Spring Intro 2023

16/02/2023

What is the Risk Management Plan?

RMP includes information on: ● Medicine's safety profile ● How its risks will be prevented or minimised in patients ● Plans for studies and other activities to gain more knowledge about the safety and efficacy of the medicine ● Risk factors for experiencing adverse reactions ● Measuring the effectiveness on risk minimisation measures.

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RMP Structure

Including PASS

Including effectiveness of activities

Public summary

Annex 1-8

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