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MADOPAR 250 levodopa 200 mg and benserazide 50 mg tablet bottle, Roche Products Pty Ltd, CON-1386

Product name
MADOPAR 250 levodopa 200 mg and benserazide 50 mg tablet bottle
Sponsor name
Roche Products Pty Ltd
ARTG details
Consent start
Consent no.
CON-1386
Duration
The consent is effective from 11 July 2025 until 31 March 2028.
Standard
subsection 6(1)(a) of Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95)
Non-compliance with standard
The products do not conform because the products are not contained within child-resistant packaging.
Conditions imposed
1.The sponsor will continue to monitor for any incidents where a child accesses the medicine inappropriately and report all such incidents to the Therapeutic Goods Administration. 2.The sponsor will make a submission to by the TGA when TGO 95 sunsetting consultation begins regarding this ongoing issue.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines