EU collaborations
| Full Title & EUPAS Link | Funding Entity | Coord. Center | Other Participating SIGMA Partners | Start year |
| Strengthening Use of Real-World Data in Medicines Development: Metadata for Data Discoverability and Study Replicability | EMA |  | AARHUS, ARS, BIPS, BPE, PHARMO, UMCU, UU
| 2020 |
| Renin-angiotensin-aldosterone system inhibitors and adverse outcomes of COVID-19: a Danish nationwide cohort study | AARHUS |  | SDU | 2020 |
| Background rates of Adverse Events of Special Interest for monitoring COVID-19 vaccines | EMA |  | ARS, BIPS, BPE, IDIAP, PHARMO, RTI-HS, UU | 2020 |
| A Retrospective Cohort Study to Assess Drug Utilisation and Long-Term Safety of Galcanezumab in European Patients in the Course of Routine Clinical Care | Lilly |  | ARS, BIPS, BPE, IDIAP, PHARMO | 2019 |
| Adherence, persistence and switching patterns – once- and twice-daily direct oral anticoagulants | Daiichi Sankyo | | ARS, BIPS, PHARMO | 2019 |
| Impact of EU label changes and revised pregnancy prevention programme for oral retinoid containing medicinal products: utilization and prescribing trends | EMA | | ARS, BPE, IDIAP, PHARMO | 2019 |
| Impact of EU label changes and pregnancy prevention programme for medicinal products containing valproate and related substances: risk awareness and adherence | EMA |  | UMCU, ARS, PHARMO | 2019 |
| Impact of EU label changes for hydroxyzine products: post-referral prescribing trends | EMA |  | DUNDEE, PHARMO, SDU | 2018 |
| The BRodalumab Assessment of Hazards: A Multinational Safety (BRAHMS) study in electronic healthcare databases | Leo Pharma |  | ARS, BIPS, PHARMO | 2018 |
| Non-interventional post-authorization multi-database safety study to characterize the risk of angioedema and other specific safety events of interest in association with use of Entresto® (sacubitril/valsartan) in adult patients with heart failure | Novartis | | AARHUS, ARS, BIPS, IDIAP | 2017 |
| Non-interventional post-authorization multi-database safety study to assess the risk of myotoxicity, hepatotoxicity and acute pancreatitis in statin-exposed heart failure patients with or without concomitant use of sacubitril/valsartan (Entresto®) | Novartis | | AARHUS, ARS, BIPS, IDIAP | 2017 |
| Cohort Study of the Incidence of Major Cardiovascular Events in New Adult Users of Lisdexamfetamine and Remote Adult Users of Other ADHD Treatments | Shire | | AARHUS | 2017 |
| Intravenous Iron Postauthorisation Safety Study (PASS): Evaluation of the Risk of Severe Hypersensitivity Reactions | Vifor (Iron Consortium) | | AARHUS, BIPS, PHARMO | 2017 |
| Risk of Skin Cancer and Lymphoma in Users of Topical Tacrolimus, Pimecrolimus, and Corticosteroids | LEO | | PHARMO, SDU | 2017 |
| Malignancies in Multiple Sclerosis: multi-country cohort database studies (feasibility study) | Merck KGaA |  | AARHUS, BPE, PHARMO | 2017 |
| Impact of EU label changes for systemic diclofenac products: post-referral prescribing trends | EMA | | DUNDEE, PHARMO, SDU | 2017 |
| Multisource Surveillance Study of Pregnancy and Infant Outcomes in Ocrelizumab-Exposed Women With Multiple Sclerosis | Roche | | AARHUS | 2017 |
| Post-authorisation safety study in patients with type 2 diabetes mellitus to assess the risk of acute liver injury, acute kidney injury and chronic kidney disease, severe complications of urinary tract infection, genital infections, and diabetic ketoacidosis among patients treated with empagliflozin compared to patients treated with DPP-4 inhibitors | BI | | AARHUS | 2016 |
| Drug utilization study of mirabegron (Betmiga®) using real-world healthcare databases from the Netherlands, Spain, United Kingdom and Finland | Astellas | | IDIAP, PHARMO | 2016 |
| Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral Anticoagulants in the EU | EMA tender | | BPE | 2016 |
| Post-authorization Safety Study Evaluation of Cardiovascular Events in Users of Mirabegron and Other Treatments for Overactive Bladder | Astellas |  | RTI-HS, SDU | 2016 |
| European Program of Post-Authorization Safety Studies for Protelos®/Osseor® through EU-ADR Alliance | Study |  | AARHUS | 2015 |
| Post-Authorisation Safety Study of Agomelatine and the Risk of Hospitalisation for Acute Liver Injury | Servier | | BIPS, IDIAP, SDU | 2015 |
| Comparison of the Risk of Cancer Between Patients With Type 2 Diabetes Exposed to Dapagliflozin and Those Exposed to Other Antidiabetic Treatments | Astra Zeneca | | PHARMO | 2015 |
| Drug Utilisation Study for Olodaterol | BI | | AARHUS, PHARMO | 2015 |
| Cohort study of cardiovascular events in patients with chronic obstructive pulmonary disease initiating olodaterol or other long-acting beta2-agonists | BI | | AARHUS | 2015 |
| Aclidinium Bromide Drug Utilisation Post-Authorisation Safety Studies (DUS): Common Protocol for Aclidinium (DUS1) and Aclidinium/Formoterol Fixed-Dose Combination (DUS2) | Astra Zeneca | | BIPS, SDU | 2014 |
| A multinational active safety surveillance study of crizotinib in Europe | Pfizer | | AARHUS, PHARMO | 2014 |
| Post-Authorization Safety Program—Validation of the Danish Data Resources for the Study of Cardiovascular and Neoplasm Events in Users of Treatments for Overactive Bladder | Astellas | | SDU | 2014 |
| Cohort Study of the Relative Incidence of Major Cardiovascular Events Among Patients Initiating Prucalopride Versus a Matched Comparator Cohort | Shire | | BIPS, DUNDEE | 2014 |
| Cilostazol Drug Utilisation Study | Otsuka | | BIPS, IDIAP | 2013 |
| Risk of Skin Cancer and Lymphoma in Users of Topical Tacrolimus, Pimecrolimus, and Corticosteroids | Astellas/LEO | | PHARMO, SDU | 2013 |
| Safety Evaluation of Adverse Reactions in Diabetes - Drug utilisation studies | EC |  | BIPS, PHARMO, RTI-HS | 2013 |
| Evaluation of the Use of Nepafenac in Selected European Populations | Alcon | | PHARMO, SDU | 2013 |
| Evaluation of potential off-label use of dabigatran etexilate in Europe | BI | | SDU | 2013 |
| Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case: Incidence rates of pertussis and pertussis related outcomes of whole-cell pertussis and acellular pertussis vaccines in pre-school children | EC |  | AARHUS ARS, IDIAP | 2013 |
| ADVANCE POC I Risk pillar - Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case: Incidence rates of safety outcomes of whole-cell pertussis and acellular pertussis vaccines in pre-school children | EC | | AARHUS, ARS, IDIAP | 2013 |
| ADVANCE POC Study Protocol - Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case. Coverage rates of acellular and whole-cell pertussis-containing vaccines in preschool children | EC | | AARHUS, ARS, IDIAP | 2013 |
| ADVANCE POC I Benefit-Risk pillar – testing new approaches to monitoring benefit/risk with pertussis vaccines as test case: benefit-risk analysis of pertussis vaccines in pre-school children comparing whole-cell and acellular formulations in the post-marketing setting | EC | | AARHUS, ARS, IDIAP | 2013 |
| Exposure and coverage to routine schedule vaccines in different EU countries | EC | | AARHUS, ARS, IDIAP, UMCU | 2013 |
| Patterns and Determinants of Use of Oral Contraceptives in the European Union | EMA | | ARS, PHARMO | 2011 |
| Safety Evaluation of Adverse Reactions in Diabetes - Comparative studies | EC | | BIPS, PHARMO, RTI-HS | 2011 |
| Study of Acute Liver Transplant: A study of NSAIDs-exposed acute liver failure in European transplant centres | Helsinn Healthcare S.A. | | RTI-HS | 2008 |
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