EMEA-000734-PIP01-09 - paediatric investigation plan

[(3S)-6-({2',6'-Dimethyl-4'-[3-(methylsulfonyl) propoxy] biphenyl-3-yl}methoxy)-2,3-dihydro-1-benzofuran-3-yl]acetic acid hydrate (TAK-875)

Key facts

• Active substance:
  [(3S)-6-({2',6'-Dimethyl-4'-[3-(methylsulfonyl) propoxy] biphenyl-3-yl}methoxy)-2,3-dihydro-1-benzofuran-3-yl]acetic acid hydrate (TAK-875)
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/243/2010
• PIP number:
  EMEA-000734-PIP01-09
• Pharmaceutical form(s):
  Film-coated 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:
  26/11/2010
• Compliance check done:
  No

Decision

P/243/2010: EMA decision of 26 November 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for [(3S)-6-({2',6'-Dimethyl-4'-[3-(methylsulfonyl) propo...

Adopted Reference Number: EMA/501874/2008