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NORDIP amlodipine (as besilate) 10mg tablet blister pack, Alphapharm Pty Ltd, CON-1373
Product name
NORDIP amlodipine (as besilate) 10mg tablet blister pack
Sponsor name
Alphapharm Pty Ltd
Batches
8191926; 8192334
Consent start
Consent no.
CON-1373
Duration
The consent is effective from 30 June 2025 until 30 June 2026.
Standard
Paragraph 8(1)(o) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not conform because on one end flap under the Nordip brand
name, the strength is displayed as 5 mg instead of 10 mg.
Conditions imposed
A ‘Dear Pharmacist’ letter will be supplied with each affected batch describing
the labelling error and requesting patients also be informed to remove any
quality concerns.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines