EMEA-002692-PIP01-19 - paediatric investigation plan

Lonapegsomatropin

Key facts

• Active substance:
  Lonapegsomatropin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0275/2020
• PIP number:
  EMEA-002692-PIP01-19
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Treatment of growth hormone deficiency
• 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:
  15/07/2020
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-002692-PIP01-19
• Compliance opinion date:
  04/09/2020

Decision

P/0275/2020: EMA decision of 15 July 2020 on the agreement of a paediatric investigation plan and on the granting of a waiver for lonapegsomatropin (EMEA-002692-PIP01-19)

Adopted Reference Number: EMA/369130/2020