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.

  • Dispensing category B
  • Authorisation number 69374
  • ATC A16AX07
  • Synthetic medicines
Authorisation data
Authorisation number69374
NameSapropterin NOBEL 100 mg
Full nameSapropterin NOBEL 100 mg, Tabletten zur Herstellung einer Lösung zum Einnehmen
Authorisation holderNOBEL Pharma Schweiz AG
Medicinal product codeSynthetic medicines
Dispensing categoryB · Prescription only
ATC codeA16AX07
First authorisation27 May 2025
Authorisation validity26 May 2030
Strengths
No.NameDispensing categoryAuthorisation date
1Sapropterin NOBEL 100 mg, Tabletten zur Herstellung einer Lösung zum EinnehmenB27 May 2025

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Pack sizes
Pack codeQuantityUnitATCIT codeDispensing category
130Tablette(n)A16AX0707.99.0.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.

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