TECHNESCAN PYP Kit for preparation of Technetium (99mTc) pyrophosphate powder for injection multidose vial, Landauer Radiopharmaceuticals Pty Ltd, CON-560
Product name
TECHNESCAN PYP Kit for preparation of Technetium (99mTc) pyrophosphate powder for injection multidose vial
Sponsor name
Landauer Radiopharmaceuticals Pty Ltd
ARTG
20025
Consent start
Consent no.
CON-560
Standard
Paragraphs 8(1)(h), 8(1)(i), 8(1)(n), and subparagraphs 9(1)(f)(iii) and 9(3)(a)(1) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines.
Non-compliance with standard
The product includes the US-registered labels for the primary pack and the vial,
which omit the Australian registration number, Australian-specific storage
conditions descriptions, name and contact details of the sponsor, a machine
readable code, the complete dosage form, and the label design does not include a
'cohesive unit'. For the vial label, the name of the dosage form is omitted, the
name and address of the sponsor is the non-local details, and for both the vial
label and string tag label, the storage conditions do not use the Australian
specific description.
Conditions imposed
1. A 'Dear Healthcare Provider' letter similar to that provided to the TGA and
dated 20 July 2020, must be supplied with each affected product unit. The letter
provides instruction that the pack insert inside the kit be disposed and
replaced with the Australian Product Information provided with each unit. 2.
The labels to which this consent applies are those provided with this
submission. This includes the supplementary label for the primary pack. The
supplementary label must be applied to the primary pack of every unit prior to
supply.
Therapeutic product type
Prescription medicines