Myozyme

Medicinal product

(Invented) name

Myozyme

Active substance (s)

Algliukozidazė alfa

Strength

50 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)

A16AB07, Alglucosidase alfa

Marketing authorisation holder

Sanofi B.V., Nyderlandai

Date of authorisation

2006-03-09

Date of renewal

Documents

Myozyme 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

Powder for concentrate for solution for infusion	1 ml
Algliukozidazė alfa	50 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
27366	29921	1029921	flakonas	20ml N1		Receptinis	EU/1/06/333/001	Tiekiama	-	-	No	-	-
27367	29922	1029922	flakonas	20 ml N10		Receptinis	EU/1/06/333/002	Netiekiama	-	-	No	-	-
27368	29923	1029923	flakonas	20 ml N25		Receptinis	EU/1/06/333/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2006-03-09	Registruotas