EPIDYOLEX cannabidiol 100 mg/mL oral liquid solution bottle, Chiesi Australia Pty Ltd , CON-651
Product name
EPIDYOLEX cannabidiol 100 mg/mL oral liquid solution bottle
Sponsor name
Chiesi Australia Pty Ltd
Consent start
Consent no.
CON-651
Standard
Paragraphs 8(1)(h), 8(1)(j), 8(2)(a) and 9(3)(a) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines.
Non-compliance with standard
The bottle and cartons 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) 9(3)(a) '“ state the name of and quantity of the active ingredient
immediately below the name of the medicine on the main label The bottle label
does not state 8(1)(i) - the name and contact details of the Australian sponsor
The carton label does not 8(2)(a) '“ include space for a dispensing label
Conditions imposed
A 'Dear Healthcare Provider' letter identical to that provided to the TGA on
20 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.
Therapeutic product type
Prescription medicines