PAS funded by this sponsor. EU PAS ID Status RMP requirementTitle Protocol uploaded Results uploaded 2113 Finalised Unspecified Avian/Pandemic Influenza Registry (AVEX Registry) Yes No 2165 Finalised EU RMP category 1 Post-Authorisation Safety Study of Esbriet® (Pirfenidone): A Prospective Observational Registry to Evaluate Long-Term Safety in Real-World Setting... Yes Yes 2353 Finalised Not included in RMP The risk of acute liver injury associated with the use of antibiotics. A methodological comparison across epidemiological data sources Yes No 2356 Finalised Not included in RMP Use of antiepileptics and risk of suicidality. An exploratory study using the UK General Practice Research Database (GPRD) and data from the Danish... Yes Yes 2382 Finalised Not included in RMP Use of antidepressants and risk of hip/femur fracture. A methodological comparison across data sources and epidemiological design Yes No 2385 Ongoing Unspecified Use of benzodiazepines and risk of hip/femur fracture. A methodological comparison across data sources and epidemiological design. Yes No 2388 Ongoing Unspecified Calcium channel blocker treatments and cancer risk. A methodological protocol to compare the results between databases, across designs: Evaluation of... Yes No 2561 Ongoing Unspecified Use of inhaled long acting beta2 adrenoceptor agonists and the risk for Acute Myocardial Infarction (AMI). A methodological comparison across data... Yes No 3125 Finalised EU RMP category 3 ZeSS: A Prospective Observational Safety Study of Patients with BRAFV600 Mutation-positive Unresectable or Metastatic Melanoma Treated with... No Yes 4683 Finalised Non-EU RMP-only Post Marketing Surveillance Study for Mircera No No 6725 Finalised EU RMP category 1 A Post Approval Safety Study (PASS): Global Observational Cohort Study on the Prediction of Unwanted Adverse Effects in Individuals Infected with... No Yes 9834 Ongoing Not included in RMP Multinational, multicentre, non-interventional study, in patients with rheumatoid arthritis (RA) treated with tocilizumab (ACT-UP) Yes No 9914 Finalised EU RMP category 3 An Observational Study of Cardiac Events in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin® (OHERA) No No 10089 Finalised Not included in RMP Non-Interventional Study To Investigate The Effectiveness, Safety And Utilization Of Vismodegib On Locally Advanced Basal Cell Carcinoma Under Real... No No 10344 Ongoing Unspecified AN OBSERVATIONAL STUDY OF AVASTIN® (BEVACIZUMAB) IN COMBINATION WITH CHEMOTHERAPY FOR TREATMENT OF FIRST LINE METASTATIC COLORECTAL ADENOCARCINOMA... No No 10394 Finalised Not included in RMP AN OBSERVATIONAL STUDY OF AVASTIN® (BEVACIZUMAB) AS FIRST LINE THERAPY IN PATIENTS WITH ADVANCED OVARIAN CANCER (OSCAR 1) No No 10547 Ongoing EU RMP category 1 OBSERVATIONAL SAFETY AND EFFECTIVENESS STUDY OF PATIENTS WITH POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS TREATED WITH TOCILIZUMAB Yes No 11788 Ongoing Unspecified A Prospective Observational Registry to describe the disease course and outcomes of Idiopathic Pulmonary Fibrosis patients in a real-world clinical... No No 11957 Finalised EU RMP category 3 Mabthera Drug Utilisation Study and Patient Alert Card Evaluation in Non-Oncology Patients in Europe: An infusion