Lacosamide Adroiq

Medicinal product

(Invented) name

Lacosamide Adroiq

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

Extrovis EU Ltd., Vengrija

Date of authorisation

2023-05-31

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
111098	97209	1097209	flakonas	20 ml N5		Receptinis	EU/1/23/1732/001	Netiekiama	-	-	No	-	-
111794	97909	1097909	flakonas	20 ml N1		Receptinis	EU/1/23/1732/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-05-31	Registruotas