Miglustat Dipharma

Medicinal product

(Invented) name

Miglustat Dipharma

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

Dipharma Arzneimittel GmbH, Vokietija

Date of authorisation

2019-02-18

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.
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
100967	87078	1087078	lizdinė plokštelė	N84		Receptinis	EU/1/18/1346/001	Netiekiama	-	-	No	-	-
103181	89282	1089282	dalomoji lizdinė plokštelė	N84x1		Receptinis	EU/1/18/1346/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-02-18	Registruotas