Temodal

Medicinal product

(Invented) name

Temodal

Active substance (s)

Temozolomidas

Strength

5 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)

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

capsules, hard	1 vnt.
Temozolomidas	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
50444	64330	1064330	paketėlis	N5		Receptinis	EU/1/98/096/024	Netiekiama	-	-	No	-	-
50445	64331	1064331	paketėlis	N20		Receptinis	EU/1/98/096/025	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
1999-01-26	Registruotas