देश: कनाडा
भाषा: अंग्रेज़ी
स्रोत: Health Canada
SARS-COV-2 RECOMBINANT SPIKE PROTEIN (OMICRON XBB.1.5)
NOVAVAX INC.
J07BN04
COVID-19, PROTEIN SUBUNIT
5MCG
SUSPENSION
SARS-COV-2 RECOMBINANT SPIKE PROTEIN (OMICRON XBB.1.5) 5MCG
INTRAMUSCULAR
15G/50G
Schedule D
Active ingredient group (AIG) number: 0165423001; AHFS:
APPROVED
2023-12-05
_ _ _Product Monograph _ _ _ NUVAXOVID ™ _ _ XBB.1.5 _, COVID-19 Vaccine (Recombinant protein, Adjuvanted) _ _Page 1 of 51 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION NUVAXOVID ™ XBB.1.5 COVID-19 Vaccine (Recombinant protein, Adjuvanted) Suspension for intramuscular injection Multidose Vial, 5 mcg / 0.5 mL (per dose) (contains 5 doses of 0.5 mL) Active Immunizing Agent ATC Classification: J07BN04 NUVAXOVID ™ XBB.1.5 COVID-19 Vaccine (Recombinant protein, Adjuvanted) vaccine is indicated for: • Active immunization against coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus in individuals 12 years of age and older. NUVAXOVID ™ XBB.1.5 COVID-19 Vaccine (Recombinant protein, Adjuvanted) vaccine has been issued marketing authorization with Terms and Conditions that need to be met by the Market Authorization Holder to ascertain the continued quality, safety and effectiveness of the vaccine. Patients should be advised of the nature of the authorization. For further information for NUVAXOVID ™ XBB.1.5 COVID-19 Vaccine (Recombinant protein, Adjuvanted) vaccine please refer to Health Canada’s COVID-19 vaccines and transfer portal. COVID-19 vaccines and treatments portal (canada.ca) Novavax, Inc. 21 Firstfield Road Gaithersburg, MD, 20878 IMPORTED BY: Innomar Strategies Inc. 3470 Superior Ct Oakville, ON, L6L 0C4 Date of Initial Authorization: December 5, 2023 Submission Control Number: 278519 _ _ _Product Monograph _ _ _ NUVAXOVID ™ _ _ XBB.1.5 _, COVID-19 Vaccine (Recombinant protein, Adjuvanted) _ _Page 2 of 51 _ RECENT MAJOR LABEL CHANGES _ _ _Product Monograph _ _ _ NUVAXOVID ™ _ _ XBB.1.5 _, COVID-19 Vaccine (Recombinant protein, Adjuvanted) _ _Page 3 of 51 _ TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES ............................................................................................... 2 TABLE OF CONTENTS ........... पूरा दस्तावेज़ पढ़ें