EMEA-000409-PIP01-08-M06 - paediatric investigation plan

Dolutegravir (DTG)

Key facts

• Invented name:
  Tivicay
• Active substance:
  Dolutegravir (DTG)
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0267/2021
• PIP number:
  EMEA-000409-PIP01-08-M06
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate formulation
• Condition(s) / indication(s):
  Treatment of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/07/2021
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000409-PIP01-08-M06
• Compliance opinion date:
  15/10/2021
• Compliance outcome:
  Positive

Decision

P/0267/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for dolutegravir (Tivicay),(EMEA-000409-PIP01-08-M06)

Adopted Reference Number: EMA/359351/2021