No funding

This sponsor has funded 38 studies across 16 countries.

PAS funded by this sponsor.
EU PAS ID Status Title Protocol uploaded Results uploaded
2884 Finalised Pregnancy outcome following maternal exposure to mirtazapine: a collaborative ENTIS study No No
8463 Ongoing Estudio de casos y controles sobre el riesgo de fractura atípica de fémur asociada al uso de bifosfonatos Yes No
9181 Finalised Adverse drug reactions that lead to hospital admission in elderly patients Yes No
9592 Finalised Effect of Incretin Analogues and Dipeptidyl-peptidase-IV inhibitors on colorectal cancer risk Yes Yes
13279 Planned Association between Pioglitazone and Bladder Cancer in a Medicare population Yes No
17776 Ongoing Incretin‐based drugs and Retinopathy risk in Medicare Enrollees Yes No
20169 Planned Time to treatment intensification in patients receiving metformin+incretin-based medicines versus metformin+other hypoglicemics (Time to treatment... Yes No
21368 Ongoing Sodium-Glucose Cotransporter-2 Inhibitor (SGLT-2i) Use and Risk of Subsequent Amputation No No
23454 Ongoing Longitudinal Analyses of Body Mass Index and Risk of Parkinson's Disease in 2 million people over 2 decades (BMI and Parkinson´s disease) No No
23746 Ongoing Sodium-glucose cotransporter-2 inhibitor initiation and the short-term risk of hospitalized acute kidney injury (SGLT2 inhibitors and short-term AKI) Yes No
23991 Finalised Shared decision making in patients with surgical or non-surgical medical disorders in a General Hospital: A pilot study (Shared Decision Making in a... No Yes
24513 Ongoing Shared decision making in patients with mental disorders (Shared decision making in mental disorders) No No
26245 Ongoing Dipeptidyl Peptidase-4 Inhibitors and Risk of Inflammatory Bowel Disease among Patients with Type 2 Diabetes Mellitus Yes No
28593 Finalised Follow-Up Survey of stakeholder actions following the EMA patient registry workshops No Yes
29426 Finalised Fluoroquinolones and the risk of tendon injury: a systematic review and meta-analysis No No
30018 Finalised Sodium-Glucose Cotransporter-2 Inhibitor Use and Risk of Fournier’s Gangrene: Validating the US Food and Drug Administration Drug Warning (SGLT2i Use... Yes Yes
30637 Ongoing Triple chronotherapy (combined total sleep deprivation, sleep phase advance and bright light therapy) to reduce acute depressive and suicidal... No No
32482 Planned Exploring differences in asthma disease severity and pathways: variation by ethnicity and socioeconomic status No No
34425 Ongoing Prospective cohort of COVID-19 cases diagnosed in Vall d'Hebron Hospital, Barcelona, during the 2020 outbreak. Yes No
34668 Finalised Anxiety and Depression in Psychiatric Patients and Mental Health Professionals During the COVID-19 pandemic (Depression and Anxiety in COVID-19... Yes No
34813 Ongoing COHORTE DE PACIENTES EN TRATAMIENTO RENAL SUSTITUTIVO HOSPITALIZADOS POR COVID-19. MORTALIDAD Y FACTORES PRONÓSTICOS (COVID19-HD) No No
34985 Planned Estudio de cohortes observacional: uso de tocilizumab (inh. de receptor de IL6) endovenoso en el síndrome de liberación de citoquinas producido por... No No
36089 Finalised Impact of use of newer glucose lowering drugs on outcomes in patients with COVID-19 Yes Yes
36692 Finalised First-line anticancer drugs in patients with advanced, primary Non-Small Cell Lung Cancer: drug-utilization and effectiveness studies from Tuscany... Yes No
41765 Finalised Antidepressants withdrawal syndrome: a pharmacovigilance study in VigiBase® Yes No
45187 Finalised Registro español de alteraciones hematoogicas durante el tratamiento con siponimod. (SILITOX Study) Yes No
45559 Ongoing Risks of arrhythmias reporting with antiepileptics including Lamotrigine: a pharmacovigilance study in VigiBase® Yes No
45738 Ongoing Regulation of psychotropic fixed dose combination drugs in India: a retrospective longitudinal study (Regulation of psychotropic FDCs in India) No No
46697 Ongoing Drugs associated with Spontaneous Coronary Artery Dissection: a WHO pharmacovigilance database disproportionality analysis No No
48420 Finalised Drug utilization of temozolomide with or without antiepileptic drugs in patients with malignant gliomas in the Tuscany region Yes No
48635 Ongoing Study on the use of non-specific immunoglobulins in patients treated at Vall d'Hebron University Hospital, Bellvitge Hospital and Germans Trias i... No No
49262 Planned Safety of psychotropic medication in pregnancy: A pharmacovigilance study of international safety data in the World Health Organization global... No No
49386 Planned Concordance between primary and secondary electronic healthcare databases: A multi-database self-controlled case series study Yes No
103542 Finalised Spanish and Irish study of lithium toxicity and extracorporeal removal (SILITOX Study) Yes No
103551 Finalised Effectiveness, safety and efficiency of the use of vernakalant in the control of the rhythm of atrial fibrillation in the emergency. Cohort study... Yes No
104033 Planned Effectiveness of antiresorptives in preventing hip fractures in older women (≥ 75 years) with osteoporosis: nested case-control study cohort (BiHip) Yes No
107663 Ongoing Changes of the right diaphragmatic kinetics following tracheal extubation in the newborn by using pulsed tissue Doppler imaging: a pilot study. (ET... No No
108167 Ongoing Pilot study for the clinical validation of an artificial intelligence algorithm to optimize the appropriateness of dermatology referrals.... Yes No

PAS by Risk Management Plan (RMP) requirement

No funding

The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.

Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.