EMEA-002324-PIP01-17-M01

Table of contents

Key facts

Active substance
  • elexacaftor
  • tezacaftor
  • ivacaftor
Therapeutic area
  • Other
  • Pneumology-allergology
Decision number
P/0397/2020
PIP number
EMEA-002324-PIP01-17-M01
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral solid dosage form
Condition(s) / indication(s)
Treatment of cystic fibrosis
Route(s) of administration
Oral use
Contact for public enquiries
Vertex Pharmaceuticals (Ireland) Limited

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

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

Decision

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