EMA — authorised 17 December 2020
- Marketing authorisation holder: ViiV Healthcare B.V.
- Status: approved
🇪🇺 Vocabria in European Union
EMA authorised Vocabria on 17 December 2020
Marketing authorisations
EMA — authorised 17 December 2020
- Application: EMEA/H/C/004976
- Marketing authorisation holder: ViiV Healthcare B.V.
- Local brand name: Vocabria
- Indication: Vocabria tablets are indicated in combination with rilpivirine tablets for the short-term 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 for: Oral lead in to assess tolerability of Vocabria and rilpivi
- Status: approved
Vocabria in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in European Union
Frequently asked questions
Is Vocabria approved in European Union?
Yes. EMA authorised it on 17 December 2020; EMA authorised it on 17 December 2020.
Who is the marketing authorisation holder for Vocabria in European Union?
ViiV Healthcare B.V. holds the EU marketing authorisation.