🇪🇺 Ammonul in European Union

EMA authorised Ammonul on 27 April 2018

Marketing authorisation

EMA — authorised 27 April 2018

  • Application: EMEA/H/C/004150
  • Marketing authorisation holder: Lucane Pharma
  • Local brand name: Prohippur
  • Indication: Treatment of non ketotic hyperglycinemia, urea cycle disorders including carbamoyl-phosphate synthase-1 deficiency, ornithine transcarbamylase deficiency, citrullinaemia type 1, argininosuccinic aciduria, hyperargininaemia, n-acetylglutamate synthase deficiency, ornithine translocase deficiency and lysinuric protein intolerance.
  • Pathway: orphan
  • Status: withdrawn

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Ammonul in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in European Union

Frequently asked questions

Is Ammonul approved in European Union?

Yes. EMA authorised it on 27 April 2018.

Who is the marketing authorisation holder for Ammonul in European Union?

Lucane Pharma holds the EU marketing authorisation.