Temozolomide HEXAL

Medicinal product

(Invented) name

Temozolomide HEXAL

Active substance (s)

Temozolomidas

Strength

100 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	100 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
40740	54477	1054477	buteliukas	N5		Receptinis	EU/1/10/616/009	Netiekiama	-	-	No	-	-
40741	54478	1054478	buteliukas	N20		Receptinis	EU/1/10/616/010	Netiekiama	-	-	No	-	-
53497	67479	1067479	paketėlis	N5x1 (vienadozis)		Receptinis	EU/1/10/616/029	Netiekiama	-	-	No	-	-
53498	67480	1067480	paketėlis	N20x1 (vienadozis)		Receptinis	EU/1/10/616/030	Netiekiama	-	-	No	-	-
61070	75382	1075382	buteliukas	N20 (4x5) (sudėtinė)		Receptinis	EU/1/10/616/039	Netiekiama	-	-	No	-	-

Stadijos

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