§ Mr. TippingTo ask the Secretary of State for Health what guidance has been given to health authorities about the prescribing of Riluzole. [1623]
§ Mr. MaloneNo guidance has been issued.
§ Mr. TippingTo ask the Secretary of State for Health what evaluation he has made of the value of Riluzole in the treatment of motor neurone disease. [1646]
§ Mr. MaloneA marketing authorisation for Riluzole was submitted to the European Medicines Evaluation Agency through the new centralised procedure set out in regulation 93/2309 EC. The United Kingdom was appointed as the rapporteur with France as the co-rapporteur for the assessment of this product. The initial assessment was therefore made by the Medicines Control Agency and advice obtained from the Committee on Safety of Medicines.
The final assessment and opinion were given by the Committee on Proprietary Medicinal Products and the authorisation to market Riluzole was given by the European Commission according to the procedure set out in regulation 93/2309 EC. This marketing authorisation is binding across all 15 member states of the European Union.
The summary of product characteristics defines the indications and use of the product and a European public assessment report describes the evaluation of the product 502W and is available from the European Medicines Evaluation Agency at 7 Westferry Circus, Canary Wharf, London E14 4HB.