🇪🇺 Upstaza in European Union

EMA authorised Upstaza on 18 July 2022

Marketing authorisations

EMA — authorised 18 July 2022

  • Application: EMEA/H/C/005352
  • Marketing authorisation holder: PTC Therapeutics International Limited
  • Local brand name: Upstaza
  • Indication: Upstaza is indicated for the treatment of patients aged 18 months and older with a clinical, molecular, and genetically confirmed diagnosis of aromatic L amino acid decarboxylase (AADC) deficiency with a severe phenotype (see section 5.1).
  • Pathway: exceptional circumstances, orphan, ATMP
  • Status: approved

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EMA — authorised 17 August 2022

  • Marketing authorisation holder: PTC Therapeutics International Limited
  • Status: approved

Upstaza in other countries

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

Other Gastroenterology approved in European Union

Frequently asked questions

Is Upstaza approved in European Union?

Yes. EMA authorised it on 18 July 2022; EMA authorised it on 17 August 2022.

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

PTC Therapeutics International Limited holds the EU marketing authorisation.