Levetiracetam Kalceks

Medicinal product

(Invented) name

Levetiracetam Kalceks

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

AS Kalceks, Latvija

Date of authorisation

2026-01-16

Date of renewal

Documents

5942_pakuotes lapelis_2026-01-16.docx

5942_Levetiracetam Kalceks.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

FI/H/1318/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone yra	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
119640	105745	1105745	flakonas	5 ml N10		Receptinis	LT/1/26/5942/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-01-16	Registruotas