EMEA-002942-PIP01-20 - paediatric investigation plan

Peptide derivative of glucagon-like-peptide 1 and glucagon with fatty acid side chain (BI 456906)

Key facts

• Active substance:
  Peptide derivative of glucagon-like-peptide 1 and glucagon with fatty acid side chain (BI 456906)
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0500/2021
• PIP number:
  EMEA-002942-PIP01-20
• 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:
  03/12/2021
• Compliance check done:
  No

Decision

P/0500/2021 : EMA decision of 3 December 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for peptide derivative of... (EMEA-002942-PIP01-20)

Adopted Reference Number: EMA/616523/2021