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TRUXIMA rituximab (rch) 100 mg/ 10 mL concentrate solution for intravenous infusion, Celltrion Healthcare Australia Pty Ltd, CON-961
Product name
TRUXIMA rituximab (rch) 100 mg/ 10 mL concentrate solution for intravenous infusion
Sponsor name
Celltrion Healthcare Australia Pty Ltd
Batches
OC3C047
Consent start
Consent no.
CON-961
Duration
The consent is effective from 1 July 2022 until 30 June 2023.
Standard
Section 9(3)(b) Section 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 product label does not comply with TGO 91 in that Section 9(3)(b) – On the
vial and the carton, the name of the active ingredient is separated from the
name of the medicine by the route of administration. Section 8 (1) (i) – On the
carton, the name and contact details of the sponsor or distributor of the
medicine is not current.
Conditions imposed
A Dear Healthcare Professional letter identical to that provided to the
Therapeutic Goods Administration on 30 June 2022 will be supplied with the
affected batch warning that the product is a New Zealand labelled product
supplied under Section 14 exemption.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines