PAS funded by this sponsor. EU PAS ID Status RMP requirementTitle Protocol uploaded Results uploaded 1591 Finalised Not included in RMP Cardiac profile of patients using rosiglitazone-containing anti-diabetes medicines: a study using the THIN database No Yes 1594 Finalised Not included in RMP Validation of statistical signal detection procedures in eudravigilance post-authorization data: a retrospective evaluation of the potential for... No No 1705 Finalised Unspecified A/H1N1 pandemic vaccines and pregnancy outcomes No Yes 1777 Finalised Not included in RMP Impact of risk minimisation in patients treated with rosiglitazone-containing products Yes Yes 1821 Finalised Not included in RMP Pattern of use of Human Growth Hormone (Somatropin) in the United Kingdom general practice setting: A Drug Utilization Study in The Health Improvement... Yes No 2474 Finalised Unspecified Isotretinoin and the effectiveness of the pregnancy prevention programmes in Europe Yes Yes 2616 Finalised Not included in RMP Risk of cardiac valve disorders associated with the use of biphosphonates (Cardiac valve disorders and biphosphonate use) Yes Yes 2738 Finalised Not included in RMP Patterns and Determinants of Use of Oral Contraceptives in the European Union (Use of OC in the EU) Yes Yes 2765 Finalised Not included in RMP Monitoring the effectiveness of risk minimisation in patients treated with pioglitazone-containing products Yes No 3712 Finalised Not included in RMP Prescription patterns of combined hormonal contraceptives with 3rd or 4th versus 2nd generation progestogens in France, Germany and the UK during... No Yes 3718 Finalised Not included in RMP EMA drug utilisation study of cyproterone-ethinylestradiol products No Yes 3772 Finalised Not included in RMP Association between anxiolytic or hypnotic drugs and total mortality Yes Yes 4389 Finalised Not included in RMP Trends in co-prescribing of renin-angiotensin system (RAS)-acting agents in France, Germany and the UK during 2001 -2012 Yes Yes 5106 Finalised Not included in RMP Prescribing of zolpidem in the primary care setting in France, Germany and the UK during 2012. (Prescribing of zolpidem in IMS Germany/France/UK) No Yes 5249 Finalised Not included in RMP Metformin use in renal impairment Yes Yes 6708 Finalised Not included in RMP EMA Self-Controlled Case Study of Fluoroquinolones and Retinal Detachment in The Health Improvement Network database No Yes 6827 Finalised Not included in RMP EMA study on prescribing of testosterone in the primary care setting No Yes 8075 Finalised Not included in RMP EMA study on prescribing of ibuprofen in the French primary care setting No Yes 8639 Finalised Not included in RMP EMA study on prescribing of codeine to children and adolescents for cough and cold No Yes 16909 Finalised Not included in RMP Product identification of biologicals in ADR reports received from European clinical practice No No 17093 Finalised Not included in RMP Prescribing of codeine for the treatment of pain in children. Drug utilisation study using IMS electronic health records in Germany and France. Yes No 18909 Finalised Not included in RMP SSRIs during pregnancy and risk of autism spectrum disorder and attention deficit hyperactivity disorder: systematic review of observational studies Yes Yes 19066 Finalised Not included in RMP Tramadol prescribing: a drug utilisation study using electronic data from France, Germany and the UK No Yes 19129 Finalised Not included in RMP Utilisation of antiepileptic medicines in girls and women of childbearing potential - a study in three European countries Yes No 19162 Finalised Not included in RMP Trends in prescriptions of valproate and valpromide for bipolar disorder in IMS France and IMS Germany between 2010 and June 2016 and in UK THIN... No Yes 20889 Finalised Not included in RMP Indications for systemic fluoroquinolone prescribing in Europe: a descriptive population based study Yes Yes 