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JURNISTA hydromorphone hydrochloride 16 mg prolonged release tablet blister pack, Janssen-Cilag Pty Ltd, CON-886
Product name
JURNISTA hydromorphone hydrochloride 16 mg prolonged release tablet blister pack
Sponsor name
Janssen-Cilag Pty Ltd
ARTG details
- 141533
Consent start
Consent no.
CON-886
Duration
The consent is effective from 26 November 2021 until 30 June 2022.
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.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines