Risk Management Plan Arzneimittel

10 1 10 3 applications renewal application if it is intended to submit an rmp type ii variations changes related to the initial submission or update of the rmp.

Risk management plan arzneimittel. When pregnancy is diagnosed treatment with aiiras should be stopped immediately and if appropriate alternative therapy should be started. The rmp details important risks of ultomiris how these risks can be minimised and how more information will be obtained about the risks. Summary of the risk management plan summary of risk management plan for soliris eculizumab this is a summary of the risk management plan rmp for soliris. The rmp is a document which is shown the consistent risk management of drug from the.

A risk management plan rmp is a document that describes the current knowledge about the safety and efficacy of a medicinal product. The rmp provides key information on plans for studies and other activities to gain more knowledge about the safety and efficacy of the medicine. Summary of risk management plan rmp in order to ensure the safety of drugs it is important to assess measures for appropriate management of the risks of drugs at any time from the development phase to the regulatory review and the post marketing phase. Summary of the risk management plan summary of risk management plan for ultomiris ravulizumab this is a summary of the risk management plan rmp for ultomiris.

The risk management plans rmps are comprehensive documents submitted as part of the application dossiers for market approval of medicinal products. Risk management plans rmp marketing authorization applications e g.