20892 Finalised Not included in RMP Risk of tendon rupture with systemic fluoroquinolone exposure: nested case-control study Yes Yes 21171 Finalised Not included in RMP Tender for Competition no.6: Methods and data sources for determining long-term effects of drug exposure during pregnancy, with application to... Yes Yes 21337 Finalised Not included in RMP Measuring the impact of medicines regulatory interventions – systematic review and methodological considerations Yes Yes 21352 Finalised Not included in RMP Study of utilisation of combined hormonal contraceptives in Europe Yes No 21356 Finalised Not included in RMP Study of regulatory communication and risk awareness following the Article 31 referral of Combined Hormonal Contraceptives in relation to... Yes Yes 21359 Finalised Not included in RMP Anti-microbial resistance: choice of therapeutic interventions and outcomes for the treatment of infections caused by MDR Gram-negative pathogens Yes No 22214 Finalised Not included in RMP Medication Errors – a characterisation of spontaneously reported cases in EudraVigilance No No 24089 Finalised Not included in RMP Impact of EU label changes for systemic diclofenac products: post-referral prescribing trends Yes Yes 24154 Finalised Not included in RMP Association between hydrochlorothiazide exposure and skin and lip cancer: a series of populationbased nested case-control studies Yes Yes 24430 Finalised Not included in RMP Impact of withdrawal of fusafungine from the market on the prescribing of alternative treatments in Germany (Fusafungine impact study) Yes No 24772 Finalised Not included in RMP Antihypertensives/diuretics and skin cancer No No 26363 Finalised Not included in RMP Impact of EU label changes for hydroxyzine products: post-referral prescribing trends Yes Yes 26545 Finalised Not included in RMP Stakeholder Survey on the ENCePP Code of Conduct (Survey ENCePP Code of Conduct) No Yes 27627 Finalised Not included in RMP Risk of peripheral neuropathy with systemic fluoroquinolone exposure: population-based nested case-control study Yes Yes 27973 Finalised Not included in RMP Use of thiazides and risk of skin cancer - systematic review and meta-analysis (Thiazides and skin cancer) Yes No 31001 Finalised Not included in RMP Impact of EU label changes and revised pregnancy prevention programme for medicinal products containing valproate: utilisation and prescribing trends Yes Yes 31095 Finalised Not included in RMP Impact of EU label changes and revised pregnancy prevention programme for oral retinoid containing medicinal products: utilization and prescribing... Yes Yes 31864 Finalised Not included in RMP Metamizole and risk of hepatotoxicity –comparative cohort study of incidence of hepatic events in patients treated with metamizole vs. patients... Yes No 31879 Finalised Not included in RMP Ability of primary care health databases to assess medicinal products discussed by the European Union Pharmacovigilance Risk Assessment Committee... No No 31895 Finalised Not included in RMP Angiotensin II receptor blockers and risk of cancer after contamination with N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) (Sartans... Yes No 31996 Finalised Not included in RMP Hydroxyethyl starch (HES) solutions and risk of acute kidney injury and mortality in acute trauma patients No Yes 32004 Finalised Not included in RMP Loperamide and the risk of Brugada syndrome No Yes 32021 Finalised Not included in RMP Changes in alternative treatments for pain and cough in children after introduction of risk minimisation measures for codeine (Alternatives to... No No 32405 Finalised Not included in RMP Impact of EU label changes and pregnancy prevention programme for medicinal products containing valproate and related substances: risk awareness and... Yes Yes 32408 Finalised Not included in RMP Impact of EU label changes and revised pregnancy prevention programme for oral retinoid containing