ZEMAIRA 4000 MG
ALPHA1-PROTEINASE INHIBITOR (HUMAN) : 4000 MG · DIN 02494760 · CSL BEHRING CANADA INC
Health Canada status: APPROVED
What is ZEMAIRA?
ZEMAIRA 4000 MG contains ALPHA1-PROTEINASE INHIBITOR (HUMAN) : 4000 MG. It is listed in the Health Canada Drug Product Database under DIN 02494760, held by CSL BEHRING CANADA INC, supplied as KIT ; POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as approved, status dated 16-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 | 02494760 |
|---|---|
| Brand name | ZEMAIRA |
| Generic / active ingredient | ALPHA1-PROTEINASE INHIBITOR (HUMAN) : 4000 MG |
| Manufacturer | CSL BEHRING CANADA INC |
| Strength | 4000 MG |
| Dosage form | KIT ; POWDER FOR SOLUTION |
| Route of administration | INTRAVENOUS |
| Schedule | Schedule D |
| ATC code | B02AB02 ALFA1 ANTITRYPSIN |
| AHFS class | 84:80.00 |
| Biosimilar | No |
| Health Canada status | APPROVED |
| Status date | 16-Dec-2019 |
| Original market date | 2020-08-26 00:00:00 |
What can be used instead?
Other Canadian products sharing ATC code B02AB02 ALFA1 ANTITRYPSIN. 2 of 10 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 |
|---|---|---|---|---|---|
| GLASSIA | 1000 MG / 50 ML | SOLUTION | TAKEDA CANADA INC | MARKETED | DIN 02522438 |
| PROLASTIN-C | 1000 MG | POWDER FOR SOLUTION | GRIFOLS THERAPEUTICS LLC | MARKETED | DIN 02204606 |
| ALPHA1-PROTEINASE INHIBITOR (HUMAN) | 1 G | POWDER FOR SOLUTION | GRIFOLS THERAPEUTICS LLC | CANCELLED PRE MARKET | DIN 02223651 |
| ALPHA1-PROTEINASE INHIBITOR (HUMAN) | 500 MG | POWDER FOR SOLUTION | GRIFOLS THERAPEUTICS LLC | CANCELLED PRE MARKET | DIN 02223643 |
| PROLASTIN INJ 25.0MG/ML | 25 MG | POWDER FOR SOLUTION | CUTTER BIOLOGICAL, DIVISION OF MILES LAB INC. | CANCELLED POST MARKET | DIN 00803529 |
| PROLASTIN-C LIQUID | 1000 MG / 20 ML | SOLUTION | GRIFOLS THERAPEUTICS LLC | APPROVED | DIN 02488787 |
| PRONEXTICA LIQUID | 1000 MG / 20 ML | SOLUTION | GRIFOLS THERAPEUTICS LLC | APPROVED | DIN 02543028 |
| ZEMAIRA | 1000 MG | POWDER FOR SOLUTION ; KIT | CSL BEHRING CANADA INC | APPROVED | DIN 02457911 |
| ZEMAIRA | 5000 MG | POWDER FOR SOLUTION ; KIT | CSL BEHRING CANADA INC | APPROVED | DIN 02494779 |
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.