VASOCARDOL CD diltiazem hydrochloride 360 mg capsule bottle, Sanofi-Aventis Australia Pty Ltd, CON-934
Product name
VASOCARDOL CD diltiazem hydrochloride 360 mg capsule bottle
Sponsor name
Sanofi-Aventis Australia Pty Ltd
Consent start
Consent no.
CON-934
Duration
The consent is effective from 27 April 2021 until 31 July 2022.
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.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines