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LAGEVRIO molnupiravir 200 mg capsules bottle, Merck Sharp Dohme Pty Ltd, CON-909

Product name
LAGEVRIO molnupiravir 200 mg capsules bottle
Sponsor name
Merck Sharp Dohme Pty Ltd
Consent start
Consent no.
CON-909
Duration
The consent is effective for all batches released for supply from 18 January 2022 until 18 January 2024.
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 product must be supplied with the labels that were considered and agreed&%23160; to as part of the evaluation under section 25 of the Therapeutic Goods Act 1989, being&%23160;&%23160;&%23160; &%23160;&%23160;&%23160;&%23160;&%23160; a. The international label as follows&%23160; &%23160;&%23160;&%23160; &%23160;&%23160;&%23160;&%23160;&%23160;&%23160;&%23160; i. Carton labels (submitted 16 November 2021)&%23160; &%23160;&%23160;&%23160;&%23160;&%23160;&%23160;&%23160; ii. Bottle labels (submitted 16 November 2021)&%23160; &%23160;&%23160;&%23160; &%23160;
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines

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