NITYR nitisinone 10 mg tablet bottle, Orpharma Pty Ltd, CON-562
Product name
NITYR nitisinone 10 mg tablet bottle
Sponsor name
Orpharma Pty Ltd
Consent start
Consent no.
CON-562
Standard
Subsections 8(2), 9(3) and 11(5) and, paragraphs 8(1)(j), (k), (o) in the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines.
Non-compliance with standard
The carton labels do not state all relevant warning statements, substances
(excipients) with known effect, the trade name is not repeated on 3 non-opposing
sides, space for a dispensing label is not included, the name and quantity of
the active ingredient are not placed on the same line immediately underneath the
trade name and the permitted storage conditions are not stated. The bottle
labels do not state all relevant warning statements, substances (excipients)
with known effect, the name and quantity of the active ingredient are not placed
on the same line immediately underneath the trade name and the permitted storage
conditions are not stated.
Therapeutic product type
Prescription medicines