RECOMBIVAX HB (WITH PRESERVATIVE) 10 MCG — DIN 00749486
HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) : 10 MCG · MERCK CANADA INC · SOLUTION · wholesale supply in Canada
Health Canada status: CANCELLED POST MARKET
What is RECOMBIVAX HB (WITH PRESERVATIVE)?
RECOMBIVAX HB (WITH PRESERVATIVE) 10 MCG contains HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) : 10 MCG. It is listed in the Health Canada Drug Product Database under DIN 00749486, held by MERCK CANADA INC, supplied as SOLUTION for INTRAMUSCULAR administration. Health Canada currently lists it as cancelled post market, status dated 08-Mar-2010. This Drug Identification Number is no longer authorized for sale in Canada, so Nexara does not supply it. The record is kept here because buyers still meet the number on old formularies, purchase orders and tender documents; Nexara can help identify an authorized alternative.
Is there a generic Hepatitis B, Purified Antigen 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.
3 holders have a Canadian DIN containing Hepatitis B, Purified Antigen, across 9 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 |
|---|---|---|---|---|
| GLAXOSMITHKLINE INC | 4 | 2 | ENGERIX-B | Sourceable in Canada |
| MERCK CANADA INC | 4 | 1 | RECOMBIVAX HB, RECOMBIVAX HB (ADULT DIALYSIS WITH PRESERVATIVE), RECOMBIVAX HB (WITH PRESERVATIVE) | Sourceable in Canada |
| VBI VACCINES INC. | 1 | 0 | PREHEVBRIO | 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 | 10 MCG |
|---|---|
| Dosage form | SOLUTION |
| Route | INTRAMUSCULAR |
Pack detail is kept as a regulatory record. This DIN is no longer authorized for sale in Canada, so Nexara does not quote this pack.
Substance and classification
| Active substance | Hepatitis B, Purified Antigen |
|---|---|
| ATC code | J07BC01 |
| AHFS class | 80:12.00 |
| 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) | 00749486 |
|---|---|
| DIN (unpadded, as printed on some documents) | 749486 |
| Brand name | RECOMBIVAX HB (WITH PRESERVATIVE) |
| Generic / active ingredient | HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) : 10 MCG |
| Market authorization holder | MERCK CANADA INC |
| Health Canada schedule | Schedule D |
| ATC code | J07BC01 |
| ATC anatomical main group | J — Anti-infectives for systemic use |
| ATC therapeutic subgroup | J07BC |
| Current status | CANCELLED POST MARKET |
| Status date | 08-Mar-2010 |
| Original market date | 1987-12-31 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
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 9 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| ENGERIX-B | 20 MCG / 1 ML | SUSPENSION | GLAXOSMITHKLINE INC | MARKETED | 02487039 |
| ENGERIX-B | 10 MCG / 0.5 ML | SUSPENSION | GLAXOSMITHKLINE INC | MARKETED | 02487020 |
| RECOMBIVAX HB | 40 MCG | SUSPENSION | MERCK CANADA INC | MARKETED | 02245977 |
| ENGERIX-B | 20 MCG / 1 ML | SUSPENSION | GLAXOSMITHKLINE INC | CANCELLED POST MARKET | 01919431 |
| ENGERIX-B | 10 MCG / 0.5 ML | SUSPENSION | GLAXOSMITHKLINE INC | CANCELLED POST MARKET | 02296454 |
| PREHEVBRIO | 10 MCG | SUSPENSION | VBI VACCINES INC. | APPROVED | 02533286 |
| RECOMBIVAX HB | 10 MCG | SUSPENSION | MERCK CANADA INC | CANCELLED POST MARKET | 02243676 |
| RECOMBIVAX HB (ADULT DIALYSIS WITH PRESERVATIVE) | 40 MCG | SOLUTION | MERCK CANADA INC | CANCELLED POST MARKET | 01934023 |
