Serroflo 250/25 fluticasone propionate/salmeterol (as xinafoate) 250 microgram/25 microgram inhalation pressurised aerosol can metered dose, Cipla Australia Pty Ltd, CON-131
Product name
Serroflo 250/25 fluticasone propionate/salmeterol (as xinafoate) 250 microgram/25 microgram inhalation pressurised aerosol can metered dose
Sponsor name
Cipla Australia Pty Ltd
ARTG
267095
Consent start
Consent no.
CON-131
Standard
British Pharmacopoeia monograph for Fluticasone and Salmeterol Pressurised Inhalation, Suspension.
Non-compliance with standard
The products do not comply with the related substances requirements.
Conditions imposed
The expiry limit for the single maximum unknown impurity of fluticasone
proprionate will be NMT 0.3%, and
The expiry limit for the single maximum unknown impurity of salmeterol
will be NMT 0.3%, and
The expiry limit for the total impurities of salmeterol will be NMT 0.8%.
Therapeutic product type
Prescription medicines