Lacosamide Accord

Medicinal product

(Invented) name

Lacosamide Accord

Active substance (s)

Lakozamidas+Lakozamidas+Lakozamidas+Lakozamidas

Strength

50 mg + 100 mg + 150 mg + 200 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

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

Film-coated tablet (50 mg)	1 vnt.
Lakozamidas	50 mg
Film-coated tablet (100 mg)	1 vnt.
Lakozamidas	100 mg
Film-coated tablet (150 mg)	1 vnt.
Lakozamidas	150 mg
Film-coated tablet (200 mg)	1 vnt.
Lakozamidas	200 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
97906	84001	1084001	lizdinė plokštelė	N56 (14x50 mg, 14x100 mg, 14x150 mg, 14x200 mg)	pakuotė gydymui pradėti	Receptinis	EU/1/17/1230/025	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-09-18	Registruotas