Opfolda

Medicinal product

(Invented) name

Opfolda

Active substance (s)

Migliustatas

Strength

65 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)

A16AX06, Miglustat

Marketing authorisation holder

Amicus Therapeutics Europe Limited, Airija

Date of authorisation

2023-06-26

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Capsule, hard	1 vnt.
Migliustatas	65 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
111194	97305	1097305	buteliukas	N4		Receptinis	EU/1/23/1737/001	Netiekiama	-	-	No	-	-
111195	97306	1097306	buteliukas	N24		Receptinis	EU/1/23/1737/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-06-26	Registruotas