2 · Same class — other molecules in ATC J07BC
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Hepatitis A, Inactivated, Whole Virus | AVAXIM · AVAXIM - PEDIATRIC · AVAXIM - PEDIATRIC -(5ML VIAL) · EPAXAL · +4 more | 8 | 4 | Yes |
| Hepatitis B, Purified Antigen | ENGERIX-B · PREHEVBRIO · RECOMBIVAX HB · RECOMBIVAX HB (ADULT DIALYSIS WITH PRESERVATIVE) · +1 more | 9 | 3 | Yes |
| Combinations | TWINRIX · TWINRIX JUNIOR | 2 | 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 J07B
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| J07BB | Influenza, Inactivated, Split Virus Or Surface Antigen · Influenza, Inactivated, Whole Virus · Influenza, Live Attenuated | 41 | 10 |
| J07BN | Covid-19, Protein Subunit · Covid-19, Rna-Based Vaccine · Covid-19, Viral Vector, Non-Replicating | 28 | 5 |
| J07BD | Measles, Combin. With Mumps And Rubella, Live Attenuated · Measles, Combinations With Mumps, Rubella And Varicella, Live Attenuated · Morbilli, Comb. With Rubella, Live Attenuated · Morbilli, Live Attenuated | 8 | 4 |
| J07BX | Chikungunya Vaccines · Ebola Vaccines · Other Viral Vaccines · Respiratory Syncytial Virus Vaccine · Smallpox And Monkeypox Vaccines | 9 | 4 |
| J07BK | Varicella Zoster Vaccines · Varicella, Live Attenuated · Zoster, Live Attenuated | 7 | 3 |
| J07BH | Rota Virus, Live Attenuated · Rota Virus, Pentavalent, Live, Reassorted | 2 | 2 |
| J07BG | Rabies, Inactivated, Whole Virus | 3 | 2 |
| J07BM | Papillomavirus (Human Types 16,18) · Papillomavirus (Human Types 6,11,16,18,31,33,45,52,58) · Papillomavirus (Human Types 6,11,16,18) | 3 | 2 |
4 · Fixed-dose combinations with Canadian supply
| Product | Active ingredients | Holder | Status | DIN |
|---|---|---|---|---|
| AVAXIM | HEPATITIS A VIRUS, INACTIVATED : 160 UNIT / 0.5 ML | SANOFI PASTEUR LIMITED | MARKETED | 02237792 |
| COMIRNATY | *SARSCOV2 S-PROTEIN MRNA, 5'[M27,3'-OGPPP(M12'-O)APG], 3'POLYA+LINKER : 30 MCG / 0.3 ML | BIONTECH MANUFACTURING GMBH | MARKETED | 02552035 |
| HAVRIX 1440 | HEPATITIS A VIRUS, INACTIVATED : 1440 UNIT | GLAXOSMITHKLINE INC | MARKETED | 02187078 |
| HAVRIX 720 JUNIOR | HEPATITIS A VIRUS, INACTIVATED : 720 UNIT / 0.5 ML | GLAXOSMITHKLINE INC | MARKETED | 02231056 |
| MRESVIA | *RSV F-PROTEIN MRNA, 5'(M7G-5'-PPP-5'-GM), 3'POLYA : 50 MCG / 0.5 ML | MODERNA BIOPHARMA CANADA CORPORATION | MARKETED | 02552914 |
| ROTARIX | ROTAVIRUS VACCINE (RIX4414 STRAIN), LIVE, ORAL, ATTENUATED (HUMAN) : 1000000 CCID50 / 1.5 ML | GLAXOSMITHKLINE INC | MARKETED | 02300591 |
| SPIKEVAX | *SARSCOV2 S-PROTEIN MRNA, 5'(M7G-5'-PPP-5'-GM), 3'POLYA : 0.1 MG | MODERNA BIOPHARMA CANADA CORPORATION | MARKETED | 02541270 |
| TWINRIX | HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) : 20 MCG / 1 ML HEPATITIS A VIRUS, INACTIVATED : 720 UNIT / 1 ML | GLAXOSMITHKLINE INC | MARKETED | 02230578 |
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.
Can this still be bought in Canada?
No. This Drug Identification Number is cancelled post market in Health Canada's Drug Product Database, so the product is no longer authorized for sale in Canada and Nexara does not supply it. This page is kept as a regulatory record.
If you are looking for a current equivalent, the alternatives above list every product sharing this therapeutic class, with the marketed ones first. Ask us to source an alternative
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.