Temozolomide Accord

Medicinal product

(Invented) name

Temozolomide Accord

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)

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	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
39950	53655	1053655	buteliukas	N5 (stiklo)		Receptinis	EU/1/10/615/013	Netiekiama	-	-	No	-	-
39951	53656	1053656	buteliukas	N20		Receptinis	EU/1/10/615/014	Netiekiama	-	-	No	-	-
66318	80843	1080843	paketėlis	N5		Receptinis	EU/1/10/615/031	Tiekiama	-	-	No	-	-
66319	80844	1080844	paketėlis	N20		Receptinis	EU/1/10/615/032	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-03-15	Registruotas