BRIEF-EMA Recommends Revoking Marketing Authorisation For Tavneos In EU

Amgen Inc.

Amgen Inc.

AMGN

0.00

- EMA:

  • EMA - RECOMMENDS REVOKING MARKETING AUTHORISATION FOR TAVNEOS IN THE EU

  • EMA - REVIEW OF TAVNEOS INITIATED OVER DATA INTEGRITY CONCERNS IN ADVOCATE STUDY

  • EMA - FINDS ADVOCATE STUDY FOR TAVNEOS BREACHED GOOD CLINICAL PRACTICE PRINCIPLES

  • EMA - RECOMMENDS NO NEW PATIENTS START TAVNEOS; SWITCH EXISTING PATIENTS TO ALTERNATIVES

  • EMA - WARNS OF SERIOUS LIVER RISKS WITH TAVNEOS; RECOMMENDS CLOSE MONITORING

  • EMA - STATES TAVNEOS STUDY DATA INCORRECT AND UNRELIABLE FOR EFFECTIVENESS

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