EMEA-000969-PIP01-10-M06 - paediatric investigation plan

cobicistat

Key facts

• Invented name:
  • Tybost
  • Tybost
• Active Substance:
  cobicistat
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0360/2022
• PIP number:
  EMEA-000969-PIP01-10-M06
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age-appropriate dispersible tablet
• Condition(s) / indication(s):
  Treatment of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Gilead Sciences International Ltd.

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  22/08/2022

Decision

P/0360/2022 :EMA decision of 22 August 2022 on the acceptance of a modification of an agreed paediatric investigation plan for cobicistat (Tybost), (EMEA-000969-PIP01-10-M06)

AdoptedReference Number: EMA/697703/2022