OCTAGAM 100 MG — DIN 02380145
IMMUNOGLOBULIN (HUMAN) : 100 MG · OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES M B H · SOLUTION · wholesale supply in Canada
Health Canada status: DORMANT
What is OCTAGAM?
OCTAGAM 100 MG contains IMMUNOGLOBULIN (HUMAN) : 100 MG. It is listed in the Health Canada Drug Product Database under DIN 02380145, held by OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES M B H, supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as dormant, status dated 24-Jul-2024. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A). This DIN is not currently being marketed in Canada, so it is sourced to order where a compliant route exists rather than held in stock.
Is there a generic Immunoglobulins, Normal Human, For Intravasc. Adm. 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.
12 holders have a Canadian DIN containing Immunoglobulins, Normal Human, For Intravasc. Adm., across 25 DINs, of which 5 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 |
|---|---|---|---|---|
| TAKEDA CANADA INC | 3 | 2 | GAMMAGARD LIQUID, GAMMAGARD S/D | Sourceable in Canada |
| GRIFOLS THERAPEUTICS LLC | 2 | 2 | GAMUNEX, IGIVNEX | Sourceable in Canada |
| CSL BEHRING CANADA INC | 3 | 1 | HIZENTRA, PRIVIGEN, SANDOGLOBULIN NF LIQUID | Sourceable in Canada |
| TALECRIS BIOTHERAPEUTICS INC | 4 | 0 | GAMIMUNE N 10% (IV), GAMIMUNE N 5% (IV), IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10%, IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 5% | No marketed DIN |
| MEDIMMUNE LLC | 3 | 0 | RESPIGAM | No marketed DIN |
| OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES M B H | 3 | 0 | OCTAGAM, OCTAGAM 5%, PANZYGA | No marketed DIN |
| INSTITUTO GRIFOLS S.A. | 2 | 0 | FLEBOGAMMA 10%, FLEBOGAMMA 5% | No marketed DIN |
| BAXALTA CANADA CORPORATION | 1 | 0 | GAMMAGARD S/D | No marketed DIN |
| BAXTER AG | 1 | 0 | IVEEGAM IMMUNO 5000MG (IV) | No marketed DIN |
| BAXTER CORPORATION | 1 | 0 | GAMMAGARD S/D (IV) | No marketed DIN |
| BAYER CORPORATION | 1 | 0 | IMMUNE GLOBULIN INTRAVENOUS (HUMAN) 5% | No marketed DIN |
| CUTTER MED & BIOL, DIVISION OF MILES CANADA LTD. | 1 | 0 | GAMIMUNE N INJ 5% (IV) | 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 | 100 MG |
|---|---|
| Dosage form | SOLUTION |
| Route | INTRAVENOUS |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Immunoglobulins, Normal Human, For Intravasc. Adm. |
|---|---|
| ATC code | J06BA02 |
| 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) | 02380145 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2380145 |
| Brand name | OCTAGAM |
| Generic / active ingredient | IMMUNOGLOBULIN (HUMAN) : 100 MG |
| Market authorization holder | OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES M B H |
| Health Canada schedule | Schedule D |
| ATC code | J06BA02 |
| ATC anatomical main group | J — Anti-infectives for systemic use |
| ATC therapeutic subgroup | J06BA |
| Current status | DORMANT |
| Status date | 24-Jul-2024 |
| Original market date | 2013-04-04 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
5 of 25 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| GAMMAGARD LIQUID | 10 % | SOLUTION | TAKEDA CANADA INC | MARKETED | 02279444 |
| GAMMAGARD S/D | 5 G | SOLUTION ; POWDER FOR SOLUTION ; KIT | TAKEDA CANADA INC | MARKETED | 02231470 |
| GAMUNEX | 10 G / 100 ML | SOLUTION | GRIFOLS THERAPEUTICS LLC | MARKETED | 02247724 |
| IGIVNEX | 10 G / 100 ML | SOLUTION | GRIFOLS THERAPEUTICS LLC | MARKETED | 02277921 |
| PRIVIGEN | 10 % | SOLUTION | CSL BEHRING CANADA INC | MARKETED | 02304619 |
| FLEBOGAMMA 10% | 100 MG | SOLUTION | INSTITUTO GRIFOLS S.A. | APPROVED | 02467526 |
| FLEBOGAMMA 5% | 50 MG | SOLUTION | INSTITUTO GRIFOLS S.A. | APPROVED | 02467488 |
| GAMIMUNE N 10% (IV) | 100 MG | SOLUTION | TALECRIS BIOTHERAPEUTICS INC | CANCELLED POST MARKET | 02229695 |
| GAMIMUNE N 5% (IV) | 50 MG | SOLUTION | TALECRIS BIOTHERAPEUTICS INC | CANCELLED POST MARKET | 02178842 |
| GAMIMUNE N INJ 5% (IV) | 50 MG | LIQUID | CUTTER MED & BIOL, DIVISION OF MILES CANADA LTD. | CANCELLED POST MARKET | 00559261 |
2 · Same class — other molecules in ATC J06BA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Immunoglobulins, Normal Human, For Extravasc. Adm | CUTAQUIG · CUVITRU · GAMASTAN · GAMASTAN S/D · +7 more | 25 | 11 | Yes |
| Immunoglobulins, Normal Human, For Intravasc. Adm. | FLEBOGAMMA 10% · FLEBOGAMMA 5% · GAMIMUNE N 10% (IV) · GAMIMUNE N 5% (IV) · +17 more | 25 | 5 | 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 |
|---|---|---|---|
| J06BB | Anti-D (Rh) Immunoglobulin · Cytomegalovirus Immunoglobulin · Hepatitis B Immunoglobulin · Rabies Immunoglobulin · Tetanus Immunoglobulin · +1 more | 36 | 10 |
| 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?
This DIN is dormant — it holds a Health Canada authorization but is not currently being marketed in Canada, so it cannot simply be ordered from Canadian stock. Where a patient need exists, supply may be possible through exceptional importation or the Special Access Programme, subject to Health Canada's requirements and the prescriber's application. Nexara can advise on the route and on marketed alternatives.
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.