EMEA-001368-PIP01-12 - paediatric investigation plan

lopinavir

lamivudine

ritonavir

zidovudine

Key facts

• Active substance:
  • lopinavir
  • lamivudine
  • ritonavir
  • zidovudine
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0175/2013
• PIP number:
  EMEA-001368-PIP01-12
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  30/07/2013
• Compliance check done:
  No

Decision

P/0175/2013: EMA decision of 30 July 2013 on the granting of a product-specific waiver for lopinavir / lamivudine / ritonavir / zidovudine (EMEA-001368-PIP01-12)

Adopted Reference Number: EMA/367930/2013