Temozolomide HEXAL

Medicinal product

(Invented) name

Temozolomide HEXAL

Active substance (s)

Temozolomidas

Strength

250 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	250 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
40752	54489	1054489	buteliukas	N5		Receptinis	EU/1/10/616/021	Netiekiama	-	-	No	-	-
40753	54490	1054490	buteliukas	N20		Receptinis	EU/1/10/616/022	Netiekiama	-	-	No	-	-
53489	67471	1067471	paketėlis	N5x1 (vienadozis)		Receptinis	EU/1/10/616/035	Netiekiama	-	-	No	-	-
53490	67472	1067472	paketėlis	N20x1 (vienadozis)		Receptinis	EU/1/10/616/036	Netiekiama	-	-	No	-	-
61067	75379	1075379	buteliukas	N20 (4x5) (sudėtinė)		Receptinis	EU/1/10/616/042	Netiekiama	-	-	No	-	-

Stadijos

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