🇪🇺 Palynziq in European Union

EMA authorised Palynziq on 3 May 2019

Marketing authorisation

EMA — authorised 3 May 2019

  • Application: EMEA/H/C/004744
  • Marketing authorisation holder: BioMarin International Limited
  • Local brand name: Palynziq
  • Indication: Palynziq is indicated for the treatment of patients with phenylketonuria (PKU) aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/l) despite prior management with available treatment options.
  • Pathway: orphan
  • Status: approved

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Palynziq 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 Palynziq approved in European Union?

Yes. EMA authorised it on 3 May 2019.

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

BioMarin International Limited holds the EU marketing authorisation.