PREZISTA 600 MG
DARUNAVIR (DARUNAVIR ETHANOLATE) : 600 MG · DIN 02324024 · JANSSEN INC
Health Canada status: CANCELLED POST MARKET
What is PREZISTA?
PREZISTA 600 MG contains DARUNAVIR (DARUNAVIR ETHANOLATE) : 600 MG. It is listed in the Health Canada Drug Product Database under DIN 02324024, held by JANSSEN INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as cancelled post market, status dated 01-Mar-2024. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is PREZISTA used for?
Treatment of HIV-1 infection in adults and pediatric patients 3 years of age and older, co-administered with 100 mg ritonavir and other antiretroviral agents.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 02324024 |
|---|---|
| Brand name | PREZISTA |
| Generic / active ingredient | DARUNAVIR (DARUNAVIR ETHANOLATE) : 600 MG |
| Manufacturer | JANSSEN INC |
| Strength | 600 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | J05AE10 DARUNAVIR |
| AHFS class | 12:20.20.24 |
| Biosimilar | No |
| Health Canada status | CANCELLED POST MARKET |
| Status date | 01-Mar-2024 |
| Original market date | 2009-07-21 00:00:00 |
How is it administered?
Must be given with ritonavir and food. Adults: 800/100 mg once daily (naïve/no DRV-RAMs) or 600/100 mg twice daily (experienced/DRV-RAMs). Pediatrics: Weight-based twice daily dosing.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in the provided text snippet (section 11 mentioned in TOC but text ends at section 7).
How is it supplied?
75 mg (480 tabs), 150 mg (240 tabs), 600 mg (60 tabs), 800 mg (30 tabs) in bottles. Oral suspension: 200 mL amber glass bottle with 6 mL oral dosing pipette.
Contraindications
Hypersensitivity; severe hepatic insufficiency (Child-Pugh Class C); co-administration with drugs highly dependent on CYP3A4 for clearance (e.g., alfuzosin, amiodarone, apixaban, rifampin, statins).
Warnings and precautions
Must be co-administered with ritonavir. Hepatotoxicity (including fatal cases); severe skin reactions; risk of hyperglycemia/diabetes; increased bleeding in hemophiliacs; lipid elevations.
What can be used instead?
Other Canadian products sharing ATC code J05AE10 DARUNAVIR. 5 of 37 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| APO-DARUNAVIR | 600 MG | TABLET | APOTEX INC | MARKETED | DIN 02487241 |
| APO-DARUNAVIR | 800 MG | TABLET | APOTEX INC | MARKETED | DIN 02487268 |
| AURO-DARUNAVIR | 600 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02486121 |
| AURO-DARUNAVIR | 800 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02486148 |
| DARUNAVIR | 800 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | DIN 02521350 |
| AURO-DARUNAVIR | 400 MG | TABLET | AURO PHARMA INC | APPROVED | DIN 02486113 |
| DARUNAVIR | 400 MG | TABLET | JAMP PHARMA CORPORATION | APPROVED | DIN 02521334 |
| DARUNAVIR | 600 MG | TABLET | JAMP PHARMA CORPORATION | DORMANT | DIN 02521342 |
| M-DARUNAVIR | 400 MG | TABLET | MANTRA PHARMA INC | CANCELLED PRE MARKET | DIN 02522276 |
| M-DARUNAVIR | 600 MG | TABLET | MANTRA PHARMA INC | CANCELLED POST MARKET | DIN 02522284 |
Who else supplies DARUNAVIR worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. DARUNAVIR appears in 97 registered pack listings across 13 markets, published on 12 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.