No funding

This sponsor has funded 38 studies across 16 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
2884 Finalised Unspecified Pregnancy outcome following maternal exposure to mirtazapine: a collaborative ENTIS study No No
8463 Ongoing Not included in RMP Estudio de casos y controles sobre el riesgo de fractura atípica de fémur asociada al uso de bifosfonatos Yes No
9181 Finalised Not included in RMP Adverse drug reactions that lead to hospital admission in elderly patients Yes No
9592 Finalised Unspecified Effect of Incretin Analogues and Dipeptidyl-peptidase-IV inhibitors on colorectal cancer risk Yes Yes
13279 Planned Not included in RMP Association between Pioglitazone and Bladder Cancer in a Medicare population Yes No
17776 Ongoing Not included in RMP Incretin‐based drugs and Retinopathy risk in Medicare Enrollees Yes No
20169 Planned Not included in RMP Time to treatment intensification in patients receiving metformin+incretin-based medicines versus metformin+other hypoglicemics (Time to treatment... Yes No
21368 Ongoing Not included in RMP Sodium-Glucose Cotransporter-2 Inhibitor (SGLT-2i) Use and Risk of Subsequent Amputation No No
23454 Ongoing Not included in RMP 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 Not included in RMP 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 Not included in RMP 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 Not included in RMP Shared decision making in patients with mental disorders (Shared decision making in mental disorders) No No
26245 Ongoing Not included in RMP Dipeptidyl Peptidase-4 Inhibitors and Risk of Inflammatory Bowel Disease among Patients with Type 2 Diabetes Mellitus Yes No
28593 Finalised Not included in RMP Follow-Up Survey of stakeholder actions following the EMA patient registry workshops No Yes
29426 Finalised Not included in RMP Fluoroquinolones and the risk of tendon injury: a systematic review and meta-analysis No No
30018 Finalised Not included in RMP 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 Not included in RMP Triple chronotherapy (combined total sleep deprivation, sleep phase advance and bright light therapy) to reduce acute depressive and suicidal... No No
32482 Planned Not included in RMP Exploring differences in asthma disease severity and pathways: variation by ethnicity and socioeconomic status No No
34425 Ongoing Not included in RMP Prospective cohort of COVID-19 cases diagnosed in Vall d'Hebron Hospital, Barcelona, during the 2020 outbreak. Yes No
34668 Finalised Not included in RMP 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 Non-EU RMP-only COHORTE DE PACIENTES EN TRATAMIENTO RENAL SUSTITUTIVO HOSPITALIZADOS POR COVID-19. MORTALIDAD Y FACTORES PRONÓSTICOS (COVID19-HD) No No
34985 Planned Not included in RMP 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 Not included in RMP Impact of use of newer glucose lowering drugs on outcomes in patients with COVID-19 Yes Yes
36692 Finalised Not included in RMP 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 Not included in RMP Antidepressants withdrawal syndrome: a pharmacovigilance study in VigiBase® Yes No
45187 Finalised Not included in RMP Registro español de alteraciones hematoogicas durante el tratamiento con siponimod. (SILITOX Study) Yes No
45559 Ongoing Not included in RMP Risks of arrhythmias reporting with antiepileptics including Lamotrigine: a pharmacovigilance study in VigiBase® Yes No
45738 Ongoing Not included in RMP Regulation of psychotropic fixed dose combination drugs in India: a retrospective longitudinal study (Regulation of psychotropic FDCs in India) No No
46697 Ongoing Not included in RMP Drugs associated with Spontaneous Coronary Artery Dissection: a WHO pharmacovigilance database disproportionality analysis No No
48420 Finalised Not included in RMP Drug utilization of temozolomide with or without antiepileptic drugs in patients with malignant gliomas in the Tuscany region Yes No
48635 Ongoing Not included in RMP 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 Not included in RMP Safety of psychotropic medication in pregnancy: A pharmacovigilance study of international safety data in the World Health Organization global... No No
49386 Planned Not included in RMP Concordance between primary and secondary electronic healthcare databases: A multi-database self-controlled case series study Yes No
103542 Finalised Not included in RMP Spanish and Irish study of lithium toxicity and extracorporeal removal (SILITOX Study) Yes No
103551 Finalised Not included in RMP 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 Not included in RMP Effectiveness of antiresorptives in preventing hip fractures in older women (≥ 75 years) with osteoporosis: nested case-control study cohort (BiHip) Yes No
107663 Ongoing Not included in RMP 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 Not included in RMP 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.