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DEXAMETHASONE MYLAN dexamethasone phosphate (as dexamethasone sodium phosphate) 4 mg/1 mL solution for injection vial, Alphapharm Pty Ltd, CON-945
Product name
DEXAMETHASONE MYLAN dexamethasone phosphate (as dexamethasone sodium phosphate) 4 mg/1 mL solution for injection vial
Sponsor name
Alphapharm Pty Ltd
Batches
7607283, 7607284 and 7607285
Consent start
Consent no.
CON-945
Duration
The consent is effective from 23 May 2022 until 23 November 2022.
Standard
The requirements of the BP monograph for Dexamethasone Sodium Phosphate Injection.
Non-compliance with standard
The product do not conform to the requirements of the BP monograph for
Dexamethasone Sodium Phosphate Injection, in that the product does not meet the
pH requirements in the monograph.
Conditions imposed
A ‘Dear Healthcare Provider’ letter identical to that provided to the TGA on 20
May 2022 will be supplied with each affected batch.
Therapeutic product type
Prescription medicines