PAS funded by this sponsor. EU PAS ID Status RMP requirementTitle Protocol uploaded Results uploaded 1999 Finalised EU RMP category 3 Nexplanon Observational Risk Assessment Study (NORA) Yes Yes 2196 Finalised EU RMP category 1 Prospective controlled cohort study on the safety of a monophasic oral contraceptive containing nomegestrol acetate (2.5mg) and 17ß-estradiol (1.5mg)... Yes Yes 2768 Finalised EU RMP category 3 Drug Utilization of Boceprevir and Clinical Management of Health Outcomes of Interest in Chronic Hepatitis C Patients (P08518) Yes Yes 3136 Finalised EU RMP category 3 An Observational Post-Authorisation Safety Specialist Cohort Monitoring Study (SCEM) to Monitor the Safety and Utilisation of Asenapine (Sycrest) in... Yes No 3603 Finalised EU RMP category 3 An Observational Post-Authorization Modified Prescription-Event Monitoring Safety Study To Monitor The Safety And Utilization Of Asenapine (Sycrest)... Yes No 3669 Planned Unspecified Practicalities of Using Boceprevir and Early Responses to Treatment: Experience of the First Eighteen Months In the UK. The Boceprevir Real LIfe... Yes No 4468 Ongoing Not included in RMP A Five-year, Observational, Non-interventional Follow-up to: A Phase III, Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to... No No 5533 Finalised EU RMP category 3 Utilization of Ribavirin in Pediatric Patients with Hepatitis C Virus - Aggregated Experience of European Specialists (MK-8908-060) No No 5547 Finalised Not included in RMP An observational follow-up study for: a phase III randomized, placebo-controlled clinical trial to assess the safety and efficacy of odanacatib... No Yes 6019 Finalised Not included in RMP An observational study to assess persistence on treatment, adherence, and patient-reported outcomes during the treatment of chronic hepatitis C... No Yes 6140 Finalised Not included in RMP Patients’, physicians', nurses’ and pharmacists’ preferences toward the attributes of biological agents used in the treatment of rheumatic diseases in... No Yes 6410 Ongoing Unspecified A description of the management of invasive fungal infections with oral posaconazole maintenance treatment following intravenous antifungal regimens... No No 6413 Ongoing Unspecified A description of the UK NHS hospital resource use and patient quality of life associated with hospitalisations for recurrent Clostridium difficile... No No 6435 Finalised Not included in RMP Study of Current Standard of Care in the U.S.: Incidence \nof postoperative events and associated costs among non\x02cardiac surgery patients exposed... No No 7134 Finalised EU RMP category 3 A non-interventional, population-based register study on the prescription of etoricoxib (Arcoxia®) to dental surgery patients in the Nordic countries... Yes Yes 7379 Planned Unspecified Current raltegravir use: clinical practice in UK centres (CRICKET) No No 7527 Finalised Not included in RMP A study assessing the use of GOlimumab in current clinical PRACTICE and its impact on patients with chronic inflammatory arthritis (MK-8259-020)... No Yes 7534 Finalised Not included in RMP A non-interventional, multicentre, prospective study to estimate the incidence of invasive fungal infections and to monitor the diagnostic and... No Yes 7607 Ongoing Unspecified Spanish Registry of Systemic Treatments in Psoriasis (Biobadaderm) Yes No 7622 Finalised EU RMP category 3 An Observational Post-Authorization Safety Study of Temodar® (Temozolomide) and Severe Acute Liver Injury in the HealthCore Integrated Research... No No 8342 Finalised Non-EU RMP-only A Study of the Effectiveness and Safety of a New Formulation of RotaTeq™ in Routine Use in a Developing World Setting Yes Yes 8426 Finalised Not included in RMP Achieving Minimal Disease Activity and Predictors of clinical response in Patients with Psoriatic Arthritis treated with Golimumab in clinical... No Yes 8658 Finalised Not included in RMP Risk of lactic acidosis with metformin use in type 2 diabetes mellitus with renal impairment: retrospective cohort study No No 8737 Finalised