TEVA-VARENICLINE 0.5 MG
VARENICLINE (VARENICLINE TARTRATE) : 0.5 MG · DIN 02426226 · TEVA CANADA LIMITED
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) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
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.
Product details and regulatory record
| DIN | 02426226 |
|---|---|
| Brand name | TEVA-VARENICLINE |
| Generic / active ingredient | VARENICLINE (VARENICLINE TARTRATE) : 0.5 MG |
| Manufacturer | TEVA CANADA LIMITED |
| Strength | 0.5 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | N07BA03 VARENICLINE |
| AHFS class | 12:02.00 |
| Biosimilar | No |
| Health Canada status | DORMANT |
| Status date | 03-May-2024 |
| Original market date | 2019-04-23 00:00:00 |
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.
How is it stored and handled?
Not explicitly detailed in the provided text (Table of Contents lists section on page 40, but text ends before page 13).
How is it supplied?
Not explicitly detailed in the provided text (mentions 0.5 mg and 1 mg strengths).
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?
Other Canadian products sharing ATC code N07BA03 VARENICLINE. 13 of 25 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-VARENICLINE | 0.5 MG | TABLET | APOTEX INC | MARKETED | DIN 02419882 |
| APO-VARENICLINE | 1 MG | KIT ; TABLET | APOTEX INC | MARKETED | DIN 02435675 |
| APO-VARENICLINE | 1 MG | TABLET | APOTEX INC | MARKETED | DIN 02419890 |
| AURO-VARENICLINE | 0.5 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02554445 |
| AURO-VARENICLINE | 1 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02554453 |
| MINT-VARENICLINE | 0.5 MG | TABLET | MINT PHARMACEUTICALS INC | MARKETED | DIN 02546949 |
| MINT-VARENICLINE | 1 MG | KIT ; TABLET | MINT PHARMACEUTICALS INC | MARKETED | DIN 02546965 |
| MINT-VARENICLINE | 1 MG | TABLET | MINT PHARMACEUTICALS INC | MARKETED | DIN 02546957 |
| NRA-VARENICLINE | 0.5 MG | TABLET | NORA PHARMA INC | MARKETED | DIN 02542951 |
| NRA-VARENICLINE | 1 MG | TABLET | NORA PHARMA INC | MARKETED | DIN 02542978 |
Who else supplies VARENICLINE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. VARENICLINE appears in 152 registered pack listings across 8 markets, published on 6 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.