LAGEVRIO molnupiravir 200 mg capsules bottle, Merck Sharp & Dohme (Australia) Pty Ltd, CON-1182
Product name
LAGEVRIO molnupiravir 200 mg capsules bottle
Sponsor name
Merck Sharp & Dohme (Australia) Pty Ltd
Batches
CKFWW, CKGHW, CKSFM, CKFWV, CKFXD and CKFXF
Consent start
Consent no.
CON-1182
Standard
of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product labels are international labels.
Conditions imposed
1. The product must be supplied with the labels that were considered and agreed
to as part of the evaluation under section 25 of the Therapeutic Goods Act 1989,
being:
a. The international label in submission as provided
i. Carton label
ii. Blister label
Therapeutic product type
Prescription medicines