Temozolomide Sun

Medicinal product

(Invented) name

Temozolomide Sun

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)

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	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
54400	68396	1068396	dalomoji lizdinė plokštelė	N5x1		Receptinis	EU/1/11/697/021	Netiekiama	-	-	No	-	-
54401	68397	1068397	dalomoji lizdinė plokštelė	N20x1		Receptinis	EU/1/11/697/022	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-07-13	Registruotas