Elaprase

Medicinal product

(Invented) name

Elaprase

Active substance (s)

Idursulfazė

Strength

2 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

A16AB09, Idursulfase

Marketing authorisation holder

Takeda Pharmaceuticals International AG Ireland Branch, Airija

Date of authorisation

2007-01-08

Date of renewal

Documents

Stage

Registruotas

Controlled?

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
Idursulfazė	2 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
25354	27962	1027962	flakonas	3 ml N1	Receptinis	EU/1/06/365/001	Tiekiama	-	-	No	-	-
25355	27963	1027963	flakonas	3 ml N4	Receptinis	EU/1/06/365/002	Netiekiama	-	-	No	-	-
25356	27964	1027964	flakonas	3 ml N10	Receptinis	EU/1/06/365/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-01-08	Registruotas