FOSCAVIR foscarnet sodium 6 g/250 mL injection bottle, Link Medical Products Pty Ltd TA Link Pharmaceuticals, CON-933
Product name
FOSCAVIR foscarnet sodium 6 g/250 mL injection bottle
Sponsor name
Link Medical Products Pty Ltd TA Link Pharmaceuticals
Batches
16QC0624
Consent start
Consent no.
CON-933
Standard
Paragraphs 8(1)(k), 8(1)(b), 8(1)(i), 9(1)(b), 9(3)(a), 10(2)(a); Subsection 9(3); and Subparagraphs 7(2)(d)(i), 11(2)(f)(iii) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product(s) do not conform to the requirements of Paragraphs 8(1)(k),
8(1)(b), 8(1)(i), 9(1)(b), 9(3)(a), 10(2)(a); Subsection 9(3); and Subparagraphs
7(2)(d)(i), 11(2)(f)(iii) of TGO 91. The product(s) labels do not include the
relevant signal heading and warning statements, include the name of the active
ingredient in accordance with its Australian Approved Name, include the name and
address of the Australian sponsor, place the name and quantity of the active
ingredient on the main label together immediately below the name of the
medicine, print the name of the active ingredient at a height of 3 mm or larger,
include the quantity of each excipient or express the strength of the medicine
as the weight of the active ingredient in the stated volume of injection.
Conditions imposed
1. A 'Dear Healthcare Provider' letter identical to that provided to the TGA on
8 December 2021 will be supplied with each affected batch outlining the
differences in the product labelling.
2. The labels to which this consent applies are those provided with your letter
dated 8 December 2021 and over-stickered with the Australian sponsor details
and the number.
Therapeutic product type
Prescription medicines