🇪🇺 NaPBA in European Union

EMA authorised NaPBA on 7 December 1999

Marketing authorisations

EMA — authorised 7 December 1999

  • Application: EMEA/H/C/000219
  • Marketing authorisation holder: Immedica Pharma AB
  • Local brand name: Ammonaps
  • Indication: Ammonaps is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase orargininosuccinate synthetase. It is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease(partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy.
  • Status: approved

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EMA

  • Application: EMEA/H/C/005901
  • Marketing authorisation holder: Amylyx Pharmaceuticals EMEA B.V.
  • Local brand name: Albrioza
  • Indication: Treatment of amyotrophic lateral sclerosis (ALS)
  • Pathway: orphan
  • Status: rejected

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Other Metabolic/Genetic Disorders approved in European Union

Frequently asked questions

Is NaPBA approved in European Union?

Yes. EMA authorised it on 7 December 1999; EMA has authorised it.

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

Immedica Pharma AB holds the EU marketing authorisation.