medicinal products: risk awareness and adherence... Yes Yes 32486 Finalised Not included in RMP Prescribing of digoxin for long-term use in atrial fibrillation in France, Germany and the UK during 2000-2014 Yes No 32500 Finalised Not included in RMP Use of products containing oestrogens alone and oestrogens in combination with progestogens (not contraceptives) between 2000 and 2014 in France,... No Yes 33148 Finalised Not included in RMP Can We Rely on Results From IQVIA Medical Research Data UK Converted to the Observational Medical Outcome Partnership Common Data Model? Yes No 33397 Finalised Not included in RMP Ranitidine and other histamine H2-receptor antagonists – a drug utilisation study Yes Yes 33919 Finalised Not included in RMP Prescribing of flupirtine in IMS Disease Analyser in Germany (Flupirtine drug utilisation in Germany) No Yes 33976 Finalised Not included in RMP Prenatal exposure to paracetamol and the risk of urogenital system disorders or neurodevelopmental disorders in offspring: a systematic review of... No No 34516 Finalised Not included in RMP Prescribing of paracetamol in patients with chronic renal failure A Drug Utilisation Study (Paracetamol doses in renal failure) No Yes 34531 Ongoing Not included in RMP Suicide and suicidality after exposure to finasteride (Suicidality with finasteride) Yes No 34901 Finalised Not included in RMP Study of evidence of potential selective prescribing of clenbuterol compared to other beta-2-agonists (Clenbuterol selective prescribing) Yes No 34908 Finalised Not included in RMP Use of ondansetron in pregnant female patients in the IMS Disease Analyzer databases in France and Germany (Ondansetron use pregnancy) No Yes 35474 Finalised Not included in RMP Survey on the collection of data on adverse events related to medicinal products through registries Yes No 35947 Finalised Not included in RMP Proposals for Engaging Patients and Healthcare Professionals in Risk Minimisation from an Analysis of Stakeholder Input to the EU Valproate Assessment... No Yes 36901 Finalised Not included in RMP Retinoid-containing medicinal products and Neuropsychiatric disorders: A descriptive analysis of EudraVigilance data Yes Yes 36912 Finalised Not included in RMP Psychosis and psychotic disorders” and “Depression and suicide/self-injury” following exposure to Hydroxychloroquine and chloroquine No Yes 37273 Finalised Not included in RMP Background rates of Adverse Events of Special Interest for monitoring COVID-19 vaccines (ACCESS-BGR) Yes Yes 37856 Finalised Not included in RMP Study of impact of EU label changes for fluoroquinolone containing medicinal products for systemic and inhalation use - post-referral prescribing... Yes Yes 38221 Finalised Not included in RMP Rapid Data Analysis – Ceftriaxone and hepatic events No Yes 38690 Finalised Not included in RMP Association of tofacitinib with psychiatric disorders No Yes 38759 Finalised Not included in RMP Systemic glucocorticoids in the treatment of COVID-19 and risks of adverse outcomes in COVID-19 patients in the primary and secondary care setting... Yes Yes 39112 Finalised Not included in RMP Serotonin and norepinephrine reuptake inhibitors, selective serotonin reuptake inhibitors and other antidepressants and persistent sexual dysfunction... No Yes 39117 Finalised Not included in RMP Vascular Endothelial Growth Factor Inhibitors and Artery dissections and aneurysms - An analysis of EudraVigilance No Yes 39122 Finalised Not included in RMP Dihydropyrimidine dehydrogenase deficiency related toxicities to fluorouracil and fluorouracil related substances containing medicinal products -... Yes Yes 39125 Finalised Not included in RMP Leuprorelin and medication error and lack of effect - An analysis of EudraVigilance No Yes 39144 Finalised Not included in RMP Cyproterone-containing medicines and Meningiomas - An EudraVigilance analysis No Yes 39226 Finalised Non-EU RMP-only Registry