TEVA-VARENICLINE 0.5 MG — DIN 02426226
VARENICLINE (VARENICLINE TARTRATE) : 0.5 MG · TEVA CANADA LIMITED · TABLET · wholesale supply in Canada
Health Canada status: DORMANT
What is TEVA-VARENICLINE?
TEVA-VARENICLINE 0.5 MG contains VARENICLINE (VARENICLINE TARTRATE) : 0.5 MG. It is listed in the Health Canada Drug Product Database under DIN 02426226, held by TEVA CANADA LIMITED, supplied as TABLET for ORAL administration. Health Canada currently lists it as dormant, status dated 03-May-2024. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A). This DIN is not currently being marketed in Canada, so it is sourced to order where a compliant route exists rather than held in stock.
What is TEVA-VARENICLINE used for?
Smoking-cessation treatment in adults, in conjunction with smoking-cessation counselling.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Varenicline cost around the world?
Varenicline is listed on 9 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. Australia publishes a ex-manufacturer; Bahrain publishes a retail (max); Belgium publishes a public. 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 |
|---|---|---|---|---|
| United States | acquisition | 2 | 33 | USD███.██ |
| Saudi Arabia | public | 11 | 17 | SAR███.██ |
| Australia | ex-manufacturer | 5 | 15 | AUD███.██ |
| South Africa | single exit price | 3 | 6 | ZAR███.██ |
| Morocco | PPV (public price) | 1 | 4 | MAD███.██ |
| Norway | max AUP (pharmacy retail) | 3 | 3 | NOK███.██ |
| Bahrain | retail (max) | 1 | 2 | BHD███.██ |
| United Kingdom | hospital | 2 | 2 | GBP███.██ |
| Belgium | public | 1 | 1 | EUR███.██ |
83 pack listings across 29 brand entries and 8 price bases, refreshed 08 Sep 2026. Ranges span every Varenicline 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 Varenicline 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.
9 holders have a Canadian DIN containing Varenicline, across 25 DINs, of which 13 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 |
|---|---|---|---|---|
| APOTEX INC | 3 | 3 | APO-VARENICLINE | Sourceable in Canada |
| MINT PHARMACEUTICALS INC | 3 | 3 | MINT-VARENICLINE | Sourceable in Canada |
| NORA PHARMA INC | 3 | 3 | NRA-VARENICLINE | Sourceable in Canada |
| AURO PHARMA INC | 2 | 2 | AURO-VARENICLINE | Sourceable in Canada |
| ZYDUS LIFESCIENCES LIMITED | 2 | 2 | ZDS-VARENICLINE | Sourceable in Canada |
| GENMED A DIVISION OF PFIZER CANADA ULC | 3 | 0 | GD-VARENICLINE | No marketed DIN |
| PFIZER CANADA ULC | 3 | 0 | CHAMPIX | No marketed DIN |
| PHARMASCIENCE INC | 3 | 0 | PMS-VARENICLINE | No marketed DIN |
| TEVA CANADA LIMITED | 3 | 0 | TEVA-VARENICLINE | 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 | 0.5 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Pack configuration (monograph) | Not explicitly detailed in the provided text (mentions 0.5 mg and 1 mg strengths). |
| Storage | Not explicitly detailed in the provided text (Table of Contents lists section on page 40, but text ends before page 13). |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Varenicline |
|---|---|
| ATC code | N07BA03 |
| AHFS class | 12:02.00 |
| 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) | 02426226 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2426226 |
| Brand name | TEVA-VARENICLINE |
| Generic / active ingredient | VARENICLINE (VARENICLINE TARTRATE) : 0.5 MG |
| Market authorization holder | TEVA CANADA LIMITED |
| Health Canada schedule | Prescription |
| ATC code | N07BA03 |
| ATC anatomical main group | N — Nervous system |
| ATC therapeutic subgroup | N07BA |
| Current status | DORMANT |
| Status date | 03-May-2024 |
| Original market date | 2019-04-23 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Titrate: 0.5 mg daily (days 1-3), 0.5 mg BID (days 4-7), then 0.5 mg or 1 mg BID. Take after eating with a full glass of water. Maximum dose is 1 mg BID.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to varenicline or to any ingredient in the formulation or component of the container.
Warnings and precautions
Serious neuropsychiatric symptoms (suicidality, agitation); serious skin reactions (SJS); angioedema; seizures; somnambulism; cardiovascular events; accidental injury (driving/machinery).
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
13 of 25 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| APO-VARENICLINE | 1 MG | TABLET | APOTEX INC | MARKETED | 02419890 |
| APO-VARENICLINE | 1 MG | KIT ; TABLET | APOTEX INC | MARKETED | 02435675 |
| APO-VARENICLINE | 0.5 MG | TABLET | APOTEX INC | MARKETED | 02419882 |
| AURO-VARENICLINE | 0.5 MG | TABLET | AURO PHARMA INC | MARKETED | 02554445 |
| AURO-VARENICLINE | 1 MG | TABLET | AURO PHARMA INC | MARKETED | 02554453 |
| MINT-VARENICLINE | 1 MG | TABLET | MINT PHARMACEUTICALS INC | MARKETED | 02546957 |
| MINT-VARENICLINE | 1 MG | KIT ; TABLET | MINT PHARMACEUTICALS INC | MARKETED | 02546965 |
| MINT-VARENICLINE | 0.5 MG | TABLET | MINT PHARMACEUTICALS INC | MARKETED | 02546949 |
| NRA-VARENICLINE | 1 MG | TABLET ; KIT | NORA PHARMA INC | MARKETED | 02542986 |
| NRA-VARENICLINE | 0.5 MG | TABLET | NORA PHARMA INC | MARKETED | 02542951 |
2 · Same class — other molecules in ATC N07BA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Varenicline | APO-VARENICLINE · AURO-VARENICLINE · CHAMPIX · GD-VARENICLINE · +5 more | 25 | 13 | Yes |
| Nicotine | NICODERM TRD 114MG NICOTINE/21 · NICODERM TRD 36MG NICOTINE/7 SQCM PATCH · NICODERM TRD 78MG NICOTINE/14 · NICORETTE GUM 2MG · +2 more | 6 | 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 N07B
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| N07BC | Buprenorphine · Buprenorphine, Combinations · Diamorphine · Methadone | 51 | 35 |
| N07BB | Acamprosate · Calcium Carbimide · Disulfiram · Naltrexone | 10 | 4 |
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 TEVA-VARENICLINE called?
The same molecule, Varenicline, 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 |
|---|---|---|
| Champix | Latin | Morocco, Norway |
| Cimuquit | Latin | Saudi Arabia |
| PHARMACOR VARENICLINE | Latin | Australia |
| VARENAPIX | Latin | Australia |
| Varenicline Lupin | Latin | Australia |
| Varenicline Sandoz | Latin | Australia |
| Varenicline Viatris | Latin | Australia |
| Champix starter pack | Latin | South Africa |
| HEROCAN | Latin | Bahrain |
| Marvi | Latin | Saudi Arabia |
| Varenyx | Latin | Saudi Arabia |
| Serna | Latin | Saudi Arabia |
| Varenicline Zentiva | Latin | Norway |
| Vareniklin axunio | Latin | Norway |
| Varlin | Latin | Saudi Arabia |
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?
This DIN is dormant — it holds a Health Canada authorization but is not currently being marketed in Canada, so it cannot simply be ordered from Canadian stock. Where a patient need exists, supply may be possible through exceptional importation or the Special Access Programme, subject to Health Canada's requirements and the prescriber's application. Nexara can advise on the route and on marketed alternatives.
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.