EMEA-000970-PIP01-10-M01

Key facts

Active substance
  • elvitegravir
  • emtricitabine
  • tenofovir disoproxil (as fumarate)
  • cobicistat
Therapeutic area
Infectious diseases
Decision number
P/0309/2016
PIP number
EMEA-000970-PIP01-10-M01
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 Limited

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
Compliance procedure number
EMEA-C-000970-PIP01-10-M01
Compliance opinion date
16/12/2016
Compliance outcome
positive

Decision

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