Kanuma

Medicinal product

(Invented) name

Kanuma

Active substance (s)

Sebelipazė alfa

Strength

2 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)

A16AB14, Sebelipase alfa

Marketing authorisation holder

Alexion Europe SAS, Prancūzija

Date of authorisation

2015-08-28

Date of renewal

Documents

Kanuma mokomoji medziaga sveikatos prieziuros specialistams.pdf

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

Concentrate for solution for infusion	1 ml
Sebelipazė alfa	2 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
63525	77965	1077965	flakonas	10 ml N1		Receptinis	EU/1/15/1033/001	Tiekiama	2025-03-27	-	No	-	-

Stadijos

Data	Stadija
2015-08-28	Registruotas