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DEXAMETHASONE VIATRIS dexamethasone phosphate (as dexamethasone sodium phosphate) 4 mg/1 mL solution for injection vial, Alphapharm Pty Ltd, CON-1152
Product name
DEXAMETHASONE VIATRIS dexamethasone phosphate (as dexamethasone sodium phosphate) 4 mg/1 mL solution for injection vial
Sponsor name
Alphapharm Pty Ltd
Batches
All batches of the product(s) with pH greater than or equal to 9.0.
Consent start
Consent no.
CON-1152
Duration
The consent is effective from 11 August 2023 until 1 August 2024.
Standard
The product does not meet the pH requirements in the monograph of British Pharmacopoeia
Non-compliance with standard
The product does not conform with the requirements of the BP monograph for
Dexamethasone Sodium Phosphate Injection.
Conditions imposed
A ‘Dear Healthcare Provider’ letter identical to that provided to the
Therapeutic Goods Administration on 1 August 2023 will be supplied with each
affected batch.
The Therapeutic 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