Naglazyme

Medicinal product

(Invented) name

Naglazyme

Active substance (s)

Galsulfazė

Strength

1 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)

A16AB08, Galsulfase

Marketing authorisation holder

BioMarin International Limited, Airija

Date of authorisation

2006-01-24

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

Concentrate for solution for infusion	1 ml
Galsulfazė	1 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
26906	29470	1029470	flakonas	5 ml N1		Receptinis	EU/1/05/324/001	Netiekiama	-	-	No	-	-
37230	50850	1050850	flakonas	5 ml N6		Receptinis	EU/1/05/324/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2006-01-24	Registruotas