XERMELO telotristat ethyl (as telotristat etiprate) 250 mg film-coated tablet blister pack, Clinect Pty Ltd, CON-1098
Product name
XERMELO telotristat ethyl (as telotristat etiprate) 250 mg film-coated tablet blister pack
Sponsor name
Clinect Pty Ltd
ARTG
Batches
U22566
Consent start
Consent no.
CON-1098
Standard
Paragraph 7(2)(b), Paragraph 8(1)(o), Section 8(2), Subparagraph 10(14)(a)(iv), Subparagraph 10(14)(a)(v) Subparagraph 10(14)(a)(ix), of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product(s) include information that is required to be on the label in a
language other than English, the correct name of the medicine is not on at least
three non-opposing sides of the carton, the label of the medicine does not
include a minimum space of 70 x 30 mm for the dispensing label, and the blister
pack for the product does not include the name of the medicine, the name of all
active ingredients in the medicine or the details of the sponsor or distributor
of the medicine
Conditions imposed
A 'Dear Healthcare Provider' letter identical to that provided to the
Therapeutic Goods Administration on 27 April 2023 will be supplied with the
affected batch describing the label changes and providing an assurance there is
no change to the medicine.
Therapeutic product type
Prescription medicines