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European Medicines Agency’s (EMA) Committee For Orphan Medicinal Products (COMP) January 2013 Meeting Results

January 15, 2013

EMA’s Committee for Orphan Medicinal Products (COMP) held a meeting January 8 – 9, 2013. The EMA COMP January 2013 Meeting Report on the review of applications for orphan designation is published January 10, 2013.  At this meeting, there are 8 positive opinions recommending orphan designation for the treatment of :

  1. –  High altitude pulmonary edema
  2. –  Moderate and severe traumatic brain injury
  3. –  Chronic thromboembolic pulmonary hypertension
  4. –   Duchenne muscular dystrophy
  5. –   Amyloid light-chain amyloidosis
  6. –   Acute myeloid leukemia
  7. –   Achromatopsia caused by mutations in the CNGB3 gene
  8. –   Systemic sclerosis.

2013 EMA COMP Calendar

  1. February 5 – 6, 2013
  2. March 12 – 13, 2013
  3. April 16 – 17, 2013
  4. May 14 – 15, 2013
  5. June 11 – 12, 2013
  6. July 9 – 10, 2013
  7. September 3 – 4, 2013
  8. October 8 – 9, 2013
  9. November 5 – 6, 2013
  10. December 10 – 11, 2013.

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