FOSCAVIR foscarnet sodium 6 g/250 mL injection bottle, Link Medical Products Pty Ltd TA Link Pharmaceuticals, CON-665
Product name
FOSCAVIR foscarnet sodium 6 g/250 mL injection bottle
Sponsor name
Link Medical Products Pty Ltd TA Link Pharmaceuticals
Consent start
Consent no.
CON-665
Standard
The products that do not conform to the requirements of paragraph 8(1)(k), 8(1)(b), 9(1)(b), 9(3)(a), 10(3)(a), subsection 9(3) and subparagraph 11(2)(f)(iii) in the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not include the relevant warning statementsthe name of active
ingredient is not described using the Australian Approved Namethe name and
quantity of the active ingredient are not on separate lines immediately below
the name of the medicinethe name of the active on the bottle label is less than
the required heightthe quantity of each excipient is not statedthe strength of
the active is not presented as weight of active in volume of injection.
Conditions imposed
'Dear Healthcare Provider' letter identical to that provided to the TGA on
29 October 2020, 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
your application and over-stickered with the batch details, expiry date,
Australian sponsor details and the number.
Therapeutic product type
Prescription medicines