mitoxantrone hydrochloride (MITOZANTRONE EBEWE) 10 mg/5 mL solution for injection vial, Sandoz Pty Ltd, CON-109
Product name
mitoxantrone hydrochloride (MITOZANTRONE EBEWE) 10 mg/5 mL solution for injection vial
Sponsor name
Sandoz Pty Ltd
ARTG
Consent start
Consent no.
CON-109
Standard
The requirements of the official standard for the products, namely the current BP monograph for Sterile Mitoxantrone Concentrate.
Non-compliance with standard
The products do not conform to the requirements of the current BP monograph for
Sterile Mitoxantrone Concentrate.
Conditions imposed
The products are tested to and must comply with the finished product
specifications (at release and expiry) provided in the application.
Therapeutic product type
Prescription medicines