TACHOSIL human fibrinogen 5.5mg/square cm and human thrombin 2.0IU/square cm medicated sponge blister pack, Takeda Pharmaceuticals Australia Pty Ltd, CON-285
Product name
TACHOSIL human fibrinogen 5.5mg/square cm and human thrombin 2.0IU/square cm medicated sponge blister pack
Sponsor name
Takeda Pharmaceuticals Australia Pty Ltd
Consent start
Consent no.
CON-285
Duration
The consent is effective from the 8 August 2018 until further notice.
Standard
Paragraphs 10(13)(a)(vi) and 10(13)(a)(vii) of Therapeutic Goods Order No. 91 - Standard for labels for prescription and related medicines.
Non-compliance with standard
The product’s immediate blister pack labels do not include the names and
quantities of all active ingredients in the medicine.
Conditions imposed
The labels to which this consent applies are those previously approved to be
exempted from compliance with subclauses 3(12)(b) and 3(2)(b) and (c) of the
Therapeutic Goods Order No. 69 - General Requirements for Labels for Medicines.
Import, Supply, &/or Export
Supply
Therapeutic product type
Prescription medicines