ANAPROX 550 Naproxen sodium 550 mg tablet blister pack, Atnahs Pharma Australia Pty Ltd, CON-753
Product name
ANAPROX 550 Naproxen sodium 550 mg tablet blister pack
Sponsor name
Atnahs Pharma Australia Pty Ltd
Consent start
Consent no.
CON-753
Duration
The consent is effective for all batches of the products manufactured from 12 February 2021 until 28 February 2022.
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 (AUST R 259113 and AUST R 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 (AUST R 66544 and AUST R 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 (AUST R 10174, AUST R 10173, AUST R 66544 and AUST R 67927) products do not include the name and quantity of the active ingredient on one line.
Import, Supply, &/or Export
Import, supply and export
Therapeutic product type
Prescription medicines