NICORANDIL APOTEX nicorandil 20 mg tablet blister pack, Apotex Pty Ltd, CON-318
Product name
NICORANDIL APOTEX nicorandil 20 mg tablet blister pack
Sponsor name
Apotex Pty Ltd
Consent start
Consent no.
CON-318
Standard
Paragraph 8 of the Therapeutic Goods Order No. 78 - Standard for tablets and capsules (TGO 78) - the products do not conform with the British Pharmacopoeia Monograph for Nicorandil Tablets, specifically the expiry limit for the assay.
Non-compliance with standard
The expiry limit for the assay is 92.5% -105.0% where the British Pharmacopoeia
Monograph for Nicorandil tablets requires 95.0%-105.0%.
Conditions imposed
The expiry limits are those currently approved and meet the default assay
requirements of TGO 78, that is 92.5% - 105.0%.
Therapeutic product type
Prescription medicines