Keppra

Medicinal product

(Invented) name

Keppra

Active substance (s)

Levetiracetamas

Strength

100 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

Yes

ATC code (s)

N03AX14, Levetiracetam

Marketing authorisation holder

UCB Pharma S.A., Belgija

Date of authorisation

2006-03-29

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Concentrate for solution for infusion	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
26421	28999	1028999	flakonas	5 ml N10		Receptinis	EU/1/00/146/001	Netiekiama	-	-	No	-	-
54836	68858	1068858	flakonas	5 ml N1 (politetrafluoretilenu dengtas kamštis)		Receptinis	EU/1/00/146/030	Netiekiama	-	-	No	-	-
54837	68859	1068859	flakonas	5 ml N10 (nedengtas kamštis)		Receptinis	EU/1/00/146/033	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2006-03-29	Registruotas