EMEA-000425-PIP02-10-M04 - paediatric investigation plan

Bosentan

Key facts

• Invented name:
  • Tracleer
  • Tracleer
• Active substance:
  Bosentan
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0090/2013
• PIP number:
  EMEA-000425-PIP02-10-M04
• Pharmaceutical form(s):
  • Film-coated tablet
  • Dispersible tablet
• Condition(s) / indication(s):
  • Treatment of interstitial pulmonary fibrosis
  • Treatment of pulmonary arterial hypertension
  • Treatment of systemic sclerosis
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/04/2013
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000425-PIP02-10-M04
• Compliance opinion date:
  21/03/2014
• Compliance outcome:
  Positive

Decision

P/0090/2013: EMA decision of 29 April 2013 on the acceptance of a modification of an agreed paediatric investigation plan for bosentan (Tracleer) (EMEA-000425-PIP02-10-M04)

Adopted Reference Number: EMA/203780/2013