XOLAIR 75 MG / 0.5 ML
OMALIZUMAB : 75 MG / 0.5 ML · DIN 02459787 · NOVARTIS PHARMACEUTICALS CANADA INC
Health Canada status: MARKETED
What is XOLAIR?
XOLAIR 75 MG / 0.5 ML contains OMALIZUMAB : 75 MG / 0.5 ML. It is listed in the Health Canada Drug Product Database under DIN 02459787, held by NOVARTIS PHARMACEUTICALS CANADA INC, supplied as SOLUTION for SUBCUTANEOUS administration. Health Canada currently lists it as marketed, status dated 28-Jun-2017. 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 XOLAIR used for?
XOLAIR (omalizumab) is indicated for adult and pediatric patients (6 years of age and above) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. XOLAIR (omalizumab) is indicated as an add-on maintenance treatment with intranasal corticosteroids in adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) inadequately controlled by intranasal corticosteroids alone. XOLAIR (omalizumab) is indicated for the treatment of adults and adolescents (12 years of age and above) with chronic idiopathic urticaria (CIU) who remain symptomatic despite H1 antihistamine treatment.
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 | 02459787 |
|---|---|
| Brand name | XOLAIR |
| Generic / active ingredient | OMALIZUMAB : 75 MG / 0.5 ML |
| Manufacturer | NOVARTIS PHARMACEUTICALS CANADA INC |
| Strength | 75 MG / 0.5 ML |
| Dosage form | SOLUTION |
| Route of administration | SUBCUTANEOUS |
| Schedule | Schedule D |
| ATC code | R03DX05 OMALIZUMAB |
| AHFS class | 90:28.16.92 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 28-Jun-2017 |
| Original market date | 2017-06-28 00:00:00 |
How is it stored and handled?
Chemical and physical stability of the reconstituted product has been demonstrated for 8 hours at 2 to 8°C and for 4 hours at 30°C. From a microbiological point of view, the product should be used immediately after reconstitution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should normally not be longer than 8 hours at 2 to 8°C or 2 hours at 25°C.
How is it supplied?
150 mg/vial lyophilized powder for subcutaneous injection, Omalizumab injection 75 mg/0.5 mL solution for subcutaneous injection, 150 mg/1.0 mL solution for subcutaneous injection, 300 mg/2.0 mL solution for subcutaneous injection
What can be used instead?
Other Canadian products sharing ATC code R03DX05 OMALIZUMAB. 8 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 |
|---|---|---|---|---|---|
| OMLYCLO | 150 MG / 1 ML | SOLUTION | CELLTRION INC. | MARKETED | DIN 02553813 |
| OMLYCLO | 75 MG / 0.5 ML | SOLUTION | CELLTRION INC. | MARKETED | DIN 02553805 |
| XOLAIR | 150 MG | POWDER FOR SOLUTION | NOVARTIS PHARMACEUTICALS CANADA INC | MARKETED | DIN 02260565 |
| XOLAIR | 150 MG / 1 ML | SOLUTION | NOVARTIS PHARMACEUTICALS CANADA INC | MARKETED | DIN 02545144 |
| XOLAIR | 150 MG / 1 ML | SOLUTION | NOVARTIS PHARMACEUTICALS CANADA INC | MARKETED | DIN 02459795 |
| XOLAIR | 300 MG / 2 ML | SOLUTION | NOVARTIS PHARMACEUTICALS CANADA INC | MARKETED | DIN 02545160 |
| XOLAIR | 75 MG / 0.5 ML | SOLUTION | NOVARTIS PHARMACEUTICALS CANADA INC | MARKETED | DIN 02545136 |
| XOLAIR | 300 MG / 2 ML | SOLUTION | NOVARTIS PHARMACEUTICALS CANADA INC | APPROVED | DIN 02545152 |
Who else supplies OMALIZUMAB worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. OMALIZUMAB appears in 806 registered pack listings across 12 markets, published on 10 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.