LEQEMBI

Medicinal product

(Invented) name

LEQEMBI

Active substance (s)

Lekanemabas

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)

No

ATC code (s)

N06DX04, lecanemab

Marketing authorisation holder

Eisai GmbH, Vokietija

Date of authorisation

2025-04-15

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

1 ml infuzinio tirpalo yra:	1 ml
Lekanemabas	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
117202	103302	1103302	flakonas	2 ml N1		Receptinis	EU/1/24/1891/001	Netiekiama	-	-	No	-	-
117203	103303	1103303	flakonas	5 ml N1		Receptinis	EU/1/24/1891/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-04-15	Registruotas