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Medicinal Products Licensing

Dáil Éireann Debate, Thursday - 29 May 2014

Thursday, 29 May 2014

Questions (120)

Róisín Shortall


120. Deputy Róisín Shortall asked the Minister for Health if his attention has been drawn to allegations of the potential side effects of a drug (details supplied) and the concerns expressed by a general practitioner from their experience with some of their patients; the current conditions attached to the prescribing of this drug here; the action he proposes to assure men that the use of the drug is safe; and if a review of the availability of the drug in Ireland has been carried out in view of these concerns. [23586/14]

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Written answers (Question to Health)

Under European and Irish legislation, before a medicine can be placed on the Irish market the manufacturer has to seek an authorisation from the Irish Medicines Board (IMB) or in the case of certain medicinal products, the European Medicines Agency (EMA). A determination on an application for authorisation of a medicine is based on a rigorous scientific assessment of the application against legal and regulatory requirements.

Propecia 1mg Tablets (which contains the active substance finasteride) is not a licensed brand of the drug finasteride in Ireland. The IMB has advised that this brand is a licensed product in the USA where it is approved for use in the treatment of male pattern hair loss (also known as androgenetic alopecia). In Ireland however, finasteride is only licensed for the treatment and control of benign prostatic hyperplasia (BPH) and for the prevention of urologic events in men and is not licensed for use in the treatment of male pattern hair loss.

Finasteride is known to be associated with a number of adverse reactions, which are detailed in the product information for healthcare professionals and patients. Effects on male sexual function are known and clearly indicated in its product information, the most commonly occurring reactions being impotence and decreased libido. The IMB considers that the benefits of treatment with finasteride outweigh its risks, when used in accordance with the approved product information and under the supervision of the prescribing specialist.