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Details
- GTIN
- 7680678060013
- Pharmacode
- -
- Product number
- 6780601
- CPT
- -
- Packaging group
- 4
- Unit
- Kapsel(n)
- Composition
- Kapsel: miglustatum 65 mg, cellulosum microcristallinum, maydis amylum, sucralosum, magnesii stearas, silica colloidalis anhydrica, Kapselhülle: gelatina, E 171, E 172 (nigrum), Drucktinte: lacca, propylenglycolum, ammoniae solutio concentrata, kalii hydroxidum, E 172 (nigrum), pro capsula.
Articles (1)
Opfolda 65 mg, Hartkapseln
Kapseln
4
Official Swissmedic V2 data
Additional information from the official database
Official medical documents
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
- Dispensation category
- B
- First authorization
- 04/07/2024
- Authorization expiration date
- 03/07/2029
- IT number
- 07.99.0.
- Domain
- Human medicine
Packaging 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