Opfolda 65 mg, Hartkapseln

7680678060013 CH-67806 Kapseln

Associated product:

OPFOLDA caps 65 mg 4 pce
Opfolda 65 mg, Hartkapseln
Opfolda 65 mg, Hartkapseln
Opfolda 65 mg, Hartkapseln
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Article details

Package size
4
Selling units
4
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 168.75
Specialties list
Yes
Generic
No

Reimbursement limitation

SL addition date: 01/11/2025

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 4 pce
Description (DE)
OPFOLDA Kaps 65 mg 4 Stk
Market launch
01/11/2025
Narcotic (BTM)
No

Available generics (1)

Miglustat Dipharma, capsula rigida
GTIN: 7680676330026
CHF 4422.00
View

Other package sizes (1)

OPFOLDA caps 65 mg bte 24 pce
24 KAP
GTIN: 7680678060020
View
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