EMEA-002079-PIP01-16-M03 - paediatric investigation plan

Lumasiran (ALN-GO1)

Key facts

• Active Substance:
  Lumasiran (ALN-GO1)
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0070/2023
• PIP number:
  EMEA-002079-PIP01-16-M03
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of hyperoxaluria
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Alnylam UK Limited

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/03/2023

Decision

P/0070/2023 : EMA decision of 10 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for lumasiran (Oxlumo), (EMEA-002079-PIP01-16-M03)

Reference Number: EMA/84334/2023