HEPAGAM B 312 UNIT — DIN 02290979
HEPATITIS B IMMUNOGLOBULIN (HUMAN) : 312 UNIT · KI BIOPHARMA LLC · SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is HEPAGAM B?
HEPAGAM B 312 UNIT contains HEPATITIS B IMMUNOGLOBULIN (HUMAN) : 312 UNIT. It is listed in the Health Canada Drug Product Database under DIN 02290979, held by KI BIOPHARMA LLC, supplied as SOLUTION for INTRAMUSCULAR ; INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 10-Nov-2022. 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 HEPAGAM B used for?
HepaGam B (Hepatitis B Immunoglobulin (Human) Injection) is indicated for post-exposure prophylaxis for acute exposure to blood containing hepatitis B surface antigen (HBsAg), perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons, and household exposure to persons with acute HBV infection. It is also indicated for the prevention of hepatitis B recurrence following liver transplantation in adult patients with hepatitis B who have no or low levels of HBV replication.
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 Immunoglobulin 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.
4 holders have a Canadian DIN containing Hepatitis B Immunoglobulin, 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 |
|---|---|---|---|---|
| GRIFOLS THERAPEUTICS LLC | 6 | 2 | HYPERHEP B, HYPERHEP B S/D | Sourceable in Canada |
| KI BIOPHARMA LLC | 1 | 1 | HEPAGAM B | Sourceable in Canada |
| ABBOTT LABORATORIES, LIMITED | 1 | 0 | H-BIG | No marketed DIN |
| CUTTER MED & BIOL, DIVISION OF MILES CANADA LTD. | 1 | 0 | HYPERHEP INJ | 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 | 312 UNIT |
|---|---|
| Dosage form | SOLUTION |
| Route | INTRAMUSCULAR ; INTRAVENOUS |
| Pack configuration (monograph) | A carton containing a 1 mL fill single dose (>312 IU/mL) in a glass vial fitted with stopper and a package insert; A carton containing a 5 mL fill single dose (>312 IU/mL) in a glass vial fitted with stopper and a package insert |
| Storage | null |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Hepatitis B Immunoglobulin |
|---|---|
| ATC code | J06BB04 |
| AHFS class | 80:04.00 |
| 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) | 02290979 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2290979 |
| Brand name | HEPAGAM B |
| Generic / active ingredient | HEPATITIS B IMMUNOGLOBULIN (HUMAN) : 312 UNIT |
| Market authorization holder | KI BIOPHARMA LLC |
| Health Canada schedule | Schedule D |
| ATC code | J06BB04 |
| ATC anatomical main group | J — Anti-infectives for systemic use |
| ATC therapeutic subgroup | J06BB |
| Current status | MARKETED |
| Status date | 10-Nov-2022 |
| Original market date | 2007-08-13 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 |
|---|---|---|---|---|---|
| HYPERHEP B | 220 UNIT | SOLUTION | GRIFOLS THERAPEUTICS LLC | MARKETED | 02520001 |
| HYPERHEP B | 110 UNIT / 0.5 ML | SOLUTION | GRIFOLS THERAPEUTICS LLC | MARKETED | 02520125 |
| H-BIG | 1.5 UNIT | LIQUID | ABBOTT LABORATORIES, LIMITED | CANCELLED POST MARKET | 00780251 |
| HYPERHEP B | 220 UNIT | SOLUTION | GRIFOLS THERAPEUTICS LLC | APPROVED | 02520133 |
| HYPERHEP B S/D | 220 UNIT | SOLUTION | GRIFOLS THERAPEUTICS LLC | CANCELLED PRE MARKET | 02379473 |
| HYPERHEP B S/D | 220 UNIT | SOLUTION | GRIFOLS THERAPEUTICS LLC | CANCELLED POST MARKET | 02230738 |
| HYPERHEP B S/D | 220 UNIT | SOLUTION | GRIFOLS THERAPEUTICS LLC | CANCELLED POST MARKET | 02379465 |
| HYPERHEP INJ | LIQUID | CUTTER MED & BIOL, DIVISION OF MILES CANADA LTD. | CANCELLED POST MARKET | 00499617 |
2 · Same class — other molecules in ATC J06BB
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Hepatitis B Immunoglobulin | H-BIG · HEPAGAM B · HYPERHEP B · HYPERHEP B S/D · +1 more | 9 | 3 | Yes |
| Anti-D (Rh) Immunoglobulin | HYP RHO D INJ 16.5% · WINRHO SD KIT INJ · WINRHO SD KIT INJ. · WINRHO SDF | 11 | 2 | Yes |
| Rabies Immunoglobulin | HYPERAB RABIES IMMUNE GLOBULIN HUMAN · HYPERRAB · HYPERRAB S/D · IMOGAM RABIES INJ 150UNIT/ML · +2 more | 7 | 2 | Yes |
| Tetanus Immunoglobulin | HYPER TET · HYPERTET · HYPERTET S/D | 4 | 1 | Yes |
| Varicella/Zoster Immunoglobulin | VARICELLA ZOSTER IMMUNE GLOBULIN INJ · VARICELLA-ZOSTER IMMUNE GLOBULIN (HUMAN) · VARIZIG | 4 | 1 | Yes |
| Cytomegalovirus Immunoglobulin | CYTOGAM | 1 | 1 | 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 J06B
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| J06BA | Immunoglobulins, Normal Human, For Extravasc. Adm · Immunoglobulins, Normal Human, For Intravasc. Adm. | 50 | 16 |
| J06BD | Casirivimab And Imdevimab · Nirsevimab · Palivizumab · Sipavibart · Sotrovimab · +1 more | 11 | 2 |
| J06B | Immunoglobulins | 1 | 0 |
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.