TEVA-ATOVAQUONE PROGUANIL 100 MG
PROGUANIL HYDROCHLORIDE : 100 MG ATOVAQUONE : 250 MG · DIN 02380927 · TEVA CANADA LIMITED
Health Canada status: MARKETED
What is TEVA-ATOVAQUONE PROGUANIL?
TEVA-ATOVAQUONE PROGUANIL 100 MG contains PROGUANIL HYDROCHLORIDE : 100 MG ATOVAQUONE : 250 MG. It is listed in the Health Canada Drug Product Database under DIN 02380927, held by TEVA CANADA LIMITED, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 01-Mar-2012. 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 TEVA-ATOVAQUONE PROGUANIL used for?
Prophylaxis of P. falciparum malaria (including chloroquine-resistant areas). Treatment of acute, uncomplicated P. falciparum malaria.
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 | 02380927 |
|---|---|
| Brand name | TEVA-ATOVAQUONE PROGUANIL |
| Generic / active ingredient | PROGUANIL HYDROCHLORIDE : 100 MG ATOVAQUONE : 250 MG |
| Manufacturer | TEVA CANADA LIMITED |
| Strength | 100 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | P01BB51 PROGUANIL AND ATOVAQUONE |
| AHFS class | 08:30.08 ; 08:30.92 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 01-Mar-2012 |
| Original market date | 2012-03-01 00:00:00 |
How is it administered?
Take with food or a milky drink. Repeat dose if vomiting occurs within 1 hour. Not recommended for treatment/prophylaxis in children weighing less than 40 kg.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text.
How is it supplied?
Not explicitly detailed in provided text (standard tablets).
Contraindications
Hypersensitivity to atovaquone, proguanil hydrochloride, or any component. Prophylaxis in patients with severe renal impairment (CrCl < 30 mL/min).
Warnings and precautions
Serious hypersensitivity (anaphylaxis) possible. Not for cerebral or complicated malaria. Monitor parasitemia if diarrhea/vomiting occurs or with certain drug interactions.
What can be used instead?
Other Canadian products sharing ATC code P01BB51 PROGUANIL AND ATOVAQUONE. 6 of 6 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 |
|---|---|---|---|---|---|
| ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS | 250 MG | TABLET | GLENMARK PHARMACEUTICALS CANADA INC. | MARKETED | DIN 02466783 |
| ATOVAQUONE PROGUANIL | 100 MG | TABLET | SANIS HEALTH INC | MARKETED | DIN 02421429 |
| MALARONE | 100 MG | TABLET | GLAXOSMITHKLINE INC | MARKETED | DIN 02238151 |
| MALARONE PEDIATRIC | 62.5 MG | TABLET | GLAXOSMITHKLINE INC | MARKETED | DIN 02264935 |
| MYLAN-ATOVAQUONE/PROGUANIL | 100 MG | TABLET | MYLAN PHARMACEUTICALS ULC | MARKETED | DIN 02402165 |
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.