EMEA-001280-PIP01-12-M06 - paediatric investigation plan

darunavir

cobicistat

Key facts

• Invented name:
  Rezolsta
• Active Substance:
  • darunavir
  • cobicistat
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0257/2023
• PIP number:
  EMEA-001280-PIP01-12-M06
• Pharmaceutical form(s):
  • Film-coated tablet
  • Dispersible tablet
• Condition(s) / indication(s):
  Treatment of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Janssen-Cilag International NV

  Tel. + 32 1460 2111; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/07/2023

Decision

P/0257/2023 : EMA decision of 14 July 2023 on the acceptance of a modification of an agreed paediatric investigation plan for darunavir / cobicistat (Rezolsta), (EMEA-001280-PIP01-12-M06)

Reference Number: EMA/306614/2023