Updated list of biological medicinal products

04 February 2016

The Danish Medicines Agency has added five new medicinal products to the list of biological and biosimilar medicinal products.

Stricter reporting requirements apply to the 17 specific biological and biosimilar medicinal products appearing from this list. When reporting adverse reactions from these medicinal products, you should state the brand name and batch number.

The list reflects our special focus on the new biological medicinal products and biosimilar medicinal products with reference medicinal products. Biological medicinal products exclusively used for cancer diagnoses are not included in the list.

We will update the list continuously as new biological and biosimilar medicinal products are marketed. Moreover, we will also assess whether the medicinal products should remain on the list.

Link

Reporting suspected adverse reactions from biological medicinal products

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