bisoprolol fumarate (BISPRO) 5 mg tablet blister pack, Alphapharm Pty Ltd, CON-178
Product name
bisoprolol fumarate (BISPRO) 5 mg tablet blister pack
Sponsor name
Alphapharm Pty Ltd
Consent start
Consent no.
CON-178
Standard
Parargraph 8 of the Therapeutic Goods Order No. 78 '“ Standard for Tablets and Capsules.
Non-compliance with standard
The drug product release and expiry limits of the products do not comply with
the individual monograph of the British Pharmacopoeia for Bisoprolol Fumarate
Tablets, particularly for the assay, dissolution and related substance
requirements.
Conditions imposed
1. The drug product release and expiry limits for the products to which this
consent applies are those currently approved (on 30 April 2007 under submission
PM-2007-0479-3).
Therapeutic product type
Prescription medicines