PAS funded by this sponsor. EU PAS ID Status RMP requirementTitle Protocol uploaded Results uploaded 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 3674 Finalised EU RMP category 2 NON-INTERVENTIONAL POST-AUTHORIZATION SAFETY STUDY TO DESCRIBE USE BY INDICATION AND CLINICAL OUTCOMES AMONG PATIENTS WITH COMPLICATED INTRA-ABDOMINAL... Yes Yes 3788 Finalised Not included in RMP EUropean REgistry in Children below six years of age treated with BeneFIX (EUREKIX) Yes Yes 4027 Finalised EU RMP category 2 A THAOS Sub-Study Evaluating the Effects of Tafamidis on Disease Progression in Patients with non-V30M Mutations and Symptomatic Neuropathy Yes Yes 4721 Ongoing Non-EU RMP-only A MULTICENTER, MULTICOUNTRY, POSTMARKETING ACTIVE SURVEILLANCE TALIGLUCERASE ALFA REGISTRY IN PATIENTS WITH GAUCHER DISEASE No No 5177 Finalised Not included in RMP POST-APPROVAL SAFETY STUDY (PASS) OF THE UTILIZATION PATTERN OF APIXABAN IN SWEDEN Yes Yes 5184 Finalised Not included in RMP POST-APPROVAL SAFETY STUDY (PASS) OF THE UTILIZATION PATTERN OF APIXABAN IN THE NETHERLANDS Yes Yes 5235 Planned Unspecified A POST AUTHORIZATION SAFETY SURVEILLANCE REGISTRY IN PREVIOUSLY UNTREATED PATIENTS WITH SEVERE HEMOPHILIA A IN USUAL CARE SETTINGS No No 5269 Finalised EU RMP category 3 Evaluation of the Potential Association Between Voriconazole Use and Squamous Cell Carcinoma (SCC) of Skin Among Patients With Lung or Lung/Heart... Yes Yes 5275 Finalised Not included in RMP Comparison of care use between cohorts differentiated by the patients adherence to statins in France between 2005 and 2008 (C2STAT) No No 5312 Finalised Not included in RMP Observational study of the persistence antiglaucoma eyedrops to No No 5395 Finalised EU RMP category 3 Cohort Study of Venous Thromboembolism and Other Clinical Endpoints among Osteoporotic Women Prescribed Bazedoxifene, Bisphosphonates or Raloxifene in... Yes Yes 5461 Finalised Not included in RMP A Non-Interventional Study of Bosutinib in Patients With Previously Treated Chronic Phase Chronic Myelogenous Leukemia (CML) Yes Yes 5703 Ongoing Non-EU RMP-only Tofacitinib Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project (OTIS PASS Tofacitinib) Yes No 5708 Finalised EU RMP category 3 An Observational, Post-Authorization Safety Study (PASS) within the Consortium of Rheumatology Researchers of North America (CORRONA) Registry... Yes Yes 5890 Finalised EU RMP category 3 A Post authorization safety surveillance registry with BeneFIX in hemophilia B patients in usual care settings Yes No 5937 Finalised EU RMP category 3 A non-interventional, open observational non-inferiority study in two cluster-assigned cohorts of children aged 14 months into the safety of... Yes Yes 7196 Ongoing Not included in RMP Juvenile arthritis Methotrexate/Biologics long-term Observation (JuMBO) No No 7389 Finalised EU RMP category 3 A cross-sectional study to evaluate the effectiveness of XALKORI Therapeutic Management Guide among physician prescribing XALKORI in Europe Yes Yes 7393 Finalised EU RMP category 3 A cross-sectional study to evaluate the effectiveness of XALKORI Patient Information Brochure among non-small cell lung cancer (NSCLC) patients... Yes Yes 7607 Ongoing Unspecified Spanish Registry of Systemic Treatments in Psoriasis (Biobadaderm) Yes No 8097 Finalised EU RMP category 3 A multinational active safety surveillance study of crizotinib in Europe and the United States Yes Yes 8231 Ongoing Not included in RMP Observational study – Evaluation of the efficacy and safety of Bosulif® under real-life conditions of use (BosEval) No No 8241 Finalised EU RMP category 3 A population-based cohort study using an existing database to evaluate the association between latanoprost use and primary malignant ocular melanoma... Yes Yes 8352 Finalised Non-EU RMP-only Safety and Effectiveness of Piperacillin/Tazobactam (Zosyn®) in the Treatment of Pediatric Hospital Acquired Pneumonia (HAP): A Retrospective Cohort... Yes Yes 8611 Planned Unspecified A retrospective nationwide register study to characterize and compare non-valvular atrial fibrillation (NVAF) patients