MYLAN-EFAVIRENZ 600 MG — DIN 02381524
EFAVIRENZ : 600 MG · MYLAN PHARMACEUTICALS ULC · TABLET · wholesale supply in Canada
Health Canada status: MARKETED
What is MYLAN-EFAVIRENZ?
MYLAN-EFAVIRENZ 600 MG contains EFAVIRENZ : 600 MG. It is listed in the Health Canada Drug Product Database under DIN 02381524, held by MYLAN PHARMACEUTICALS ULC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 30-Jul-2013. 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 MYLAN-EFAVIRENZ used for?
Mylan-Efavirenz (efavirenz) is indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Efavirenz cost around the world?
Efavirenz is listed on 12 of the national price registers Nexara ingests. Each country publishes on a different basis, so those figures are not comparable with one another — or with a Canadian wholesale price.
What a market publishes matters more than the number it publishes. Austria publishes a KVP (Kassenverkaufspreis); Belgium publishes a public; Brazil publishes a preco fabrica (ex-factory ceiling). Comparing an ex-factory ceiling against a pharmacy public price tells you nothing about either, and comparing either against a Canadian landed cost tells you less.
| Market | Price basis published there | Brands | Packs listed | Range |
|---|---|---|---|---|
| South Africa | single exit price | 45 | 50 | ZAR███.██ |
| Sweden | AIP (pharmacy purchase price) | 8 | 12 | SEK███.██ |
| Belgium | public | 6 | 6 | EUR███.██ |
| Morocco | PPV (public price) | 3 | 5 | MAD███.██ |
| Romania | max producer price | 4 | 5 | RON███.██ |
| Norway | max AUP (pharmacy retail) | 4 | 4 | NOK███.██ |
| United States | acquisition | 1 | 4 | USD███.██ |
| Brazil | preco fabrica (ex-factory ceiling) | 2 | 3 | BRL███.██ |
| Saudi Arabia | public | 3 | 3 | SAR███.██ |
| Austria | KVP (Kassenverkaufspreis) | 2 | 2 | EUR███.██ |
| Luxembourg | reimbursement | 2 | 2 | EUR███.██ |
| Hungary | producer price (ex-factory) | 1 | 1 | HUF███.██ |
97 pack listings across 81 brand entries and 11 price bases, refreshed 07 Sep 2026. Ranges span every Efavirenz pack in that market, so a high figure is usually a larger pack rather than the same product.
Canada publishes no comparable public list price. For a delivered Canadian price on a licensed account, verify your licence — it takes about a minute.
Is there a generic Efavirenz in Canada, and who makes it?
Every market authorization holder with a Canadian DIN for this molecule, and how many of their listings Health Canada currently shows as marketed.
5 holders have a Canadian DIN containing Efavirenz, across 8 DINs, of which 3 are currently marketed. Marketed count is the number that matters: an approval that is not marketed cannot be bought.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| AURO PHARMA INC | 1 | 1 | AURO-EFAVIRENZ | Sourceable in Canada |
| MYLAN PHARMACEUTICALS ULC | 1 | 1 | MYLAN-EFAVIRENZ | Sourceable in Canada |
| TEVA CANADA LIMITED | 1 | 1 | TEVA-EFAVIRENZ | Sourceable in Canada |
| BRISTOL-MYERS SQUIBB CANADA | 4 | 0 | SUSTIVA 100MG, SUSTIVA 200MG, SUSTIVA 50MG, SUSTIVA TABLETS | No marketed DIN |
| JAMP PHARMA CORPORATION | 1 | 0 | JAMP-EFAVIRENZ | No marketed DIN |
Health Canada’s Drug Product Database does not flag which listing is the originator and which are subsequent-entry products, so Nexara does not label them here. Interchangeability is determined provincially, not federally — confirm for your province before a formulary switch. Nexara can confirm which of these is actually obtainable, and on what lead time, per order.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 600 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Pack configuration (monograph) | Tablets 600 mg are yellow, film coated, capsule shaped, biconvex tablets, debossed with “M” on one side of the tablet and “EZ6” on the other side. Available in bottles containing 30 tablets and 100 tablets. |
| Storage | Mylan-Efavirenz (efavirenz tablets) should be stored between 15°C and 30°C. |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation, because this listing covers more than one of them.
