MedPath

Raxtozinameran

Generic Name
Raxtozinameran
Drug Type
Biotech

Overview

No overview information available.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2021/09/02
N/A
Active, not recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
COMIRNATY Omicron XBB.1.5 (raxtozinameran) COVID-19 VACCINE 3 micrograms/0.2 mL concentrated suspension for injection multidose vial
419332
Medicine
A
12/22/2023
COMIRNATY Omicron XBB.1.5 (raxtozinameran) COVID-19 VACCINE 10 micrograms/0.3 mL suspension for injection multidose vial
419372
Medicine
A
12/22/2023
COMIRNATY Omicron XBB.1.5 (raxtozinameran) COVID-19 VACCINE 10 micrograms/0.3 mL suspension for injection single dose vial
419371
Medicine
A
10/9/2023
COMIRNATY Omicron XBB.1.5 (raxtozinameran) COVID-19 VACCINE 3 micrograms/0.3 mL concentrated suspension for injection multidose vial
428610
Medicine
A
12/22/2023
COMIRNATY Omicron XBB.1.5 (raxtozinameran) COVID-19 VACCINE 30 micrograms/0.3 mL suspension for injection prefilled glass syringe
442810
Medicine
A
8/12/2024
COMIRNATY Omicron XBB.1.5 (raxtozinameran) COVID-19 VACCINE 30 micrograms/0.3 mL suspension for injection multidose vial
419330
Medicine
A
10/9/2023
COMIRNATY Omicron XBB.1.5 (raxtozinameran) COVID-19 VACCINE 10 micrograms/0.2 mL concentrated suspension for injection multidose vial
419331
Medicine
A
12/22/2023
COMIRNATY Omicron XBB.1.5 (raxtozinameran) COVID-19 VACCINE 30 micrograms/0.3 mL suspension for injection sinigle dose vial
419370
Medicine
A
12/22/2023
COMIRNATY Omicron XBB.1.5 (raxtozinameran) COVID-19 VACCINE 30 micrograms/0.3 mL suspension for injection prefilled plastic syringe
442811
Medicine
A
8/12/2024

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
COMIRNATY OMICRON XBB.1.5
02541831
Suspension - Intramuscular
10 MCG / 0.2 ML
N/A
COMIRNATY OMICRON XBB.1.5
02541866
Suspension - Intramuscular
3 MCG / 0.2 ML
10/24/2023

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
COMIRNATY OMICRON XBB.1.5 (10 MICROGRAMOS)/DOSIS DISPERSION INYECTABLE
1201528023
DISPERSIÓN INYECTABLE
Medicamento Sujeto A Prescripción Médica
Not Commercialized
COMIRNATY OMICRON XBB.1.5 (30 MICROGRAMOS)/DOSIS DISPERSION INYECTABLE
1201528019
DISPERSIÓN INYECTABLE
Medicamento Sujeto A Prescripción Médica
Not Commercialized
COMIRNATY OMICRON XBB.1.5 (3 MICROGRAMOS/DOSIS) CONCENTRADO PARA DISPERSION INYECTABLE
1201528024
CONCENTRADO PARA DISPERSION 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
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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