Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: LeBasi Pharmaceuticals (Pty) Ltd, San Domenico Building, Unit 6, Ground Floor, 10 Church Street, Durbanville, 7551
DapiRing vaginal delivery system.
| Pharmaceutical Form |
|---|
|
Vaginal delivery system. The dapivirine vaginal ring is a flexible, off-white vaginal ring with an outer diameter of 56 mm and a cross-sectional diameter of 7,7 mm. |
Each dapivirine vaginal ring contains 25 mg of dapivirine and releases approximately 4 mg of dapivirine over a period of one month.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dapivirine |
Dapivirine is an NNRTI with potent antiviral activity against HIV-1. It prevents viral replication by binding directly to HIV-1 reverse transcriptase (RT) and blocking its activity. Dapivirine binding is non-competitive against both the RNA template and the nucleotide substrate. |
| List of Excipients |
|---|
|
Dimeticone, 1,000 centistokes (cSt)
|
Each DapiRing is packaged into a laminated (PET-Alu/Adhesive/PP), square, heat-sealed pouch.
A carton contains either one pouch (1 ring) or three pouches (3 rings).
LeBasi Pharmaceuticals (Pty) Ltd, San Domenico Building, Unit 6, Ground Floor, 10 Church Street, Durbanville, 7551
55/20.2.8/0786
8 March 2022
| Drug | Countries | |
|---|---|---|
| DAPIRING | South Africa |
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