Pulmicort 0.5mg/ml nebuliser suspension, AstraZeneca Pty Ltd, CON-1230
Product name
Pulmicort 0.5mg/ml nebuliser suspension
Sponsor name
AstraZeneca Pty Ltd
Consent start
Consent no.
CON-1230
Standard
of Therapeutic Goods Order No. 70C - Standards for Export Only Medicine
Non-compliance with standard
the product specification does not include all the tests required by the
British Pharmacopoeia (BP) monograph; ' the test method for related substances
with regard to mobile phase, system suitability and limits were not carried out
and instead replaced by an in-house validated test; and ' the assay specified as
mg/ml in the product specification to determine the amount of active available
in the product at shelf life stage is outside the range specified in the BP
monograph of 92.5% to 105.0% of the stated amount.
Therapeutic product type
Other therapeutic goods listed