Temomedac

Medicinal product

(Invented) name

Temomedac

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)

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	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
39276	52959	1052959	buteliukas	N5		Receptinis	EU/1/09/605/007	Netiekiama	-	-	No	-	-
39277	52960	1052960	buteliukas	N20		Receptinis	EU/1/09/605/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-01-25	Registruotas