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VEKLURY remdesivir 100 mg powder for injection vial, Gilead Sciences Pty Ltd, CON-907
Product name
VEKLURY remdesivir 100 mg powder for injection vial
Sponsor name
Gilead Sciences Pty Ltd
Consent start
Consent no.
CON-907
Duration
The consent is effective from 4 February 2022 until 10 July 2022.
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 3 February 2022 .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