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COUMADIN warfarin sodium 5mg tablet bottle, Viatris Pty Ltd, CON-955
Product name
COUMADIN warfarin sodium 5mg tablet bottle
Sponsor name
Viatris Pty Ltd
ARTG details
Consent start
Consent no.
CON-955
Duration
The consent is effective from the 15 June 2022 until 15 June 2023.
Standard
Paragraph 8(1)(i) of Therapeutics Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product label does not include the name and address of the current sponsor
or distributor of the goods.
Conditions imposed
The labels to which this consent applies are those previously approved for the
former sponsor and arrangements are in place such that consumers and healthcare
professionals will be redirected from the old (www.mylan.com.au) to the new
website (www.viatris.com.au).
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines