MYTOLAC lanreotide (as acetate) 120 mg solution for injection pre-filled syringe, Amdipharm Mercury Australia Pty Ltd, CON-1304
Product name
MYTOLAC lanreotide (as acetate) 120 mg solution for injection pre-filled syringe
Sponsor name
Amdipharm Mercury Australia Pty Ltd
Consent start
Consent no.
CON-1304
Duration
The consent is effective from 20 December 2024 until 31 March 2026.
Standard
• Paragraph 7(2)(a) – The information required by this Order to be included on the label or labels must be in English
• Section 8(3) - If the information required on the label on the container is obscured by intermediate packaging, then the label on the intermediate packaging must include:
o (a) the name of the medicine; and
o (b) the name(s) of all active ingredients in the medicine; and
o (c) the quantity or proportion of all active ingredients in the medicine; and
o (d) the batch number of the medicine preceded by the batch number prefix; and
o (e) the expiry date of the medicine preceded by the expiry date prefix; and
o (f) the name of the sponsor or distributor, or a registered trademark if it readily identifies the sponsor or distributor of the medicine.
• With respect to Section 10(5) Injections in a container with a capacity of 3.0 millilitres or less:
• Paragraph 10(5)(e) - the batch number of the medicine preceded by the batch number prefix; and
• Paragraph 10(5)(f) the expiry date of the medicine preceded by the expiry date prefix; and
• Paragraph 10(5)(g) the approved route of administration for the medicine, such as ‘intravenous’, ‘intramuscular’ or ‘subcutaneous’ or other phrase, word or abbreviation denoting the approved route(s) of administration.
of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
• Section 8(3) - If the information required on the label on the container is obscured by intermediate packaging, then the label on the intermediate packaging must include:
o (a) the name of the medicine; and
o (b) the name(s) of all active ingredients in the medicine; and
o (c) the quantity or proportion of all active ingredients in the medicine; and
o (d) the batch number of the medicine preceded by the batch number prefix; and
o (e) the expiry date of the medicine preceded by the expiry date prefix; and
o (f) the name of the sponsor or distributor, or a registered trademark if it readily identifies the sponsor or distributor of the medicine.
• With respect to Section 10(5) Injections in a container with a capacity of 3.0 millilitres or less:
• Paragraph 10(5)(e) - the batch number of the medicine preceded by the batch number prefix; and
• Paragraph 10(5)(f) the expiry date of the medicine preceded by the expiry date prefix; and
• Paragraph 10(5)(g) the approved route of administration for the medicine, such as ‘intravenous’, ‘intramuscular’ or ‘subcutaneous’ or other phrase, word or abbreviation denoting the approved route(s) of administration.
of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
• The syringe label and the intermediate pouch around the syringe (but inside a
correctly labelled carton) which be labelled with a Spanish label. • The
information is not all in English; and • the incorrect batch number and expiry
date prefixes are used: and • the name of the medicine is not identical to the
Australian name (Mytolac in Australia versus Myrelez 120mg); and • the route of
administration is not included on the syringe in English, • the active
ingredient is not referred to with the AAN (Lanreotida where is should be
lanreotide (as acetate)); and • The name of the Australian Sponsor is not
clearly included on the pouch.
Conditions imposed
1. A ‘Dear Healthcare Provider’ letter identical to that provided to the TGA
on 6 December 2024 (e006128 (0017-) - Cover letter Mytolac 120- S14-14a
(#14)) will be supplied with each affected batch describing the use of the
German labels on the pouch and syringe label, and asking HCP to refer
patients to the Australian PI which will be included in the carton.
2. You will repackage each pouch with syringe into the Australian registered
outer carton and include the Australian Product Information with each unit
from batch 4400992IR1.
Therapeutic product type
Prescription medicines