DBL SODIUM NITRITE 0.3 g/10 mL injection BPC ampoule, Pfizer Australia Pty Ltd, CON-1129
Product name
DBL SODIUM NITRITE 0.3 g/10 mL injection BPC ampoule
Sponsor name
Pfizer Australia Pty Ltd
ARTG details
16290
Batches
241007
Consent start
Consent no.
CON-1129
Duration
The consent is effective from 12 July 2023 until 30 September 2024.
Standard
The USP-NF Sodium Nitrite Injection monograph requirements for Assay and Related substances. of United States Pharmacopoeia
Non-compliance with standard
The product is not tested as per the requirements of the monograph, as assay is
tested by titration and there is no related substance method as per the USP-NF
requirements
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines