DILTIAZEM SANDOZ CD diltiazem hydrochloride 360 mg capsule bottle (unprinted), Sanofi-Aventis Australia Pty Ltd, CON-934
Product name
DILTIAZEM SANDOZ CD diltiazem hydrochloride 360 mg capsule bottle (unprinted)
Sponsor name
Sanofi-Aventis Australia Pty Ltd
Consent start
Consent no.
CON-934
Standard
Subsection 17(2) of the Therapeutic Goods Order No. 101 - Standard for Tablets, Capsules and Pills (TGO 101)
Non-compliance with standard
The product(s) do not conform to the requirements of subsection 17(2) of the
Therapeutic Goods Order No. 101 - Standard for Tablets, Capsules and Pills (TGO
101), in that the product(s) 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 and reiterated in this application dated 6 April 2022.
Therapeutic product type
Prescription medicines