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BIFAP is an electronic database made up of medical records from Primary Care destined for pharmacoepidemiological studies and belonging to the Spanish Agency of Medicines and Medical Devices (AEMPS). It features the collaboration of the Autonomous Communities and the support of the main scientific societies involved.

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Confidentiality

We protect the confidentiality of patient information contained in the database in accordance with current data protection legislation.

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Collaboration

We promote the collaboration of Primary Care physicians and maintain high standards of information quality and benefits.

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Research

We encourage quality research from Primary Health Care, ensuring high levels of scientific quality.

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Independence

We develop independent research lines on aspects relevant to the Scientific community and the Public Health of the population.

                 RESEARCH ON COVID-19 AT BIFAP

Data for Public Health and Drug Safety.

BIFAP includes information provided by general practitioners and primary care paediatricians from the National Health System.

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14.810

Family doctors and paediatricians

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20.831.855

Anonymised Electronic Medical Records

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188.223.510

Person-years of follow-up

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9,04

Average years of follow-up per patient

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837.000.000

Health problem records

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2.400.000.000

Medication records

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97.000.000

Immunisation records

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8.700.000.000

General and analytical data records

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Collaborators

If you are a primary care physician from the National Health System in one of the participating autonomous communities you can actively collaborate in the BIFAP programme. As a partner you can also request research studies.

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Researchers

If you are a researcher attached to a public body you can use BIFAP as a source of information to conduct research. Sign up to learn about the process and we'll be in touch with you.

BIFAP Collaborators

Currently, family doctors or paediatricians who perform a primary care activity of the National Health System in one of the participating Autonomous Communities may be BIFAP collaborators.

It is not an indispensable requirement that they hold a quota, so resident internal doctors, alternate, interim or continued care doctors at Primary Care may also apply to be collaborators. 

BIFAP collaborators are Primary Care professionals in participating communities who voluntarily choose to help the BIFAP programme. This help is firstly realized by improving the way they record information during their usual clinical practice. To this end, recommendations on how best to record information are sent to collaborators on a regular basis so that it can be used in epidemiological studies.

Collaborating physicians may, on a voluntary basis, actively participate in improving the quality of BIFAP research by performing some more specific tasks whose dedication time can be quantified to be subsequently recognised:

1. Participating in database quality improvement tasks, dedicating time to perform standardisation tasks related to diagnostic and prescription drug information contained in BIFAP. This standardisation is carried out using online tools made available to collaborating physicians.

2. Providing expert clinical knowledge to help improve the quality of specific studies by other researchers by responding to surveys or conducting their own studies as a principal investigator. 

In addition to assisting in the maintenance of a national and public-owned epidemiological source of information aimed at improving the safety of the medicinal product, collaborating physicians are beneficiaries of the following services:

1. They access the BIFAP Services website where they have aggregate statistics on BIFAP patients both globally and within their Autonomous Community. Collaborators who hold a quota also have access to the aggregate data of their patients.

2. They have the specific support of the BIFAP Collaborator Support Unit to carry out their own research studies using BIFAP data.

3. In addition, by filling-in the Profile-Plus, they can share their interests in different areas of research and participate in research studies conducted at BIFAP.

4. All physicians who are registered as BIFAP collaborators and show their commitment to good HCE registration will receive, upon request, a document certifying that as of the day of issue they are listed as BIFAP collaborating physicians.

5. Physicians who have also performed specific database improvement tasks for which the time to perform can be quantified will receive a document certifying the number of hours for each calendar year, provided that they exceed a minimum of 10 hours in that period. 

Advisory Committee

El Comité Asesor tiene funciones consultivas y vela para que BIFAP se consolide y se desarrolle dentro de lo establecido en los convenios de colaboración con las CCAA participantes.  

Está compuesto por dos representantes de la Agencia Española de Medicamentos y Productos Sanitarios y un representante de cada una de las Comunidades Autónomas que participan en BIFAP.

  • César Hernández - Head of the Medicines for Human Use Department at the AEMPS
  • Dolores Montero - Head of the Pharmacovigilance and Pharmacoepidemiology Division at the AEMPS
  • Antonio Poncel Falcó, Aragón
  • Jesús Ruíz Salazar, Asturias
  • Fidelina de la Nuez Viera, Canarias
  • Mario González Ruiz, Cantabria
  • Judith Ceruelo Bermejo, Castilla y León
  • María José Calvo Alcántara , Madrid
  • María José Peñalver Jara, Murcia
  • Juan Erviti López, Navarra
  • Fuencisla Iglesias Alonso, Castilla - La Mancha
  • Amparo Esteban Reboll, Comunidad Valenciana

Data Access Governance 

The document entitled “BIFAP Data Access Governance” reflects the action protocol that is carried out to ensure data protection.
It describes the different treatments to which the data is subjected, the management of access to the data, the use of the data by virtue of the user type, and the requirements and conditions applicable to the BIFAP studies researchers.
The main recipients of this document are:

  1. Potential researchers from the public field who are proposed to carry out studies using BIFAP, and who must take into account the conditions and procedures established for it.
  2. The collaborating institutions, physicians, patients and the general population, since the dissemination of the requirements and processes involved in accessing the data contained in BIFAP supports the necessary trust that health data is used safely in order to obtain, through quality research studies, relevant knowledge to improve the health of the population.
  3. 3. In addition, the AEMPS database administrators and all its users have an obligation to know and apply it.
In addition, essential information on BIFAP's data processing activities, in compliance with the duty of information and transparency in accordance with data protection regulations, is presented in the “Information clause on the processing of personal data”.

