Key facts

Invented name
  • Orkambi
  • Orkambi
Active Substance
  • Lumacaftor
  • ivacaftor
Therapeutic area
Other
Decision number
P/0506/2020
PIP number
EMEA-001582-PIP01-13-M10
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 date

Decision

P/0506/2020: EMA decision of 22 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for lumacaftor / ivacaftor (Orkambi), (EMEA-001582-PIP01-13-M10)

How useful do you find this page?