EMEA-000452-PIP02-10-M06 - paediatric investigation plan

tadalafil

Key facts

• Invented name:
  • • Adcirca
    • Cialis
  • • Cialis
    • Adcirca (previously Tadalafil Lilly)
• Active substance:
  tadalafil
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0376/2020
• PIP number:
  EMEA-000452-PIP02-10-M06
• Pharmaceutical form(s):
  • Film-coated tablet
  • Oral suspension
• Condition(s) / indication(s):
  Treatment of pulmonary arterial hypertension
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/09/2020
• Compliance check done:
  No

Decision

P/0376/2020: EMA decision of 11 September 2020 on the acceptance of a modification of an agreed paediatric investigation plan for tadalafil (Adcirca, Cialis), (EMEA-000452-PIP02-10-M06)

Adopted Reference Number: EMA/455623/2020