Regulatory PathRegulatory requirements compared

Active substance

Ectoine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Artelac Ectoin SDU20 mgEye drops · Ocular use20 AmpouleSAR 36.85Generic · OTCDr. Gerhard Mann Chem. - Pharma. Fabrik GmbHValid
BETADINE SOOTHING RELIEF DRY & TIRED EYES0.5 %Eye drops · Ophthalmic use10 BottleSAR 18.60Health · OTCMUNDIPHARMA MEDICAL COMPANYWithdrawn by MAH · Not Marketed
BETADINE SOOTHING RELIEF EAR CANAL RELIEF2 %Spray · Auricular use1 BottleSAR 17.00Generic · OTCMUNDIPHARMA MEDICAL COMPANYWithdrawn by MAH · Not Marketed
BETADINE SOOTHING RELIEF EYE ALLERGY AMPOULE2 %Eye drops · Ophthalmic use10 BottleSAR 18.60Health · OTCMUNDIPHARMA MEDICAL COMPANYWithdrawn by MAH · Not Marketed
BETADINE SOOTHING RELIEF EYE ALLERGY BOTTLE2 %Eye drops · Ophthalmic use1 BottleSAR 37.20Health · OTCMUNDIPHARMA MEDICAL COMPANYWithdrawn by MAH · Not Marketed
ECTOLLERG 1% EYE DROPS1 %Eye drops · Ophthalmic use20 AmpouleSAR 37.20Generic · OTCBitop AGWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ALLERGIC CONJUCTIVITIS (AC); BELL'S PALSY; SJOGREN'S SYNDROME; VIRAL CONJUNCTIVITS, HERPESVIRAL KERATITIS, HERPESVIRAL CONJUNCTIVITIS, VARICELLA KERATITIS, ZOSTER CONJUNCTIVITIS, ZOSTER KERATITIS, MEASLES KERATITIS AND KERATOCONJUNCTIVITIS, VIRAL CONJUNCTIVITIS, KERATITIS

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), 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.