EMEA-001640-PIP01-14-M05

Key facts

Invented name
Symkevi
Active substance
  • 1-(2,2-difluoro-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl}cyclopropanecarboxamide (VX-661)
  • ivacaftor
Therapeutic area
Pneumology-allergology
Decision number
P/0250/2019
PIP number
EMEA-001640-PIP01-14-M05
Pharmaceutical form(s)
  • Film-coated tablet
  • Age appropriate oral formulation
Condition(s) / indication(s)
Treatment of cystic fibrosis
Route(s) of administration
Oral use
Contact for public enquiries
Vertex Pharamceuticals (Europe) Ltd.

Tel. +1 8776348789
E-mail: medicalinfo@vrtx.com

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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