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Medicinal Products

Dáil Éireann Debate, Thursday - 19 April 2018

Thursday, 19 April 2018

Ceisteanna (22)

Ruth Coppinger

Ceist:

22. Deputy Ruth Coppinger asked the Minister for Health if he will make information available on the safety of Misoprostol and Mifepristone; and if he will make a statement on the matter. [17120/18]

Amharc ar fhreagra

Freagraí scríofa

There are several misoprostol-containing medicines authorised for use in Ireland, two of which contain misoprostol as the sole, active ingredient. All misoprostol-containing medicines are available only on foot of a prescription. As prescription-only medicines, they should only be taken by a patient when prescribed for them by their medical practitioner, or other healthcare professional, as appropriate.

A medicine can only be placed on the Irish market when it has been granted a marketing authorisation. This marketing authorisation may be granted following an application by the pharmaceutical company to the Health Products Regulatory Authority or the European Medicines Agency.

A marketing authorisation may only be granted following a review of the safety, quality and efficacy data submitted by a company as part of this application and where it is considered that there is a positive benefit-risk associated with that medicine.

No medicine is completely free from the risk of side-effects. Therefore, this marketing authorisation process considers and weighs up the various benefits and risks associated with the use of a medicine before determining whether or not to grant the marketing authorisation. It also informs the manner in which the medicine may be used, or the restrictions placed around its use, so as to ensure the protection of patient safety.

The safety information associated with all medicines can be found in the Summary of Product Characteristics which accompanies, and forms part of, the marketing authorisation for a medicine.

The patient leaflet, which is included in the medicines package, contains similar information and is also available on the Health Products Regulatory Authority website, along with the more comprehensive Summary of Product Characteristics.

There are currently no medicines containing mifepristone authorised in Ireland and therefore there is no associated Summary of Product Characteristics containing this safety information.

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