PAS funded by this sponsor. EU PAS ID Status RMP requirementTitle Protocol uploaded Results uploaded 2333 Finalised Not included in RMP Diabetes, Insulin and Malignancies Study New User Protocol (DIMSum) Yes Yes 2480 Finalised Unspecified International Study of Incident Cancer- Breast Cancer (ISICA) No No 2679 Finalised EU RMP category 3 SURVEILLANCE STUDY OF PHOTOCONTACT DERMATITIS LEADING TO HOSPITALIZATION IN EUROPE WITH A SPECIAL FOCUS ON TOPICAL KETOPROFEN AND OTHER TOPICAL... Yes No 2999 Finalised Not included in RMP WP6 replication study: The risk of liver injury associated with the use of antibiotics: A study using a US database with linkage with hospital data No Yes 3025 Finalised Not included in RMP WP6 negative control study: The risk of myocardial infarction not associated with the use of antibiotics: A study using a US database Yes Yes 3105 Finalised Not included in RMP Cancer risk estimation study program in patients treated with insulin in France (GROC) Yes No 3351 Finalised Not included in RMP RELATIVE EFFECTIVENESS OF DRONEDARONE VS. OTHER TREATMENTS OF ATRIAL FIBRILLATION (EFFECT-AF) No No 4062 Finalised EU RMP category 3 Non-interventional post-authorization study on effectiveness of reversal of local anaesthesia and on the occurrence of local reactions and... No Yes 4242 Finalised EU RMP category 3 An assessment of physician knowledge and understanding of the risks of vandetanib (Caprelsa®) within the European Union Yes Yes 4836 Finalised EU RMP category 3 Prospective international observational cohort non-comparative study describing the safety and effectiveness of ZALTRAP® administered in combination... Yes Yes 5094 Finalised EU RMP category 2 International Observational, Study to Evaluate the Benefit/Risk of Vandetanib (Caprelsa™) 300 mg in RET Mutation Negative and RET Mutation Positive... Yes Yes 5365 Finalised EU RMP category 3 Drug Utilization Study of ZALTRAP® (aflibercept) Using European Databases (Zaltrap Utilization Study) Yes Yes 5602 Finalised EU RMP category 3 An International Pregnancy Exposure registry of Women With Multiple Sclerosis (MS) exposed to Teriflunomide (OBS12751) Yes Yes 7346 Ongoing EU RMP category 3 A prospective, multicenter, observational, post-authorization safety study (PASS) to evaluate the long term safety profile of LEMTRADA® (alemtuzumab)... No No 9678 Finalised EU RMP category 3 A Joint Drug Utilisation Study (DUS) of valproate and related substances, in Europe, using databases No Yes 10391 Finalised Not included in RMP FUJI study: Follow-Up of Jevtana® in real lIfe Yes Yes 10872 Finalised EU RMP category 3 Post Authorisation Safety Study (PASS): an European observational cohort of patients with type 1 diabetes treated via intraperitoneal route with... Yes No 11634 Finalised Unspecified A non-interventional, observational study in Germany to evaluate the effectiveness of reversal of local anesthesia and occurrence of adverse events in... Yes Yes 11650 Finalised Unspecified Actual conditions of use of OraVerse® in patients among resident dentists throughout Germany (OraDUS) Yes Yes 11765 Finalised EU RMP category 1 Evaluation of the Effectiveness of Risk Minimisation Measures: A Joint PASS Survey among Health Care Professionals to Assess their Knowledge and... Yes Yes 12423 Finalised EU RMP category 1 Prospective, observational cohort, evaluating the incidence of nephrotoxicity, and other adverse events of interest, in patients treated with the... Yes Yes 13205 Finalised EU RMP category 3 Incidence and pattern description of gastrointestinal, skin, genital, corneal, and mucosal erosions, ulcerations, perforations, haemorrhages,... Yes No 17065 Ongoing EU RMP category 3 Teriflunomide Pregnancy Outcome Exposure Registry: An OTIS Autoimmune Diseases in Pregnancy Project (OBS13499) No No 17314 Finalised EU RMP category 3 Monitoring the safety of alirocumab in HIV patients: A Post-Authorization Safety Study Using Healthcare Databases Yes Yes 18153 Finalised EU RMP category 3 Concomitant use of dronedarone and digoxin (or statins) and the risk of digitalis intoxication (or rhabdomyolysis and myopathy)-- a post-marketing... Yes Yes 19610 Finalised EU RMP category 3 Prospective Cohort Study of Long-Term Safety of Teriflunomide in Multiple Sclerosis Patients in Europe (OBS12573) Yes Yes 19769 Ongoing EU RMP category 3 Programme of Epidemiological Studies of Lixisenatide and other GLP-1 Receptor Agonists Yes Yes 19826 Finalised Not included in RMP Clinical experience with cabazitaxel in patients with metastatic castrate resistant prostate cancer (ECLIPSE) (ELIPSE) No Yes 21314 Finalised EU RMP category 3 A drug utilization study (DUS) of alirocumab in Europe to assess the effectiveness of the dosing recommendation to avoid very low LDL-C levels Yes Yes 23920 Finalised EU RMP category 3 SURVEY