FOSCAVIR foscarnet sodium 6g/250 mL injection bottle, Link Medical Products Pty Ltd TA Link Pharmaceuticals, CON-905
Product name
FOSCAVIR foscarnet sodium 6g/250 mL injection bottle
Sponsor name
Link Medical Products Pty Ltd TA Link Pharmaceuticals
Batches
16QC0624
Consent start
Consent no.
CON-905
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 Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product does 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 Therapeutic Goods Order No. 91 - Standard for
labels of prescription and related medicines (TGO 91), in that the product
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 the required minimum height of 3 mm, - include the quantity of
each excipient, - include the Registration number on the carton or primary pack
- 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 the letter
dated 8 December 2021 and over-stickered with the Australian sponsor details
and the number.
Therapeutic product type
Prescription medicines