Replagal

Medicinal product

(Invented) name

Replagal

Active substance (s)

Agalsidazė alfa

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)

A16AB03, Agalsidase alfa

Marketing authorisation holder

Takeda Pharmaceuticals International AG Ireland Branch, Airija

Date of authorisation

2001-08-03

Date of renewal

Documents

Replagal mokomoji medziaga sveikatos prieziuros specialistams.PDF

Replagal mokomoji medziaga pacientams.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

concentrate for solution for infusion	1 ml
Agalsidazė alfa	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
28125	30661	1030661	flakonas	3,5 ml N1		Receptinis	EU/1/01/189/001	Tiekiama	-	-	No	-	-
28126	30662	1030662	flakonas	3.5 ml N4		Receptinis	EU/1/01/189/002	Netiekiama	-	-	No	-	-
28127	30663	1030663	flakonas	3,5 ml N10		Receptinis	EU/1/01/189/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2001-08-03	Registruotas