Caplanusi, Irina http://orcid.org/0009-0006-0694-4469
Szmigiel, Agnieszka http://orcid.org/0009-0006-6049-9634
van der Elst, Menno http://orcid.org/0009-0005-6151-6419
Schougaard Christiansen, Marie Louise http://orcid.org/0009-0000-1963-0895
Thirstrup, Steffen http://orcid.org/0000-0003-0903-682X
Zaccaria, Cosimo http://orcid.org/0000-0002-1441-6061
Cappelli, Bénédicte http://orcid.org/0009-0007-5119-6508
Genov, Georgy http://orcid.org/0009-0000-5139-3981
Straus, Sabine http://orcid.org/0009-0006-9266-3312
Article History
Accepted: 4 February 2024
First Online: 23 February 2024
Declarations
:
: No funding was received to assist with the preparation of this article.
: The authors have no competing interests to declare that are relevant to the content of this article. Irina Caplanusi, Agnieszka Szmigiel, Steffen Thirstrup, Cosimo Zaccaria, Benedicte Cappelli and Georgy Genov are employees of the European Medicines Agency (EMA). Sabine Straus and Menno van der Elst are members of EMA’s Pharmacovigilance Risk Assessment Committee and employees of the Medicines Evaluation Board, the Netherlands. Marie Louise Schougaard Christiansen is member of EMA’s Pharmacovigilance Risk Assessment Committee and employee of the Danish Medicines Agency, Denmark.
: Not applicable.
: Not applicable.
: Not applicable.
: Not applicable.
: Not applicable.
: Irina Caplanusi and Agnieszka Szmigiel shared first authorship. All authors contributed towards writing the article and have read and approved the final manuscript.