🇪🇺 LOARGYS in European Union

EMA authorised LOARGYS on 15 December 2023

Marketing authorisation

EMA — authorised 15 December 2023

  • Application: EMEA/H/C/005484
  • Marketing authorisation holder: Immedica Pharma AB
  • Local brand name: Loargys
  • Indication: Loargys is indicated for the treatment of arginase 1 deficiency (ARG1 D), also known as hyperargininemia, in adults, adolescents and children aged 2 years and older.
  • Pathway: exceptional circumstances, orphan
  • Status: approved

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LOARGYS 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 LOARGYS approved in European Union?

Yes. EMA authorised it on 15 December 2023.

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

Immedica Pharma AB holds the EU marketing authorisation.