EMEA-000020-PIP01-07-M05 - paediatric investigation plan

maraviroc

Key facts

• Invented name:
  • Celsentri
  • Celsentri
• Active Substance:
  maraviroc
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0237/2015
• PIP number:
  EMEA-000020-PIP01-07-M05
• Pharmaceutical form(s):
  • Film-coated tablet
  • Oral solution
• Condition(s) / indication(s):
  Treatment of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  ViiV Healthcare UK Ltd

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/10/2015
• Compliance procedure number:
  EMEA-C-000020-PIP01-07-M05
• Compliance opinion date:
  29/04/2016
• Compliance outcome:
  Positive

Decision

P/0237/2015: EMA decision of 30 October 2015 on the acceptance of a modification of an agreed paediatric investigation plan for maraviroc (Celsentri), (EMEA-000020-PIP01-07-M05)

AdoptedReference Number: EMA/624833/2015