Fabrazyme

Medicinal product

(Invented) name

Fabrazyme

Active substance (s)

Agalsidazė beta

Strength

35 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)

A16AB04, Agalsidase beta

Marketing authorisation holder

Sanofi B.V., Nyderlandai

Date of authorisation

2001-08-03

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.
Agalsidazė beta	35 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
25774	28369	1028369	flakonas	N1		Receptinis	EU/1/01/188/001	Tiekiama	-	-	No	-	-
25775	28370	1028370	flakonas	N5		Receptinis	EU/1/01/188/002	Netiekiama	-	-	No	-	-
25776	28371	1028371	flakonas	N10		Receptinis	EU/1/01/188/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2001-08-03	Registruotas