in Norway treated with novel... Yes No 8748 Finalised Not included in RMP Smoking cessation by combined medication and counseling in lung cancer patients – effectiveness in a high prevalence real life setting Yes Yes 9449 Finalised EU RMP category 3 The acute effects of azithromycin use on cardiovascular mortality, as compared with amoxicillin Yes Yes 10428 Finalised EU RMP category 3 Evaluation of the effectiveness of additional risk minimisation measures (aRMMs) that aim to reduce the risks of phototoxicity, squamous cell... Yes Yes 10443 Finalised EU RMP category 3 Evaluation of the effectiveness of Eliquis® (apixaban) risk minimization tools in European No No 10541 Ongoing EU RMP category 3 The Mycophenolate Pregnancy Registry Yes No 11313 Finalised Not included in RMP Comparative risk of major bleeding with new oral anticoagulants (NOACs) and Phenprocoumon in patients with atrial fibrillation: a retrospective claims... Yes No 11599 Finalised EU RMP category 3 Post-Authorization Safety Study (PASS) of conjugated estrogens/bazedoxifene (CE/BZA) in the United States Yes Yes 11604 Finalised EU RMP category 3 Drug Utilisation Study of conjugated oestrogens/bazedoxifene (CE/BZA) in the European Union (EU) Yes Yes 12624 Finalised EU RMP category 3 An Active Safety Surveillance Program To Monitor Selected Events In Patients With Long-Term Voriconazole Use Yes Yes 12963 Finalised EU RMP category 3 A descriptive study of potential sight threatening event and severe visual loss following exposure to XALKORI (crizotinib) Yes Yes 13180 Finalised Not included in RMP Apixaban drug utilization study in Stroke prevention in atrial fibrillation (SPAF) Yes Yes 13431 Finalised Non-EU RMP-only An Observational Study of Xeljanz® (tofacitinib citrate) and Biologic Rheumatoid Arthritis Treatments to Characterize their General Treatment... Yes Yes 13470 Finalised Not included in RMP Beyond Pooled – Part of the BEYOND study program (Benefit of NOACs study of non-valvular AF patients in nordic countries) (BEYOND Pooled (Denmark,... Yes Yes 13869 Finalised Not included in RMP Retrospective Assessment of Treatment Patterns and Outcomes Associated with Palbociclib in Combination With Letrozole in Postmenopausal Women With... Yes Yes 13908 Finalised Not included in RMP ADVANCE POC Study Protocol - Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case. Coverage rates of acellular and... Yes Yes 14052 Ongoing Not included in RMP A multinational, multi-centre, prospective, non-interventional, post-authorisation safety study in healthy donors (HDs) exposed to Nivestim... Yes No 14665 Finalised Not included in RMP A Retrospective Cohort Study of the Risk of Severe Hepatoxicity in Hospitalized patients Treated with Echinocandins Yes Yes 14786 Finalised Not included in RMP Post-Authorisation Safety Study (PASS) of the Utilisation Patterns of Apixaban in Denmark Yes Yes 15449 Finalised Not included in RMP Post-Authorization Safety Study (PASS): Investigating the occurrence of major bleedings in real life, in patients with atrial fibrillation (AF)... Yes Yes 15478 Finalised Not included in RMP Real World Evaluation of Venous Thromboembolism (VTE): Analysis of Electronic Health Record Data No Yes 15951 Finalised Not included in RMP Prospective Observational Study of Mobile App-Based Patient-Reported Outcomes in Advanced Breast Cancer (MADELINE) Yes Yes 16706 Finalised Not included in RMP Understanding Early and Ongoing Treatment Utilization of Palbociclib in a US Community Oncology Setting Yes Yes 16710 Finalised Not included in RMP Descriptive Analyses of Clinical Characteristics and Treatment Patterns of Breast Cancer Patients Initiating Palbociclib (Ibrance®) Treatment in the... Yes Yes 17206 Finalised EU RMP category 3 The Acute Effects of Azithromycin Use on Cardiovascular Mortality, as Compared with Amoxicillin-Clavulanate in Veterans Yes Yes 17684 Planned Not included in RMP Oral Anticoagulant Use in Patients with Non Valvular Atrial Fibrillation: Analysis of Electronic Medical Record Data No No 18323 Finalised Not included in RMP Comparative risk of major bleeding with new