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Hydromorphone: CMDh Scientific conclusions and grounds for variation, amendments to the product info

Taking into account the PRAC Assessment Report on the PSUR(s) for hydromorphone, the scientific conclusions are as follows: There were cumulatively 27 reports, describing 11 cases (during the reporting period there were 8 reports, describing 5 cases) of neonatal withdrawal syndrome reported with hydromorphone, while the use of hydromorphone is either not recommended or contra-indicated during pregnancy.


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