HEPAGAM B 312 UNIT
HEPATITIS B IMMUNOGLOBULIN (HUMAN) : 312 UNIT · DIN 02290979 · KI BIOPHARMA LLC
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.
Product details and regulatory record
| DIN | 02290979 |
|---|---|
| Brand name | HEPAGAM B |
| Generic / active ingredient | HEPATITIS B IMMUNOGLOBULIN (HUMAN) : 312 UNIT |
| Manufacturer | KI BIOPHARMA LLC |
| Strength | 312 UNIT |
| Dosage form | SOLUTION |
| Route of administration | INTRAMUSCULAR ; INTRAVENOUS |
| Schedule | Schedule D |
| ATC code | J06BB04 HEPATITIS B IMMUNOGLOBULIN |
| AHFS class | 80:04.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 10-Nov-2022 |
| Original market date | 2007-08-13 00:00:00 |
How is it stored and handled?
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How is it supplied?
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
What can be used instead?
Other Canadian products sharing ATC code J06BB04 HEPATITIS B IMMUNOGLOBULIN. 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 |
|---|---|---|---|---|---|
| HYPERHEP B | 110 UNIT / 0.5 ML | SOLUTION | GRIFOLS THERAPEUTICS LLC | MARKETED | DIN 02520125 |
| HYPERHEP B | 220 UNIT | SOLUTION | GRIFOLS THERAPEUTICS LLC | MARKETED | DIN 02520001 |
| H-BIG | 1.5 UNIT | LIQUID | ABBOTT LABORATORIES, LIMITED | CANCELLED POST MARKET | DIN 00780251 |
| HYPERHEP B | 220 UNIT | SOLUTION | GRIFOLS THERAPEUTICS LLC | APPROVED | DIN 02520133 |
| HYPERHEP B S/D | 220 UNIT | SOLUTION | GRIFOLS THERAPEUTICS LLC | CANCELLED PRE MARKET | DIN 02379473 |
| HYPERHEP B S/D | 220 UNIT | SOLUTION | GRIFOLS THERAPEUTICS LLC | CANCELLED POST MARKET | DIN 02230738 |
| HYPERHEP B S/D | 220 UNIT | SOLUTION | GRIFOLS THERAPEUTICS LLC | CANCELLED POST MARKET | DIN 02379465 |
| HYPERHEP INJ | LIQUID | CUTTER MED & BIOL, DIVISION OF MILES CANADA LTD. | CANCELLED POST MARKET | DIN 00499617 |
Who else supplies HEPATITIS B IMMUNOGLOBULIN worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. HEPATITIS B IMMUNOGLOBULIN 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.