ATACAND PLUS candesartan cilexetil & hydrochlorothiazide 16/12.5 tablet blister pack, Link Medical Products Pty Ltd, CON-1245
Product name
ATACAND PLUS candesartan cilexetil & hydrochlorothiazide 16/12.5 tablet blister pack
Sponsor name
Link Medical Products Pty Ltd
Batches
60046304, 60046633, 60047041, 60047042, 60047043, 60047854, 60047853, 60047855, 60048162, 60048163, 60048171
Consent start
Consent no.
CON-1245
Standard
Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product(s) have the incorrect details, with AstraZeneca Pty Ltd listed on
the labels along with their contact details whilst the sponsor is now Link
Medical Products Pty Ltd Trading As Link Pharmaceuticals
Conditions imposed
The sponsor must maintain a relationship with AstraZeneca Pty Ltd throughout the
shelf life of the products for the redirection of any correspondence received in
relation to the relevant batches, to ensure that all adverse events, product
complaints and general enquiries are managed appropriately.
Therapeutic product type
Prescription medicines