Institution identification

PURI

https://redirect.ema.europa.eu/resource/3331404

Institution ID

3331404

Institution full name and acronym

European Medicines Agency (EMA)

ENCePP partner

No
Institution details
Experience with collecting data directly from individual patients or respondents:
No
Interest in carrying out research that is funded by pharmaceutical companies:
No

Studies conducted by the institution

Ability of primary care health databases to assess medicinal products discussed by the European Union Pharmacovigilance Risk Assessment Committee (CAPs and NAPs in primary EHDs)
Angiotensin II receptor blockers and risk of cancer after contamination with N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) (Sartans contamination -feasibility study)
Antihypertensives/diuretics and skin cancer
Association between exposure to GLP-1 receptor agonists and risk of suicide-related and self-harm-related events
Association between hydrochlorothiazide exposure and skin and lip cancer: a series of populationbased nested case-control studies
Association between use of direct oral anticoagulants (DOACs) and increased risk of interstitial lung disease
Association of tofacitinib with psychiatric disorders
Background incidence rates of Interstitial Lung Disease
Calcium channel blocker treatments and cancer risk. A methodological protocol to compare the results between databases, across designs: Evaluation of the impact of design/database/population differences on the outcome of the studied association
Can We Rely on Results From IQVIA Medical Research Data UK Converted to the Observational Medical Outcome Partnership Common Data Model?
Cardiac profile of patients using rosiglitazone-containing anti-diabetes medicines: a study using the THIN database
Changes in alternative treatments for pain and cough in children after introduction of risk minimisation measures for codeine (Alternatives to codeine)
Cohort Study of Psychiatric Adverse Events Following Exposure to Levonorgestrel-Containing Intrauterine Devices in UK General Practice
COVID-19 and Real-World Evidence: A Scoping Review on Factors That Affected Real-World Data Quality and Collection during the Pandemic and Methods to Address these Issues
Cyproterone-containing medicines and Meningiomas - An EudraVigilance analysis
Depression following exposure to anastrozole
Dihydropyrimidine dehydrogenase deficiency related toxicities to fluorouracil and fluorouracil related substances containing medicinal products - EudraVigilance analysis and literature review
Drug utilisation study of macrolide-containing medicinal products during pregnancy
EHDS2 Pilot Use Case: Natural history of coagulopathy in COVID-19 patients and persons vaccinated against SARS-CoV-2 during the Omicron period.
EMA drug utilisation study of cyproterone-ethinylestradiol products
EMA Self-Controlled Case Study of Fluoroquinolones and Retinal Detachment in The Health Improvement Network database
EMA study on prescribing of codeine to children and adolescents for cough and cold
EMA study on prescribing of ibuprofen in the French primary care setting
EMA study on prescribing of testosterone in the primary care setting
Follow-Up Survey of stakeholder actions following the EMA patient registry workshops
Glucocorticoid-induced osteoporosis (GIOP): prescription patterns of glucocorticoids in paediatric patients
Hydroxyethyl starch (HES) solutions and risk of acute kidney injury and mortality in acute trauma patients
Immune thrombocytopenia following vaccination with DTaP-IPV or TdaP-IPV in children
Impact of withdrawal of fusafungine from the market on the prescribing of alternative treatments in Germany (Fusafungine impact study)
Inactivated varicella zoster vaccine and herpes zoster
Incidence of Central Retinal Artery Occlusion in the Neovascular Age-related Macular Degeneration Population (RAO in neovascular AMD)
Incidence of phimosis and paraphimosis in patients treated with SGLT2 inhibitors
Incidence rates of adverse events of special interest: Guillain-Barré syndrome and Bell’s palsy
Incidence rates of Cutaneous T-Cell Lymphomas (CTCL) among patients with atopic dermatitis (AD)
Incidence rates of morphoea, systemic sclerosis and scleroderma
Incidence rates of pemphigus and pemphigoid following COVID-19 vaccines
Incidence rates of vulval ulceration following Comirnaty vaccine
Indications for systemic fluoroquinolone prescribing in Europe: a descriptive population based study
Leuprorelin and medication error and lack of effect - An analysis of EudraVigilance
Loperamide and the risk of Brugada syndrome
Measuring the impact of medicines regulatory interventions – systematic review and methodological considerations
Medication Errors – a characterisation of spontaneously reported cases in EudraVigilance
Metamizole and risk of hepatotoxicity –comparative cohort study of incidence of hepatic events in patients treated with metamizole vs. patients treated with paracetamol in IMS Disease Analyzer Germany between January 2009 and December 2018 (Metamizole and hepatotoxicity)
Patients and HCP understanding on additonal monitoring
Pattern of use of Human Growth Hormone (Somatropin) in the United Kingdom general practice setting: A Drug Utilization Study in The Health Improvement Network (THIN) database (Somatropin use in routine clinical practice in UK)
