Celltrion

This sponsor has funded 6 studies across 15 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
8571 Ongoing EU RMP category 3 An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Rheumatoid Arthritis Yes Yes
9491 Ongoing EU RMP category 3 An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Ankylosing Spondylitis(AS) Yes No
9917 Ongoing EU RMP category 3 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 EU RMP category 3 Post-Marketing Surveillance of REMSIMA 100mg (Infliximab) (monoclonal antibody, gene recombination) to Evaluate Its Safety and Efficacy in Korea... Yes Yes
46141 Ongoing EU RMP category 3 Post-Marketing Surveillance of REGKIRONA ® 960mg (Regdanvimab)(monoclonal antibody, gene recombination) to Evaluate Its Safety and Efficacy (CT-P59... No No
50207 Ongoing EU RMP category 3 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.