Dapivirine Vaginal Ring 25 mg H-W-2168
Name of the medicinal product | Dapivirine Vaginal Ring 25 mg |
Opinion holder | International Partnership for Microbicides Belgium AISBL |
Active substance | dapivirine |
International non-proprietary name or common name | dapivirine |
Pharmaco-therapeutic group | Other antiinfectives and antiseptics |
ATC code | G01AX17 |
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. |
Orphan medicinal product designation date | Not applicable |
-
List item
Dapivirine Vaginal Ring 25 mg: Medicine overview (PDF/113.88 KB)
First published: 24/07/2020
Last updated: 04/01/2021
EMA/409700/2020 -
-
List item
Dapivirine Vaginal Ring 25 mg: All authorised presentations (PDF/44.21 KB)
First published: 04/01/2021 -
List item
Dapivirine Vaginal Ring 25 mg: Risk-management-plan summary (PDF/158.77 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: Procedural steps taken and scientific information after the authorisation (PDF/94.28 KB) (new)
First published: 02/03/2021
*This document includes:
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
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.