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Thalidomide: Legal and Medical Perspectives Current Regulatory Approach

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

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Thalidomide: Legal and Medical Perspectives Current Regulatory Approach

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  1. Thalidomide:Legal and Medical PerspectivesCurrent Regulatory Approach Dr June Raine Director Vigilance & Risk Management Medicines and Healthcare products Regulatory Agency 20 November 2012

  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

  3. 10 million active patients 25 years of data 98 million hospital referrals 2.5 billion prescriptions Children’s and Pregnancy Datamart by end year Clinical Practice Research Datalink

  4. Information resources on ADRs

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