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Refers to information on a new or known side effect that may be caused by a drug and is typically generated from more than a single report of a suspected side effect. It’s important to note that a signal does not indicate a direct causal relationship between a side effect and a medicine, but is essentially only a hypothesis that, together with data and arguments, justifies the need for further assessment.
Signals are continuously monitored, evaluated and presented in the PSUR by pharmaceutical companies.
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