EMEA-000718-PIP01-09-M06 - paediatric investigation plan

riociguat

Key facts

• Invented name:
  • Adempas
  • Adempas
• Active substance:
  riociguat
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0289/2016
• PIP number:
  EMEA-000718-PIP01-09-M06
• Pharmaceutical form(s):
  • Film-coated tablet
  • Oral liquid
• Condition(s) / indication(s):
  Treatment of pulmonary hypertension
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  04/11/2016
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000718-PIP01-09-M06
• Compliance opinion date:
  11/12/2020
• Compliance outcome:
  Positive

Decision

P/0289/2016: EMA decision of 4 November 2016 on the acceptance of a modification of an agreed paediatric investigation plan for riociguat (Adempas), (EMEA-000718-PIP01-09-M06)

Reference Number: EMA/639656/2016