Regulatory PathRegulatory requirements compared

Active substance

Polihexanide

Open in the medicines table

EMA European Union — centrally authorised medicines

Akantior SIFI SPA · Authorised · authorised 22 Aug 2024 · ATC S01AX24

Therapeutic indication (EMA)

Akantior is indicated for the treatment of Acanthamoeba keratitis in adults and children from 12 years of age.

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
AKANTIOR 0.8 MG/ML EYE DROPS, SOLUTION IN SINGLE-DOSE CONTAINERPL 36078/0007SIFI S.P.A.POM

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.