Nitisinon NOBEL 5 mg
Nitisinon NOBEL 5 mg is a medicine authorised by Swissmedic under authorisation number 68331. 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 01 June 2022 and the authorisation is limited until 31 May 2027. ATC code A16AX04 places the medicine in the group Other alimentary tract and metabolism products.
| Authorisation number | 68331 |
|---|---|
| Name | Nitisinon NOBEL 5 mg |
| Full name | Nitisinon NOBEL 5 mg, Hartkapseln |
| Authorisation holder | NOBEL Pharma Schweiz AG |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | A16AX04 |
| First authorisation | 01 June 2022 |
| Authorisation validity | 31 May 2027 |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Nitisinon NOBEL 5 mg, Hartkapseln | B | 01 June 2022 |
| 2 | Nitisinon NOBEL 10 mg, Hartkapseln | B | 01 June 2022 |
| 3 | Nitisinon NOBEL 20 mg, Hartkapseln | B | 01 June 2022 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 60 | Kapsel(n) | A16AX04 | 07.99.0. | B |
| 2 | 60 | Kapsel(n) | A16AX04 | 07.99.0. | B |
| 3 | 60 | Kapsel(n) | A16AX04 | 07.99.0. | B |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Nitisinon NOBEL 5 mg authorised in Switzerland?
Yes. Nitisinon NOBEL 5 mg is authorised by Swissmedic under authorisation number 68331, data as of 01 September 2026. The authorisation is limited until 31 May 2027.
Which dispensing category does Nitisinon NOBEL 5 mg have?
Nitisinon NOBEL 5 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 Nitisinon NOBEL 5 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.