EMEA-001582-PIP01-13-M08

Key facts

Invented name
Orkambi
Active substance
  • Lumacaftor
  • ivacaftor
Therapeutic area
Other
Decision number
P/0407/2018
PIP number
EMEA-001582-PIP01-13-M08
Pharmaceutical form(s)
  • Film-coated tablet
  • granules
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

How useful was this page?

Add your rating