EMEA-000335-PIP01-08-M13

Key facts

Invented name
Kalydeco
Active substance
ivacaftor
Therapeutic area
Other
Decision number
P/0353/2018
PIP number
EMEA-000335-PIP01-08-M13
Pharmaceutical form(s)
  • Film-coated tablet
  • Granules in sachet
Condition(s) / indication(s)
Treatment of cystic fibrosis
Route(s) of administration
Oral use
Contact for public enquiries
Vertex Pharmaceuticals (Europe) Limited

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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