RECOMBIVAX HB 40 MCG — DIN 02245977
HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) : 40 MCG · MERCK CANADA INC · SUSPENSION · wholesale supply in Canada
Health Canada status: MARKETED
What is RECOMBIVAX HB?
RECOMBIVAX HB 40 MCG contains HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) : 40 MCG. It is listed in the Health Canada Drug Product Database under DIN 02245977, held by MERCK CANADA INC, supplied as SUSPENSION for INTRAMUSCULAR administration. Health Canada currently lists it as marketed, status dated 10-Apr-2006. 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 RECOMBIVAX HB used for?
RECOMBIVAX HB® (hepatitis B vaccine [recombinant]) is indicated for immunization against infection caused by all known subtypes of hepatitis B virus. RECOMBIVAX HB® should prevent hepatitis D (caused by the delta virus), since hepatitis D does not occur in the absence of hepatitis B infection.
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 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 | 40 MCG |
|---|---|
| Dosage form | SUSPENSION |
| Route | INTRAMUSCULAR |
| Pack configuration (monograph) | Pediatric Presentation: available in packages of 1 single-dose vial. Adult Presentation: available in packages of 1 and 10 single-dose vials. Adult Dialysis Presentation: available in packages of 1 single-dose vial. Pediatric Presentation (prefilled syringe): available in packages of 1 single dose pre-filled syringe. Adult Presentation (prefilled syringe): available in packages of 1 and 10 single dose pre-filled syringes. |
| Storage | null |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation, because this listing covers more than one of them.
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) | 02245977 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2245977 |
| Brand name | RECOMBIVAX HB |
| Generic / active ingredient | HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) : 40 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 | MARKETED |
| Status date | 10-Apr-2006 |
| Original market date | 2002-10-24 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
3-dose regimen (0, 1, 6 months) or accelerated. Adolescents (11-15y) may use a 2-dose regimen (0, 4-6 months). Administer IM (deltoid for adults, anterolateral thigh for infants/children).
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to the drug, any ingredient in the formulation, or component of the container.
Warnings and precautions
Epinephrine must be available for anaphylaxis. Use caution in latex-sensitive individuals (stopper/tip cap contain latex). May not prevent infection if incubation is already present.
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 |
| ENGERIX-B | 10 MCG / 0.5 ML | SUSPENSION | GLAXOSMITHKLINE INC | CANCELLED POST MARKET | 02296454 |
| ENGERIX-B | 20 MCG / 1 ML | SUSPENSION | GLAXOSMITHKLINE INC | CANCELLED POST MARKET | 01919431 |
| 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 |
| RECOMBIVAX HB (WITH PRESERVATIVE) | 10 MCG | SOLUTION | MERCK CANADA INC | CANCELLED POST MARKET | 00749486 |
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.
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.