The Pharmaceutical Evaluation Division of the Ministry of Health, Labour and Welfare’s Pharmaceutical Safety Bureau issued an administrative notice to prefectural governments regarding the designation of Santen Pharmaceutical’s Alesion eye drops as an OTC drug requiring pharmacist guidance.
The Ministry of Health, Labour and Welfare’s Pharmaceutical Evaluation Division notified prefectural governments and other authorities of its policy to designate Santen Pharmaceutical’s Alesion eye drops (epinastine hydrochloride) as an OTC drug requiring pharmacist guidance. The date of the notice is based on the wording in the article. The product’s indications and usage are expected to change as a result.
Consideration had previously been under way to designate Alesion eye drops as an OTC drug requiring pharmacist guidance rather than a general OTC drug, and this administrative notice forms part of that process. The specific scope of application and any changes to sales conditions are expected to be communicated through future ministerial notifications and public announcements.