SAI - Detailed view

MIGLUSTAT Dipharma Kaps 100 mg 84 Stk

Drug

Name

Miglustat Dipharma, capsule

ATC

A16AX06 - MIGLUSTAT

07.99.0. – various

Use

HAM – Human medicine

pharmaceutical form

KAPS – Capsule

Remedy code

S – synthetic products for human use

Dispensing categories

B – Dispensed on prescription by a physician or veterinarian (B)

Authorisation status

Z – approved

Authorisation number

67633

Initial registration date

4/3/2020

Expiry date

4/2/2025

Dosage strength

Name

Miglustat Dipharma 100 mg, capsule

Field of application

Gaucher di tipo 1, Niemann-Pick di tipo C

Dosage strength number

Authorisation status

Z – approved

Package

GTIN**

7680676330019

Trade status*

No information made available

Status

A/R – Authorised / referenced

Package size

84 capsule(s)

Package code

001

Authorisation status

Z – approved

Declaration

Component

Active substance

100 mg miglustatum

Excipient

magnesii stearas
gelatina
E 171
lacca
propylenglycolum
kalii hydroxidum
E 172 (nigrum)

Spezialitätenliste***

Status

Date of deletion

Compulsory until

Public price (CHF)

5376.35

Limitation points

None

Limitation

Yes

SB Deductible

10%

Generic

Yes

Authorisation holder

GLN**

7601001408234

Address

Dipharma SA
Piazza Col C. Bernasconi 5
6830 Chiasso (TI)

Date of revision of the text

6/29/2023

Information for prof.

Leaflet

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Data source: Swissmedic, *authorisation holder, **Refdata foundation, ***FOPH.