ENGERIX-B 10 MCG / 0.5 ML
HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) : 10 MCG / 0.5 ML · DIN 02487020 · GLAXOSMITHKLINE INC
Health Canada status: MARKETED
What is ENGERIX-B?
ENGERIX-B 10 MCG / 0.5 ML contains HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) : 10 MCG / 0.5 ML. It is listed in the Health Canada Drug Product Database under DIN 02487020, held by GLAXOSMITHKLINE INC, supplied as SUSPENSION for INTRAMUSCULAR administration. Health Canada currently lists it as marketed, status dated 07-Oct-2019. 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 ENGERIX-B used for?
ENGERIX-B (hepatitis B surface antigen (recombinant)) is indicated for: active immunization against hepatitis B virus infection.
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 | 02487020 |
|---|---|
| Brand name | ENGERIX-B |
| Generic / active ingredient | HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) : 10 MCG / 0.5 ML |
| Manufacturer | GLAXOSMITHKLINE INC |
| Strength | 10 MCG / 0.5 ML |
| Dosage form | SUSPENSION |
| Route of administration | INTRAMUSCULAR |
| Schedule | Schedule D |
| ATC code | J07BC01 HEPATITIS B, PURIFIED ANTIGEN |
| AHFS class | 80:12.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 07-Oct-2019 |
| Original market date | 2019-10-07 00:00:00 |
How is it stored and handled?
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How is it supplied?
0.5 mL single dose prefilled syringes are packaged in a 1 pack carton with a Package Leaflet. 1.0 mL single dose prefilled syringes are packaged in a 1 or 25 pack carton with a Package Leaflet.
What can be used instead?
Other Canadian products sharing ATC code J07BC01 HEPATITIS B, PURIFIED ANTIGEN. 3 of 9 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 |
|---|---|---|---|---|---|
| ENGERIX-B | 20 MCG / 1 ML | SUSPENSION | GLAXOSMITHKLINE INC | MARKETED | DIN 02487039 |
| RECOMBIVAX HB | 40 MCG | SUSPENSION | MERCK CANADA INC | MARKETED | DIN 02245977 |
| ENGERIX-B | 10 MCG / 0.5 ML | SUSPENSION | GLAXOSMITHKLINE INC | CANCELLED POST MARKET | DIN 02296454 |
| ENGERIX-B | 20 MCG / 1 ML | SUSPENSION | GLAXOSMITHKLINE INC | CANCELLED POST MARKET | DIN 01919431 |
| PREHEVBRIO | 10 MCG | SUSPENSION | VBI VACCINES INC. | APPROVED | DIN 02533286 |
| RECOMBIVAX HB | 10 MCG | SUSPENSION | MERCK CANADA INC | CANCELLED POST MARKET | DIN 02243676 |
| RECOMBIVAX HB (ADULT DIALYSIS WITH PRESERVATIVE) | 40 MCG | SOLUTION | MERCK CANADA INC | CANCELLED POST MARKET | DIN 01934023 |
| RECOMBIVAX HB (WITH PRESERVATIVE) | 10 MCG | SOLUTION | MERCK CANADA INC | CANCELLED POST MARKET | DIN 00749486 |
Who else supplies HEPATITIS B, PURIFIED ANTIGEN worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. HEPATITIS B, PURIFIED ANTIGEN appears in 66 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.