oral anticoagulants (NOACs) and Phenprocoumon in patients with atrial fibrillation – effectiveness... Yes Yes 18431 Finalised Not included in RMP An evaluation of non-melanoma skin cancer and melanoma skin cancer rates among patients treated for moderately to severely active rheumatoid arthritis... Yes Yes 18435 Finalised Not included in RMP An evaluation of early use patterns to assess the effectiveness of Xeljanz® (tofacitinib citrate) in rheumatoid arthritis: A retrospective... Yes Yes 18970 Finalised Not included in RMP Real-world Comparisons of Stroke, Major Bleeding, Myocardial Infarction, Acute Limb Ischemia and Death among Non-Valvular Atrial Fibrillation Patients... Yes Yes 20081 Finalised Not included in RMP An observational cohort study to evaluate the risk of adverse pregnancy outcomes in patients treated with etanercept compared to those not treated... Yes Yes 21045 Ongoing Not included in RMP Treatment patterns and clinical effectiveness outcomes of palbociclib in combination with aromatase inhibitor (AI) or fulvestrant in hormone receptor... Yes No 21413 Finalised Not included in RMP Canadian Non-Interventional Study of Xeljanz in Rheumatoid Arthritis (CANTORAL) Yes Yes 21948 Finalised Not included in RMP Safety of Palbociclib Among Breast Cancer Patients in the United States Yes Yes 21984 Finalised EU RMP category 3 Pregnancy and birth outcome assessment in a population-based cohort after exposure to Trumenba Yes Yes 22289 Finalised Not included in RMP Post-Marketing Observational Cohort Study of Patients with Inflammatory Bowel Disease (IBD) Treated with CT-P13 in Usual Clinical Practice... Yes Yes 22444 Finalised Not included in RMP Observational, real-world study of INFLECTRA in patients with inflammatory bowel disease (IBD) in the United States and Canada (ONWARD) Yes Yes 23012 Ongoing Not included in RMP Observational multicentric national longitudinal study evaluating Ibrance (palbociclib) in a real life setting conditions in patients 70 years old and... No No 23056 Finalised EU RMP category 2 A Non-Interventional Post-Authorisation Safety Study (PASS) of Inotuzumab Ozogamicin to Characterize Complications Post-Hematopoietic Stem Cell... Yes Yes 23344 Finalised Non-EU RMP-only Malignancy and Cardiovascular Risk Assessment Using the Consortium of Rheumatology Researchers of North America Registry (Corrona) as an External... Yes Yes 23428 Planned Not included in RMP Real life effect of an epoietin alpha biosimilar Retacrit® on response to chemotherapy-induced anemia and fatigue at 16 weeks in elderly patients... Yes No 23593 Finalised Not included in RMP Prospective Observational Study of Mobile App-Based Patient-Reported Outcomes in Advanced Breast Cancer in Asia (MADELINE ASIA) Yes No 24422 Planned Not included in RMP Thromboembolic and Bleeding Risks of Apixaban, Rivaroxaban and Dabigatran versus Warfarin in Patients with Non-Valvular Atrial Fibrillation No No 24718 Finalised Not included in RMP Observatory of ATTR amyloidosis and of patients treated with Vyndaqel® (tafamidis) OBSAMYL study Yes Yes 24790 Finalised Not included in RMP An Evaluation of the Misuse and Abuse of Pregabalin using RADARS® System Programs in the United States and the European Union Yes Yes 24902 Finalised Not included in RMP Comparative Clinical and Economic Outcomes among Venous Thromboembolism Patients who Initiated Apixaban or Warfarin in the United States Medicare... Yes Yes 25230 Finalised Not included in RMP Clinical and Economic Outcomes and Treatment Patterns for Non-Valvular Atrial Fibrillation Patients Who Newly Initiated Oral Anticoagulants in the US... Yes Yes 25238 Finalised Not included in RMP Hospital Readmissions Among Nonvalvular Atrial Fibrillation Patients Treated with Oral Anticoagulants in the U.S. Yes Yes 25305 Finalised Not included in RMP Real-world Evidence of Prolonged Apixaban Treatment of Unprovoked Venous Thromboembolism Yes Yes 25308 Finalised Not included in RMP Evaluation of Anticoagulants among Venous Thromboembolism Patients with Active Cancer: Pooled Analysis from Claims Databases Yes Yes 25626 Ongoing Not included