Opfolda 65 mg, Hartkapseln

7680678060020 CH-67806 Kapseln
Opfolda 65 mg, Hartkapseln
Opfolda 65 mg, Hartkapseln
Opfolda 65 mg, Hartkapseln
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Article details

Package size
24
Selling units
24
Measure
Kapsel(n)
Galenic form
Kapseln
Galenic group
Tabletten

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Patient information leaflet
Allemand
05/08/2025
Patient information leaflet
Français
05/08/2025
Patient information leaflet
Italien
05/08/2025
Summary of Product Characteristics
Allemand
05/08/2025
Summary of Product Characteristics
Français
05/08/2025
Summary of Product Characteristics
Italien
05/08/2025

Detailed composition

Substance Quantity Type Category
miglustatum
65.0 MG Substance Wirkstoff (Principe actif)
cellulosum microcristallinum
- Substance HNIDK
maydis amylum
- Substance HNIDK
sucralosum
- Substance HNIDK
magnesii stearas
- Substance HNIDK
silica colloidalis anhydrica
- Substance HNIDK
gelatina
- Substance HNIDK
E 171
- Substance FNIDK
E 172 (nigrum)
- Substance FTODK
lacca
- Substance HNIDK
propylenglycolum
- Substance Hilfsstoff ohne Deklarationspflicht (Excipient sans obligation de déclaration)
ammoniae solutio concentrata
- Substance HNIDK
kalii hydroxidum
- Substance HNIDK
E 172 (nigrum)
- Substance FTODK

Reimbursement information

Public price
CHF 930.50
Specialties list
Yes
Generic
No

Reimbursement limitation

SL addition date: 01/01/2025

Authorization holder

Amicus Therapeutics Switzerland GmbH

8008 Zürich

Authorization information

Swissmedic authorization number
67806
Drug name
Opfolda, Hartkapseln
Galenic form
KAHA
ATC Code
A16AX06
Authorization status
Z
Dispensing category
B
First authorization
04/07/2024
Authorization expiration date
03/07/2029
IT Number
07.99.0.
Domain
Human medicine
Field of application
Behandlung der Glykogenspeicherkrankheit Typ II (Morbus Pompe)

Package details

Description (FR)
OPFOLDA caps 65 mg bte 24 pce
Description (DE)
OPFOLDA Kaps 65 mg Ds 24 Stk
Market launch
04/07/2024
Narcotic (BTM)
No

Available generics (1)

Miglustat Dipharma, capsula rigida
GTIN: 7680676330026
CHF 4422.00
View

Other package sizes (1)

OPFOLDA caps 65 mg 4 pce
4 KAP
GTIN: 7680678060013
View
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