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
CAP
65.0 MG Substance Wirkstoff (Principe actif)
CAP
- Substance HNIDK
CAP
- Substance HNIDK
CAP
- Substance HNIDK
CAP
- Substance HNIDK
CAP
- Substance HNIDK
CAP
- Substance HNIDK
CAP
- Substance FNIDK
CAP
- Substance FTODK
CAP
- Substance HNIDK
CAP
- Substance Hilfsstoff ohne Deklarationspflicht (Excipient sans obligation de déclaration)
CAP
- Substance HNIDK
CAP
- Substance HNIDK
CAP
- Substance FTODK

Reimbursement information

Public price
CHF 1110.25
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 (2)

Miglustat Dipharma, capsule
GTIN: 7680676330019
CHF 4422.00
View
Miglustat Dipharma, capsule
GTIN: 7680676330026
CHF 4422.00
View

Other package sizes (1)

None
4 KAP
GTIN: None
Not in V1