Temozolomide HEXAL

Medicinal product

(Invented) name

Temozolomide HEXAL

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

Hexal AG, Vokietija

Date of authorisation

2010-03-15

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Capsule, 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
40732	54469	1054469	buteliukas	N5		Receptinis	EU/1/10/616/001	Netiekiama	-	-	No	-	-
40733	54470	1054470	buteliukas	N20		Receptinis	EU/1/10/616/002	Netiekiama	-	-	No	-	-
53491	67473	1067473	paketėlis	N5x1 (vienadozis)		Receptinis	EU/1/10/616/025	Netiekiama	-	-	No	-	-
53492	67474	1067474	paketėlis	N20x1 (vienadozis)		Receptinis	EU/1/10/616/026	Netiekiama	-	-	No	-	-
61068	75380	1075380	buteliukas	N20 (4x5) (sudėtinė)		Receptinis	EU/1/10/616/037	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-09-15	Išregistruotas
2010-03-15	Registruotas