DAPIRING Vaginal delivery system Ref.[50157] Active ingredients: Dapivirine

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

Product name and form

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.

Qualitative and quantitative composition

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) Silicone Elastomer (DDU-4870): Siloxanes and silicones, dimethyl, vinyl group-terminated Platinum(0)-1,3-divinyl-1,1,3,3-tetramethyldisiloxane Silica, amorphous, fumed, crystalline free Siloxanes and silicones, dimethyl, methyl vinyl, methyl hydrogen, hydroxyl-terminated

Pack sizes and marketing

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).

Marketing authorization holder

LeBasi Pharmaceuticals (Pty) Ltd, San Domenico Building, Unit 6, Ground Floor, 10 Church Street, Durbanville, 7551

Marketing authorization dates and numbers

55/20.2.8/0786

8 March 2022

Drugs

Drug	Countries
DAPIRING	South Africa

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