EMEA-001230-PIP01-11-M05 - paediatric investigation plan

Lurasidone hydrochloride

Key facts

• Invented name:
  • Latuda
  • Latuda
• Active substance:
  Lurasidone hydrochloride
• Therapeutic area:
  Psychiatry
• Decision number:
  P/0359/2019
• PIP number:
  EMEA-001230-PIP01-11-M05
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of schizophrenia
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  04/11/2019
• Compliance check done:
  Ja
• Compliance procedure number:
  EMEA-C-001230-PIP01-11-M05
• Compliance opinion date:
  11/12/2019
• Compliance outcome:
  Positive

Decision

P/0359/2019: EMA decision of 4 November 2019 on the acceptance of a modification of an agreed paediatric investigation plan for lurasidone (hydrochloride) (Latuda) (EMEA-001230-PIP01-11-M05)

Adopted Reference Number: EMA/584816/2019