Sapropterin Dipharma 100 mg
Sapropterin Dipharma 100 mg is a medicine authorised by Swissmedic under authorisation number 68224. The authorisation holder is Dipharma SA. 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 23 February 2022 and the authorisation is valid without a time limit. ATC code A16AX07 places the medicine in the group Other alimentary tract and metabolism products.
| Authorisation number | 68224 |
|---|---|
| Name | Sapropterin Dipharma 100 mg |
| Full name | Sapropterin Dipharma 100 mg, compressa dispersibile |
| Authorisation holder | Dipharma SA |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | A16AX07 |
| First authorisation | 23 February 2022 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Sapropterin Dipharma 100 mg, compressa dispersibile | B | 23 February 2022 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 30 | Tablette(n) | A16AX07 | 07.99.0. | B |
| 2 | 120 | Tablette(n) | A16AX07 | 07.99.0. | B |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Sapropterin Dipharma 100 mg authorised in Switzerland?
Yes. Sapropterin Dipharma 100 mg is authorised by Swissmedic under authorisation number 68224, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Sapropterin Dipharma 100 mg have?
Sapropterin Dipharma 100 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 Sapropterin Dipharma 100 mg?
The authorisation holder is Dipharma SA. 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.