EMEA-000150-PIP02-10 - paediatric investigation plan

(1R, 4S, 5S, 6S)-4-[[(2s)-2-amino-4-(methylthio)-1-oxobutyl]amino]-2-thiabicyclo[3.1.0]hexane-4,6-dicarboxylic acid,2,2-dioxide, monohydrate (LY2140023)

Key facts

• Active Substance:
  (1R, 4S, 5S, 6S)-4-[[(2s)-2-amino-4-(methylthio)-1-oxobutyl]amino]-2-thiabicyclo[3.1.0]hexane-4,6-dicarboxylic acid,2,2-dioxide, monohydrate (LY2140023)
• Therapeutic area:
  Psychiatry
• Decision number:
  P/253/2011
• PIP number:
  EMEA-000150-PIP02-10
• Pharmaceutical form(s):
  Coated tablet
• Condition(s) / indication(s):
  Treatment of schizophrenia
• 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:
  26/10/2011

Decision

P/253/2011: EMA decision of 26 October 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (1R, 4S, 5S, 6S)-4-[[(2s)-2-amino-4-(methylthio)-1-oxo...

AdoptedReference Number: EMA/777093/2011