Darunavir - paediatric investigation plan

darunavir

Key facts

• Invented name:
  • Prezista
  • Prezista
• Active Substance:
  darunavir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/138/2010
• PIP number:
  Darunavir
• Pharmaceutical form(s):
  • Film-coated tablet
  • Oral suspension
• 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

  E-mail: [e-mail]; Country: Belgium; Phone: [phone]; Fax: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  31/07/2010
• Compliance procedure number:
  EMEA-C-000038-PIP01-07-M03
• Compliance opinion date:
  13/12/2011
• Compliance outcome:
  Positive

Decision

P/138/2010: European Medicines Agency decision of 30 July 2010 on the acceptance of a modification of an agreed paediatric investigation plan for darunavir (Prezista), (EMEA-000038-PIP01-07-M03) in accordance with Regula...

AdoptedReference Number: EMA/463333/2010