for pregnant women exposed to SARS-CoV-2 (COVID-19, CONSIGN study) (COVI-PREG) Yes No 39272 Finalised Not included in RMP Patients and HCP understanding on additonal monitoring No Yes 39289 Finalised Not included in RMP ACCESS template protocols for effectiveness of COVID-19 vaccines (ACCESS-effectiveness) Yes No 39322 Finalised Not included in RMP Strengthening Use of Real-World Data in Medicines Development: Metadata for Data Discoverability and Study Replicability (MINERVA) No Yes 39361 Finalised Not included in RMP ACCESS template protocol for safety of COVID-19 vaccines Yes Yes 39370 Finalised Not included in RMP Coverage of COVID-19 vaccines in electronic healthcare databases: a protocol template from the ACCESS project Yes Yes 39438 Ongoing Not included in RMP CONSIGN study: COVID-19 infection and medicines in pregnancy - a multinational registry based study Yes No 39770 Finalised Not included in RMP Depression following exposure to anastrozole No Yes 39798 Finalised Not included in RMP Cohort Event Monitoring of safety of COVID-19 vaccines (Early-) Covid-Vaccine-Monitor (Covid-Vaccine-Monitor ECVM CVM) Yes Yes 40283 Finalised Not included in RMP Rapid Data Analysis (RDA) – Amfepramone drug utilisation No Yes 40290 Finalised Not included in RMP Rapid Data Analysis – Tolperisone drug utilisation No Yes 40317 Planned Not included in RMP Description of international collaboration in the area of medicines use and effects in COVID-19 affected pregnancies (CONSIGN-International)) Yes No 40404 Finalised Not included in RMP Cohort monitoring of Adverse Events of Special Interest and COVID-19 diagnoses prior to and after COVID-19 vaccination (ECVM) Yes No 40414 Finalised Not included in RMP Natural history of coagulopathy and use of anti-thrombotic agents in COVID-19 patients and persons vaccinated against SARS-CoV-2 Yes Yes 40519 Finalised Not included in RMP Use of sulfonamide-trimethoprim combinations during pregnancy in IMRD-Germany and IMRD-France No Yes 40527 Finalised Not included in RMP Incidence rates of adverse events of special interest: Guillain-Barré syndrome and Bell’s palsy No Yes 41039 Finalised Not included in RMP Inactivated varicella zoster vaccine and herpes zoster No Yes 41433 Finalised Not included in RMP Trade-offs between benefits and harms of drugs: a stated preference study with adult patients with cancer in Europe (Patient preferences) Yes Yes 42268 Finalised Not included in RMP Report on PRAC Pilot on Rapid Data Analytics No Yes 42467 Finalised Not included in RMP Rapid Safety Assessment of SARS-CoV-2 vaccines in EU Member States using electronic health care datasources (CVM Covid19-Vaccine-Monitor-EHR) Yes Yes 42504 Finalised Not included in RMP Cohort Event Monitoring of safety of COVID-19 vaccines in special populations (pregnant and lactating women, children and adolescents,... Yes Yes 42641 Finalised Not included in RMP Rapid Data Analysis – Systemic fluoroquinolones and thrombotic thrombocytopenic purpura (TTP) Yes Yes 43709 Finalised Not included in RMP Single-arm studies with external comparators for cancer drug development: a statistical methodology study to evaluate External Comparator Arm (ECA)... No No 44229 Finalised Not included in RMP Benefit Risk contextualisation of COVID-19 vaccines in the EU Yes Yes 44469 Finalised Not included in RMP ASSOCIATION BETWEEN THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (TTS) OR THROMBOEMBOLIC EVENTS, AND COVID-19 VACCINES Yes Yes 44548 Finalised Not included in RMP Study of exposure and use patterns of alternatives to ranitidine-containing medicines in patients treated with ranitidine (Ranitidine) Yes Yes 44827 Finalised Not included in RMP Impact of EU label changes for medicinal products containing methotrexate for weekly administration: risk awareness and adherence, A survey study Yes Yes 44839 Finalised Not included in RMP Glucocorticoid-induced osteoporosis (GIOP): prescription patterns