ROPIVACAINE KABI ropivacaine hydrochloride 50 mg/10 mL solution for injection ampoule, Fresenius Kabi Australia Pty Ltd, CON-747
Product name
ROPIVACAINE KABI ropivacaine hydrochloride 50 mg/10 mL solution for injection ampoule
Sponsor name
Fresenius Kabi Australia Pty Ltd
Consent start
Consent no.
CON-747
Standard
Paragraphs 10(4)(d) and 10(4)(k) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product(s) do not conform to the requirements of paragraphs 10(4)(d) and
10(4)(k) of Therapeutic Goods Order No. 91 - Standard for labels of prescription
and related medicines in that the product packaging (ampoule label) do not
include the active ingredient in a text height of at least 2.0 millimetres; and
the approved route of administration for the medicine is not captured on the
ampoules.
Therapeutic product type
Prescription medicines