MOVAPO PFS apomorphine hydrochloride hemihydrate 50mg/10mL solution for subcutaneous infusion pre-filled syringe, Stada Pharmaceuticals Australia Pty Ltd, CON-1370

The product does not comply as it will be imported and supplied with the label used for the product in Ireland. The label does not comply because: • The colours of the carton label are not strongly contrasting with the background. • The name of the medicine is not as entered in the ARTG (i.e. “APO-go PFS” (the UK approved name) instead of “MOVAPO PFS”). • The name of the active ingredient is not as entered in the ARTG (i.e. “apomorphine hydrochloride” instead of “apomorphine hydrochloride hemihydrate” (AAN)). • The name of the dosage form is not as entered in the ARTG (i.e. “solution for infusion” instead of “solution for injection”). • Sodium metabisulfite is not expressed as required (i.e. states “contains: sodium metabisulfite (E223)” instead of “contains sulfites”). • There is no space (70 x 30 mm) provided on the carton for a dispensing label. • The name of the medicine and name of the active ingredient is not a cohesive unit (i.e. the name of the medicine and active ingredient is separated by the text “Solution for Infusion in Pre-filled Syringe”). • The name of the medicine is not as entered in the ARTG (i.e. “APO-go PFS” (the UK approved name) instead of “MOVAPO PFS”). • With respect to the container label: The name of the Sponsor on the container label will not appear as it is on the primary pack (the carton will be over-labelled with the Australian sponsor details). • The storage temperature condition is not expressed as permitted (i.e. the UK label states “Do not store above 25°C” whereas the regulation requires “Store below 25°C”).