Union Chimique Belge (UCB)

This sponsor has funded 18 studies across 20 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
3357 Planned Unspecified Retrospective Cohort Study of Certolizumab Pegol (Cimzia®) and Other Subcutaneous Anti-Tumour Necrosis Factor-Alpha Drugs in Rheumatoid Arthritis to... No No
4714 Finalised Not included in RMP An Open-Label Study to Investigate the Safety and Efficacy of Rotigotine Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With... No Yes
5507 Finalised Not included in RMP A multicenter postmarketing study to evaluate the placental transfer of certolizumab pegol in pregnant women receiving treatment with Cimzia®... No Yes
6785 Finalised Not included in RMP A multicenter, postmarketing study to evaluate the concentration of certolizumab pegol in the breast milk of mothers receiving treatment with Cimzia®... No Yes
11321 Finalised Not included in RMP An observational follow-up study of women who become pregnant while participating in a certolizumab pegol (CZP) clinical study or whose pregnancies... No Yes
14867 Finalised EU RMP category 3 Healthcare Professional and Patient Surveys to Evaluate the Effectiveness of the Risk Minimisation Educational Materials for Certolizumab Pegol (CZP;... Yes Yes
15024 Finalised EU RMP category 3 XYREM EU-RMP: Effectiveness Assessment Protocol of Educational Materials Yes Yes
23356 Ongoing Not included in RMP Multinational Observational Database Study on Imminent Osteoporotic Fracture Risk: Stage 1 (IFRISK) No No
26595 Finalised Not included in RMP Comparing the incidence of acute renal failure in patients with epilepsy exposed to levetiracetam versus other antiepileptic drugs Yes Yes
29415 Ongoing Not included in RMP Observational Patient Evidence for Regulatory Approval and uNderstanding Disease (OPERAND) No No
32246 Finalised Not included in RMP A MULTICENTER, OBSERVATIONAL POST-MARKET CLINICAL FOLLOW-UP STUDY IN PATIENTS WITH RA, PsA, OR axSpA ASSESSING THE PATIENT EXPERIENCE WITH THE CIMZIA... No Yes
32597 Finalised Not included in RMP EVALUATING THE OCCURRENCE OF ADVERSE EVENTS AMONG PEDIATRIC PATIENTS EXPOSED TO INTRAVENOUS LACOSAMIDE (VIMPAT®) USING REAL WORLD DATA Yes Yes
35881 Ongoing EU RMP category 3 European non-interventional post-authorization safety study related to serious cardiovascular events of myocardial infarction and stroke, and... Yes No
35956 Ongoing EU RMP category 3 EUROPEAN NON-INTERVENTIONAL POST-AUTHORIZATION SAFETY STUDY RELATED TO ADHERENCE TO THE RISK MINIMIZATION MEASURES FOR ROMOSOZUMAB BY THE EU-ADR... Yes No
36005 Ongoing EU RMP category 3 EUROPEAN NON-INTERVENTIONAL POST AUTHORIZATION SAFETY STUDY RELATED TO SERIOUS INFECTIONS FOR ROMOSOZUMAB BY THE EU ADR ALLIANCE Yes No
36734 Ongoing Not included in RMP VALIDATION STUDY PROTOCOL (OP0007) FOR THE EUROPEAN NON-INTERVENTIONAL POST- AUTHORIZATION SAFETY STUDY RELATED TO SERIOUS CARDIOVASCULAR EVENTS OF... Yes No
41206 Ongoing Not included in RMP A 12-MONTH NONINTERVENTIONAL OBSERVATIONAL MULTINATIONAL STUDY TO EVALUATE EFFECTIVENESS, TOLERABILITY, AND QUALITY OF LIFE OF BRIVARACETAM ADJUNCTIVE... No No
48741 Ongoing EU RMP category 3 A European Study of the Effectiveness of Risk Minimisation Measures for Fenfluramine in Dravet Syndrome (TAPESTRY eRMM) No No

PAS by Risk Management Plan (RMP) requirement

Union Chimique Belge (UCB)

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.