Lacosamide Accord

Medicinal product

(Invented) name

Lacosamide Accord

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

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2017-09-18

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

Solution for infusion	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
107667	93772	1093772	flakonas	20 ml N1		Receptinis	EU/1/17/1230/026	Netiekiama	-	-	No	-	-
107668	93773	1093773	flakonas	20 ml N5		Receptinis	EU/1/17/1230/027	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-09-18	Registruotas