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Ammonaps

Active substance: sodium phenylbutyrate

sodium phenylbutyrate

Centralised EU authorisationActive

Marketing holder: Immedica Pharma AB

Verified 2026-10-09 · EMA

Analogues in other countries
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
US 15
  • BUPHENYL
    TABLET · SODIUM PHENYLBUTYRATE 500 mg/1
    75987-060
    Horizon Therapeutics USA, Inc.
  • Buphenyl
    POWDER · SODIUM PHENYLBUTYRATE .94 g/g
    75987-070
    Horizon Therapeutics USA, Inc.
  • OLPRUVA
    KIT · sodium phenylbutyrate
    72542-200
    Acer Therapeutics Inc.
  • OLPRUVA
    KIT · sodium phenylbutyrate
    72542-667
    Acer Therapeutics Inc.
  • OLPRUVA
    KIT · sodium phenylbutyrate
    72542-600
    Acer Therapeutics Inc.
All products in this country (15)
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-3094-711a-a85f-ed7c1bf26f0b,01a1208e-5599-70e6-9a81-df11657d1378,01a1208f-09b1-7f86-8882-4de0c99e8e3a,01a1208f-09b6-7029-b974-15284f2c4393,01a1208f-108c-7a65-a16f-c6775ff786bd;count=15 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/000219
Registration status
Active
ATC code
A16AX03
Sources
  • product · EMA · EMEA/H/C/000219 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/000219 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/000219 · Verified 2026-10-09