MITOZANTRONE EBEWE mitozantrone (as hydrochloride) 10 mg/5 mL solution for injection vial., Sandoz Pty Ltd, CON-539
Product name
MITOZANTRONE EBEWE mitozantrone (as hydrochloride) 10 mg/5 mL solution for injection vial.
Sponsor name
Sandoz Pty Ltd
ARTG
Consent start
Consent no.
CON-539
Standard
British Pharmaeocopia monograph for Mitoxantrone Infusion
Non-compliance with standard
The product(s) do not conform to the requirements of BP monograph for
Mitoxantrone Infusion, in that the pH test limited applied to the product is pH
2.5 - 4.0, which is not within the BP monograph requirement of pH 3.0 - 4.5.
Conditions imposed
The products are tested to and must comply with the finished product
specifications (at release and expiry) provided in your Certified Product
Details (CPD) dated 10 April 2018
Therapeutic product type
Prescription medicines