Lacosamide Fresenius Kabi

Medicinal product

(Invented) name

Lacosamide Fresenius Kabi

Active substance (s)

Lakozamidas

Strength

10 mg/ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N03AX18, Lacosamide

Marketing authorisation holder

Fresenius Kabi Polska Sp.z.o.o., Lenkija

Date of authorisation

2022-10-24

Date of renewal

Documents

5054 Pakuotės lapelis 2024 01 04.docx

5054 Lacosamide Fresenius Kabi PCS PL 2024 01 04.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/6957/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Lakozamidas	10 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
109656	95762	1095762	flakonas	20 ml N1		Receptinis	LT/1/22/5054/001	Netiekiama	-	-	No	-	-
109657	95763	1095763	flakonas	20 ml N5		Receptinis	LT/1/22/5054/002	Netiekiama	-	-	No	-	-
109658	95764	1095764	flakonas	20 ml N10		Receptinis	LT/1/22/5054/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-10-24	Registruotas