Galafold 123 mg
Galafold 123 mg is a medicine authorised by Swissmedic under authorisation number 66108. 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 28 October 2016 and the authorisation is valid without a time limit. ATC code A16AX14 places the medicine in the group Other alimentary tract and metabolism products.
| Authorisation number | 66108 |
|---|---|
| Name | Galafold 123 mg |
| Full name | Galafold 123 mg, Kapseln |
| Authorisation holder | Amicus Therapeutics Switzerland GmbH |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | A16AX14 |
| First authorisation | 28 October 2016 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Galafold 123 mg, Kapseln | B | 28 October 2016 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 14 | Kapsel(n) | A16AX14 | 07.99.0. | B |
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Other medicines from this authorisation holder
Frequently asked questions
Is Galafold 123 mg authorised in Switzerland?
Yes. Galafold 123 mg is authorised by Swissmedic under authorisation number 66108, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Galafold 123 mg have?
Galafold 123 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 Galafold 123 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.