EMEA-002222-PIP01-17 - paediatric investigation plan

1H-Isoindol-1-one,2-[[1-[2-(4-fluorophenyl)-2-oxoethyl]-4-piperidinyl]methyl]-2,3-dihydro-,hydrochloride, hydrate (1:1:2) (MIN-101)

Key facts

• Active Substance:
  1H-Isoindol-1-one,2-[[1-[2-(4-fluorophenyl)-2-oxoethyl]-4-piperidinyl]methyl]-2,3-dihydro-,hydrochloride, hydrate (1:1:2) (MIN-101)
• Therapeutic area:
  Psychiatry
• Decision number:
  P/0303/2017
• PIP number:
  EMEA-002222-PIP01-17
• Pharmaceutical form(s):
  Gastro-resistant tablet
• Condition(s) / indication(s):
  Treatment of schizophrenia
• Route(s) of administration:
  Oral use
• Decision type:
  RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
• Decision date:
  08/11/2017

Decision

P/0303/2017: EMA decision of 9 November 2017 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the refusal of a waiver for 1H-Isoindol-1-one,2-[[1-[2-(4-fluorophenyl)-2-oxoethyl]-...

AdoptedReference Number: EMA/735836/2017