EMEA-001115-PIP01-10-M08 - paediatric investigation plan

loxapine

Key facts

• Invented name:
  Adasuve
• Active Substance:
  loxapine
• Therapeutic area:
  Psychiatry
• Decision number:
  P/0200/2022
• PIP number:
  EMEA-001115-PIP01-10-M08
• Pharmaceutical form(s):
  Inhalation powder (pre-dispensed)
• Condition(s) / indication(s):
  • Treatment of bipolar disorder
  • Treatment of schizophrenia
• Route(s) of administration:
  Inhalation use
• Contact for public enquiries:

  Ferrer Internacional, S.A.

  E-mail: [e-mail]; Tel.: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/06/2023

Decision

P/0200/2022 : EMA decision of 10 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for loxapine (Adasuve), (EMEA-001115-PIP01-10-M08)

AdoptedReference Number: EMA/266656/2022