Sapropterin NOBEL 100 mg
Sapropterin NOBEL 100 mg is a medicine authorised by Swissmedic under authorisation number 69374. The authorisation holder is NOBEL Pharma Schweiz 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 27 May 2025 and the authorisation is limited until 26 May 2030. ATC code A16AX07 places the medicine in the group Other alimentary tract and metabolism products.
| Authorisation number | 69374 |
|---|---|
| Name | Sapropterin NOBEL 100 mg |
| Full name | Sapropterin NOBEL 100 mg, Tabletten zur Herstellung einer Lösung zum Einnehmen |
| Authorisation holder | NOBEL Pharma Schweiz AG |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | A16AX07 |
| First authorisation | 27 May 2025 |
| Authorisation validity | 26 May 2030 |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Sapropterin NOBEL 100 mg, Tabletten zur Herstellung einer Lösung zum Einnehmen | B | 27 May 2025 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 30 | 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 NOBEL 100 mg authorised in Switzerland?
Yes. Sapropterin NOBEL 100 mg is authorised by Swissmedic under authorisation number 69374, data as of 01 September 2026. The authorisation is limited until 26 May 2030.
Which dispensing category does Sapropterin NOBEL 100 mg have?
Sapropterin NOBEL 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 NOBEL 100 mg?
The authorisation holder is NOBEL Pharma Schweiz 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.