MYAMBUTOL ethambutol hydrochloride 100 mg tablet bottle, Aspen Pharma Pty Ltd, CON-204
Product name
MYAMBUTOL ethambutol hydrochloride 100 mg tablet bottle
Sponsor name
Aspen Pharma Pty Ltd
Consent start
Consent no.
CON-204
Standard
Sections 8(1)(a), (h), (i), (j), (o); 8(2); 9(1)(a); 9(2) and 9(3) of the Therapeutic Goods Order No. 91.
Non-compliance with standard
The UK labelled product does not bear#58; The Australian registered name of the
medicine. The Australian approved storage condition. The name and contact
details of the Australian sponsor or Australian distributor of the medicine on
the bottle label only. A declaration of the presence of substances referred to
in Schedule. The Australian registered name of the medicine on three
non-opposing side of the carton. Space for a pharmacy dispensing label on the
carton label. The name of the medicine and, the name and quantity of the active
ingredient as a cohesive unit on the main label.
Conditions imposed
1. The UK bottle and carton labels to which this consent applies are those
provided withtheletter of application.2. The carton label will be over-labelled
with a sticker stating the Australian sponsor's name and address and, AUST R
number.3. The 'Dear Doctor', 'Dear Pharmacist' and 'Dear Wholesaler' letters,
identical to that provided withtheemail dated 4 August 2017, will be sent to the
relevant stakeholders advising the reason for supplying UK-packaged stock in
Australia and that this product must be stored under Australian approved storage
condition, i.e. 'store below 25°C'.
Therapeutic product type
Prescription medicines