Celltrion

This sponsor has funded 6 studies across 15 countries.

PAS funded by this sponsor.
EU PAS ID Status Title Protocol uploaded Results uploaded
8571 Ongoing An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Rheumatoid Arthritis Yes Yes
9491 Ongoing An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Ankylosing Spondylitis(AS) Yes No
9917 Ongoing An observational, prospective cohort study to evaluate the safety and efficacy of Remsima in patients with Crohn's disease (CD) and Ulcerative Colitis... Yes No
10911 Finalised Post-Marketing Surveillance of REMSIMA 100mg (Infliximab) (monoclonal antibody, gene recombination) to Evaluate Its Safety and Efficacy in Korea... Yes Yes
46141 Ongoing Post-Marketing Surveillance of REGKIRONA ® 960mg (Regdanvimab)(monoclonal antibody, gene recombination) to Evaluate Its Safety and Efficacy (CT-P59... No No
50207 Ongoing An Observational, Prospective Cohort Study to Evaluate Safety of Remsima® Subcutaneous in Patients with Rheumatoid Arthritis, Ankylosing... No No

PAS by Risk Management Plan (RMP) requirement

Celltrion

The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.

Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.