ROPIVACAINE READYFUSOR ropivacaine hydrochloride 0.2% solution for injection, bottle in dispenser device, BioQ Pharma Pty Ltd, CON-873
Product name
ROPIVACAINE READYFUSOR ropivacaine hydrochloride 0.2% solution for injection, bottle in dispenser device
Sponsor name
BioQ Pharma Pty Ltd
Consent start
Consent no.
CON-873
Standard
Subsections 7(2) and 9(5), and subparagraphs 9(3)(a)(i) and 9(1)(f)(i), of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
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, in that the
product label does not have text at the minimum height required, does not
include the name and quantity of the active ingredient immediately below the
name of the product on the main panel, and does not include the approved route
of administration on the main panel.
Therapeutic product type
Prescription medicines