ARANESP darbepoetin alfa (rch) 10 microgram/0.4 mL injection syringe, Amgen Australia Pty Ltd, CON-1007
Product name
ARANESP darbepoetin alfa (rch) 10 microgram/0.4 mL injection syringe
Sponsor name
Amgen Australia Pty Ltd
Consent start
Consent no.
CON-1007
Duration
The consent is effective for all batches of the products manufactured until 01 March 2024.
Standard
paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91).
Non-compliance with standard
The products’ labels do not comply with the TGO 91 in that the contact details of the distributor of the medicine are not current on the cartons.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines