Temozolomide HEXAL

Medicinal product

(Invented) name

Temozolomide HEXAL

Active substance (s)

Temozolomidas

Strength

180 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	180 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
40748	54485	1054485	buteliukas	N5		Receptinis	EU/1/10/616/017	Netiekiama	-	-	No	-	-
40749	54486	1054486	buteliukas	N20		Receptinis	EU/1/10/616/018	Netiekiama	-	-	No	-	-
53501	67483	1067483	paketėlis	N5x1 (vienadozis)		Receptinis	EU/1/10/616/033	Netiekiama	-	-	No	-	-
53502	67484	1067484	paketėlis	N20x1 (vienadozis)		Receptinis	EU/1/10/616/034	Netiekiama	-	-	No	-	-
61072	75384	1075384	buteliukas	N20 (4x5) (sudėtinė)		Receptinis	EU/1/10/616/041	Netiekiama	-	-	No	-	-

Stadijos

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