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ACTEMRA tocilizumab (rch) 200 mg/10 mL injection concentrated vial, Roche Products Pty Ltd, CON-867
Product name
ACTEMRA tocilizumab (rch) 200 mg/10 mL injection concentrated vial
Sponsor name
Roche Products Pty Ltd
Batches
1163406, 1164929, 1163292, 1163279, 1162729, 1163299, 1164608 and 1164287
Consent start
Consent no.
CON-867
Duration
The consent is effective from 16 September 2021 until supply of the affected clinical trial labelled batches 1163406, 1164929, 1163292, 1163279, 1162729, 1163299, 1164608, and 1164287 is exhausted.
Standard
Therapeutic Goods Order No. 91- Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not conform to the requirements of Therapeutic Goods Order No.
91- Standard for labels of prescription and related medicines, in that the
product is labelled for clinical trial use only as per Annex 13 of the PIC/S
Guide to GMP (Investigational Medicinal Products) labelling requirements.
Conditions imposed
Information will be provided to the relevant healthcare professionals to confirm
the product supplied is identical to Australian registered Actemra product and
to explain the difference in product packaging compared to commercial product,
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines