Rekambys (rilpivirine)
- Region
- 🇪🇺 EU
- Active substance
- rilpivirine
- Company
- Janssen-Cilag International NV
- Status
- Authorised
- Therapeutic area
- HIV Infections
- CHMP opinion
- Thu 15 Oct 2020
- EU approval
- Thu 17 Dec 2020
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005060
- ATC
- J05AG05
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Emtricitabine / Rilpivirine / Tenofovir Alafenamide Viatris Authorised · Viatris Limited
- 🇪🇺 Eviplera Authorised · Gilead Sciences International Ltd
- 🇪🇺 Juluca Authorised · ViiV Healthcare B.V.
- 🇪🇺 Edurant Authorised ·
- 🇪🇺 Odefsey Authorised · Gilead Sciences Ireland UC
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.