EMEA-001005-PIP01-10-M01 - paediatric investigation plan

lopinavir

ritonavir

Key facts

• Invented name:
  • Kaletra
  • Kaletra
• Active substance:
  • lopinavir
  • ritonavir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0144/2012
• PIP number:
  EMEA-001005-PIP01-10-M01
• Pharmaceutical form(s):
  • Oral solution
  • Capsule, soft
  • Film-coated tablet
• 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:
  23/07/2012
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001005-PIP01-10-M01
• Compliance opinion date:
  17/07/2015
• Compliance outcome:
  Positive

Decision

P/0144/2012: EMA decision of 23 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for lopinavir / ritonavir (Kaletra) (EMEA-001005-PIP01-10-M01)

Adopted Reference Number: EMA/451374/2012