Key facts

Invented name
  • Descovy
  • Descovy
Active Substance
  • emtricitabine
  • tenofovir alafenamide
Therapeutic area
Infectious diseases
Decision number
P/0139/2018
PIP number
EMEA-001577-PIP03-17
Pharmaceutical form(s)
Film-coated tablet
Condition(s) / indication(s)
Prevention of human immunodeficiency virus (HIV-1) infection
Route(s) of administration
Oral use
Contact for public enquiries

Gilead Sciences International Ltd

E-mail: regulatory.pip@gilead.com
Tel. +44 (0)1223 897300

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date
Compliance procedure number
EMEA-C-001577-PIP03-17
Compliance opinion date
Compliance outcome
Positive

Decision

P/0139/2018: EMA decision of 7 May 2018 on the agreement of a paediatric investigation plan and on the granting of a waiver for emtricitabine / tenofovir alafenamide (Descovy), (EMEA-001577-PIP03-17)

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