Not included in RMP Post-marketing Observational Study to Characterize the Safety and Effectiveness Profile of Orgalutran® in Chinese Women Undergoing Controlled Ovarian... No Yes 11131 Finalised Not included in RMP A Post-Marketing Observational Study of Implanon® Radiopaque among Chinese Women Aged 18 and Older Requesting Contraception (MK-8415-038) No Yes 11484 Finalised EU RMP category 3 A Non-interventional Observational Longitudinal Post-Authorization Safety Study (PASS) of SIMPONI® in Treatment of Ulcerative Colitis using Nordic... Yes Yes 12848 Ongoing Unspecified Observational, Cross-sectional Multicenter Study to Characterize and to Determine the Proportion of Ambulatory Type 2 Diabetes Mellitus Patients with... No No 13151 Finalised Not included in RMP Post-licensure Observational Safety Study of Gardasil 9 (V503-028) 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 15038 Finalised EU RMP category 3 Association between use of desloratadine and risk of seizures, supraventricular tachycardia, and atrial fibrillation or flutter: A Nordic... Yes Yes 15752 Finalised EU RMP category 3 A Post-Authorization Safety Study of Golimumab in Ulcerative Colitis Using the Spanish ENEIDA Registry Yes Yes 16520 Ongoing EU RMP category 1 Prospective and retrospective, single-cohort, multicenter observational long-term study in short children born small for gestational age (SGA) after... Yes No 17502 Finalised EU RMP category 3 Post-Licensure Observational Study of the Long-term Effectiveness of ZOSTAVAX(TM) (V211-024) Yes Yes 17505 Finalised EU RMP category 3 GARDASIL(TM) Vaccine Impact in Population (VIP) Study (V501-033) No No 17526 Finalised EU RMP category 3 Etoricoxib Prescribing Patterns and Adverse Events of Interest during Etoricoxib Treatment in UK Primary Care (MK-0663-162) Yes Yes 17620 Finalised EU RMP category 3 Finasteride and male breast cancer – a register-based nested case-control study in Denmark, Finland, Norway, and Sweden (MK-0906-162) Yes Yes 17631 Finalised EU RMP category 3 An Observational Post-Authorization Safety Surveillance (PASS) Study of SYCREST® (asenapine) among Patients aged 18 and older Diagnosed with Bipolar... Yes Yes 17675 Finalised EU RMP category 3 Post-Licensure Observational Study of the Safety of GARDASIL(TM) in Males (V501-070) Yes Yes 17681 Finalised EU RMP category 3 An Observational Drug Utilization Study of SYCREST® (asenapine) in the United Kingdom (P08308) Yes Yes 17730 Finalised EU RMP category 3 A Post-licensure Surveillance Program for the Safety of GARDASIL™ in a Managed Care Organization Setting (V501-031) No No 17909 Finalised EU RMP category 3 The Risk of Esophageal Cancer in Relation to the Treatment and Prevention of Osteoporosis in Women (MK-0217A-352) Yes Yes 17912 Finalised EU RMP category 3 Observational Safety Data Analysis from Routine Follow-up in the EuroSIDA Study of Patients Treated with Raltegravir in a Five-Year Post Authorization... No No 17981 Finalised Not included in RMP Post-Licensure Safety Study of ISENTRESS™ in a US Managed Care Network No No 19013 Planned Not included in RMP A mixed methods observational study to evaluate the implementation of a smartphone software application (App) and computerised decision-support system... No No 19094 Finalised EU RMP category 3 A Nested Case-control Post-authorization Safety Study of Etoricoxib and Other Non-steroidal Anti-inflammatory Therapies in a Cohort of Patients with... Yes Yes 19202 Finalised EU RMP category 3 Safety Data on Etoricoxib From Swedish Registries of Spondyloarthropathy/Ankylosing Spondylitis Patients (MK-0663-159; EP07013.013.11.082) Yes No 19686 Finalised Not included in RMP Consequences for life of children with in utero exposure to metformin in Finland (CLUE) – a register-based cohort study Yes Yes 20781 Ongoing EU RMP category 3 An observational post-approval safety study of golimumab in treatment of polyarticular Juvenile Idiopathic Arthritis (pJIA) using the German Biologics... Yes No 21870 Finalised Not included in RMP Malignancies in Multiple Sclerosis: multi-country cohort database studies (feasibility study) (MALBEC-f) No No 23451 Ongoing Not included in RMP Multi-centre study of the in vitro activity of ceftolozane/tazobactam and other commonly used antibiotics against Pseudomonas aeruginosa isolates from... Yes No 24076 Finalised Non-EU RMP-only Evaluate the Knowledge and Understanding of Anesthesiologists Use of BRIDION® solution for injection, 100 mg/mL sugammadex (as sugammadex sodium) in... No No 24403 Ongoing Not included in RMP Analysis of the Burden of Cytomegalovirus Infection and Disease in Hematopoietic Stem Cell Transplant Recipients Yes No 24484 Ongoing EU RMP category 3 Long term, prospective, observational cohort study evaluating the safety profile in patients with highly active relapsing multiple sclerosis (RMS)... Yes No 24833 Finalised Not included in RMP Optimal dementia risk prediction models and validation for young individuals No Yes 25027 Ongoing EU RMP category 3 Pregnancy outcomes in women exposed to oral cladribine: a multi-country cohort database study (CLEAR) No No 25338 Ongoing EU RMP category 3 Non-interventional cohort registry study to assess characteristics and management of patients with Merkel Cell Carcinoma in Germany (MCC-TRIM) No No 25626 Ongoing Not included in RMP Long-term non-interventional monitoring of patients newly diagnosed with bronchogenic carcinoma (LUCAS) No No 25783 Planned Not included in RMP Long-term effectiveness of cladribine in patients previously treated with oral cladribine: a Real-World Evidence analysis using data from the Italian... Yes No 26467 Planned Not included in RMP A Retrospective Evaluation of PD-L1 expression on primary non-small cell lung cancer samples and associated involved hilar or mediastinal lymph nodes... Yes No 26535 Finalised Not included in RMP Malignancies in Multiple Sclerosis: Multi-country cohort database studies – French Study (MALBEC) Yes No 27673 Finalised Not included in RMP Healthcare utilisation by patients with chronic cough No Yes 28953 Finalised Not included in RMP SGLT2 Inhibitors and the Risk of Hospitalization for Fournier’s Gangrene: a Nested Case-control Study (MK-8835-067) No No 29415 Ongoing Not included in RMP Observational Patient Evidence for Regulatory Approval and uNderstanding Disease (OPERAND) No No 29952 Finalised Not included in RMP Post Marketing Active Surveillance to Evaluate the Safety and Efficacy of Aprepitant (EMEND®) for the Prevention of Chemotherapy-Induced Nausea and... No No 30148 Ongoing Not included in RMP Real World Utilisation of Raltegravir Once Daily 1200mg (RETRO Study) Yes No 30702 Finalised Not included in RMP Spatio-temporal impact of Rotavirus vaccine coverage on Rotavirus Hospitalizations in the Valencia Region, Spain Yes Yes 30769 Ongoing Not included in RMP HPV vaccines effectiveness to prevent genital warts in Valencia Region, Spain Yes No 30772 Ongoing Not included in RMP Impact of Rotavirus Vaccination on Acute Gastroenteritis outpatient and emergency department visits using “Real World Data” from the Valencia Region,... Yes No 30818 Finalised EU RMP category 3 A study to evaluate the risk of de novo hepatocellular carcinoma in patients with compensated cirrhosis treated with direct-acting antivirals for... Yes Yes 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 33807 Ongoing Not included in RMP A post-licensure prospective observational registry study in real-world Taiwanese cancer patients with microsatellite instability-high (MSI-H) or... Yes No 34319 Ongoing Non-EU RMP-only Non-interventional post-marketing safety study (PMSS) to collect information on hepatic function disorders among Japanese patients with radically... Yes No 35812 Finalised Not included in RMP Post-marketing surveillance to monitor the incidence of intussusception after large-scale vaccination with Reassortant Rotavirus Vaccine, Live, Oral,... Yes Yes 35911 Finalised Not included in RMP Association between use of desloratadine and risk of seizures, supraventricular tachycardia, and atrial fibrillation or flutter: A Nordic... Yes