TECHNESCAN PYP Kit for preparation of Technetium (99mTc) pyrophosphate powder for injection multidose vial, Landauer Radiopharmaceuticals Pty Ltd, CON-480
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-480
Standard
Paragraphs 3(2)(e), 3(2)(j) and 3(2)(l) in the Therapeutic Goods Order No. 69 '“ General Requirements for Labels for Medicines 2017
Non-compliance with standard
The product(s) do not conformin that the vial label, the name of the dosage form
is omitted, the name andaddress 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 on 4
July 2019, but including the text'Please note the storage conditions applied to
the reconstituted product is 'Store below 30°C' and not as described on the
string tag label',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 thissubmission on 4
July 2019. This includes the supplementary label for theprimary pack. The
supplementary label must be applied to the primary pack ofevery unit prior to
supply.
Therapeutic product type
Prescription medicines