EMEA-001768-PIP02-15-M03 - paediatric investigation plan

rolapitant

Key facts

• Invented name:
  • Varuby
  • Varuby
• Active substance:
  rolapitant
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0194/2020
• PIP number:
  EMEA-001768-PIP02-15-M03
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral dosage formulation
• Condition(s) / indication(s):
  Prevention of nausea and vomiting
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  15/05/2020
• Compliance check done:
  No

Decision

P/0194/2020: EMA decision of 15 May 2020 on the acceptance of a modification of an agreed paediatric investigation plan for rolapitant (Varuby), (EMEA-001768-PIP02-15-M03)

Reference Number: EMA/178696/2020