Remsima

Remsima, a drug containing infliximab used to treat conditions like rheumatoid arthritis, Crohn's disease, and psoriasis, is being recalled across the European Union due to a newly identified contraindication. This means the drug has been found to be unsafe for certain patients who were previously thought to be able to use it. The recall affects all patients in the EU who are currently taking or may have been prescribed this medication.

Product
Active substances: infliximab. Therapeutic area: Arthritis, Psoriatic;Spondylitis, Ankylosing;Colitis, Ulcerative;Psoriasis;Crohn Disease;Arthritis, Rheumatoid. ATC code: L04AB02
Reason
New contraindication
Classification
Class II
Category
drug recall
Country
European Union
Agency
EMA-DHPC
Recall date
2025-12-08
Status
Ongoing
Distribution
European Union

Official recall notice from EMA-DHPC

Recall details on Nibble Recalls: https://trynibble.app/recalls/086e7437-4ffb-49ad-a04f-79e477249db2