EMEA-000573-PIP02-13-M03 - paediatric investigation plan

solifenacin (succinate)

Key facts

• Invented name:
  Vesicare and associated names
• Active Substance:
  solifenacin (succinate)
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0115/2015
• PIP number:
  EMEA-000573-PIP02-13-M03
• Pharmaceutical form(s):
  • Oral suspension
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of neurogenic detrusor overactivity
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  05/06/2015
• Compliance procedure number:
  EMEA-C-000573-PIP02-13-M03
• Compliance opinion date:
  16/12/2016
• Compliance outcome:
  Positive

Decision

P/0115/2015: EMA decision of 5 June 2015 on the acceptance of a modification of an agreed paediatric investigation plan for solifenacin (succinate) (Vesicare and associated names) (EMEA-000573-PIP02-13-M03)

AdoptedReference Number: EMA/355269/2015