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CARDIZEM CD diltiazem hydrochloride 360 mg capsule bottle, Sanofi-Aventis Australia Pty Ltd, CON-871
Product name
CARDIZEM CD diltiazem hydrochloride 360 mg capsule bottle
Sponsor name
Sanofi-Aventis Australia Pty Ltd
Consent start
Consent no.
CON-871
Standard
subsection 17(2) of the Therapeutic Goods Order No. 101 - Standard for tablets, Capsules and Pills
Non-compliance with standard
The products that do not conform to the requirements of subsection 17(2) of the
Therapeutic Goods Order No. 101 - Standard for Tablets, Capsules and Pills., in
that the products do not meet the approved dissolution limits after long term
storage.
Conditions imposed
The extent of the non-compliance is only as described in the application dated 9
September 2021.
Therapeutic product type
Prescription medicines