Substance and classification
| Active substance | Efavirenz |
|---|---|
| ATC code | J05AG03 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 02381524 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2381524 |
| Brand name | MYLAN-EFAVIRENZ |
| Generic / active ingredient | EFAVIRENZ : 600 MG |
| Market authorization holder | MYLAN PHARMACEUTICALS ULC |
| Health Canada schedule | Prescription |
| ATC code | J05AG03 |
| ATC anatomical main group | J — Anti-infectives for systemic use |
| ATC therapeutic subgroup | J05AG |
| Current status | MARKETED |
| Status date | 30-Jul-2013 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
The recommended dosage of Mylan-Efavirenz tablets in combination with other antiretroviral agents is 600 mg orally, once daily. It is recommended that Mylan-Efavirenz be taken on an empty stomach, preferably at bedtime. The increased efavirenz concentrations observed following administration of Mylan-Efavirenz with food may lead to an increase in frequency of adverse events. Dosing at bedtime may improve the tolerability of nervous system symptoms. For pediatric patients weighing greater than 40 kg, the recommended dosage is 600 mg, once daily. Mylan-Efavirenz tablets are not recommended for children weighing less than 40 kg because no appropriate dose adjustment can be made. If a dose is missed, patients should take the dose as soon as possible and then return to their normal schedule. However, if a dose is skipped, the patient should not double the next dose.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Mylan-Efavirenz (efavirenz) is contraindicated in patients with clinically significant hypersensitivity to any of its components. Mylan-Efavirenz must not be administered concurrently with cisapride, midazolam, triazolam, pimozide or ergot derivatives because competition for CYP3A4 by efavirenz could result in inhibition of metabolism of these drugs and create the potential for serious and/or life-threatening adverse events (e.g., cardiac arrhythmias, prolonged sedation or respiratory depression). Coadministration of efavirenz with elbasvir, grazoprevir, or voriconazole is contraindicated, due to the potential for significant decreases in plasma concentrations of elbasvir, grazoprevir, or voriconazole. This effect is due to an induction of CYP3A4 by efavirenz, and may result in loss of therapeutic effect. Herbal preparations containing St. John's wort (Hypericum perforatum) must not be used while taking Mylan-Efavirenz due to the risk of decreased plasma concentrations and reduced clinical effects of efavirenz.
Warnings and precautions
Coadministration of Mylan-Efavirenz with ATRIPLA, a fixed-dose combination tablet containing efavirenz, emtricitabine and tenofovir disoproxil fumarate, is not recommended. Mylan-Efavirenz may cause dizziness, impaired concentration, and/or drowsiness. Patients should be instructed that, if they experience these symptoms, they should avoid potentially hazardous tasks such as driving or operating machinery. QTc prolongation has been observed with the use of efavirenz. Consider alternatives to Mylan-Efavirenz when coadministered with a drug with a known risk of Torsade de Pointes or when administered to patients at higher risk of Torsade de Pointes. Serum lipid and blood glucose levels may increase during antiretroviral therapy (ART). Postmarketing reports of hepatic failure have occurred including some cases in patients without pre-existing hepatic disease or other identifiable risk factors. Elevated triglycerides have been reported in patients receiving efavirenz, in some cases to levels which can predispose a patient to pancreatitis. Immune Reconstitution Inflammatory Syndrome has been reported in patients treated with combination antiretroviral therapy, including efavirenz. Autoimmune disorders have also been reported. Caution should be taken in any patient with a history of seizures. Convulsions have been observed infrequently in patients receiving efavirenz, generally in the presence of known medical history of seizures. Serious psychiatric adverse experiences have been reported in patients treated with efavirenz. Mylan-Efavirenz must not be used as a single agent to treat HIV or added on as a sole agent to a failing regimen. Efavirenz is not recommended for patients who have had a life-threatening cutaneous reaction (e.g., Stevens-Johnson syndrome). Mylan-Efavirenz should be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal involvement or fever. Efavirenz may cause fetal harm when administered during the first trimester to a pregnant woman. Pregnancy should be avoided in women receiving Mylan-Efavirenz and for 12 weeks after discontinuation. Barrier contraception must always be used in combination with other methods of contraception. It is recommended that women living with HIV do not breast-feed their infants in order to avoid transmission of HIV. Efavirenz has been shown to be excreted in human milk.
