Temomedac

Medicinal product

(Invented) name

Temomedac

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

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

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
39268	52951	1052951	buteliukas	N5		Receptinis	EU/1/09/605/001	Netiekiama	-	-	No	-	-
39269	52952	1052952	buteliukas	N20		Receptinis	EU/1/09/605/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-01-25	Registruotas