Temozolomide Sandoz

Medicinal product

(Invented) name

Temozolomide Sandoz

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

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	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
40768	54505	1054505	buteliukas	N5 (stiklo)		Receptinis	EU/1/10/617/013	Netiekiama	-	-	No	-	-
40769	54506	1054506	buteliukas	N20		Receptinis	EU/1/10/617/014	Netiekiama	-	-	No	-	-
53687	67670	1067670	paketėlis	N5x1 (vienadozis)		Receptinis	EU/1/10/617/031	Netiekiama	-	-	No	-	-
53688	67671	1067671	paketėlis	N20x1 (vienadozis)		Receptinis	EU/1/10/617/032	Netiekiama	-	-	No	-	-

Stadijos

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