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
1 · Same molecule, other Canadian presentations
3 of 8 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| AURO-EFAVIRENZ | 600 MG | TABLET | AURO PHARMA INC | MARKETED | 02418428 |
| TEVA-EFAVIRENZ | 600 MG | TABLET | TEVA CANADA LIMITED | MARKETED | 02389762 |
| JAMP-EFAVIRENZ | 600 MG | TABLET | JAMP PHARMA CORPORATION | DORMANT | 02458233 |
| SUSTIVA 100MG | 100 MG | CAPSULE | BRISTOL-MYERS SQUIBB CANADA | CANCELLED POST MARKET | 02239887 |
| SUSTIVA 200MG | 200 MG | CAPSULE | BRISTOL-MYERS SQUIBB CANADA | CANCELLED POST MARKET | 02239888 |
| SUSTIVA 50MG | 50 MG | CAPSULE | BRISTOL-MYERS SQUIBB CANADA | CANCELLED POST MARKET | 02239886 |
| SUSTIVA TABLETS | 600 MG | TABLET | BRISTOL-MYERS SQUIBB CANADA | CANCELLED POST MARKET | 02246045 |
2 · Same class — other molecules in ATC J05AG
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Efavirenz | AURO-EFAVIRENZ · JAMP-EFAVIRENZ · MYLAN-EFAVIRENZ · SUSTIVA 100MG · SUSTIVA 200MG · SUSTIVA 50MG · SUSTIVA TABLETS · TEVA-EFAVIRENZ | 8 | 3 | Yes |
| Nevirapine | APO-NEVIRAPINE · APO-NEVIRAPINE XR · AURO-NEVIRAPINE · JAMP NEVIRAPINE · MYLAN-NEVIRAPINE · TEVA-NEVIRAPINE · VIRAMUNE · VIRAMUNE XR | 8 | 3 | Yes |
| Etravirine | INTELENCE | 3 | 2 | Yes |
| Doravirine | PIFELTRO | 1 | 1 | Yes |
| Rilpivirine | EDURANT | 1 | 1 | Yes |
| Delavirdine | RESCRIPTOR | 1 | 0 | Not in Canada |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC J05A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| J05AB | Acyclovir · Brincidofovir · Cidofovir · Famciclovir · Ganciclovir · Remdesivir · Valaciclovir · Valganciclovir | 143 | 55 |
| J05AF | Abacavir · Adefovir Dipivoxil · Didanosine · Emtricitabine · Entecavir · Lamivudine · Stavudine · Telbivudine · Tenofovir Alafenamide · Tenofovir Disoproxil · Zalcitabine · Zidovudine | 71 | 39 |
| J05AR | Antivirals For Treatment Of Hiv Infections, Combinations · Atanazavir And Cobicistat · Darunavir And Cobicistat · Dolutegravir And Rilpivirine · Emtricitabine And Tenofovir Alafenamide · Emtricitabine, Tenofovir Alafenamide And Bictegravir · Emtricitabine, Tenofovir Alafenamide And Rilpivirine · Emtricitabine, Tenofovir Alafenamide, Darunavir And Cobicistat · Emtricitabine, Tenofovir Alafenamide, Elvitegravir And Cobicistat · Emtricitabine, Tenofovir Disoproxil And Efavirenz · Emtricitabine, Tenofovir Disoproxil And Rilpivirine · Emtricitabine, Tenofovir Disoproxil, Elvitegravir And Cobicistat · Lamivudine And Abacavir · Lamivudine And Dolutegravir · Lamivudine, Abacavir And Dolutegravir · Lamivudine, Tenofovir Disoproxil And Doravirine · Lopinavir And Ritonavir · Tenofovir Disoproxil And Emtricitabine · Zidovudine And Lamivudine · Zidovudine, Lamivudine And Abacavir · Zidovudine, Lamivudine And Nevirapine | 56 | 39 |
| J05AH | Neuraminidase Inhibitors · Oseltamivir · Zanamivir | 33 | 16 |
| J05AE | Amprenavir · Atazanavir · Darunavir · Fosamprenavir · Indinavir · Nelfinavir · Nirmatrelvir And Ritonavir · Ritonavir · Saquinavir · Tipranavir | 75 | 14 |
