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REANDRON 1000 testosterone undecanoate 1000mg in 4mL oily solution for injection vial, Aspen Pharmacare Australia Pty Ltd, CON-1258
Product name
REANDRON 1000 testosterone undecanoate 1000mg in 4mL oily solution for injection vial
Sponsor name
Aspen Pharmacare Australia Pty Ltd
Consent start
Consent no.
CON-1258
Duration
The consent is effective from 31 July 2024 until 31 December 2025.
Standard
Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product contains the name and contact details of the previous sponsor, Bayer
Australia Pty Ltd, rather than the current sponsor, Aspen Pharmacare Australia
Pty Ltd.
Conditions imposed
The agreement in place and forwarded to the TGA on 30 July 2024 regarding
adverse events, product complaints and enquires will remain valid until the
exhaustion of stock in the market.
Import, Supply, &/or Export
supply
Therapeutic product type
Prescription medicines