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PFIZER DAPTOMYCIN daptomycin 500 mg powder for injection vial, Pfizer Australia Pty Ltd, CON-1179
Product name
PFIZER DAPTOMYCIN daptomycin 500 mg powder for injection vial
Sponsor name
Pfizer Australia Pty Ltd
Batches
HH8322AA
Consent start
Consent no.
CON-1179
Duration
The consent is effective from 15 November 2023 until the earliest date of either exhaustion or expiry of the batch specified.
Standard
of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Conditions imposed
1. A Dear Healthcare Provider’ letter identical to that provided to the
Therapeutics Goods Administration on 6 November 2023 will be supplied with the
affected batch describing the differences between the approved label and the
supplied label and any precautions the user needs to take.
2. The labels to be supplied are those included with the application dated 6
November 2023.
The label will include the information on the over-sticker.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines