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 |
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Dapivirine Vaginal Ring 25 mg: Medicine overview (PDF/113.88 KB)
First published: 24/07/2020
Last updated: 04/01/2021
EMA/409700/2020 -
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Dapivirine Vaginal Ring 25 mg: All authorised presentations (PDF/44.21 KB)
First published: 04/01/2021 -
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Dapivirine Vaginal Ring 25 mg: Risk-management-plan summary (PDF/158.77 KB)
First published: 04/01/2021 -
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Dapivirine Vaginal Ring 25 mg: Public assessment report (PDF/3.02 MB)
Adopted
First published: 04/01/2021
EMA/430198/2020 -
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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
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