XEMBIFY 20 %
IMMUNOGLOBULIN (HUMAN) : 20 % · DIN 02494426 · GRIFOLS THERAPEUTICS LLC
Health Canada status: APPROVED
What is XEMBIFY?
XEMBIFY 20 % contains IMMUNOGLOBULIN (HUMAN) : 20 %. It is listed in the Health Canada Drug Product Database under DIN 02494426, held by GRIFOLS THERAPEUTICS LLC, supplied as SOLUTION for SUBCUTANEOUS administration. Health Canada currently lists it as approved, status dated 10-Dec-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.
Product details and regulatory record
| DIN | 02494426 |
|---|---|
| Brand name | XEMBIFY |
| Generic / active ingredient | IMMUNOGLOBULIN (HUMAN) : 20 % |
| Manufacturer | GRIFOLS THERAPEUTICS LLC |
| Strength | 20 % |
| Dosage form | SOLUTION |
| Route of administration | SUBCUTANEOUS |
| Schedule | Schedule D |
| ATC code | J06BA01 IMMUNOGLOBULINS, NORMAL HUMAN, FOR EXTRAVASC. ADM |
| AHFS class | 80:04.00 |
| Biosimilar | No |
| Health Canada status | APPROVED |
| Status date | 10-Dec-2019 |
What can be used instead?
Other Canadian products sharing ATC code J06BA01 IMMUNOGLOBULINS, NORMAL HUMAN, FOR EXTRAVASC. ADM. 11 of 25 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 |
|---|---|---|---|---|---|
| CUVITRU | 200 MG | SOLUTION | TAKEDA CANADA INC | MARKETED | DIN 02461692 |
| GAMASTAN | 18 % | SOLUTION | GRIFOLS THERAPEUTICS LLC | MARKETED | DIN 02486598 |
| HIZENTRA | 200 MG | SOLUTION | CSL BEHRING CANADA INC | MARKETED | DIN 02498251 |
| HIZENTRA | 200 MG | SOLUTION | CSL BEHRING CANADA INC | MARKETED | DIN 02463067 |
| HIZENTRA | 200 MG | SOLUTION | CSL BEHRING CANADA INC | MARKETED | DIN 02463059 |
| HIZENTRA | 200 MG | SOLUTION | CSL BEHRING CANADA INC | MARKETED | DIN 02535424 |
| HYQVIA | 1600 UNIT / 10 ML | SOLUTION | TAKEDA CANADA INC | MARKETED | DIN 02524392 |
| HYQVIA | 200 UNIT / 1.25 ML | SOLUTION | TAKEDA CANADA INC | MARKETED | DIN 02524368 |
| HYQVIA | 30 G / 300 ML | SOLUTION | TAKEDA CANADA INC | MARKETED | DIN 02524406 |
| HYQVIA | 5 G / 50 ML | SOLUTION | TAKEDA CANADA INC | MARKETED | DIN 02524376 |
How can I get it?
This product is approved by Health Canada but not yet marketed in Canada, so there is no Canadian supply to draw on today. Nexara can tell you whether it has been launched, and can look at supply from other markets where a Canadian pack is not required or where importation is 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.