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

lopinavir
ritonavir
PIP Human

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
Contact for public enquiries

AbbVie Ltd
E-mail: paediatricteam@abbvie.com
Tel. +44 (0)1628 408248

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance check done
Yes
Compliance procedure number
EMEA-C-001005-PIP01-10-M01
Compliance opinion date
Compliance outcome
Positive

Decision

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