EMEA-001766-PIP01-15-M03

Table of contents

Key facts

Invented name
Biktarvy
Active substance
  • bictegravir
  • emtricitabine
  • tenofovir alafenamide
Therapeutic area
Infectious diseases
Decision number
P/0038/2021
PIP number
EMEA-001766-PIP01-15-M03
Pharmaceutical form(s)
  • Age-appropriate oral formulation
  • 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
Gilead Sciences International Ltd. 

Tel. +44 (0)1223 897 300 
E-mail: regulatory.pip@gilead.com

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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