Xenpozyme

Medicinal product

(Invented) name

Xenpozyme

Active substance (s)

Olipudazė alfa

Strength

4 mg

Pharmaceutical form

milteliai infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A16AB25, olipudase alfa

Marketing authorisation holder

Sanofi B.V., Nyderlandai

Date of authorisation

2022-06-24

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

Powder for concentrate for solution for infusion	1 vnt.
Olipudazė alfa	4 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
110976	97087	1097087	flakonas	N1		Receptinis	EU/1/22/1659/005	Netiekiama	-	-	No	-	-
110977	97088	1097088	flakonas	N5		Receptinis	EU/1/22/1659/006	Netiekiama	-	-	No	-	-
110978	97089	1097089	flakonas	N10		Receptinis	EU/1/22/1659/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-06-24	Registruotas