The List of Selected Biological Medicinal Products

The following list of selected biological medicinal products is continuously updated by the Danish Medicines Agency, and all new biological medicinal products are added to the list as they enter the market.

Focus on Reports of Suspected Side Effects

Since the Danish Medicines Agency monitors side effects of all approved and marketed medicines in Denmark, our monitoring of selected biological medicinal products aims to increase the likelihood of detecting any batch-related side effect issues.

All reports of suspected side effects related to medicines on this list should, as far as possible, include information about the medicine’s product name and batch number. The requirements for the contents of a side effect report are outlined in § 7 of the Executive Order on Reporting of Adverse Reactions to Medicinal Products etc. (No. 1823 of December 15, 2015).

All reports concerning biological medicinal products, including biosimilar products, are quality-assured upon receipt. If a report concerning a medicine on this list lacks the product name and batch number, the Danish Medicines Agency will, where possible, obtain this information.

All medicines on this list also appear on the list of medicines with stricter reporting obligations. This means that doctors, dentists, and midwives are required to report all suspected side effects of the given medicine.

Continuous Evaluation of the List

The Danish Medicines Agency regularly assesses whether medicines should remain on the list. If no safety signals are observed or very few side effect reports are received over time, despite a certain usage level, medicines are removed from the list (though not earlier than two years after the first marketing date).

Older biological medicinal products may also be added to the list if it is deemed necessary to collect more data in order to assess patient safety.

Stay Updated on Revisions

You can stay updated on revisions to the list of selected biological medicinal products. On the homepage of lmst.dk, under ‘News’, you can subscribe to the category “Notifications about medicines to healthcare professionals”.

List of Selected Biological Medicinal Products

Below is the list of selected biological medicinal products – sorted alphabetically by active substance. The list was last updated 12 July 2024.

Reminder: Healthcare professionals are required to record the medicine product name and batch number when reporting suspected side effects related to medicines on this list.