DIACOMIT stiripentol 500 mg powder for oral suspension sachet, Chiesi Australia Pty Ltd, CON-668
Product name
DIACOMIT stiripentol 500 mg powder for oral suspension sachet
Sponsor name
Chiesi Australia Pty Ltd
Consent start
Consent no.
CON-668
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The labels do not 8(1)(h) '“ state storage conditions 8(1)(j) '“ declare the
presence of sesame seed products, sucralose and alcohol (as % v/v ethanol)
8(1)(o) '“ the name of the medicine is not on three non-opposing sides of the
powder for suspension cartons8(2)(a) '“ include space for a dispensing label
(carton only)9(3)(a) '“ state the name of and quantity of the active ingredient
immediately below the name of the medicine on the main label
Conditions imposed
1. A 'Dear Healthcare Provider' letter identical to that provided to the
Therapeutic Goods Administration on 23 October 2020 will be supplied with
each affected batch outlining missing information on the labels, e.g. the
Australian approved storage conditions and 'Schedule 1' declarable substances.
2. The labels to which this consent applies are the labels provided with the
letter of application.
Therapeutic product type
Prescription medicines