Temozolomide HEXAL

Medicinal product

(Invented) name

Temozolomide HEXAL

Active substance (s)

Temozolomidas

Strength

140 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	140 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
40744	54481	1054481	buteliukas	N5		Receptinis	EU/1/10/616/013	Netiekiama	-	-	No	-	-
40745	54482	1054482	buteliukas	N20		Receptinis	EU/1/10/616/014	Netiekiama	-	-	No	-	-
53499	67481	1067481	paketėlis	N5x1 (vienadozis)		Receptinis	EU/1/10/616/031	Netiekiama	-	-	No	-	-
53500	67482	1067482	paketėlis	N20x1 (vienadozis)		Receptinis	EU/1/10/616/032	Netiekiama	-	-	No	-	-
61071	75383	1075383	buteliukas	N20 (4x5) (sudėtinė)		Receptinis	EU/1/10/616/040	Netiekiama	-	-	No	-	-

Stadijos

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