LIVIAL tibolone 2.5 mg tablet blister pack, Organon Pharma Pty Ltd, CON-896
Product name
LIVIAL tibolone 2.5 mg tablet blister pack
Sponsor name
Organon Pharma Pty Ltd
Batches
T042948 and U025299
Consent start
Consent no.
CON-896
Duration
The consent is effective for the aforementioned batches only from 16 December 2021 until 31 July 2022.
Standard
Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The packaging does not conform with the requirements of paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) in that the labels do not include the current sponsor details (Organon Pharma Pty Ltd).
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines