Temomedac

Medicinal product

(Invented) name

Temomedac

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

medac Gesellschaft für klinische Spezialpräparate mbH, Vokietija

Date of authorisation

2010-01-25

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

Capsules, 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
39278	52961	1052961	buteliukas	N5		Receptinis	EU/1/09/605/009	Netiekiama	-	-	No	-	-
39279	52962	1052962	buteliukas	N20		Receptinis	EU/1/09/605/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-01-25	Registruotas