oxycodone hydrochloride (OXYCONTIN) 20 mg modified release tablet blister pack, Mundipharma Pty Ltd, CON-124
Product name
oxycodone hydrochloride (OXYCONTIN) 20 mg modified release tablet blister pack
Sponsor name
Mundipharma Pty Ltd
Consent start
Consent no.
CON-124
Standard
British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets.
Non-compliance with standard
The products do not comply with the current British Pharmacopoeia (BP) monograph
2016 for Prolonged-release Oxycodone Tablets in regard to the test limits for
assay and related substances.
Conditions imposed
The products comply with the requirements of the current British
Pharmacopoeia (BP) monograph for Prolonged-release Oxycodone Tablets except for
the tests and limits for assay and related substances.
The products must comply with the currently approved finished expiry
specifications throughout their shelf life, including use of the in-house test
methods.
The on-going stability testing of the 10 mg (batches 185644 and 192704)
and 15 mg (batch 192705) tablets should continue to at least 36 months when
store at 25°C/60%RH in order to obtain more data to verify/confirm any trend in
assay and formation of the N-oxide impurity.
Therapeutic product type
Prescription medicines