Sapropterin Spirig HC 100 mg
Sapropterin Spirig HC 100 mg is a medicine authorised by Swissmedic under authorisation number 69871. The authorisation holder is Spirig HealthCare AG. 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 18 October 2024 and the authorisation is limited until 17 October 2029. ATC code A16AX07 places the medicine in the group Other alimentary tract and metabolism products.
| Authorisation number | 69871 |
|---|---|
| Name | Sapropterin Spirig HC 100 mg |
| Full name | Sapropterin Spirig HC 100 mg, Tabletten zur Herstellung einer Lösung zum Einnehmen |
| Authorisation holder | Spirig HealthCare AG |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | A16AX07 |
| First authorisation | 18 October 2024 |
| Authorisation validity | 17 October 2029 |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Sapropterin Spirig HC 100 mg, Tabletten zur Herstellung einer Lösung zum Einnehmen | B | 18 October 2024 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 30 | Flasche(n) | A16AX07 | 07.99.0. | B |
| 2 | 120 | Flasche(n) | A16AX07 | 07.99.0. | B |
| 3 | 30 | Tablette(n) | A16AX07 | 07.99.0. | B |
| 4 | 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 Spirig HC 100 mg authorised in Switzerland?
Yes. Sapropterin Spirig HC 100 mg is authorised by Swissmedic under authorisation number 69871, data as of 01 September 2026. The authorisation is limited until 17 October 2029.
Which dispensing category does Sapropterin Spirig HC 100 mg have?
Sapropterin Spirig HC 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 Spirig HC 100 mg?
The authorisation holder is Spirig HealthCare AG. 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.