EMEA-000317-PIP01-08-M10

Key facts

Invented name
Edurant
Active substance
Rilpivirine (hydrochloride)
Therapeutic area
Infectious diseases
Decision number
P/0322/2018
PIP number
EMEA-000317-PIP01-08-M10
Pharmaceutical form(s)
  • Film-coated tablet
  • dispersible tablet
Condition(s) / indication(s)
Treatment of human immunodeficiency virus (HIV-1) infection
Route(s) of administration
Oral use
Contact for public enquiries
Janssen-Cilag International NV

E-mail: contact@janssen-emea.com
Tel. +32 1460 2111

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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