EMEA-001173-PIP01-11-M01 - paediatric investigation plan

Lumacaftor

Key facts

• Active Substance:
  Lumacaftor
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0268/2013
• PIP number:
  EMEA-001173-PIP01-11-M01
• 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 Pharmaceuticals (Europe) Ltd.

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  19/12/2013

Decision

P/268/2013: EMA decision of 19 December 2013 on the acceptance of a modification of an agreed paediatric investigation plan for lumacaftor (EMEA-001173-PIP01-11-M01)

AdoptedReference Number: EMA/592149/2013

Lumacaftor - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision