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MOVAPO PFS apomorphine hydrochloride hemihydrate 50mg/10mL solution for subcutaneous infusion pre-filled syringe , Stada Pharmaceuticals Australia Pty Ltd, CON-1333
Product name
MOVAPO PFS apomorphine hydrochloride hemihydrate 50mg/10mL solution for subcutaneous infusion pre-filled syringe
Sponsor name
Stada Pharmaceuticals Australia Pty Ltd
Batches
3043560
Consent start
Consent no.
CON-1333
Duration
The consent is effective from 6 March 2025 until 31 December 2025.
Standard
Paragraphs (7)(2)(e), 8(1)(a), 9(1)(a), 8(1)(b), 9(1)(b), 8(1)(d), 9(1)(d), 8(1)(j), 8(2)(a), 9(3)(a), 10(4)(c), 10(4)(j), 11(5) and Schedule 1 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not comply as the label used is for the product in the United
Kingdom.
Conditions imposed
A 'Dear Healthcare Provider', 'Dear Patient' and 'Dear Carer' letter will be
supplied with the affected batch, describing the differences between the labels
and explaining the medicine is the same.
Particular information will over stickered on the label.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines