EMEA-003058-PIP01-21 - paediatric investigation plan

Humanised KLB/FGFR1c monoclonal antibody (MK-3655)

Key facts

• Active substance:
  Humanised KLB/FGFR1c monoclonal antibody (MK-3655)
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0186/2022
• PIP number:
  EMEA-003058-PIP01-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of non-alcoholic steatohepatitis (NASH)
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  16/05/2022
• Compliance check done:
  No

Decision

P/0186/2022 : EMA decision of 16 May 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for humanised KLB/FGFR1c monoclonal antibody (MK-3655) (EMEA-003058-PIP01-21)

Adopted Reference Number: EMA/258327/2022