🇪🇺 Rilpivirine Injectable Suspension in European Union

EMA authorised Rilpivirine Injectable Suspension on 17 December 2020

Marketing authorisation

EMA — authorised 17 December 2020

  • Application: EMEA/H/C/005060
  • Marketing authorisation holder: Janssen-Cilag International NV
  • Local brand name: Rekambys
  • Indication: REKAMBYS is indicated, in combination with cabotegravir injection, for the treatment of human immunodeficiency virus type 1 (HIV 1) infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the non-nucleoside reverse transcriptase inhibitor (NNRTI) and integrase inhibitor (INI) class.
  • Status: approved

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Other Infectious Disease / Virology approved in European Union

Frequently asked questions

Is Rilpivirine Injectable Suspension approved in European Union?

Yes. EMA authorised it on 17 December 2020.

Who is the marketing authorisation holder for Rilpivirine Injectable Suspension in European Union?

Janssen-Cilag International NV holds the EU marketing authorisation.