Temozolomide Accord

Medicinal product

(Invented) name

Temozolomide Accord

Active substance (s)

Temozolomidas

Strength

100 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	100 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
39946	53651	1053651	buteliukas	N5 (stiklo)		Receptinis	EU/1/10/615/009	Netiekiama	-	-	No	-	-
39947	53652	1053652	buteliukas	N20		Receptinis	EU/1/10/615/010	Netiekiama	-	-	No	-	-
66316	80841	1080841	paketėlis	N5		Receptinis	EU/1/10/615/029	Tiekiama	-	-	No	-	-
66317	80842	1080842	paketėlis	N20		Receptinis	EU/1/10/615/030	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-03-15	Registruotas