EMEA-002989-PIP01-21-M01 - paediatric investigation plan

Leniolisib

Key facts

• Active Substance:
  Leniolisib
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0259/2022
• PIP number:
  EMEA-002989-PIP01-21-M01
• Pharmaceutical form(s):
  • Capsule (hard)
  • Film-coated tablet
  • Granules
• Condition(s) / indication(s):
  Treatment of activated phosphoinositide 3-kinase delta syndrome (APDS)
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Pharming Group N.V.

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/07/2022

Decision

P/0259/2022: EMA decision of 15 July 2022 on the acceptance of a modification of an agreed paediatric investigation plan for leniolisib phosphate (EMEA-002989-PIP01-21-M01)

AdoptedReference Number: EMA/628925/2022