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SINEMET 250/25 levodopa/carbidopa 250 mg/25 mg tablet bottle, ORGANON PHARMA PTY LTD, CON-1408
Product name
SINEMET 250/25 levodopa/carbidopa 250 mg/25 mg tablet bottle
Sponsor name
ORGANON PHARMA PTY LTD
Consent start
Consent no.
CON-1408
Duration
The consent is effective from 15 September 2025 until 10 November 2026.
Standard
Paragraph 8(1)i of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products do not conform because the products are labelled with the sponsor's
previous contact details that do not align with the currently registered address
and a period of 12 months has passed since the change in address has occurred.
Conditions imposed
There are arrangements in place for the prompt referral of any queries or
complaints concerning the products to Organon Pharma Pty Ltd.’s current contact
details.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines