DEXAMETHASONE MYLAN dexamethasone phosphate (as dexamethasone sodium phosphate) 8mg/2mL solution for injection vial, Alphapharm Pty Ltd, CON-1105
Product name
DEXAMETHASONE MYLAN dexamethasone phosphate (as dexamethasone sodium phosphate) 8mg/2mL solution for injection vial
Sponsor name
Alphapharm Pty Ltd
Consent start
Consent no.
CON-1105
Standard
The product does not meet the pH requirements in the monograph for Dexamethasone Sodium Phosphate Injection of British Pharmacopoeia
Non-compliance with standard
Does not meet the pH requirements in the monograph
Conditions imposed
1. 'Dear Healthcare Provider' letters identical to those provided to the
Therapeutic Goods Administration on 24 April 2023 will be supplied with each
affected batch;
2. The Therapeutics Goods Administration must be informed immediately by writing
to the decision delegate if any batch of the product(s) is analysed and the
results obtained for pH are greater than or equal to pH 9.0.
Therapeutic product type
Prescription medicines