Levetiracetam Actavis Group

Medicinal product

(Invented) name

Levetiracetam Actavis Group

Active substance (s)

Levetiracetamas

Strength

100 mg/ml

Pharmaceutical form

geriamasis tirpalas

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

Yes

ATC code (s)

N03AX14, Levetiracetam

Marketing authorisation holder

Actavis Group PTC ehf., Islandija

Date of authorisation

2011-12-05

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

Oral solution	1 ml
Levetiracetamas	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
50342	64226	1064226	buteliukas	300 ml N1 (+10 ml geriamasis švrikštas)		Receptinis	EU/1/11/738/001	Netiekiama	-	-	No	-	-
50343	64227	1064227	buteliukas	300 ml N1 (+1 ml geriamasis švrikštas ir adapteris)		Receptinis	EU/1/11/738/002	Netiekiama	-	-	No	-	-
50344	64228	1064228	buteliukas	300 ml N1 (+3 ml geriamasis švrikštas ir adapteris)		Receptinis	EU/1/11/738/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-12-05	Registruotas