§ Mrs. BeckettTo ask the Secretary of State for Health if she will indicate her reasons for not licensing the drug Tacrine for the treatment of Alzheimer's disease; and if she will list the countries in Europe where it is licensed. [19901]
§ Mr. MurphyTo ask the Secretary of State for Health what progress has been made towards the processing of Cognex (Tacrine) by the United Kingdom. [20319]
§ Mr. SackvilleThe Committee on Safety of Medicines (CSM), has provisionally concluded that, on grounds relating to safety and efficacy, they are unable to advise the licensing authority that Tacrine should be licensed at this stage. Under the United Kingdom licensing procedures, applicants for drug licences have extensive rights of appeal against the provisional conclusions of the CSM. The company promoting Tacrine is exercising these rights and the CSM will consider its appeal at the hearing.
The European Union's Committee for Proprietary Medicinal Products has also concluded that Tacrine has not met the requirements for licensing under article 5 of directive 65/65/EEC. The majority of the European Union member states have decided to abide by this decision.
Tacrine is licensed in France and Sweden.