List of selected biological medicinal products

At 4 November 2021

Please state the name and batch number of the medicinal product when you report suspected adverse reactions

Comments on the selection of the medicines on the list

We have chosen to focus on the new biological medicinal products and the medicines available as both biosimilar medicinal products and reference medicinal products.

The list is sorted in alphabetical order by active substance.

The medicinal products on the above list are also included in the list of medicines with stricter reporting requirements for doctors, dentists and midwives to report adverse reactions (list of medicines with stricter reporting requirements).

In future, we will add new biological medicinal products as they are marketed (and added to the list of medicines subject to stricter reporting requirements). When selected new biosimilar medicinal products are marketed, we will also add their reference medicinal products to the list of medicines subject to stricter reporting requirements. Moreover, we will continuously assess whether the medicinal products should remain on the list. After a period with no signals and/or only very few ADR reports compared to a certain consumption level, we will remove medicines from the list (but not until after two years after marketing).

Quality control of all reports concerning biological medicinal products, including biosimilar medicinal products, will be made on receipt. If a report concerns one of the medicinal products on the list and does not include the name and batch number of the medicinal product, we will request the information, if possible.