EMEA-002552-PIP01-19 - paediatric investigation plan

tris(hydroxymethyl)aminomethane trihydrate (PF-05221304-82)

Key facts

• Active substance:
  tris(hydroxymethyl)aminomethane trihydrate (PF-05221304-82)
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0098/2020
• PIP number:
  EMEA-002552-PIP01-19
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of non-alcoholic steatohepatitis (NASH)
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  18/03/2020
• Compliance check done:
  No

Decision

P/0098/2020: EMA decision of 18 March 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tris(hydroxymethyl)aminomethane trihydrate (PF-05221304-82) (EMEA- 002552-PIP01-19)

Adopted Reference Number: EMA/115516/2020