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MYTOLAC lanreotide (as acetate) 90 mg solution for injection pre-filled syringe, Amdipharm Mercury Australia Pty Ltd, CON-1266

Product name
MYTOLAC lanreotide (as acetate) 90 mg solution for injection pre-filled syringe
Sponsor name
Amdipharm Mercury Australia Pty Ltd
ARTG details
Batches
4400167IR1
Consent start
Consent no.
CON-1266
Duration
The consent is effective from 27 August 2024 until 31 January 2026.
Standard
Paragraph 7(2)(a); paragraphs 8(3)(a)-(f); paragraph 10(5)(e); paragraph 10(5)(f); paragraph 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 (but inside a correctly labelled carton) are labelled with a German label; 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 Mytolac 90 mg); The route of administration is not included on the syringe; The active ingredient is not referred to with the AAN (Lanreotide where is should be lanreotide (as acetate)); The name of the Australian Sponsor is not clearly included on the pouch.
Conditions imposed
The sponsor will provide a ‘Dear Healthcare Provider’ letter (identical to that provided to the TGA on August) with each affected batch describing the use of the German labels on the pouch and syringe label, and asking the Healthcare Provider to refer patients to the Australian Product Information (PI) which will be included in the carton. The sponsor will repackage each pouch with syringe into the Australian registered outer carton and include the Australian Product Information with each unit from batch 4400167IR1.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines