Prepalepan

Medicinal product

(Invented) name

Prepalepan

Active substance (s)

Levetiracetamas

Strength

5 mg/ml

Pharmaceutical form

infuzinis tirpalas

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

EVER Neuro Pharma GmbH, Austrija

Date of authorisation

2013-12-27

Date of renewal

Documents

3472_1_3 Prepalepan inf PCS PL keit.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename mililitre yra	1 ml
Levetiracetamas	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
53836	67821	1067821	maišelis	100 ml N10		Receptinis	LT/1/13/3472/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-05-05	Išregistruotas
2013-12-27	Registruotas