Overview
The Omicron variant of SARS-CoV-2 is a variant of concern that was first reported in November 2021. It tends to cause less severe disease but is significantly more virulent than both the original virus and earlier variants (e.g. Delta). As of November 2022, it is the primary circulating variant of concern according to the World Health Organization. The Omicron variant comprises several distinct lineages and sublineages (e.g. BA.4, BA.5) which, although similar, may behave differently from one another. Riltozinameran is an mRNA vaccine encoding the S glycoprotein of SARS-CoV-2 Omicron variant lineage BA.1. It is administered in combination with tozinameran for active immunization against COVID-19 caused by SARS-CoV-2, including infection caused by Omicron BA.1
Indication
Riltozinameran, in combination with tozinameran (Comirnaty Original / Omicron BA.1), is indicated in patients ≥12 years of age as a booster dose for active immunization against COVID-19 caused by SARS-CoV-2. It may be given 3 to 6 months after completion of a primary course of Comirnaty and/or a previous booster dose of Comirnaty.
Associated Conditions
- Coronavirus Disease 2019 (COVID‑19)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/09/02 | N/A | Active, not recruiting |
FDA Drug Approvals
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| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| COMIRNATY ORIGINAL/OMICRON BA.1 | 02532018 | Suspension - Intramuscular | 15 MCG / 0.3 ML | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| COMIRNATY ORIGINAL/OMICRON BA.1 (15/15 MICROGRAMOS)/DOSIS DISPERSION INYECTABLE | 1201528006 | DISPERSIÓN INYECTABLE | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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