Miglustat Gen.Orph

Medicinal product

(Invented) name

Miglustat Gen.Orph

Active substance (s)

Migliustatas

Strength

100 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

Gen. Orph, Prancūzija

Date of authorisation

2017-11-10

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Hard capsule	1 vnt.
Migliustatas	100 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
98388	84490	1084490	lizdinė plokštelė	N84		Receptinis	EU/1/17/1232/001	Netiekiama	-	-	No	-	-
107847	93952	1093952	dalomoji lizdinė plokštelė	N84×1		Receptinis	EU/1/17/1232/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-11-10	Registruotas