Medicinal Products

Dáil Éireann Debate, Thursday - 19 June 2025

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Thursday, 19 June 2025

Questions (385)

Robert O'Donoghue

Question:

385. Deputy Robert O'Donoghue asked the Minister for Health if she will address the situation regarding the unavailability of phyllocontin and uniphyllin (theophylline) tablets, which were previously used to manage asthma and were covered under the medical card scheme; if uniphyllin continus PR, which is believed to be the replacement, will be made available under the medical card given its high monthly cost; and if she will make a statement on the matter. [33234/25]

Written answers

Minister for Health

The following information is available from our national medicines regulator, the Health Products Regulatory Authority (HPRA).

Ennogen Healthcare (Europe) Limited, the Marketing Authorisation Holder for Phyllocontin Continus 225 mg Prolonged Release Tablets, have informed pharmacies of their intention to discontinue marketing of Phyllocontin Continus 225 mg Prolonged Release Tablets in Ireland, the HPRA has confirmed with the MAH. The HPRA’s website has been updated to reflect the current marketing status of this medicinal product.

Based on a notification received from Ennogen Healthcare (Europe) Limited, the Marketing Authorisation Holder for Uniphyllin Continus 200mg, 300mg & 400mg Prolonged-release tablets, the company decided to cease marketing of the products in Ireland in December 2024 due to “commercial reasons”.

The HPRA cannot compel marketing authorisation holders to market medicines in Ireland.

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