EMEA-000774-PIP01-09-M03 - paediatric investigation plan

emtricitabine
rilpivirine hydrochloride
tenofovir disoproxil fumarate
PIPHuman

Key facts

Invented name
Eviplera
Active Substance
  • emtricitabine
  • rilpivirine hydrochloride
  • tenofovir disoproxil fumarate
Therapeutic area
Infectious diseases
Decision number
P/0274/2018
PIP number
EMEA-000774-PIP01-09-M03
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

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

Decision type
W: decision granting a waiver in all age groups for all conditions or indications
Decision date

Decision

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