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Medicinal Products Licensing

Dáil Éireann Debate, Tuesday - 30 January 2018

Tuesday, 30 January 2018

Questions (437)

Mattie McGrath

Question:

437. Deputy Mattie McGrath asked the Minister for Health if the hormone-based treatment drug Primodos was ever licensed or dispensed here; and if he will make a statement on the matter. [4360/18]

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Written answers (Question to Health)

The Health Products Regulatory Authority (HPRA) is the competent authority for the regulation of medicines in Ireland. The HPRA has advised that Primodos, which was also known by the brand name Duogynon, was never authorised (i.e. licensed for use) in Ireland, although it is understood that Duogynon was available in Ireland during the 1970s, with distribution discontinued in 1978.

Duogynon was not an authorised medicinal product; however, the 1975 annual report of the National Drugs Advisory Board (NDAB, a predecessor of the HPRA) outlined the consideration given by the NDAB to the use of hormonal testing for pregnancy. In April 1975, the NDAB issued a warning letter to practitioners regarding the use of hormonal pregnancy testing preparations. This letter reminded practitioners that these preparations had not been assessed by the NDAB and that their use as a means of pregnancy testing had not been accepted by the NDAB. The letter also highlighted that these preparations should be avoided as a firm statement of safety could not be given and other, more efficient methods of pregnancy testing were available.

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