Dapivirine Vaginal Ring 25 mg: Opinion on medicine for use outside EU
dapivirine
Table of contents
Overview
Dapivirine Vaginal Ring 25 mg is a vaginal ring used to reduce the risk of a woman getting infected with human immunodeficiency virus type 1 (HIV-1) through vaginal intercourse.
It is for use with safer sex practices (such as use of condoms) by women 18 years of age or above, when taking pre-exposure prophylaxis (PrEP) medicines by mouth is not feasible. It is intended for use outside the EU.
Dapivirine Vaginal Ring 25 mg contains the active substance dapivirine.
Opinion details
Product details | |
---|---|
Name of medicinal product |
Dapivirine Vaginal Ring 25 mg
|
Agency opinion number |
H-W-2168
|
Opinion status |
Positive opinion
|
Active substance |
dapivirine
|
International non-proprietary name (INN) or common name |
dapivirine
|
Therapeutic area (MeSH) |
Anti-HIV Agents
|
Anatomical therapeutic chemical (ATC) code |
G01AX17
|
Publication details | |
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Opinion holder |
International Partnership for Microbicides Belgium AISBL |
Date of opinion |
23/07/2020
|
Product information
01/09/2022 Dapivirine Vaginal Ring 25 mg II/0015/G
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturer responsible for batch release
- Annex IIB - Recommendations to the opinion holder - conditions of use
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Therapeutic indication
Reducing the risk of HIV-1 infection via vaginal intercourse in HIV-uninfected women 18 years and older in combination with safter sex practices when oral PrEP is not/cannot be used or is not available.
Assessment history
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List item
Dapivirine Vaginal Ring 25 mg : Procedural steps taken and scientific information after authorisation (PDF/194.72 KB)
First published: 02/03/2021
Last updated: 15/09/2022 -
List item
Dapivirine Vaginal Ring 25 mg : All presentations (PDF/44.21 KB)
First published: 04/01/2021 -
List item
Dapivirine Vaginal Ring 25 mg : Public assessment report (PDF/3.02 MB)
Adopted
First published: 04/01/2021
EMA/430198/2020 -
List item
Dapivirine Vaginal Ring 25 mg - Summary of opinion (PDF/145.98 KB)
Adopted
First published: 24/07/2020
EMA/CHMP/330850/2020