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RUZURGI amifampridine 10 mg tablet bottle, ORSPEC Pharma Pty Ltd, CON-865
Product name
RUZURGI amifampridine 10 mg tablet bottle
Sponsor name
ORSPEC Pharma Pty Ltd
Consent start
Consent no.
CON-865
Duration
The consent is effective from 10 September 2021 until 10 September 2023.
Standard
Subsections 9(1), 9(2) and 9(3) of Therapeutic Goods Order No. 95 - Child‑resistant packaging requirements for medicines 2017
Non-compliance with standard
The product does not conform to the requirements of subsections 9(1), 9(2) and
9(3) of Therapeutic Goods Order No. 95 - Child‑resistant packaging requirements
for medicines 2017, in that testing of child resistance has not yet been
completed and documented.
Therapeutic product type
Prescription medicines