Centre Based Approach (Mabthera DUS) Yes Yes 12456 Finalised Not included in RMP A 2-Year Observational Study to Describe the Characteristics and Progression of Patients Suffering from Idiopathic Pulmonary Fibrosis Treated with... Yes Yes 12875 Finalised EU RMP category 3 Assessing the safety of oseltamivir exposure in pregnant women No Yes 13849 Finalised Not included in RMP Belova: A non-interventional study to collect data on the safety and efficacy of frontline bevacizumab treatment in Figo Stage IV Ovarian Cancer... Yes Yes 16133 Finalised EU RMP category 3 Risk of Cardiovascular Events in Patients Using Tocilizumab as Compared With Other Biologics in Multiple Large Healthcare Databases (EUPAS16133) No No 16143 Finalised EU RMP category 3 Incidence of Gastrointestinal Perforation in Users of ACTEMRA® (Tocilizumab), Abatacept and Anti-Tumor Necrosis Factor Alpha Agents No No 16359 Finalised EU RMP category 3 LONG-TERM SURVEILLANCE STUDY OF RITUXIMAB (MABTHERA)-TREATED PATIENTS WITH GRANULOMATOSIS WITH POLYANGIITIS (GPA) OR MICROSCOPIC POLYANGIITIS (MPA)... Yes Yes 16482 Finalised Not included in RMP Incidence of Interstitial Lung Disease (ILD) in Users of ACTEMRA® (Tocilizumab), Rituxan® (Rituximab), Abatacept and Anti-Tumor Necrosis Factor Alpha... No No 16960 Finalised Not included in RMP Incidence of Gastrointestinal Perforation in Users of ACTEMRA® (Tocilizumab), Rituxan® (Rituximab), Abatacept and Anti-Tumor Necrosis Factor Alpha... No No 17462 Finalised Not included in RMP OUTCOMES OF THE SPANISH COHORT OF EARLY ACCESS TO PERTUZUMAB AND TRASTUZUMAB EMTANSINE (KNOWHER STUDY) Yes No 18539 Finalised EU RMP category 3 A NON-INTERVENTIONAL STUDY TO INVESTIGATE THE EFFECTIVENESS, SAFETY AND UTILIZATION OF COBIMETINIB AND VEMURAFENIB IN PATIENTS WITH AND WITHOUT BRAIN... Yes Yes 18844 Finalised EU RMP category 3 Rates for Anaphylaxis for Patients with Rheumatoid Arthritis Treated with Tocilizumab or Other Biologics: An Analysis Based on Health Claims Data No No 19948 Finalised Not included in RMP COMPARATIVE SAFETY OF TOCILIZUMAB VERSUS OTHER BIOLOGIC DMARDS IN PATIENTS WITH RHEUMATOID ARTHRITIS: A LARGE MULTI-DATABASE COHORT STUDY Yes Yes 20684 Finalised EU RMP category 3 AN OBSERVATIONAL STUDY OF CARDIAC EVENTS IN PATIENTS WITH HER2- POSITIVE METASTATIC BREAST CANCER WHO HAVE A LEFT VENTRICULAR EJECTION FRACTION (LVEF)... Yes Yes 20994 Finalised Not included in RMP Characterising Patient Pathways to the Diagnosis of Idiopathic Pulmonary Fibrosis: Real World Data Study Yes No 21160 Finalised Not included in RMP Risk of squamous cell carcinoma in patients treated for basal cell carcinoma with Vismodegib or other therapies No Yes 21920 Finalised EU RMP category 3 Survey to Evaluate the Effectiveness of Risk Minimisation Measures for Atezolizumab Use in the European Union Yes Yes 22002 Finalised Not included in RMP Global Evaluation of the Interstitial Lung Disease Diagnostic Pathway (Global ILD-MDT study) Yes No 22426 Ongoing Not included in RMP A EUROPEAN DISEASE REGISTRY STUDY TO PROSPECTIVELY OBSERVE TREATMENT PATTERNS AND OUTCOMES IN PATIENTS WITH HER2-POSITIVE UNRESECTABLE LOCALLY... Yes No 22951 Ongoing Not included in RMP Safety and Effectiveness of Ocrelizumab under Real World Conditions: a Non-Interventional