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VEKLURY remdesivir 100 mg powder for injection vial, Gilead Sciences Pty Ltd, CON-864
Product name
VEKLURY remdesivir 100 mg powder for injection vial
Sponsor name
Gilead Sciences Pty Ltd
Batches
21090201M (28,000 units)
Consent start
Consent no.
CON-864
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product does not conform to the requirements of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91).
Conditions imposed
The labels to which this consent applies are those provided with the request, submitted 10 September 2021.A ‘Medicines Fact Sheet’ will be supplied with the affected batch that will detail the appropriate use and storage of the product in accordance with the approved Australian Product Information (PI).
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines