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Kuvan

Active substance: sapropterin

sapropterin dihydrochloride

Centralised EU authorisationActive

Marketing holder: BioMarin International Limited

Verified 2026-10-09 · EMA

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
US 23
  • JAVYGTOR
    POWDER, FOR SOLUTION · SAPROPTERIN DIHYDROCHLORIDE 500 mg/1
    43598-162
    Dr. Reddys Laboratories Inc
  • JAVYGTOR
    TABLET · SAPROPTERIN DIHYDROCHLORIDE 100 mg/1
    43598-096
    Dr. Reddys Laboratories Inc
  • JAVYGTOR
    POWDER, FOR SOLUTION · SAPROPTERIN DIHYDROCHLORIDE 100 mg/1
    43598-097
    Dr. Reddys Laboratories Inc
  • Kuvan
    TABLET · SAPROPTERIN DIHYDROCHLORIDE 100 mg/1
    68135-300
    BioMarin Pharmaceutical Inc.
  • Kuvan
    POWDER, FOR SOLUTION · SAPROPTERIN DIHYDROCHLORIDE 100 mg/1
    68135-301
    BioMarin Pharmaceutical Inc.
All products in this country (23)
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-cb24-7da4-b597-1decb974924c,01a1208c-d02e-7e65-8b83-476824c0ed93,01a1208d-1b66-7dae-9b8f-c326678e5474,01a1208e-3bca-7b92-bb55-1ed733a3a55f,01a1208e-4272-7698-8c42-613f9cc6da56;count=23 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/000943
Registration status
Active
ATC code
A16AX07
Sources
  • product · EMA · EMEA/H/C/000943 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/000943 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/000943 · Verified 2026-10-09