DEXAMETHASONE VIATRIS dexamethasone phosphate (as dexamethasone sodium phosphate) 8mg/2mL solution for injection vial, Alphapharm Pty Ltd, CON-1234
Product name
DEXAMETHASONE VIATRIS dexamethasone phosphate (as dexamethasone sodium phosphate) 8mg/2mL solution for injection vial
Sponsor name
Alphapharm Pty Ltd
Consent start
Consent no.
CON-1234
Standard
British Pharmacopeia monograph for Dexamethasone Sodium Phosphate Injection of British Pharmacopoeia
Non-compliance with standard
The products do not meet the pH requirements in the monograph as they exceed the
upper limit of pH 8.5.
Conditions imposed
The consent is effective for all relevant batches of the product from 24 April
2024 until 30 April 2025.
' The consent does not apply to any batches of the product(s) with pH greater
than or equal to 9.0.
' The 'Dear Healthcare Provider' letters identical to those provided to the TGA
on 16 April 2024 will be supplied with each affected batch
' You must inform the TGA 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