of glucocorticoids in paediatric patients No Yes 44970 Finalised Not included in RMP Impact of EU label changes and regulatory communication on SARS-CoV-2 adenovirus vector vaccines in context of thrombosis with thrombocytopenia... Yes Yes 45098 Finalised Not included in RMP Vaccine-induced immune thrombotic thrombocytopenia and thrombosis syndrome (VITT/TTS) after vaccination against SARS-CoV-2 (COVID-19) Yes Yes 45202 Finalised Not included in RMP Prevalence of hypereosinophilic syndrome (HES) in the paediatric population in EU (Hypereosinophilic syndrome in children) No No 45978 Finalised Not included in RMP Review of studies evaluating the effectiveness of risk minimisation measures evaluated by PRAC (EffectiveRMM) Yes No 46057 Ongoing Not included in RMP Quantitative structure Activity Relationships (QSAR) for nitrosamine risk assessment. EMA/2020/46/TDA/01(Lot 1) SC01 under FWC EMA/2020/46/TDA/L1.02... Yes No 46420 Finalised Not included in RMP Statistical methods for time-to-event endpoints with non-proportional hazards in clinical trials pivotal for benefit risk decision making Yes Yes 46537 Finalised Not included in RMP Comparative effectiveness of heterologous and homologous primary- and booster SARS-CoV-2 vaccination schedules in the Nordic countries Yes Yes 47563 Ongoing Not included in RMP Review of PRAC assessed PASS evaluating risk minimisation measures (RMM) (EffectiveRMM2) No No 47588 Finalised Not included in RMP Implementation of EU risk minimisation measures for medicinal products in clinical guidelines Yes Yes 47697 Finalised Not included in RMP Safety and effectiveness of COVID-19 maternal immunisation: An update of available evidence No Yes 47725 Finalised Not included in RMP Effectiveness of heterologous and booster Covid-19 vaccination in 5 European countries, using a cohort approach in children and adults with a full... Yes Yes 48036 Finalised Not included in RMP Prevalence of narcolepsy in two European countries - France and Germany No Yes 48979 Finalised Not included in RMP Association between COVID-19 vaccines and paediatric safety outcomes in children and adolescents aged 5-19 years in the Nordic countries: Myocarditis,... Yes Yes 49303 Finalised Not included in RMP Establish an EU catalogue of sources of real-world data, characterised by a common set of metadata and data quality measurements No No 49355 Finalised Not included in RMP In vitro mutagenicity methodology for nitrosamines (InVitroNAmutagenicity) Yes Yes 50093 Planned Not included in RMP Safety and Effectiveness of MVA-BN vaccination against MPXV infection in at-risk individuals in Germany (SEMVAc) (DRKS ID: DRKS00029638 (SEMVAc)) Yes No 50476 Ongoing Not included in RMP A registry-based cohort study of Spinal Muscular Atrophy (SMA) disease to describe the natural history of SMA, the evolution of SMA care management... Yes No 50510 Finalised Not included in RMP Incidence rates of morphoea, systemic sclerosis and scleroderma Yes Yes 50516 Finalised Not included in RMP Incidence rates of Cutaneous T-Cell Lymphomas (CTCL) among patients with atopic dermatitis (AD) Yes Yes 50609 Finalised Not included in RMP Incidence rates of vulval ulceration following Comirnaty vaccine Yes Yes 50623 Finalised Not included in RMP Background incidence rates of Interstitial Lung Disease Yes Yes 50715 Finalised Not included in RMP Incidence rates of pemphigus and pemphigoid following COVID-19 vaccines Yes Yes 50789 Finalised Not included in RMP DARWIN EU® - Drug utilisation of valproate-containing medicinal products in women of childbearing potential Yes Yes 50800 Finalised Not included in RMP DARWIN EU® – Prevalence of rare blood cancers in Europe Yes Yes 103381 Finalised Not included in RMP DARWIN EU® - DUS of Antibiotics in the ‘Watch’ category of the WHO AWaRe classification of antibiotics for evaluation and monitoring of use Yes Yes 103936 Ongoing Not included in RMP DARWIN EU® - Background rates of serious adverse events to contextualise safety assessments in clinical trials and non-interventional studies in... Yes No 104093 Ongoing Not included in RMP Establish an EU catalogue with metadata of data sources and studies No No 104284 Finalised Not included in RMP Population incidence rates of pemphigoid in six European countries Yes Yes 104290 Finalised Not included in RMP Immune thrombocytopenia following vaccination with DTaP-IPV or TdaP-IPV in children Yes Yes 104293 Finalised Not included in RMP Prevalence of palmoplantar psoriasis and pustular psoriasis in children Yes Yes 104296 Finalised Not included in RMP Drug utilisation study of macrolide-containing medicinal products during pregnancy Yes Yes 104302 Finalised Not included in RMP Treatment patterns in patients with pulmonary arterial hypertension Yes No 104305 Finalised Not included in RMP Prevalence of primary and secondary arterial hypertension in children and treatment with angiotensin II receptor blockers Yes Yes 104328 Finalised Not included in RMP Prevalence of multiple myeloma Yes Yes 104331 Finalised Not included in RMP Prevalence of immunocompromised patients with a diagnosis of cytomegalovirus infection Yes Yes 104334 Finalised Not included in RMP Prevalence of Acute Liver Injury Yes Yes 104386 Ongoing Not included in RMP Effectiveness and safety of MVA-BN vaccination against Mpox in at-risk individuals in the United States (USMVAc) (USMVAC study) Yes Yes 105033 Ongoing Not included in RMP DARWIN EU® CC - Multiple myeloma: patient characterisation, treatments and survival in the period 2012-2022 Yes Yes 105257 Ongoing Not included in RMP Study of Operating characteristic of Bayesian methods that borrow treatment effects No No 105641 Ongoing Not included in RMP DARWIN EU® CC - Drug utilization study of prescription opioids Yes No 105644 Ongoing Not included in RMP DARWIN EU® CC - Use of take-home naloxone for opioid overdose treatment Yes No 106052 Ongoing Not included in RMP DARWIN EU® CC - Co-prescribing of endothelin receptor antagonists (ERAs) and phosphodiesterate-5 inhibitors (PDE-5is) in pulmonary arterial... Yes No 106436 Ongoing Not included in RMP DARWIN EU® CC Treatment patterns of drugs used in adult and paediatric population with systemic lupus erythematosus Yes No 106558 Ongoing Not included in RMP Effectiveness of bivalent Covid-19 booster vaccines in the Nordic countries Yes No 106600 Finalised Not included in RMP To examine the impact of additional confounder adjustment for the potential association between second line T2DM therapy and thyroid cancer: a nested... Yes Yes 106679 Ongoing Not included in RMP DARWIN EU® CC - EHDS Use Case: Natural history of coagulopathy in COVID-19 patients and persons vaccinated against SARS-CoV-2 in the context of the... Yes No 106685 Ongoing Not included in RMP DARWIN EU® CC - Rates of occurrence of treatment-related intercurrent events in patients with major depressive disorder Yes No 106798 Ongoing Not included in RMP DARWIN EU® CC - Drug utilisation study of medicines with prokinetic properties in children and adults diagnosed with gastroparesis Yes No 106882 Finalised Not included in RMP Incidence of phimosis and paraphimosis in patients treated with SGLT2 inhibitors Yes Yes 107454 Ongoing Not included in RMP DARWIN EU® CC - Natural history of dermatomyositis (DM) and polymyositis (PM) in adults and paediatric populations Yes Yes 107615 Ongoing Not included in RMP DARWIN EU® Effectiveness of COVID 19 vaccines on severe COVID 19 and post acute outcomes of SARS CoV 2 infection No No 107650 Ongoing Not included in RMP DARWIN EU® Characterization of patients with chronic hepatitis B and C No No 107708 Ongoing Not included in RMP DARWIN EU® Age specific incidence rates of RSV related disease in Europe No No 107932 Ongoing Not included in RMP DARWIN EU® – Monitoring prescription of medicines for public health emergencies at risk of shortages No No