in RMP Long-term non-interventional monitoring of patients newly diagnosed with bronchogenic carcinoma (LUCAS) No No 25655 Finalised Not included in RMP An Analysis of Real-World Data on the Safety of Etanercept in Elderly Patients with Rheumatoid Arthritis Yes Yes 26550 Ongoing Not included in RMP OZAVIE : Prospective observational study in patients treated with Zavicefta® (ceftazidime/avibactam) under real conditions of use No No 27339 Finalised EU RMP category 3 A Population-based Cohort Study of Pregabalin to Characterize Pregnancy Outcomes Yes Yes 27343 Finalised EU RMP category 3 Effectiveness of the Additional Risk Minimization Measures in Conveying Safety Information to HCPs Dispensing, Administering or Prescribing... Yes Yes 27346 Finalised Not included in RMP Survey of pharmacists to evaluate the effectiveness of the Viagra Connect national additional Risk Minimisation Measure (aRMM) in the United Kingdom... Yes Yes 29415 Ongoing Not included in RMP Observational Patient Evidence for Regulatory Approval and uNderstanding Disease (OPERAND) No No 29910 Ongoing Not included in RMP Venous Thromboembolism Treatment (VOLT) No No 29963 Finalised Not included in RMP Outcomes among venous thromboembolism patients who were admitted into the emergency department and treated with apixaban or warfarin in the U.S. (VTE... Yes Yes 30314 Ongoing EU RMP category 3 A Long-Term, Observational Study within the Corrona Inflammatory Bowel Disease (IBD) Registry to Characterize the Safety of Tofacitinib in Patients... Yes No 30448 Finalised Not included in RMP Predictors of Treatment and the Comparative Clinical and Economic Outcomes among Non-Valvular Atrial Fibrillation Patients Treated versus Untreated... Yes Yes 30455 Finalised EU RMP category 3 A population based cohort study to monitor the safety and effectiveness of sirolimus in patients with sporadic lymphangioleiomyomatosis (S-LAM) Yes Yes 30803 Ongoing Not included in RMP A national, multi-centre, longitudinal observational study evaluating the efficacy and safety under real-life conditions of use of TALZENNA®... No No 31126 Ongoing EU RMP category 3 An active surveillance, post-authorization safety study (PASS) of serious infection, malignancy, cardiovascular and other safety events of interest... Yes No 31129 Ongoing EU RMP category 3 An active surveillance, post-authorization safety study of serious infection, malignancy, cardiovascular and other safety events of interest among... Yes No 31157 Ongoing EU RMP category 3 An Active Surveillance, Post Authorization Safety Study (PASS) of Serious Infection, Malignancy, Cardiovascular (CV) and Other Safety Events of... Yes No 31164 Ongoing Non-EU RMP-only An Active Surveillance, Post Authorization Safety Study (PASS) of Serious Infection, Malignancy, Cardiovascular (CV) and Other Safety Events of... Yes No 31718 Ongoing EU RMP category 3 Post-authorization safety study to assess the risk of diabetic ketoacidosis among type 2 diabetes mellitus patients treated with ertugliflozin... Yes No 32365 Finalised Not included in RMP Evaluation of the Safety and Effectiveness of Anticoagulants Among Sub-Groups of Venous Thromboembolism Patients (VTE Subgroups) Yes Yes 32829 Planned Not included in RMP Non-interventional, real-world study of patients with early stage, human epidermal growth factor receptor 2 (HER2) positive breast cancer (BC)... Yes No 34260 Ongoing Not included in RMP Outcome of progression free survival in patients with advanced or metastatic, hormone receptor positive, HER2-negative breast cancer treated with... No No 35384 Finalised Not included in RMP A Descriptive Retrospective Database Study to Evaluate Serious Clinical Manifestations and Outcomes among SARS-CoV-2 Diagnosed Patients with RA, PsA... Yes Yes 35782 Finalised Not included in RMP Big data analysis on treatment patterns and safety events in patients identified as rheumatoid arthritis according to International Statistical... Yes Yes 35867 Planned Not included in RMP An Evaluation of the Misuse and Abuse of Pregabalin using RADARS® System Programs in the United States and the European Union – 2019 Yes No 35888 Ongoing Not included in RMP Anticoagulant treatment patterns and outcomes among venous thrombosis patients in France: a retrospective cohort analysis using SNDS database No No 36041 Ongoing EU RMP category 3 An Active Surveillance, Post-Authorization Study to Assess Tofacitinib Utilization Patterns and to Characterize the Safety of Tofacitinib Use in... Yes No 36240 Ongoing Not included in RMP Registry to study factors that may impact COVID-19 occurrence and severity (CARE) No No 36330 Finalised Not included in RMP AF In Real practice on Management of oral Anticoagulation (AFIRMA 4.0) Yes Yes 37119 Ongoing Non-EU RMP-only Tafamidis Pregnancy Surveillance Study No No 37385 Finalised Not included in RMP Real-World Observational Study of Outcomes for Acute Myeloid Leukemia (AML) Patients Treated With Glasdegib or Venetoclax in US Community Oncology... Yes Yes 37475 Planned Not included in RMP A Non-Interventional Post-Authorisation Safety Study to Characterize Toxicity following Gemtuzumab Ozogamicin Treatment and Hematopoietic Stem Cell... No No 37495 Finalised Not included in RMP A non comparative , multi centre observational study: Isavuconazole (Cresemba) in Invasive Mould Infections (Invasive Aspergillosis, Invasive... Yes Yes 37688 Ongoing Not included in RMP An Active Surveillance, Post Authorization Safety Study (PASS) to Estimate Incidence Rates of Serious Infection, Malignancy, Cardiovascular (CV) and... Yes No 37691 Ongoing Not included in RMP An Active Surveillance, Post Authorization Safety Study (PASS) to Estimate Incidence Rates of Serious Infection, Malignancy, Cardiovascular (CV ) and... Yes No 37694 Ongoing Not included in RMP An Active Surveillance, Post Authorization Safety Study (PASS) to Estimate Incidence Rates of Serious Infection, Malignancy, Cardiovascular (CV ) and... Yes No 38305 Finalised Not included in RMP A descriptive study examining abortion-related complications following reported off-label use of misoprostol (alone or in combination with diclofenac)... Yes Yes 38515 Finalised Not included in RMP Real world evidence of the usage of tofacitinib in Ulcerative Colitis patients in Lebanon Yes Yes 38620 Finalised EU RMP category 3 A Population-based Study of the Safety of Gabapentin Use During Pregnancy Yes Yes 38671 Finalised Not included in RMP HERO-Together: A post-Emergency Use Authorization observational cohort study to evaluate the safety of the Pfizer-BioNTech COVID-19 vaccine in US... Yes Yes 39242 Finalised Not included in RMP A Retrospective Database Study to Evaluate Rates of Influenza and Related Diagnoses between Patients Treated with Tofacitinib and Other Systemic... Yes Yes 39635 Finalised Not included in RMP Real-world evaluation of effectiveness, persistence and usage patterns of tofacitinib in treatment of psoriatic arthritis in Australia. Yes Yes 39779 Ongoing EU RMP category 3 Post-Emergency Use Authorization Active Safety Surveillance Study among Individuals in the Veteran’s Affairs Health System Receiving Pfizer BioNTech... Yes Yes 40131 Ongoing EU RMP category 3 An Active Surveillance, Post-Authorisation Study to Characterize the Safety of Tofacitinib in Patients with Moderately to Severely Active Ulcerative... Yes No 40263 Ongoing Not included in RMP NON-INTERVENTIONAL STUDY TO REVIEW THE CHANGES OF DEPRESSION AFTER FIRST-YEAR OF TOFACITINIB TREATMENT IN RHEUMATOID ARTHRITIS (XELJANZ® ) Yes No 41054 Ongoing Not included in RMP REal Life Safety and effectiveness of tofAcitinib in comparison to TNF InhibitOrs using the French National Healthcare Database (RELATION) Yes No 41302 Ongoing EU RMP category 3 A Non-Interventional Post-Authorization Safety Study (PASS) for Active Safety Surveillance of Recipients of the Pfizer-BioNTech COVID-19 mRNA vaccine... Yes No 41439 Ongoing Not included in RMP A Longitudinal, Retrospective, Multi-centre Observational Study to Evaluate Effectiveness, Persistence, Treatment Patterns and Safety of Australian... Yes No 41623 Ongoing EU RMP category 3 Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19)... Yes No 41803 Ongoing Not included