Temozolomide Accord

Medicinal product

(Invented) name

Temozolomide Accord

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)

No

ATC code (s)

L01AX03, Temozolomide

Marketing authorisation holder

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2010-03-15

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

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
39936	53641	1053641	buteliukas	N5 (stiklo)		Receptinis	EU/1/10/615/001	Netiekiama	-	-	No	-	-
39937	53642	1053642	buteliukas	N20 (stiklo)		Receptinis	EU/1/10/615/002	Netiekiama	-	-	No	-	-
66312	80837	1080837	paketėlis	N5		Receptinis	EU/1/10/615/025	Netiekiama	-	-	No	-	-
66313	80838	1080838	paketėlis	N20		Receptinis	EU/1/10/615/026	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-03-15	Registruotas