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Marketing authorisation with orphan designation - USA

  • Tradename: CERDELGA
  • ATC code : A16AX10
  • EU Number: -
  • MA date : 19/08/2014
  • MA holder: GENZYME CORPORATION

Therapeutic indication

Long-term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test.

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