ANDRIOL TESTOCAPS testosterone undecanoate 40 mg capsule blister pack, Merck Sharp Dohme (Australia) Pty Ltd, CON-674
Product name
ANDRIOL TESTOCAPS testosterone undecanoate 40 mg capsule blister pack
Sponsor name
Merck Sharp Dohme (Australia) Pty Ltd
ARTG
92904
Consent start
Consent no.
CON-674
Standard
The Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product does not conform with the requirements of TGO 91 due to global
supply chain issues in introducing the TGO 91 compliant labels into the
manufacturing process. However, the product is supplied with labels that have
been approved by the TGA, assessed against TGO 69 requirements.
Therapeutic product type
Prescription medicines