PULMICORT Respules budesonide 0.125 mg/mL nebuliser suspension, AstraZeneca Pty Ltd, CON-239
Product name
PULMICORT Respules budesonide 0.125 mg/mL nebuliser suspension
Sponsor name
AstraZeneca Pty Ltd
Consent start
Consent no.
CON-239
Standard
Does not conform to the requirements of the British Pharmacopoeia monograph Budesonide Nebuliser Suspension.
Non-compliance with standard
The product specification does not include all the tests required by this
monograph. Specifically, the tests for related substances with regard to mobile
phase, system suitability and limits were not carried out and the assay
performed to determine the amount of product available at 'shelf life' stage is
outside of the range specified in the British Pharmacopoeia monograph of 92.5 to
105.0% of the stated amount.
Therapeutic product type
Other therapeutic goods listed