EMEA-002712-PIP01-19-M01 - paediatric investigation plan

Cotadutide

Key facts

• Active Substance:
  Cotadutide
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0273/2021
• PIP number:
  EMEA-002712-PIP01-19-M01
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of non-alcoholic steatohepatitis (NASH)
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/07/2021

Decision

P/0273/2021 : EMA decision of 8 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for cotadutide (EMEA-002712-PIP01-19-M01)

AdoptedReference Number: EMA/359529/2021