JURNISTA hydromorphone hydrochloride 64 mg prolonged release tablet blister pack, Janssen-Cilag Pty Ltd, CON-886
Product name
JURNISTA hydromorphone hydrochloride 64 mg prolonged release tablet blister pack
Sponsor name
Janssen-Cilag Pty Ltd
ARTG
141535
Consent start
Consent no.
CON-886
Standard
Paragraph 8(1)(b) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products do not conform to the requirements of paragraph 8(1)(b) of
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related
medicines, in that the products active ingredient name is misspelled on one
carton panel.
Therapeutic product type
Prescription medicines