EMEA-001091-PIP02-15

Key facts

Invented name
Truvada
Active substance
  • emtricitabine
  • tenofovir disoproxil fumarate
Decision number
P/0294/2015
PIP number
EMEA-001091-PIP02-15
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
United Kingdom
Tel. +44 1223 897342
E-mail: regulatory.pip@gilead.com
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Compliance procedure number
EMEA-C-001091-PIP02-15
Compliance opinion date
16/12/2016
Compliance outcome
positive

Decision

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