Xenpozyme

Medicinal product

(Invented) name

Xenpozyme

Active substance (s)

Olipudazė alfa

Strength

20 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	20 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
108920	95026	1095026	flakonas	N1		Receptinis	EU/1/22/1659/001	Netiekiama	-	-	No	-	-
108921	95027	1095027	flakonas	N5		Receptinis	EU/1/22/1659/002	Netiekiama	-	-	No	-	-
108922	95028	1095028	flakonas	N10		Receptinis	EU/1/22/1659/003	Netiekiama	-	-	No	-	-
108923	95029	1095029	flakonas	N25		Receptinis	EU/1/22/1659/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-06-24	Registruotas