EMEA-001280-PIP01-12-M04

Table of contents

Key facts

Invented name
Rezolsta
Active substance
  • darunavir
  • cobicistat
Therapeutic area
Infectious diseases
Decision number
P/0254/2021
PIP number
EMEA-001280-PIP01-12-M04
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

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

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

Decision

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