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Volume 300: debated on Thursday 13 November 1997

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To ask the Secretary of state for Health for what reasons Glaxo was granted a lincence for Myodil; and what assessment he has made of overseas evidence that the drug is unsafe. [14608]

Myodil has been in use since the 1940s and was granted a Product Licence of Right (PLR), when the Medicines Act 1968 came into force . PLRs were reviewed by the Committee on Review of Medicines, which issued advice to the Licensing Authority. Applications for reviewed PLRs were assessed on the basis of the safety, quality for Myodil was granted in 1987 . However, Myodil was taken off the market by Glaxo for commercial reasons later in 1987. The safety of all licensed medicines is kept under continuous review by the committee on safety of Medicines and Medicines Control Agency. Safety data from all sources, including overseas, are included in this process.