bisoprolol fumarate (BISOPROLOL SANDOZ) 5 mg film-coated tablet blister pack, Sandoz Pty Ltd, CON-113
Product name
bisoprolol fumarate (BISOPROLOL SANDOZ) 5 mg film-coated tablet blister pack
Sponsor name
Sandoz Pty Ltd
Consent start
Consent no.
CON-113
Standard
The requirements of section 8 of Therapeutic Goods Order No. 78 '“ Standard for Tablets and Capsules.
Non-compliance with standard
The finished drug product release and expiry specifications of the products do
not comply with the individual monograph of the British Pharmacopoeia for
Bisoprolol Fumarate Tablets, particularly for the assay and related substance
specifications.
Conditions imposed
The finished product release and expiry specifications for the products to
which this consent applies are those provided as 'attachment 1' withthe letter
of application, which are the current specifications approved on 17 August 2016
under submission PM-2016-02260-1-3 and;
A compliance check forthe products listed above is to be conducted with
the aim of investigating compliance with the BP monograph, as stated inthe
letter of application.
Therapeutic product type
Prescription medicines