Thalidomide: Legal and Medical Perspectives Current Regulatory Approach
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© Crown copyright 2012
Thalidomide:Legal and Medical Perspectives
Current Regulatory Approach
Dr June RaineDirector Vigilance & Risk Management
Medicines and Healthcare products Regulatory Agency
20 November 2012
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© Crown copyright 2012Slide 2
PRESS RELEASE
CHMP concluded that the benefits of Thalidomide outweigh its risks for treatment of multiple myeloma….
Clinical studies have shown that adding Thalidomide can prolong survival time by about 18 months in newly-diagnosed multiple myeloma patients over 65 years of age as compared to patients….16 April 2008
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© Crown copyright 2012Slide 3
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Clinical Practice Research Datalink
10 million active patients25 years of data98 million hospital referrals2.5 billion prescriptions
Children’s and PregnancyDatamart by end year
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© Crown copyright 2012Slide 6
Information resources on ADRs
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© Crown copyright 2012Slide 7
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© Crown copyright 2012Slide 8