Temozolomide HEXAL

Medicinal product

(Invented) name

Temozolomide HEXAL

Active substance (s)

Temozolomidas

Strength

20 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	20 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
40736	54473	1054473	buteliukas	N5		Receptinis	EU/1/10/616/005	Netiekiama	-	-	No	-	-
40737	54474	1054474	buteliukas	N20		Receptinis	EU/1/10/616/006	Netiekiama	-	-	No	-	-
53495	67477	1067477	paketėlis	N5x1 (vienadozis)		Receptinis	EU/1/10/616/027	Netiekiama	-	-	No	-	-
53496	67478	1067478	paketėlis	N20x1 (vienadozis)		Receptinis	EU/1/10/616/028	Netiekiama	-	-	No	-	-
61069	75381	1075381	buteliukas	N20 (4x5) (sudėtinė)		Receptinis	EU/1/10/616/038	Netiekiama	-	-	No	-	-

Stadijos

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