Additional risk minimisation material for medicinal product

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 additional risk minimisation material 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 preparing additional risk minimisation materials for a medicinal product (pdf) updated 28.2.2025

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 (pdf)

EpiPen/EpiPen Jr. (adrenaline)
Autoinjector user guide_EpiPen/EpiPen Jr. published 24.4.2025 (pdf)

Gliolan (5-Aminolevulinic acid hydrochloride)
Training manual for Health Care 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)

Keytruda (pembrolitsumab)
Patient card_Keytruda published 10.1.2025 (pdf)

Lariam (mefloquine)
Patient card_Lariam published 12.7.2024 (pdf)

Lariam (mefloquine) Paranova
Patient card_Lariam 4.12.2023 (pdf)

Myozyme (alglucosidase alfa)
Safety Information Packet (SIP)_Myozyme published 27.11.2024 (pdf)

Olumiant (baricitinib)
Patient card_Olumiant 27.3.2023 (pdf)

Rinvoq (upadacitinib)
Patient card_Rinvoq 14.8.2023 (pdf)

Tysabri (natalizumab)
Patient card_Tysabri 2.9.2021 (pdf)