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
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.
Therapeutic product type
Prescription medicines