NUVAXOVID (SARS-CoV-2 rS [NVX-CoV2373]) COVID-19 VACCINE adjuvanted suspension for injection vial, Biocelect Pty Ltd , CON-962
Product name
NUVAXOVID (SARS-CoV-2 rS [NVX-CoV2373]) COVID-19 VACCINE adjuvanted suspension for injection vial
Sponsor name
Biocelect Pty Ltd
Consent start
Consent no.
CON-962
Standard
Therapeutic Goods Order No. 91 ˆ’ Standard for labels of prescription and related medicines (TGO 91).
Non-compliance with standard
The product does not comply with the requirements of TGO 91 in the labels are
international labels
Conditions imposed
1. The product must be supplied with the labels that were considered and agreed
to as part of the evaluation under section 9D(3) of the Therapeutic Goods
Act 1989, being
* The international carton referred to in the submission as follows
* Update of carton with the removal of two (2) agents for pH adjustment
from the carton text as submitted 14 June 2022 Sodium hydroxide and
hydrochloric acid. OR The labels that were considered and agreed to as
part of the evaluation under section 25 of the Therapeutic Goods Act 1989,
being the international vial and carton labels referred to in submission
dated 19 January 2022
Therapeutic product type
Prescription medicines