Population incidence rates of pemphigoid in six European countries
Prenatal exposure to paracetamol and the risk of urogenital system disorders or neurodevelopmental disorders in offspring: a systematic review of observational studies
Prescribing of codeine for the treatment of pain in children. Drug utilisation study using IMS electronic health records in Germany and France.
Prescribing of digoxin for long-term use in atrial fibrillation in France, Germany and the UK during 2000-2014
Prescribing of flupirtine in IMS Disease Analyser in Germany (Flupirtine drug utilisation in Germany)
Prescribing of paracetamol in patients with chronic renal failure A Drug Utilisation Study (Paracetamol doses in renal failure)
Prescribing of zolpidem in the primary care setting in France, Germany and the UK during 2012. (Prescribing of zolpidem in IMS Germany/France/UK)
Prescription patterns of combined hormonal contraceptives with 3rd or 4th versus 2nd generation progestogens in France, Germany and the UK during 2002- 2011: A retrospective analysis of the IMS Disease Analyser databases
Prevalence of Acute Liver Injury
Prevalence of hypereosinophilic syndrome (HES) in the paediatric population in EU (Hypereosinophilic syndrome in children)
Prevalence of immunocompromised patients with a diagnosis of cytomegalovirus infection
Prevalence of multiple myeloma
Prevalence of narcolepsy in two European countries - France and Germany
Prevalence of palmoplantar psoriasis and pustular psoriasis in children
Prevalence of primary and secondary arterial hypertension in children and treatment with angiotensin II receptor blockers
Product identification of biologicals in ADR reports received from European clinical practice
Proposals for Engaging Patients and Healthcare Professionals in Risk Minimisation from an Analysis of Stakeholder Input to the EU Valproate Assessment Using the Novel Analysing Stakeholder Safety Engagement Tool (ASSET)
Psychosis and psychotic disorders” and “Depression and suicide/self-injury” following exposure to Hydroxychloroquine and chloroquine
Rapid Data Analysis (RDA) – Amfepramone drug utilisation
Rapid Data Analysis – Ceftriaxone and hepatic events
Rapid Data Analysis – Systemic fluoroquinolones and thrombotic thrombocytopenic purpura (TTP)
Rapid Data Analysis – Tolperisone drug utilisation
Report on PRAC Pilot on Rapid Data Analytics
Retinoid-containing medicinal products and Neuropsychiatric disorders: A descriptive analysis of EudraVigilance data
Risk of peripheral neuropathy with systemic fluoroquinolone exposure: population-based nested case-control study
Risk of tendon rupture with systemic fluoroquinolone exposure: nested case-control study
Safety and effectiveness of COVID-19 maternal immunisation: An update of available evidence
Serotonin and norepinephrine reuptake inhibitors, selective serotonin reuptake inhibitors and other antidepressants and persistent sexual dysfunction - An EudraVigilance analysis
SSRIs during pregnancy and risk of autism spectrum disorder and attention deficit hyperactivity disorder: systematic review of observational studies
Study of evidence of potential selective prescribing of clenbuterol compared to other beta-2-agonists (Clenbuterol selective prescribing)
Suicide and suicidality after exposure to finasteride (Suicidality with finasteride)
Survey on the collection of data on adverse events related to medicinal products through registries
To examine the impact of additional confounder adjustment for the potential association between second line T2DM therapy and thyroid cancer: a nested case-control study (GLP1i and thyroid cancer)
Tramadol prescribing: a drug utilisation study using electronic data from France, Germany and the UK
Treatment patterns in patients with pulmonary arterial hypertension
Trends in co-prescribing of renin-angiotensin system (RAS)-acting agents in France, Germany and the UK during 2001 -2012
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 between 1999 and 2015
Use of antiepileptics and risk of suicidality. An exploratory study using the UK General Practice Research Database (GPRD) and data from the Danish registries with an evaluation of available data from further European data sources.
Use of benzodiazepines and risk of hip/femur fracture. A methodological comparison across data sources and epidemiological design.
Use of inhaled long acting beta2 adrenoceptor agonists and the risk for Acute Myocardial Infarction (AMI). A methodological comparison across data sources and epidemiological design
Use of ondansetron in pregnant female patients in the IMS Disease Analyzer databases in France and Germany (Ondansetron use pregnancy)
Use of products containing oestrogens alone and oestrogens in combination with progestogens (not contraceptives) between 2000 and 2014 in France, Germany and the UK
Use of sulfonamide-trimethoprim combinations during pregnancy in IMRD-Germany and IMRD-France
Use of thiazides and risk of skin cancer - systematic review and meta-analysis (Thiazides and skin cancer)
Validation of statistical signal detection procedures in eudravigilance post-authorization data: a retrospective evaluation of the potential for earlier signalling.
Vascular Endothelial Growth Factor Inhibitors and Artery dissections and aneurysms - An analysis of EudraVigilance