TO EVALUATE THE KNOWLEDGE AND UNDERSTANDING OF THE KEY SAFETY MESSAGES IN THE HEALTHCARE PROFESSIONAL GUIDE AND THE PATIENT GUIDE FOR SULIQUA Yes Yes 25203 Ongoing Not included in RMP Asthma and Type 2 Comorbidities - Real-life Characterisation of Patients with Active Asthma and Type 2 Asthma Comorbidities Yes No 27883 Ongoing Not included in RMP A prospective, observational, UK study to describe patient reported quality of life in relapsing remitting multiple sclerosis patients treated with... Yes No 28596 Finalised Not included in RMP A Retrospective study to analyse the treatment outcomes of patients with severe atopic dermatitis (AD) who were enrolled in the Early Access to... Yes Yes 29415 Ongoing Not included in RMP Observational Patient Evidence for Regulatory Approval and uNderstanding Disease (OPERAND) No No 31013 Finalised EU RMP category 3 Behavior and knowledge survey to assess the effectiveness of educational materials among healthcare professionals who prescribe AUBAGIO®... Yes Yes 31210 Ongoing EU RMP category 3 A Pregnancy Registry to Evaluate the Safety of Dengue Vaccine among Inadvertently Exposed Pregnant Women and their Offsprings No No 31883 Finalised EU RMP category 3 Behavior and knowledge survey to assess the effectiveness of educational materials in patients treated with AUBAGIO® (teriflunomide) (cross-sectional... Yes Yes 35468 Ongoing EU RMP category 3 Post-authorization Safety Surveillance Program for Sarilumab using existing European Rheumatoid Arthritis Registries in Germany, Spain, Sweden and... No No 35547 Finalised EU RMP category 3 Knowledge survey to assess the effectiveness of educational materials among healthcare professionals who prescribe Lemtrada® (alemtuzumab) Yes Yes 35552 Finalised EU RMP category 3 Knowledge survey to assess the effectiveness of educational materials among patients prescribed LEMTRADA® (alemtuzumab) Yes Yes 37342 Planned EU RMP category 3 POST AUTHORIZATION SAFETY STUDY OF FEXINIDAZOLE FOR HUMAN AFRICAN TRYPANOSOMIASIS : Analysis of real-life safety and effectiveness data on... No No 38093 Ongoing EU RMP category 3 The MenQuadfi™ Pregnancy Registry: A surveillance registry to assess the safety of MenQuadfi™ among exposed pregnant women and their offspring... No No 39096 Ongoing EU RMP category 3 COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER) No No 41565 Ongoing Not included in RMP Assessing Long-Term Outcomes of DUPIXENT® Treatment in Patients with Chronic Rhinosinusitis with Nasal Polyposis (AROMA) No No 41963 Ongoing Not included in RMP Registry of Asthma Patients Initiating DUPIXENT® (RAPID) No No 42461 Finalised Not included in RMP A Retrospective Evaluation of Conjunctivitis and Keratitis Among Individuals with Moderate-to-severe Atopic Dermatitis Treated with Dupilumab in the... No Yes 43819 Ongoing EU RMP category 3 Post-Authorization Safety Study to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy... No No 43837 Ongoing EU RMP category 3 Dupilumab and Pregnancy Outcomes: A Retrospective Cohort Study Using Administrative Healthcare Databases (Dupi PODS) No No 43864 Ongoing Not included in RMP Effectiveness and Safety of Enoxaparin: Higher versus Standard Dose for Thromboprophylaxis in Patients of Varying Body Mass Index – A Retrospective... No No 46988 Ongoing EU RMP category 3 Non-Interventional Post-Authorisation Safety Study (PASS) survey to evaluate the effectiveness of the Isatuximab Educational Materials, to minimise... No No 47664 Planned Not included in RMP Association between the Use of Hydrochlorothiazide and the Risk of Skin Cancers: A Population-Based Retrospective Cohort Study in Taiwan Yes No 49201 Ongoing Not included in RMP Characteristics of type 2 asthma phenotypes and oral corticosteroid (OCS) use in the International Severe Asthma Registry (ISAR) (STAR) No No 50220 Ongoing Not included in RMP A retrospective observational study on effectiveness of influenza vaccine Supemtek® compared to other vaccines in adults aged 18 years and above in... No No 50650 Ongoing Not included in RMP Determining the prevalence of severe asthma in children in UK primary care No No 50782 Ongoing EU RMP category 3 Effectiveness evaluation of the local additional risk minimisation measures for STAMARIL® in the United Kingdom: a survey for healthcare professionals... No No 103426 Ongoing Not included in RMP Closing the loop for Fabry disease and Pompe disease in the UK (RARE) No No 105374 Ongoing Not included in RMP Anti-IL-5/5R versus anti-IL4R switching strategies for uncontrolled severe asthma treated by anti-IL5/5R : A target trial emulation (RAMSES-Switch) No No 107472 Planned EU RMP category 3 A Post-Authorization Safety Study (PASS) to Assess Long-term Safety in Patients with Pompe Disease Treated with Avalglucosidase alfa in the Real-World... No No