HYDROXO-B12 hydroxocobalamin chloride 1mg/1mL injection ampoule, Aspen Pharmacare Australia Pty Ltd, CON-1336
Product name
HYDROXO-B12 hydroxocobalamin chloride 1mg/1mL injection ampoule
Sponsor name
Aspen Pharmacare Australia Pty Ltd
Consent start
Consent no.
CON-1336
Duration
The consent is effective from 11 March 2025 until 11 March 2027.
Standard
Monograph for Hydroxocobalamin Chloride of European Pharmacopoeia
Non-compliance with standard
The products do not conform because the Hydroxocobalamin Chloride Loss on Drying
specification limit of between 8.0% and 12.0% is not met when tested by the
finished product manufacturer.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines