COMIRNATY OMICRON XBB.1.5 10 MCG / 0.2 ML
RAXTOZINAMERAN : 10 MCG / 0.2 ML · DIN 02541831 · BIONTECH MANUFACTURING GMBH
Health Canada status: CANCELLED PRE MARKET
What is COMIRNATY OMICRON XBB.1.5?
COMIRNATY OMICRON XBB.1.5 10 MCG / 0.2 ML contains RAXTOZINAMERAN : 10 MCG / 0.2 ML. It is listed in the Health Canada Drug Product Database under DIN 02541831, held by BIONTECH MANUFACTURING GMBH, supplied as SUSPENSION for INTRAMUSCULAR administration. Health Canada currently lists it as cancelled pre market, status dated 24-Sep-2024. 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 COMIRNATY OMICRON XBB.1.5 used for?
Active immunization against COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older.
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 | 02541831 |
|---|---|
| Brand name | COMIRNATY OMICRON XBB.1.5 |
| Generic / active ingredient | RAXTOZINAMERAN : 10 MCG / 0.2 ML |
| Manufacturer | BIONTECH MANUFACTURING GMBH |
| Strength | 10 MCG / 0.2 ML |
| Dosage form | SUSPENSION |
| Route of administration | INTRAMUSCULAR |
| Schedule | Prescription |
| ATC code | J07BN01 COVID-19, RNA-BASED VACCINE |
| Biosimilar | No |
| Health Canada status | CANCELLED PRE MARKET |
| Status date | 24-Sep-2024 |
How is it administered?
Administered intramuscularly. 12+ years: 0.3 mL single dose. 5-<12 years: 0.2 mL (diluted) or 0.3 mL (ready-to-use). 6 months-<5 years: 3-dose primary series or single dose if primary series complete.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Frozen vials: -90°C to -60°C. Thawed vials: 2°C to 8°C for up to 10 weeks. Once punctured, store at 2°C to 25°C and discard after 12 hours.
How is it supplied?
Single dose and multiple dose vials. Gray cap (12+ yrs), Orange cap (5-<12 yrs, dilute), Blue cap (5-<12 yrs, no dilute), Maroon cap (6 mo-<5 yrs, dilute).
Contraindications
Contraindicated in individuals who are hypersensitive to the active substance or to any ingredient in the formulation.
Warnings and precautions
No known serious warnings at time of authorization. Monitor for hypersensitivity/anaphylaxis. Potential risk of myocarditis/pericarditis following vaccination.
What can be used instead?
Other Canadian products sharing ATC code J07BN01 COVID-19, RNA-BASED VACCINE. 5 of 20 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 |
|---|---|---|---|---|---|
| COMIRNATY | 10 MCG / 0.3 ML | SUSPENSION | BIONTECH MANUFACTURING GMBH | MARKETED | DIN 02541858 |
| COMIRNATY | 30 MCG / 0.3 ML | SUSPENSION | BIONTECH MANUFACTURING GMBH | MARKETED | DIN 02541823 |
| COMIRNATY | 30 MCG / 0.3 ML | SUSPENSION | BIONTECH MANUFACTURING GMBH | MARKETED | DIN 02552035 |
| SPIKEVAX | 0.1 MG | DISPERSION | MODERNA BIOPHARMA CANADA CORPORATION | MARKETED | DIN 02541270 |
| SPIKEVAX | 50 MCG / 0.5 ML | DISPERSION | MODERNA BIOPHARMA CANADA CORPORATION | MARKETED | DIN 02557770 |
| COMIRNATY | 10 MCG / 0.2 ML | SUSPENSION | BIONTECH MANUFACTURING GMBH | CANCELLED POST MARKET | DIN 02522454 |
| COMIRNATY | 3 MCG / 0.2 ML | SUSPENSION | BIONTECH MANUFACTURING GMBH | CANCELLED POST MARKET | DIN 02530325 |
| COMIRNATY | 3 MCG / 0.3 ML | SUSPENSION | BIONTECH MANUFACTURING GMBH | APPROVED | DIN 02552078 |
| COMIRNATY | 30 MCG / 0.3 ML | SUSPENSION | BIONTECH MANUFACTURING GMBH | CANCELLED POST MARKET | DIN 02509210 |
| COMIRNATY | 30 MCG / 0.3 ML | SUSPENSION | BIONTECH MANUFACTURING GMBH | CANCELLED POST MARKET | DIN 02527863 |
Can this still be bought in Canada?
No. This Drug Identification Number is cancelled pre market in Health Canada's Drug Product Database, so the product is no longer authorized for sale in Canada and Nexara does not supply it. This page is kept as a regulatory record.
If you are looking for a current equivalent, the alternatives above list every product sharing this therapeutic class, with the marketed ones first. Ask us to source an alternative
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.