Temozolomide Sandoz

Medicinal product

(Invented) name

Temozolomide Sandoz

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

Sandoz GmbH, Austrija

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
40760	54497	1054497	buteliukas	N5 (stiklo)		Receptinis	EU/1/10/617/005	Netiekiama	-	-	No	-	-
40761	54498	1054498	buteliukas	N20		Receptinis	EU/1/10/617/006	Netiekiama	-	-	No	-	-
53683	67666	1067666	paketėlis	N5x1 (vienadozis)		Receptinis	EU/1/10/617/027	Netiekiama	-	-	No	-	-
53684	67667	1067667	paketėlis	N20x1 (vienadozis)		Receptinis	EU/1/10/617/028	Netiekiama	-	-	No	-	-

Stadijos

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