Post Authorization Safety Study in Patients Diagnosed with... Yes No 23079 Ongoing Not included in RMP A DISEASE REGISTRY STUDY TO PROSPECTIVELY OBSERVE TREATMENT PATTERNS AND OUTCOMES IN PATIENTS WITH HER2-POSITIVE UNRESECTABLE LOCALLY ADVANCED OR... Yes No 23177 Ongoing EU RMP category 3 Surveillance Of Emicizumab-Treated Patients: An Analysis of the EUHASS Pharmacovigilance Registry (Emicizumab Pharmacovigilance: EUHASS registry) Yes No 23334 Ongoing Not included in RMP UK – A DISEASE REGISTRY STUDY TO PROSPECTIVELY OBSERVE TREATMENT PATTERNS AND OUTCOMES IN PATIENTS WITH HER2-POSITIVE UNRESECTABLE LOCALLY ADVANCED OR... Yes No 23708 Finalised EU RMP category 3 A SECONDARY DATA USE STUDY OF LONG TERM SAFETY OF TOCILIZUMAB BASED ON ANTI RHEUMATIC THERAPY IN SWEDEN (ARTIS) PATIENT REGISTRY Yes Yes 24812 Finalised Not included in RMP A PROSPECTIVE, NON-INTERVENTIONAL STUDY ASSESSING THE DIAGNOSTIC, THERAPEUTIC PROCEEDINGS AND SAFETY OF ANTI-HER2 TREATMENT IN ELDERLY PATIENTS (≥70... Yes Yes 25626 Ongoing Not included in RMP Long-term non-interventional monitoring of patients newly diagnosed with bronchogenic carcinoma (LUCAS) No No 28490 Finalised Not included in RMP Real World Evidence of Safety and Dosing of Mircera in Children with Chronic Kidney Disease Yes Yes 28619 Ongoing EU RMP category 3 Long-Term Surveillance of Ocrelizumab Treated Patients With Multiple Sclerosis (MANUSCRIPT Study) Yes No 29244 Finalised EU RMP category 3 Alecensa Survey to Prescribers: Effectiveness Measure to Investigate the Correct Implementation of Alecensa Label Guidance by Prescribers Yes Yes 30451 Finalised EU RMP category 3 Hemlibra Survey to Prescribers and Patients/Carers to Evaluate Awareness, Knowledge and Compliance to Additional Risk Minimization Measures Yes Yes 30752 Ongoing Not included in RMP An Observational Study of Ocrelizumab Treated Patients with Multiple Sclerosis to Determine the Incidence and Mortality Rates of Breast Cancer and All... Yes No 31342 Ongoing Not included in RMP Ocrelizumab Pregnancy Registry Yes No 31954 Ongoing EU RMP category 3 Emicizumab Use in Pediatric Patients in the Real World: an Analysis of the PedNet Registry Yes No 33879 Planned EU RMP category 3 Multisource Surveillance Study of Pregnancy and Infant Outcomes in Ocrelizumab-Exposed Women With Multiple Sclerosis (MELODIC Study) Yes No 42517 Ongoing EU RMP category 3 COVID-19 International Drug Pregnancy Registry (COVID-PR) No No 43694 Ongoing Not included in RMP A secondary data use study of pregnancy and infant outcomes following administration of casirivimab + imdevimab (Ronapreve, REGEN-COV) during... No No 47679 Ongoing EU RMP category 3 Risdiplam Single-Arm Pregnancy Safety Study Yes No 47916 Ongoing Not included in RMP A Prospective, Observational, Post-Authorisation Efficacy Study to Assess Long-term Effectiveness of Risdiplam in Patients with Genetically Confirmed... Yes No 47980 Ongoing EU RMP category 3 Satralizumab Single-Arm Pregnancy Safety Study: A Global, Observational, Single-Arm, 10-Year Study of Pregnancy and Infant Outcomes in... Yes No 107730 Ongoing EU RMP category 3 Incidence of Retinal Vasculitis With or Without Retinal Vascular Occlusion Among Eyes Treated With Approved Anti-Vascular Endothelial Growth Factor... No No