Dáil Éireann Debate, Wednesday - 18 February 2026
280. Deputy Marie Sherlock asked the Minister for Health the reason that preservative-free cosopt eye drops have not been made available on the drugs payment scheme given that it is being prescribed to patients in Ireland; the reason that the licence for preservative-free cosopt drops was withdrawn by the Health Products Regulatory Authority; and if she will make a statement on the matter. [13130/26]
View answerUnder the Health (Pricing and Supply of Medical Goods) Act 2013, a medicine must have a marketing authorisation (licence) to be included in the formal list of reimbursable items. A pharmaceutical company can apply to the HSE for reimbursement for a specific indication of a specific licensed medicine. Medicines can have more than one licensed (market authorised) indication and each indication represents a separate application.
The Health Products Regulatory Authority have advised that Santen OY, the previous Marketing Authorisation Holder for the product COSOPT Preservative-Free 20 mg / ml + 5 mg / ml, eye drops (licence number PA0879/005/002), withdrew the product licence from the Irish market in October 2024 for commercial reasons.
