FOSCAVIR foscarnet sodium 6 g/250 mL injection bottle, Link Medical Products Pty Ltd T/A Link Pharmaceuticals, CON-769
Product name
FOSCAVIR foscarnet sodium 6 g/250 mL injection bottle
Sponsor name
Link Medical Products Pty Ltd T/A Link Pharmaceuticals
Batches
16PF7962
Consent start
Consent no.
CON-769
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
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, in that the following is absent
the relevant warning statementsthe name of active ingredient using the
Australian Approved Name the name and address of the Australian sponsor are not
includedthe name and quantity of the active ingredient are not on separate lines
immediately below the name of the medicine the name of the active on the bottle
label is less than the required height (3 mm)the quantity of each excipient is
not stated the Registration number is not included on the cartonthe strength of
the active is not presented as weight of active in the stated volume of
injection
Conditions imposed
'Dear Healthcare Provider' letter identical to that provided to the
Therapeutic Goods Administration on 12 February 2021 will be supplied with
each affected batch outlining the differences in the product labelling.
The labels to which this consent applies are the 'UK labels' provided with
the letter dated 12 February 2021 and over-stickered with the batch details,
expiry date, Australian sponsor details and the number.
Therapeutic product type
Prescription medicines