Galafold

Medicinal product

(Invented) name

Galafold

Active substance (s)

Migalastatas

Strength

123 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A16AX14, Migalastat

Marketing authorisation holder

Amicus Therapeutics Europe Limited, Airija

Date of authorisation

2016-05-26

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

Hard capsule	1 vnt.
Migalastatas	123 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
65949	80462	1080462	lizdinė plokštelė	N14		Receptinis	EU/1/15/1082/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-05-26	Registruotas