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European Medicines Agency (EMA) Issues European Public Assessment Report (EPAR) For Revestive (Teduglutide) For Short Bowel Syndrome (SBS)

September 28, 2012

          The European Medicines Agency (EMA) issues on September 24, 2012, the European Public Assessment Report (EPAR) for Revestive (Teduglutide; Gattex in US) for treatment of Short Bowel Syndrome (SBS) in adults :

  1. EPAR (Summary)
  2. EPAR (Full Details).

          The EPAR “explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favor of granting a marketing authorization & its recommendations on the conditions of use for Revestive”.  

          A brief history of the European Medicines Agency (EMA) actions for orphan drug Revestive for Short Bowel Syndrome :

  1. The positive opinion EMA’s Committee for Medicinal Products for Human Use (CHMP) issues on June 21, 2012 for Revestive for adults with SBS
  2. Takeda Pharmaceuticals and NPS Pharmaceuticals jointly announces on September 4, 2012 in a Press Release, that the European Commission (EC) grants European market authorization for teduglutide (Revestive in Europe; Gattex in US) as a once-daily treatment for adults with Short Bowel Syndrome (SBS)
  3. EMA issues EPAR on September 24, 2012.

Copyright  © 2012-2013, Ann-Teresa Cusenza and Orphan Druganaut Blog.  All rights reserved.

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