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DEXAMETHASONE MYLAN dexamethasone phosphate (as dexamethasone sodium phosphate) 8 mg/2 mL solution for injection vial, Alphapharm Pty Ltd, CON-968
Product name
DEXAMETHASONE MYLAN dexamethasone phosphate (as dexamethasone sodium phosphate) 8 mg/2 mL solution for injection vial
Sponsor name
Alphapharm Pty Ltd
Consent start
Consent no.
CON-968
Duration
The consent is effective for all relevant batches of the product from the 15 July 2022 until 28 February 2023.
Standard
The product does not conform with the requirements of the British Pharmacopeia monograph for Dexamethasone Sodium Phosphate Injection.
Non-compliance with standard
The product is non-compliant with the British Pharmacopeia monograph in that it
does not meet the pH acceptance requirements. This consent does not apply to any
product with a pH greater than or equal to 9.0.
Conditions imposed
1. A ‘Dear Healthcare Provider’ letter identical to that provided to the TGA on
15 July 2022 will be supplied with each affected batch.
2. The Sponsor must inform the Therapeutics Goods Administration immediately
by writing to the decision delegate if any batch of the product is analysed
and the results obtained for pH are greater than or equal to pH 9.0.
Therapeutic product type
Prescription medicines