Thalidomide: Legal and Medical Perspectives Current Regulatory Approach

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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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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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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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Information resources on ADRs

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