© Crown copyright 2012 Thalidomide: Legal and Medical Perspectives Current Regulatory Approach Dr June Raine Director Vigilance & Risk Management Medicines.

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© Crown copyright 2012 Thalidomide: Legal and Medical Perspectives Current Regulatory Approach Dr June Raine Director Vigilance & Risk Management Medicines and Healthcare products Regulatory Agency 20 November 2012

© Crown copyright 2012 Slide 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

© Crown copyright 2012 Slide 3

© Crown copyright 2012 Slide 4

© Crown copyright 2012 Slide 5 Clinical Practice Research Datalink 10 million active patients 25 years of data 98 million hospital referrals 2.5 billion prescriptions Children’s and Pregnancy Datamart by end year

© Crown copyright 2012 Slide 6 Information resources on ADRs

© Crown copyright 2012 Slide 7

© Crown copyright 2012 Slide 8

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