EMEA-001237-PIP01-11 - paediatric investigation plan

3-[[4-[(1S)-1-[4-(4-tert-butylphenyl)-3,5-dimethyl-phenoxy]-4,4,4-trifluorobutyl]benzoyl]amino]propanoic acid

Key facts

• Active substance:
  3-[[4-[(1S)-1-[4-(4-tert-butylphenyl)-3,5-dimethyl-phenoxy]-4,4,4-trifluorobutyl]benzoyl]amino]propanoic acid
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0173/2013
• PIP number:
  EMEA-001237-PIP01-11
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of type II diabetes mellitus
• 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:
  30/07/2013
• Compliance check done:
  No

Decision

P/0173/2013: EMA decision of 30 July 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 3-[[4-[(1S)-1-[4-(4-tert-butylphenyl)-3,5-dimethyl-pheno...

Adopted Reference Number: EMA/375056/2013