Temozolomide Sun

Medicinal product

(Invented) name

Temozolomide Sun

Active substance (s)

Temozolomidas

Strength

5 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

L01AX03, Temozolomide

Marketing authorisation holder

Sun Pharmaceutical Industries Europe B. V., Nyderlandai

Date of authorisation

2011-07-13

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Capsule, hard	1 vnt.
Temozolomidas	5 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
54392	68388	1068388	dalomoji lizdinė plokštelė	N5x1		Receptinis	EU/1/11/697/013	Netiekiama	-	-	No	-	-
54393	68389	1068389	dalomoji lizdinė plokštelė	N20x1		Receptinis	EU/1/11/697/014	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-07-13	Registruotas