🇪🇺 POLIHEXANIDE in European Union

EMA authorised POLIHEXANIDE on 22 August 2024

Marketing authorisation

EMA — authorised 22 August 2024

  • Application: EMEA/H/C/005858
  • Marketing authorisation holder: SIFI SPA
  • Local brand name: Akantior
  • Indication: Akantior is indicated for the treatment of Acanthamoeba keratitis in adults and children from 12 years of age.
  • Pathway: orphan
  • Status: approved

The European Medicines Agency (EMA) has approved Akantior, a medicine containing POLIHEXANIDE, for the treatment of Acanthamoeba keratitis. This rare eye infection is caused by a parasite and can lead to vision loss if left untreated. Akantior is indicated for adults and children aged 12 and above with this condition.

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POLIHEXANIDE in other countries

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

Frequently asked questions

Is POLIHEXANIDE approved in European Union?

Yes. EMA authorised it on 22 August 2024.

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

SIFI SPA holds the EU marketing authorisation.