ALENDROBELL PLUS D3 70 mg/70 microgram alendronate (as sodium) 70 mg and colecalciferol 70 microgram tablet blister pack, Dr Reddy's Laboratories (Australia) Pty Ltd, CON-261
Product name
ALENDROBELL PLUS D3 70 mg/70 microgram alendronate (as sodium) 70 mg and colecalciferol 70 microgram tablet blister pack
Sponsor name
Dr Reddy's Laboratories (Australia) Pty Ltd
ARTG
206934
Consent start
Consent no.
CON-261
Standard
Subsection 11(b) of the Therapeutic Goods Order 78 - Standard for Tablets and Capsules (TGO 78).
Non-compliance with standard
The products do not meet the expiry assay limits of 92.5% - 107.5 % for the
stated content of colecalciferol.
Conditions imposed
The expiry colecalciferol assay limits for the products are 90.0% - 110.0%.
Therapeutic product type
Prescription medicines