EMEA-001219-PIP01-11-M06 - paediatric investigation plan

dolutegravir
abacavir
lamivudine
PIPHuman

Key facts

Invented name
  • Triumeq
  • Triumeq
Active Substance
  • dolutegravir
  • abacavir
  • lamivudine
Therapeutic area
Infectious diseases
Decision number
P/0038/2023
PIP number
EMEA-001219-PIP01-11-M06
Pharmaceutical form(s)
  • Film-coated tablet
  • Dispersible tablet
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 Limited
E-mail: eu.paediatric-plans@gsk.com 
Tel: +1 4388998201

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-001219-PIP01-11-M06
Compliance opinion date
Compliance outcome
Positive

Decision

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