PMS-BUPRENORPHINE-NALOXONE 8 MG — DIN 02424878
BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) : 8 MG NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE) : 2 MG · PHARMASCIENCE INC · TABLET · wholesale supply in Canada
Health Canada status: MARKETED
What is PMS-BUPRENORPHINE-NALOXONE?
PMS-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 02424878, held by PHARMASCIENCE INC, supplied as TABLET for SUBLINGUAL administration. Health Canada currently lists it as marketed, status dated 24-Nov-2017. 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 PMS-BUPRENORPHINE-NALOXONE used 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.
Is there a generic Buprenorphine, Combinations 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 Buprenorphine, Combinations, across 16 DINs, of which 12 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 |
|---|---|---|---|---|
| INDIVIOR UK LIMITED | 8 | 8 | SUBOXONE | Sourceable in Canada |
| PHARMASCIENCE INC | 2 | 2 | PMS-BUPRENORPHINE-NALOXONE | Sourceable in Canada |
| TEVA CANADA LIMITED | 2 | 2 | TEVA-BUPRENORPHINE/NALOXONE | Sourceable in Canada |
| MYLAN PHARMACEUTICALS ULC | 2 | 0 | MYLAN-BUPRENORPHINE/NALOXONE | No marketed DIN |
| TARO PHARMACEUTICALS INC | 2 | 0 | TARO-BUPRENORPHINE/NALOXONE | 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 | 8 MG |
|---|---|
| Dosage form | TABLET |
| Route | SUBLINGUAL |
| Pack configuration (monograph) | Bottles of 30 tablets. |
| Storage | Not explicitly detailed in provided text (standard section 11 was in TOC but text cut off), but typically 15-30°C. |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Buprenorphine, Combinations |
|---|---|
| ATC code | N07BC51 |
| AHFS class | 28:10.00 ; 28:08.12 |
| 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) | 02424878 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2424878 |
| Brand name | PMS-BUPRENORPHINE-NALOXONE |
| Generic / active ingredient | BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) : 8 MG NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE) : 2 MG |
| Market authorization holder | PHARMASCIENCE INC |
| Health Canada schedule | NARCOTICS (CDSA I) |
| ATC code | N07BC51 |
| ATC anatomical main group | N — Nervous system |
| ATC therapeutic subgroup | N07BC |
| Current status | MARKETED |
| Status date | 24-Nov-2017 |
| Original market date | 2014-12-10 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Sublingual use only. Induction: 2-4 mg increments, target 8-12 mg Day 1. Maintenance: 12-16 mg daily (max 24 mg). Do not swallow, crush, or chew. Wait 1 hour before brushing teeth after dissolution.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity; opioid naïve; severe respiratory or hepatic impairment; acute alcoholism; GI obstruction; suspected surgical abdomen; severe CNS depression; MAO inhibitors; seizure disorders.
Warnings and precautions
Serious risk of addiction, abuse, misuse; life-threatening respiratory depression; fatal if ingested by children; risk of overdose in opioid-naïve patients; interaction with alcohol/benzos.
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
12 of 16 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| PMS-BUPRENORPHINE-NALOXONE | 0.5 MG | TABLET | PHARMASCIENCE INC | MARKETED | 02424851 |
| SUBOXONE | 8 MG | TABLET | INDIVIOR UK LIMITED | MARKETED | 02295709 |
| SUBOXONE | 0.5 MG | TABLET | INDIVIOR UK LIMITED | MARKETED | 02295695 |
| SUBOXONE | 12 MG | TABLET | INDIVIOR UK LIMITED | MARKETED | 02468085 |
| SUBOXONE | 16 MG | TABLET | INDIVIOR UK LIMITED | MARKETED | 02468093 |
| SUBOXONE | 0.5 MG | FILM, SOLUBLE | INDIVIOR UK LIMITED | MARKETED | 02502313 |
| SUBOXONE | 1 MG | FILM, SOLUBLE | INDIVIOR UK LIMITED | MARKETED | 02502321 |
| SUBOXONE | 2 MG | FILM, SOLUBLE | INDIVIOR UK LIMITED | MARKETED | 02502348 |
| SUBOXONE | 3 MG | FILM, SOLUBLE | INDIVIOR UK LIMITED | MARKETED | 02502356 |
| TEVA-BUPRENORPHINE/NALOXONE | 0.5 MG | TABLET | TEVA CANADA LIMITED | MARKETED | 02453908 |
2 · Same class — other molecules in ATC N07BC
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Methadone | APO-METHADONE · JAMP METHADONE ORAL CONCENTRATE · METADOL · METADOL-D · +5 more | 28 | 19 | Yes |
| Buprenorphine, Combinations | MYLAN-BUPRENORPHINE/NALOXONE · PMS-BUPRENORPHINE-NALOXONE · SUBOXONE · TARO-BUPRENORPHINE/NALOXONE · +1 more | 16 | 12 | Yes |
| Diamorphine | DIACETYLMORPHINE HYDROCHLORIDE · DIAMORPHINE HYDROCHLORIDE INJ 100MG/ML BP · DIAMORPHINE HYDROCHLORIDE INJ 30MG/ML BP | 4 | 2 | Yes |
| Buprenorphine | PROBUPHINE · SUBLOCADE | 3 | 2 | Yes |
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 |
|---|---|---|---|
| N07BA | Nicotine · Varenicline | 31 | 13 |
| 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.
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.