TEVA-BUPRENORPHINE/NALOXONE 8 MG
BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) : 8 MG NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE) : 2 MG · DIN 02453916 · TEVA CANADA LIMITED
Health Canada status: MARKETED
What is TEVA-BUPRENORPHINE/NALOXONE?
TEVA-BUPRENORPHINE/NALOXONE 8 MG contains BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) : 8 MG NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE) : 2 MG. It is listed in the Health Canada Drug Product Database under DIN 02453916, held by TEVA CANADA LIMITED, supplied as TABLET for SUBLINGUAL administration. Health Canada currently lists it as marketed, status dated 22-Mar-2021. 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-BUPRENORPHINE/NALOXONE used for?
Teva - Buprenorphine/Naloxone (buprenorphine and naloxone) is indicated for substitution treatment in adults with problematic opioid drug dependence.
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 | 02453916 |
|---|---|
| Brand name | TEVA-BUPRENORPHINE/NALOXONE |
| Generic / active ingredient | BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) : 8 MG NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE) : 2 MG |
| Manufacturer | TEVA CANADA LIMITED |
| Strength | 8 MG |
| Dosage form | TABLET |
| Route of administration | SUBLINGUAL |
| Schedule | NARCOTICS (CDSA I) |
| ATC code | N07BC51 BUPRENORPHINE, COMBINATIONS |
| AHFS class | 28:08.12 ; 28:10.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 22-Mar-2021 |
| Original market date | 2017-09-28 00:00:00 |
How is it stored and handled?
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How is it supplied?
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What can be used instead?
Other Canadian products sharing ATC code N07BC51 BUPRENORPHINE, COMBINATIONS. 12 of 16 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 |
|---|---|---|---|---|---|
| PMS-BUPRENORPHINE-NALOXONE | 0.5 MG | TABLET | PHARMASCIENCE INC | MARKETED | DIN 02424851 |
| PMS-BUPRENORPHINE-NALOXONE | 8 MG | TABLET | PHARMASCIENCE INC | MARKETED | DIN 02424878 |
| SUBOXONE | 0.5 MG | FILM, SOLUBLE | INDIVIOR UK LIMITED | MARKETED | DIN 02502313 |
| SUBOXONE | 0.5 MG | TABLET | INDIVIOR UK LIMITED | MARKETED | DIN 02295695 |
| SUBOXONE | 1 MG | FILM, SOLUBLE | INDIVIOR UK LIMITED | MARKETED | DIN 02502321 |
| SUBOXONE | 12 MG | TABLET | INDIVIOR UK LIMITED | MARKETED | DIN 02468085 |
| SUBOXONE | 16 MG | TABLET | INDIVIOR UK LIMITED | MARKETED | DIN 02468093 |
| SUBOXONE | 2 MG | FILM, SOLUBLE | INDIVIOR UK LIMITED | MARKETED | DIN 02502348 |
| SUBOXONE | 3 MG | FILM, SOLUBLE | INDIVIOR UK LIMITED | MARKETED | DIN 02502356 |
| SUBOXONE | 8 MG | TABLET | INDIVIOR UK LIMITED | MARKETED | DIN 02295709 |
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.