Opfolda 65 mg
Opfolda 65 mg is a medicine authorised by Swissmedic under authorisation number 67806. The authorisation holder is Amicus Therapeutics Switzerland GmbH. The medicinal product code is Synthetic medicines and the dispensing category is B: Supplied only against a prescription which, at the prescriber's discretion, may be dispensed repeatedly. First authorisation was granted on 04 July 2024 and the authorisation is limited until 03 July 2029. ATC code A16AX06 places the medicine in the group Other alimentary tract and metabolism products.
| Authorisation number | 67806 |
|---|---|
| Name | Opfolda 65 mg |
| Full name | Opfolda 65 mg, Hartkapseln |
| Authorisation holder | Amicus Therapeutics Switzerland GmbH |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | A16AX06 |
| First authorisation | 04 July 2024 |
| Authorisation validity | 03 July 2029 |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Opfolda 65 mg, Hartkapseln | B | 04 July 2024 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 4 | Kapsel(n) | A16AX06 | 07.99.0. | B |
| 2 | 24 | Kapsel(n) | A16AX06 | 07.99.0. | B |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Opfolda 65 mg authorised in Switzerland?
Yes. Opfolda 65 mg is authorised by Swissmedic under authorisation number 67806, data as of 01 September 2026. The authorisation is limited until 03 July 2029.
Which dispensing category does Opfolda 65 mg have?
Opfolda 65 mg is in dispensing category B. Supplied only against a prescription which, at the prescriber's discretion, may be dispensed repeatedly.
Who is the authorisation holder of Opfolda 65 mg?
The authorisation holder is Amicus Therapeutics Switzerland GmbH. The holder carries the legal responsibility for quality, safety and product information of the medicine in Switzerland.
Sources
Swissmedic data as of 01 September 2026. No medical advice. Independent directory, not affiliated with Swissmedic or the FOPH.