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Apomorphine: CMDh Scientific conclusions and grounds for the variation, amendments to the Product In

At least eleven (11) cases of Dopamine dysregulation syndrome (DDS) were described in the PSUR, of which eight (8) were found in published literature. Other available data sources include some studies which also provide information on the topic, including apomorphine-treated patients. Additionally, a large number of publications mention DDS either generally for dopaminergic medications, or for other specific dopaminergic drugs. DDS is also mentioned in the Danish and the British clinical guidelines for management of Parkinson’s disease. Based on the available data the PRAC concluded that a warning on DDS should be included in the Summary of Product Characteristics (SmPC) of apomorphine to recommend relevant precautions. Further data is requested of the Marketing Authorisation Holders before concluding on the need to include this term in section 4.8 of the SmPC.

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