Yes 36132 Finalised Not included in RMP Post-Marketing surveillance for the safety of GARDASIL® and GARDASIL®9 in a cohort of Chinese women Yes Yes 36135 Finalised Not included in RMP Post-Marketing surveillance for HPV infection related serious disease in a cohort of Chinese women who received GARDASIL® and GARDASIL®9 Yes Yes 36666 Ongoing Not included in RMP Post-marketing study to assess serotype-specific effectiveness of Reassortant Rotavirus Vaccine, Live, Oral, Pentavalent (Vero Cell) (ROTATEQ®) in... Yes No 38736 Planned EU RMP category 3 INFORM - Interferon-Beta Exposure in the 2nd and 3rd Trimester of Pregnancy - a Register-Based Drug Utilisation Study in Finland and Sweden Yes No 39007 Finalised Non-EU RMP-only A national, multicenter, prospective, single-arm registry PASS of pulmonary hypertension patients treated with Riociguat (Adempas®) in China... Yes Yes 41175 Planned Not included in RMP A non-interventional register-based comparative effectiveness study of rhFSH-alfa reference product vs. highly purified human menopausal gonadotropin... Yes No 41295 Finalised Non-EU RMP-only A Post-marketing Database Surveillance to Investigate the Risk of Hepatic Events in Hypercholesterolemic Patients Treated with ATOZET or Ezetimibe... Yes Yes 41341 Finalised Non-EU RMP-only A Post-marketing Database Surveillance to Investigate the Risk of Rhabdomyolysis and Myopathy in Hypercholesterolemic Patients Treated with ATOZET or... Yes Yes 41414 Finalised Non-EU RMP-only A Post-marketing Database Surveillance to Investigate the Risk of Hyperglycemia and Diabetes Mellitus in Hypercholesterolemic Patients Treated with... Yes Yes 41657 Finalised Not included in RMP Direct-acting antivirals (DAAs) for the treatment of chronic hepatitis C virus (HCV) infection and the risk of hepatocellular carcinoma (HCC)... Yes Yes 42202 Planned Not included in RMP A Multicenter, Prospective, Observational Study Investigating Clinical Outcomes Associated with Antimicrobial Therapy among Chinese Patients with... No No 42517 Ongoing EU RMP category 3 COVID-19 International Drug Pregnancy Registry (COVID-PR) No No 43893 Ongoing Not included in RMP An observational, multicenter, prospective, phase IV study evaluating cladribine tablets’ effects on PROs and their correlation with clinical and... No No 44059 Ongoing Not included in RMP OPTIMISE:MS A Prospective, Real World Pharmacovigilance Study in Multiple Sclerosis Yes No 47602 Planned Not included in RMP Disease Registry on Patients with Advanced NSCLC Harboring METex14 Skipping Alterations (MOMENT) No No 48452 Ongoing Not included in RMP Population-based retrospective nested case-control study evaluating effectiveness of GARDASIL™ against adult-onset recurrent respiratory... Yes No 49334 Planned Not included in RMP Prospective Observational Study Aimed at Evaluating Treatment Satisfaction and Effectiveness in Patients with Relapsing Multiple Sclerosis Starting... No No 50387 Planned Not included in RMP Retrospective cohort study evaluating effectiveness of GARDASIL™ against adult-onset recurrent respiratory papillomatosis in Norway Yes No 50458 Ongoing Not included in RMP Population-based retrospective nested case-control study evaluating effectiveness of GARDASIL™ and GARDASIL 9™ against adult-onset recurrent... Yes No 103993 Ongoing Not included in RMP Post-marketing study to assess the effectiveness of doravirine-included in highly active antiretroviral therapy (HAART) in HIV-1 infected adult... Yes No 107702 Planned Not included in RMP A multi-center prospective non-interventional study to understand the use of next generation sequencing (NGS) in patients with metastatic non-small... No No 108114 Planned Non-EU RMP-only Non-interventional post-authorization study of belzutifan in adult patients with von Hippel-Lindau disease-associated renal cell carcinoma, pancreatic... No No 108481 Ongoing Not included in RMP Post Marketing Surveillance of Effectiveness (All-Cause Mortality) of Posaconazole Injection and Tablet Treatment of Invasive Aspergillosis in Chinese... Yes No