in RMP Real-World Treatment Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor as First Line Therapy in Post-Menopausal Women and Men... No Yes 42367 Finalised Non-EU RMP-only A Retrospective Chart-Review Study to Evaluate the Safety, Effectiveness and Dosing of Dalteparin for Treatment of Venous Thromboembolism (VTE) in... Yes Yes 42869 Ongoing EU RMP category 3 Pfizer-BioNTech COVID-19 Vaccine Exposure during Pregnancy: A Non-Interventional Post-Approval Safety Study of Pregnancy and Infant Outcomes in the... Yes No 43143 Finalised EU RMP category 3 Evaluation of the effectiveness of additional risk minimisation measures (aRMM) materials for Xeljanz® (tofacitinib) in Europe via a survey of... Yes Yes 43468 Ongoing EU RMP category 3 A Non-Interventional Post-Approval Safety Study of Pfizer-BioNTech COVID-19 Vaccine in the United States Yes No 43681 Finalised Not included in RMP Major bleeding in patients with atrial fibrillation treated with apixaban versus warfarin in combination with amiodarone: the APIXAMIO study Yes Yes 43715 Ongoing Not included in RMP Pfizer Registry of Outcomes in Growth hormone RESearch (PROGRES): A multi country, non-interventional prospective cohort study among patients with... No No 44543 Ongoing Not included in RMP ARIA: Real-world utilization and outcomes with dacomitinib first-line treatment for EGFR mutation-positive advanced non-small cell lung cancer among... No No 44551 Ongoing Not included in RMP Retrospective observational study of the conditions of use, safety and efficacy of MYLOTARG® (Gemtuzumab Ozogamicin, GO) in the treatment of patients... No No 44985 Finalised Not included in RMP 12- and 18-Month Outcomes and Long- Term Survival of Tofacitinib in Ulcerative Colitis Yes Yes 45035 Finalised Not included in RMP Comparative Effectiveness of Tofacitinib Versus Ustekinumab and Vedolizumab among Ulcerative Colitis Patients With Prior Anti- Tumor Necrosis Factor... Yes Yes 45389 Planned Not included in RMP A Real-World Study Evaluating the Safety of Pantoprazole Sodium IV in Infants Aged 1 Month to Yes No 45602 Ongoing Not included in RMP A Comparative Observational Study Evaluating the Incidence Rate of Endometrial Cancer in Women aged 50 Years and Over Who Use Low dose Vaginal... Yes No 46286 Finalised Not included in RMP Retrospective Post-Marketing Safety Surveillance Study of Tofacitinib in Psoriatic Arthritis (PsA) and Rheumatoid Arthritis (RA) Yes Yes 46910 Ongoing EU RMP category 3 A Post-Authorisation Safety Study of the Utilisation and Prescribing Patterns of Xeljanz® (tofacitinib) in the European Union Using Secondary Data... Yes No 47708 Planned EU RMP category 3 Post-Authorisation Active Surveillance Study of Myocarditis and Pericarditis Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus... Yes No 48566 Ongoing Not included in RMP An Immuno-Dermatological disease registry to understand the burden of Atopic dermatitis (AD), Alopecia areata (AA), and Vitiligo in Indian Patients Yes No 48654 Ongoing Not included in RMP A standing cohort to understand the characteristics of patients with COVID-19 and contextualize the COVID-19 complication and safety events of... Yes No 48683 Planned Not included in RMP World Federation of Hemophilia Gene Therapy Registry (WFH GTR) No No 48735 Planned Not included in RMP A Real-World Observational Study of Zavicefta® (CAZ-AVI) to Describe the Effectiveness, Safety and Treatment Patterns Among Patients Infected with... No Yes 48998 Planned EU RMP category 3 Observational Study of Effectiveness and Safety of Recombinant Zoster Vaccine (Shingrix)® in Moderately-to-Severely Active Ulcerative Colitis (UC) or... No No 49268 Planned Not included in RMP GO-First: Real-world treatment patterns and effectiveness outcomes associated with gemtuzumab ozogamicin in first-line Acute Myeloid Leukaemia Yes No 49290 Planned Not included in RMP Safety evaluation of biosimilar trastuzumab in breast cancer: Experience of Colombian institutions Yes No 50117 Planned EU RMP category 3 Use and Safety of Paxlovid During Pregnancy Yes No 50123 Planned EU RMP category 3 Use and Safety