Summaries of Risk Management Plans
The Agency for Medicinal Products and Medical devices (HALMED) is publishing on its webpages Summaries of Risk Management Plans
The summary of risk management plan is information on risks of use of an individual medicinal product written in a simple and comprehensible manner and proved and verified from the relevant competent authority. The summary of risk management plan is intended to healthcare professionals and patients or their carers who want relevant and evidenced based information on the most important risks associated with use of a certain medicine.
Summaries of available RMPs of authorised medicines are accessible here.
More information on summaries of risk management plans is accessible on the HALMED webpages, in the Pharmacovigilance/Information for marketing authorisation holders/Question and answers on summaries of RMPs section.