Vocabria
cabotegravir
Table of contents
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.
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List item
Vocabria : EPAR - Medicine overview (PDF/123 KB)
First published: 05/01/2021
EMA/565621/2020 -
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List item
Vocabria : EPAR - Risk-management-plan summary (PDF/318.9 KB)
First published: 05/01/2021
Authorisation details
Product details | |
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Name |
Vocabria
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Agency product number |
EMEA/H/C/004976
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Active substance |
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International non-proprietary name (INN) or common name |
cabotegravir
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Therapeutic area (MeSH) |
HIV Infections
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Anatomical therapeutic chemical (ATC) code |
J05AX
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Additional 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 | |
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Marketing-authorisation holder |
ViiV Healthcare B.V.
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Date of issue of marketing authorisation valid throughout the European Union |
17/12/2020
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Contact address |
Product information
17/12/2020 Vocabria - EMEA/H/C/004976 -
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.