EMEA-001460-PIP01-13-M05 - paediatric investigation plan

elvitegravir
cobicistat
emtricitabine
tenofovir alafenamide
PIPHuman

Key facts

Invented name
Genvoya
Active Substance
  • elvitegravir
  • cobicistat
  • emtricitabine
  • tenofovir alafenamide
Therapeutic area
Infectious diseases
Decision number
P/0435/2020
PIP number
EMEA-001460-PIP01-13-M05
Pharmaceutical form(s)
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 897300
E-mail: regulatory.pip@gilead.com

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-001460-PIP01-13-M05
Compliance opinion date
Compliance outcome
Positive

Decision

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