Product-specific risk minimisation material

Product-specific risk minimisation material (uusi)

The risk management plans for medicinal products often include additional risk minimisation materials (educational materials, instructions for physicians and patients, patient charts, checklists etc.).

The content and dissemination of such product-specific risk management materials are agreed with the marketing authorisation holder of the medicinal product and Fimea. The marketing authorisation holder holds copyrights to the materials and is responsible for the content and dissemination of the material.

Instructions for the submission of product-specific risk minimisation material (pdf)

Combined hormonal contraceptives (CHCs)
Checklist for prescribers_CHCs 15.5.2019 (pdf)
Patient information card_CHCs 15.5.2019 (pdf)
Questions and answers on combined hormonal contraceptives_CHCs 15.5.2019

Gliolan (5-Aminolevulinic acid hydrochloride)
Training manual for health professionals_Gliolan 29.8.2022 (pdf)

Humira (adalimumab)
Patient Card for Adults_Humira 12.4.2021 (pdf)
Patient Card for Children_Humira 12.4.2021 (pdf)

Lariam (mefloquine)
Patient alert card_Lariam 25.2.2019 (pdf)

Myozyme (alglucosidase alfa)
Safety Information Packet (SIP)_Myozyme 4.3.2021 (pdf)

Olumiant (baricitinib)
Patient card_Olumiant 5.7.2022 (pdf)

Rinvoq (upadacitinib)
Patient Alert Card_Rinvoq 5.10.2021 (pdf)

Tecentriq (atezolizumab)
Patient Alert Card_Tecentriq 21.4.2021 (pdf)

Tysabri (natalizumab)
​​​​​​​Patient Alert Card_Tysabri 2.9.2021 (pdf)