List of selected biological medicinal products

Updated 14 October 2019

At 14 October 2019

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

Productname

Active substance

Date of marketing

Amgevita

Adalimumab

19-11-2018

Humira

Adalimumab

13-10-2003

Hyrimos

Adalimumab

19-11-2018

Imraldi

Adalimumab

05-11-2018

Tecentriq

Atezolizumab

06-11-2017

Fasenra

Benralizumab

12-03-2018

Darzalex

Daratumumab

01-08-2016

Dupixent

Dupilumab

18-12-2017

Tremfya

Guselkumab

15-01-2018

Zessly

Infliximab

11-03-2019

Remicade

Infliximab

20-09-1999

Besponsa

Inotuzumab ozagimicin

28-08-2017

Refixia

Nonacog betapegol

18-12-2017

Spinraza

Nusinersen

03-07-2017

Ocrevus

Ocrelizumab

29-01-2018

Pelgraz

Pegfilgrastim

03-12-2018

Neulasta

Pegfilgrastim

14-04-2003

Mabthera

Rituximab

16-11-1998

Ritemvia

Rituximab

18-12-2017

Rixathon

rituximab

08-10-2018

Adynovi 

Rurioctocog alfa pegol

26-02-2018

Ontruzant

Trastuzumab

30-07-2018

Herceptin

Trastuzumab

25-12-2000


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. Vaccines are not included.

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.

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