A5000012394- SARS-CoV-2 and COVID-19 Research
- Pregnancy and Medication Impact
- Reproductive Health and Contraception
- COVID-19 Clinical Research Studies
- Pharmacological Effects and Toxicity Studies
- Vaccine Coverage and Hesitancy
- Retinoids in leukemia and cellular processes
- Heparin-Induced Thrombocytopenia and Thrombosis
- Pediatric Pain Management Techniques
- Viral Infections and Immunology Research
- Immunodeficiency and Autoimmune Disorders
- COVID-19 and healthcare impacts
- Intramuscular injections and effects
- Chronic Obstructive Pulmonary Disease (COPD) Research
- Neutropenia and Cancer Infections
- Influenza Virus Research Studies
- Bone health and osteoporosis research
- Pharmacovigilance and Adverse Drug Reactions
- Respiratory and Cough-Related Research
- Pericarditis and Cardiac Tamponade
- Bone health and treatments
- Blood disorders and treatments
- Venous Thromboembolism Diagnosis and Management
- Bone and Joint Diseases
- Estrogen and related hormone effects
Agencia Española de Medicamentos y Productos Sanitarios
2022-2024
Pharmaceuticals and Medical Devices Agency
2024
Agenzia Regionale di Sanità della Toscana
2022
In May 2020, the ACCESS (The vACCine covid-19 monitoring readinESS) project was launched to prepare real-world of COVID-19 vaccines. Within this project, study aimed generate background incidence rates 41 adverse events special interest (AESI) contextualize potential safety signals detected following administration A dynamic cohort conducted using a distributed data network 10 healthcare databases from 7 European countries (Italy, Spain, Denmark, The Netherlands, Germany, France and United...
Estimates of the association between COVID-19 vaccines and myo-/pericarditis risk vary widely across studies due to scarcity events, especially in age- sex-stratified analyses.
Due to established teratogenicity of valproates, the EU risk minimisation measures (RMMs) with a pregnancy prevention programme (PPP) for valproate were updated in March 2018.To investigate effectiveness 2018 RMMs on utilisation five European countries/regions.A multi-database, times series study females childbearing potential (12-55 years) was conducted using electronic medical records from countries/regions (01.01.2010-31.12.2020): Denmark, Tuscany (Italy), Spain, Netherlands, and UK....
Using 4 data-sources (Spain, Italy, United Kingdom) data and a 1:1 matched cohort study, we aimed to estimate vaccine effectiveness (VE) in preventing SARS-CoV-2 infections with hospitalisations (±30 days) death (±56 general population clinical subgroups homologous/heterologous booster schedules (Comirnaty-BNT Spikevax-MOD original COVID-19 vaccines) by comparison unboosted individuals, during Delta beginning of Omicron variants. Hazard Ratio (HR, Cox models) VE ([1-HR]*100) were calculated...
Background: In March 2018, the European pregnancy prevention programme for oral retinoids was updated as part of risk minimisation measures (RMM), emphasising their contraindication in pregnant women. Objective: To measure impact 2018 revision RMMs Europe by assessing utilisation patterns isotretinoin, alitretinoin and acitretin, contraceptive measures, testing, discontinuation, occurrence concomitantly with a retinoid prescription. Methods: An interrupted time series (ITS) analysis to...
Abstract We test the robustness of self-controlled risk interval (SCRI) design in a setting where time between doses may introduce time-varying confounding, using both negative control outcomes (NCOs) and quantitative bias analysis (QBA). All vaccinated cases identified from 5 European databases September 1, 2020, end data availability were included. Exposures 1-3 Pfizer, Moderna, AstraZeneca, Janssen COVID-19 vaccines; myocarditis and, as NCO, otitis externa. The SCRI used 60-day window...
Concerns over serious respiratory depression in children led to two European Union (EU) referral procedures (in 2013 and 2015) review the benefit-risk balance of codeine this population when used for pain relief, cough or cold. Consequently, should no longer be aged < 12 years restrictions were introduced treatment ≥ years.This multinational collaborative study aimed assess effectiveness these risk minimisation measures by evaluating changes prescribing alternative treatments.Children under...
Setting Primary and/or secondary health care data from four European countries: Italy, the Netherlands, United Kingdom, Spain Participants Individuals with complete for year preceding enrollment or those born at start of observation time. The cohort comprised 25,720,158 subjects. Interventions First and second dose Pfizer, AstraZeneca, Moderna, Janssen COVID-19 vaccine. Main outcome measures 29 adverse events special interest (AESI): acute aseptic arthritis, coronary artery disease,...
Antithrombotics have been widely used to treat and prevent COVID-19-related thrombosis; however, studies on their use at population levels are limited. We aimed describe antithrombotic patterns during the pandemic in Spanish primary care hospital-admitted patients with COVID-19. Methods: A real-world data study was performed. Data were obtained from BIFAP’s electronic health records. investigated prescriptions made within ±14 days after diagnosis between March 2020 February 2022, divided...