharp & Dohme B.V., Nyderlandai

Date of authorisation

1999-01-26

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

Powder for solution for infusion	1 ml
Temozolomidas	2,5 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
34183	36538	1036538	flakonas	N1		Receptinis	EU/1/98/096/023	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
1999-01-26	Registruotas