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MYTOLAC lanreotide (as acetate) 120 mg solution for injection pre-filled syringe, Amdipharm Mercury Australia Pty Ltd, CON-1387

Product name
MYTOLAC lanreotide (as acetate) 120 mg solution for injection pre-filled syringe
Sponsor name
Amdipharm Mercury Australia Pty Ltd
ARTG details
Batches
4400703IR1; 4400991IR1 and 4401159IR1
Consent start
Consent no.
CON-1387
Duration
The consent is effective from 14 July 2025 until 31 July 2026.
Standard
Paragraphs 7(2)(a), 8(3)(a), 8(3)(b), 8(3)(c), 8(3)(d), 8(3)(e), 8(3)(f), 10(5)(e), 10(5)(f) and 10(5)(g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not conform because: • The syringe label and the intermediate pouch around the syringe is labelled with a Spanish label (but packaged within a correctly labelled carton). • The information is not all in English. • The incorrect batch number and expiry date prefixes are used. • The name of the medicine is not identical to the Australian name (Mytolac in Australia versus Myrelez 120mg). • The route of administration is not included on the syringe in English. • The active ingredient is not referred to with the Australian Approved Name (Lanreotida where is should be lanreotide (as acetate)). • The name of the Australian Sponsor is not clearly included on the pouch.
Conditions imposed
1. A ‘Dear Healthcare Provider’ letter will be supplied with each affected batch describing the use of the Spanish labels on the pouch and syringe label, and asking the Healthcare Provider to refer patients to the Australian PI which will be included in the carton. 2. The sponsor will repackage each pouch with syringe into the Australian registered outer carton and include the Australian Product Information with each unit from batches 4400703IR1, 4400991IR1 and 4401159IR1. 3. The sponsor will prioritise the release of Australian labelled stock when it becomes available.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines