Kisunla

Medicinal product

(Invented) name

Kisunla

Active substance (s)

Donanemabas

Strength

350 mg

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)

N06DX05, donanemab

Marketing authorisation holder

Eli Lilly Nederland B.V., Nyderlandai

Date of authorisation

2025-09-24

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

Flakone (20 ml tirpalo) yra:	20 ml
Donanemabas	350 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
118849	104956	1104956	flakonas	N1		Receptinis	EU/1/25/1926/001	Netiekiama	-	-	No	-	-
118850	104957	1104957	flakonas	N2 (2×1)		Receptinis	EU/1/25/1926/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-09-24	Registruotas