of Paxlovid Among Patients with Moderate or Severe Hepatic or Renal Impairment Yes No 50473 Planned Not included in RMP CIBINQO™ Pregnancy Registry: An Observational Study of the Safety of Abrocitinib Exposure in Pregnant Women and Their Offspring Yes No 103409 Planned Not included in RMP A Multicenter, Retrospective, Observational Study Using Real-world Data to Describe the Safety, Treatment Pattern and Effectiveness of... Yes No 103443 Ongoing Not included in RMP Risk of Safety Events Among Patients with UC and PsA Treated with Tofacitinib and Other Advanced Treatments in the United States Yes No 103517 Ongoing Not included in RMP Viral SARS-CoV-2 rebounds in commercial pharmacy-based SARS-CoV-2 PCR testing Yes No 103626 Planned Not included in RMP An Active Safety Surveillance Study to Estimate Incidence Rates of Safety Events of Interest among Patients Treated with Tofacitinib for Polyarticular... Yes No 103632 Planned EU RMP category 3 An Active Surveillance, Post-Authorization Study to Characterize the Safety of Tofacitinib in Patients With Moderately to Severely Active Ulcerative... Yes No 103727 Planned Not included in RMP A multicenter evaluation of the treatment persistence of advanced therapies (Biological disease-modifying agents and Targeted synthetic Disease... Yes No 103990 Planned EU RMP category 3 Post-authorisation Safety Study of Rimegepant in Patients with Migraine and History of Cardiovascular Disease in European Countries Yes No 104403 Planned Not included in RMP Assessment of risk factors for Myocarditis in the United States (US) using Electronic Health Records and Claims data Yes No 105791 Ongoing Not included in RMP HERO-Together Boost: A post-Emergency Use Authorization observational cohort study to evaluate the safety of the Pfizer-BioNTech COVID-19 vaccine Yes No 105913 Planned Not included in RMP Impact of tafamidis in Colombian patients diagnosed with ATTR-CA in quality of life during two year of follow up No No 106321 Planned Not included in RMP Pregnancy and Infant Outcomes Following Exposure to PAXLOVID: A Post-Authorization Safety Study Yes No 106401 Planned Not included in RMP An International, Multicenter, Non-interventional Post-Authorization Safety Study to Evaluate the Effectiveness and Safety of Elranatamab in... No No 106719 Planned Not included in RMP An International, Multicenter, Prospective Non-Interventional Study of Real-World Treatment Outcomes in Patients with Metastatic Castrate Resistant... No No 107192 Planned EU RMP category 3 Post-Authorisation Active Safety Surveillance Program Among Patients Treated With Tofacitinib for Polyarticular Juvenile Idiopathic Arthritis (pJIA)... Yes No 107199 Planned EU RMP category 3 Post-AuthorisationActive Safety Surveillance Program Among Patients Treated With Tofacitinib for Polyarticular Juvenile Idiopathic Arthritis (pJIA)... Yes No 107203 Planned EU RMP category 3 Post-Authorisation Active Safety Surveillance Program Among Patients Treated WithTofacitinib for Polyarticular Juvenile Idiopathic Arthritis (pJIA)... Yes No 107217 Planned EU RMP category 3 An Active Surveillance Study to Monitor the Real-World Long-term Safety of Somatrogon Among Paediatric Patients in Europe No No 107604 Planned Not included in RMP Uveitis in chronic inflammatory conditions and ulcerative colitis-related pyoderma gangrenosum and axial spondylarthritis: an observational study of... Yes No 108135 Planned Not included in RMP Post-Approval Observational Cohort Study to Evaluate the Safety of the COMIRNATY 2023-2024 Formula in the United States Yes No 108141 Ongoing Not included in RMP A network meta-analysis of real-world studies comparing tofacitinib with other advanced therapies in the treatment of moderate-to-severe ulcerative... Yes No 108468 Finalised Not included in RMP A pan-European registry-based observational study of abrocitinib and conventional systemic therapies in moderate and severe atopic dermatitis (Dream... No No 108847 Planned EU RMP category 3 Post-Authorisation Safety Study of Comirnaty Original/Omicron BA.1 and Comirnaty Original/Omicron BA.4-5 in Europe No No