§ Mr. Carter-Jones
asked the Secretary of State for Social Services (1) in what year Depo Provera was first used in the United Kingdom;
(2) what additional clinical data on Depo Provera has been studied by the Committee on Safety of Medicines other than that provided by the company which manufactures the drug;
(3) if the Committee on Safety of Medicines has any intention of extending the categories under which Depo Provera is licensed for use at present.
§ Dr. Vaughan
I understand that Depo Provera was first marketed in the United Kingdom for the treatment of endometriosis and for use in the support of pregnancy in 1963, prior to the establishment of any regulatory body. It was marketed as a short-term contraceptive in 1974. The application for a product licence as a contraceptive was considered by the Committee on Safety of Medicines solely on the basis of clinical trial data submitted in the prescribed form by the company. I am unable to provide any information about applications for the extension of use of current licences made by companies to the licensing authority. These are treated as confidential for commercial reasons.