Dapivirine Vaginal Ring 25 mg: Opinion on medicine for use outside EU


Opinion on medicine for use outside the European Union
Positive opinion


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
Opinion status
Positive opinion
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Anti-HIV Agents
Anatomical therapeutic chemical (ATC) code
Publication details
Opinion holder

International Partnership for Microbicides Belgium AISBL
Square de Meeus 38/40
1000 Brussels

Date of opinion

Product information

01/09/2022 Dapivirine Vaginal Ring 25 mg II/0015/G


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Pharmacotherapeutic group

Other antiinfectives and antiseptics

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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