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PROXEN SR 1000 naproxen sustained release 1000 mg tablet blister pack, Atnahs Pharma Australia Pty Ltd, CON-753
Product name
PROXEN SR 1000 naproxen sustained release 1000 mg tablet blister pack
Sponsor name
Atnahs Pharma Australia Pty Ltd
Consent start
Consent no.
CON-753
Standard
Subsections 8(2) and 9(5); paragraphs 8(1)(j), 9(3)(a) and subparagraph 9(3)(a)(i) of Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product packaging does not conform with the requirements of subsections 8(2)
and 9(5); paragraphs 8(1)(j), 9(3)(a) and and subparagraph 9(3)(a)(i) of
Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related
medicines in that The carton labels for the products listed above do not include
a designated space for dispensing label. The carton labels for the PROXEN SR 750
and PROXEN SR 1000 (259113 and 259112) products do not include the
name and quantity of the active ingredient immediately below the medicine name
and the text height for the name and quantity of the active ingredient on the
carton main label is less than 3.0 millimetres. The carton labels for the
ANAPROX 550 and CRYSANAL (66544 and 67927) products do not state
the total sodium content per tablet. The carton labels for the NAPROSYN SR 750,
NAPROSYN SR 1000, ANAPROX 550 and CRYSANAL (10174, 10173, AUST R
66544 and 67927) products do not include the name and quantity of the
active ingredient on one line.
Therapeutic product type
Prescription medicines