| J05AX | Baloxavir Marboxil · Bulevirtide · Enfuvirtide · Fostemsavir · Inosine Pranobex · Lenacapavir · Letermovir · Maraviroc · Maribavir · Other Antivirals | 19 | 14 |
| J05AJ | Cabotegravir · Dolutegravir · Elvitegravir · Raltegravir | 12 | 6 |
| J05AP | Asunaprevir · Boceprevir · Daclatasvir · Dasabuvir, Ombitasvir, Paritaprevir And Ritonavir · Elbasvir And Grazoprevir · Glecaprevir And Pibrentasvir · Ombitasvir, Paritaprevir And Ritonavir · Ribavirin · Simeprevir · Sofosbuvir · Sofosbuvir And Ledipasvir · Sofosbuvir, Velpatasvir And Voxilaprevir · Telaprevir | 22 | 6 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
What else is MYLAN-EFAVIRENZ called?
Also recorded in Canada as: efavirenz 400 MG / lamivudine 300 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Symfi] (US), efavirenz 600 MG / lamivudine 300 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Symfi] (US), efavirenz 200 MG Oral Capsule [Sustiva] (US), efavirenz 50 MG Oral Capsule [Sustiva] (US), efavirenz 600 MG Oral Tablet [Sustiva] (US), efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Atripla] (US), efavirenz 200 MG Oral Tablet (US), efavirenz 400 MG / lamivudine 300 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet (US), efavirenz 200 MG Oral Capsule (US), efavirenz 100 MG Oral Capsule (US), efavirenz 50 MG Oral Capsule (US), efavirenz 600 MG Oral Tablet (US), efavirenz 30 MG/ML Oral Solution (US), efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet (US), efavirenz 600 MG / lamivudine 300 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet (US).
The same molecule, Efavirenz, is registered under other names elsewhere. Buyers and prescribers searching from outside Canada — or working from a foreign prescription or tender document — often know it by one of these:
| Name | Script | Registered in |
|---|---|---|
| Efavirenz Teva | Latin | Sweden |
| AVIRANZ | Latin | Morocco |
| EFAVIR | Latin | Morocco |
| Efavirenz Sandoz | Latin | Norway, Sweden |
| Efavirenz Winthrop | Latin | South Africa |
| Efavirenz/Emtricitabine/Tenofovir disoproxil Krka | Latin | Norway, Sweden |
| Elteno Tablets | Latin | South Africa |
| EVIR | Latin | Brazil |
| Odimune | Latin | South Africa |
| Stocrin | Latin | Morocco, South Africa |
| Arion | Latin | South Africa |
| Arrow Efavirenz | Latin | South Africa |
| ATRIPLA | Latin | South Africa |
| Citenvir | Latin | South Africa |
| COMTREFEV | Latin | South Africa |
Names are taken from national medicine registers and published price lists. A product registered abroad is not authorized for sale in Canada unless it holds its own DIN; import is possible only through the routes Health Canada permits.
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. Patients and unlicensed buyers are routed to a partner pharmacy.
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.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
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.