Supervision

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 (pdf) 15.5.2019
Patient information card_CHCs (pdf) 15.5.2019
Questions and answers on combined hormonal contraceptives_CHCs
(pdf) 15.5.2019

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 (pdf) 25.2.2019

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

Rinvoq (upadacitinib)
Patient alesrt card_Rinvoq (pdf) 17.10.2019

Tecentriq (atezolizumab)
Patient Alert Card_Tecentriq 21.4.2021 (pdf)