Vocabria

RSS

cabotegravir

Authorised
This medicine is authorised for use in the European Union.

Overview

Vocabria is used together with another medicine called rilpivirine to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). It is used in adults whose infection is under control with antiretroviral medicines (medicines for HIV).

Vocabria contains the active substance cabotegravir.

This EPAR was last updated on 05/01/2021

Authorisation details

Product details
Name
Vocabria
Agency product number
EMEA/H/C/004976
Active substance
  • Cabotegavir sodium
  • Cabotegravir
International non-proprietary name (INN) or common name
cabotegravir
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AX
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
ViiV Healthcare B.V.
Date of issue of marketing authorisation valid throughout the European Union
17/12/2020
Contact address

Van Asch van Wijckstraat 55 H
3811 LP Amersfoort
The Netherlands

Product information

17/12/2020 Vocabria - EMEA/H/C/004976 -

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Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic 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 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 NNRTI and INI class for:

  • oral lead in to assess tolerability of Vocabria and rilpivirine prior to administration of long acting cabotegravir injection plus long acting rilpivirine injection.
  • oral therapy for adults who will miss planned dosing with cabotegravir injection plus rilpivirine injection.

Vocabria injection is indicated, in combination with rilpivirine injection, for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults 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 NNRTI and INI class.

Assessment history

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