EMEA-000035-PIP02-09-M02 - paediatric investigation plan

tiotropium bromide (monohydrate)

Key facts

• Active substance:
  tiotropium bromide (monohydrate)
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0005/2015
• PIP number:
  EMEA-000035-PIP02-09-M02
• Pharmaceutical form(s):
  • Inhalation solution
  • Inhalation powder
  • Capsule, hard
• Condition(s) / indication(s):
  Treatment of asthma
• Route(s) of administration:
  Inhalation use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/01/2015
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000035-PIP02-09-M02
• Compliance opinion date:
  27/05/2016
• Compliance outcome:
  Positive

Decision

P/0005/2015: EMA decision of 30 January 2015 on the acceptance of a modification of an agreed paediatric investigation plan for tiotropium bromide (monohydrate) (Spiriva Respimat, Spiriva), (EMEA-000035-PIP02-09-M02)

Adopted Reference Number: EMA/793410/2014