Summary of the benefit-risk analysis and the risk management, including information regarding known or foreseeable risks, any undesirable effects, contraindications and warnings.
Achoimre ar an anailís tairbhe-riosca agus an bhainistiú riosca, lena n-áirítear faisnéis maidir le rioscaí aitheanta nó rioscaí intuartha, aon éifeachtaí neamh-inmhianaithe, fritásca agus rabhaidh.