Written answers
Wednesday, 15 May 2019
Department of Health
Medicinal Products Licensing
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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163. To ask the Minister for Health the clinical trials conducted on sodium valproate here prior to its licensing in 1975; and if no clinical trials were conducted here, the international clinical trial data used as the basis for its approval. [20976/19]
Simon Harris (Wicklow, Fine Gael)
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The Health Products Regulatory Authority (HPRA) has advised my Department that it will take some time to compile the information requested by the Deputy. Therefore, I have asked the HPRA to reply directly to the Deputy on this occasion.
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