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TRIMBOW 100/6/10 beclometasone dipropionate 100 ug formoterol fumarate dihydrate 6 ug glycopyrronium 10 ug pressurised inhalation solution pack , Chiesi Australia Pty Ltd, CON-1400
Product name
TRIMBOW 100/6/10 beclometasone dipropionate 100 ug formoterol fumarate dihydrate 6 ug glycopyrronium 10 ug pressurised inhalation solution pack
Sponsor name
Chiesi Australia Pty Ltd
Batches
1216522
Consent start
Consent no.
CON-1400
Duration
The consent is effective from 19 August 2025 until 31 March 2027.
Standard
Paragraphs 10(11)(d), 10(11)(g) and 11(2)(h) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products do not conform because: they are in a small container and the
active ingredient 'formoterol fumarate dihydrate' is included as 'formoterol
(eformoterol) fumarate dihydrate', which is not the Australian Approved name.
The name of dosage form is recorded as ‘Pressurised inhalation solution’ instead
of ‘pressurised inhalation’ and the quantity of the dose delivered is recorded
as 'sprays per container' instead of 'actuations per container'.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines