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Medicinal Products

Dáil Éireann Debate, Wednesday - 21 November 2018

Wednesday, 21 November 2018

Questions (161)

James Browne

Question:

161. Deputy James Browne asked the Minister for Health the position regarding the drug minocycline as a treatment for schizophrenia (details supplied); and if he will make a statement on the matter. [48433/18]

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Written answers

Minocycline is a broad-spectrum antibiotic which is authorised in Ireland for the treatment of infections caused by tetracycline-sensitive organisms.  It is not currently authorised as a treatment for schizophrenia. 

The Health Products Regulatory Authority (HPRA), the competent authority for medicines in Ireland, have advised that there is a clinical trial registered in the UK investigating the role of this therapy in schizophrenia. 

If the safe and efficacious use of Minocycline in the treatment of schizophrenia is shown through successful trials, the marketing authorisation holder may choose to apply to the European Medicines Agency or the HPRA for its indicated use to be expanded to include treatment of schizophrenia. It is important to note however that I as Minister for Health have no role in the authorisation process for medicinal products and such decisions can only be made by the marketing authorisation holder. 

The HPRA has confirmed that there are no ongoing clinical trials in Ireland investigating minocycline in the treatment of schizophrenia.

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