Lareb
Lareb is the Pharmacovigilance Centre of the Netherlands. Lareb manages the national spontaneous reporting system on behalf of the Dutch Medicine Evaluation Board CBG and forwards the reports to EudraVigilance. The Netherlands Pharmacovigilance Centre Lareb identifies risks associated with the use of medicines in daily practice and is the Knowledge centre for adverse drug reactions (ADRs).
Lareb gathers 20.000 to 25.000 reports of ADRs yearly. These reports are then further analyzed, and this leads to certain signals about adverse drug reactions. These signals are reported to and reviewed by CBG to reevaluate the drug’s further safety and efficacy. CBG will also take additional measurements if needed to maintain the risk-benefit balance.
Such measurements can include:
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Changing the leaflet of the drug
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Extra surveillance on the drug
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Direct health professional communication (DHPC) to inform health care professionals about new, important information about a drug
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Withdrawal of the drug due to safety reasons