MedPath

SARS-CoV-2 vaccine

Generic Name
SARS-CoV-2 vaccine
Drug Type
Biotech

Overview

SARS-CoV-2 vaccine is an adjuvanted recombinant protein-based COVID-19 vaccine candidate being developed collaboratively by GlaxoSmithKline (GSK) and Sanofi. This vaccine candidate is composed of a spike protein antigen which aims to stimulate immune system production of antibodies against SARS-CoV-2; it uses technology previously employed for a recombinant influenza vaccine.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

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
Authorised
12/20/2021

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
NUVAXOVID DISPERSION FOR INJECTION COVID-19 VACCINE 5 µg/dose (RECOMBINANT, ADJUVANTED)
SIN16886P
INJECTION, SUSPENSION
5 µg/dose
10/17/2023

NMPA Drug Approvals

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

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
NUVAXOVID
novavax inc.
02543656
Suspension - Intramuscular
5 MCG / 0.5 ML
12/8/2023
NUVAXOVID
novavax inc.
02525364
Suspension - Intramuscular
5 MCG / 0.5 ML
3/31/2022

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

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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