Temozolomide Sandoz

Medicinal product

(Invented) name

Temozolomide Sandoz

Active substance (s)

Temozolomidas

Strength

100 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	100 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
40764	54501	1054501	buteliukas	N5 (stiklo)		Receptinis	EU/1/10/617/009	Netiekiama	-	-	No	-	-
40765	54502	1054502	buteliukas	N20		Receptinis	EU/1/10/617/010	Netiekiama	-	-	No	-	-
53685	67668	1067668	paketėlis	N5x1 (vienadozis)		Receptinis	EU/1/10/617/029	Netiekiama	-	-	No	-	-
53686	67669	1067669	paketėlis	N20x1 (vienadozis)		Receptinis	EU/1/10/617/030	Netiekiama	-	-	No	-	-

Stadijos

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