EMEA-001280-PIP01-12-M02

Key facts

Invented name
Rezolsta
Active substance
  • darunavir
  • cobicistat
Therapeutic area
Infectious diseases
Decision number
P/0006/2019
PIP number
EMEA-001280-PIP01-12-M02
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral solid dosage form
  • Age-appropriate oral liquid dosage form
Condition(s) / indication(s)
Treatment of 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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