Kuvan

Kuvan is a medicine authorised by Swissmedic under authorisation number 58475. The authorisation holder is DRAC 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 12 October 2009 and the authorisation is valid without a time limit. ATC code A16AX07 places the medicine in the group Other alimentary tract and metabolism products.

  • Dispensing category B
  • Authorisation number 58475
  • ATC A16AX07
  • Synthetic medicines
Authorisation data
Authorisation number58475
NameKuvan
Full nameKuvan, Tabletten
Authorisation holderDRAC AG
Medicinal product codeSynthetic medicines
Dispensing categoryB · Prescription only
ATC codeA16AX07
First authorisation12 October 2009
Authorisation validityunlimited
Strengths
No.NameDispensing categoryAuthorisation date
1Kuvan, TablettenB12 October 2009

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Pack sizes
Pack codeQuantityUnitATCIT codeDispensing category
130Tablette(n)A16AX0707.99.0.B
2120Tablette(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 Kuvan authorised in Switzerland?

Yes. Kuvan is authorised by Swissmedic under authorisation number 58475, data as of 01 September 2026. The authorisation is valid without a time limit.

Which dispensing category does Kuvan have?

Kuvan 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 Kuvan?

The authorisation holder is DRAC 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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