EMEA-002723-PIP01-19-M01 - paediatric investigation plan

Plasma kallikrein inhibitor

Key facts

• Active Substance:
  Plasma kallikrein inhibitor
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0379/2022
• PIP number:
  EMEA-002723-PIP01-19-M01
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age-appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of hereditary angioedema
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  KalVista Pharmaceuticals Ltd

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  27/09/2022

Decision

P/0379/2022 : EMA decision of 27 September 2022 on the acceptance of a modification of an agreed paediatric investigation plan for plasma kallikrein inhibitor (EMEA-002723-PIP01-19-M01)

AdoptedReference Number: EMA/709041/2022