Autonomous Communities  

BIFAP draws on the data provided by the autonomous communities that voluntarily participate through collaboration agreements. These agreements detail the commitments of the Autonomous Community and the Spanish Agency of Medicines and Medical Devices , as well as other operational aspects related to data processing, monitoring commissions, etc.
You can access the agreements of the different participating autonomous communities as follows:


Cantabria (BOE 18 Febrero 2021)
Castilla y León (Adhesión 22 Abril 2021)
Canarias (BOE 12 Marzo 2018
Castilla-La Mancha (Adhesión 24 Marzo 2021
Comunidad Valenciana (Adhesión 14 Mayo 2021)


BIFAP Scientific Committee

The BIFAP Scientific Committee’s mission is to ensure the scientific and technical quality of the projects carried out with the database as well as the implementation of activities that may have an impact on the quality of the information contained in the database. It meets on a monthly basis.

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1) To promote quality research with the BIFAP database.
2) To evaluate the scientific quality, relevance, feasibility and interest of the study proposals received.
3) To prioritise, if necessary, the implementation of certain projects.



Spokesperson designated by the AEMPS: Lucía Cea Soriano (President)
Spokesperson acting on behalf of the AEMPS: Miguel Ángel Maciá Martínez (Secretary)
Spokespeople acting on behalf of the Advisory Committee: Eduardo Fernández Quintana, Jesús Ruiz Salazar
Spokesperson acting on behalf of public research bodies: Beatriz Pérez Gómez
Spokesperson acting on behalf of the collaborating physicians: Aida Moreno Juste
Spokesperson acting on behalf of the BIFAP team: Elisa Martín Merino

The following are the planned meeting dates of the BIFAP Scientific Committee (Note: they could be changed if necessary):

September 27, 2022
October 25, 2022
November 22, 2022
December 12, 2022

In order to evaluate the protocols at each meeting, all the necessary documentation must be submitted at least 10 working days before the corresponding meeting. The Scientific Committee will communicate its opinion to the principal investigator normally in less than one month from the request, and within two months at most.

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Research Projects

Projects started in 2021

TitlePrincipal Investigator Scientific Committee ApprovalStatus
Real-world effectiveness of different COVID-19 vaccines in Spain: a cohort study based on public electronic health records (BIFAP),
Elisa Martín Merino
AEMPS
2021/04/29Active
Rapid Safety Assessment of SARS-CoV-2 vaccines in EU Member States using electronic health care datasources.

Patricia García Poza
AEMPS
2021/08/30Active
Rapid monitoring of exposure, Adverse Events of Special Interest and COVID-19 diagnoses prior to and after COVID-19 vaccination.

María del Mar Martín Pérez
AEMPS
2021/02/24Active
Extracción automática de reacciones adversas en textos de Atención Primaria.

Jorge Tenorio Berrio
UNED
2021/05/25Active
Metamizole and risk of agranulocitosis.


Elisa Martín Merino
AEMPS
2020/12/03Active
Ambulatory use of antibiotics in Spain: an analysis of national prescribing data using the indicators of the National Action Plan on Antimicrobial Resistances.

Carmen Marina Meseguer Barros
Servicio de Farmacia Atención Primaria. Comunidad de Madrid
2020/12/03Active
Características demográficas, clínicas y de tratamiento de una cohorte de pacientes con covid-19. Datos procedentes de la base de datos BIFAP.

Consuelo Huerta Alvarez
EMA / AEMPS
2021/01/27Active
Impacto en salud del tratamiento con trinomia en pacientes en prevención primaria y secundaria en vida real. Estudio TRIAP.

Sergio Cinza Sanjurjo
Centro de Salud Porto do Son. Santiago de Compostela
2021/01/27Active
Comparación de las distintas aproximaciones del índice de propensión y los modelos de regresión para análisis de supervivencia en un escenario real.
Airam de Burgos González
AEMPS
2021/08/30Completed

Projects started in 2020

TitlePrincipal Investigator Scientific Committee ApprovalStatus
Feasibility analysis of an EU infrastructure for COVID-19 vaccine monitoring.

Consuelo Huerta Alvarez
EMA / AEMPS
2020/10/28Completed
SYSADOA (symptomatic slow acting drugs for ostearthritis) Y RIESGO CARDIOVASCULAR.

Ramón Mazzucchelli Esteban
Hospital Universitario Fundación Alcorcón Comunidad de Madrid
2020/07/01Completed
Impact of EU label changes and revised pregnancy prevention programme for oral retinoid containing medicinal products: utilization and prescribing trends.Consuelo Huerta Alvarez
EMA / AEMPS
2020/01/23Active
Effect of regulatory interventions on agomelatine incidence rates use in Spain: a multiple intervention time-series analysis in an electronic health care database.

Diana González Bermejo
AEMPS
2020/03/26Active
Impact of EU label changes and revised pregnancy prevention programme for medicinal products containing valproate: utilisation and prescribing trends.

Consuelo Huerta Alvarez
EMA / AEMPS
2020/01/23Active
Vacunación antigripal y riesgo de eventos aterotrombóticos (infarto agudo de miocardio y accidentes cerebrovasculares): un estudio de casos y controles de base poblacional.Francisco de Abajo Iglesias
Universidad de Alcalá de Henares
2020/02/26Completed
Antiplatelet drugs and chemoprevention of digestive cancer: a propensity-score matched cohort study.Francisco de Abajo Iglesias
Universidad de Alcalá de Henares
2020/03/26Active
COVID-19 y embarazo: Principales efectos en la embarazada y en el desarrollo del embarazo utilizando datos secundarios procedentes de BIFAP.

Lucia Cea Soriano
Universidad Complutense de Madrid
2020/10/28Active
Deploying of machine learning models for personalized risk stratification and prognosis of renal damage in BIFAP. ML-PRD.
Luis Miguel Ruilope Urioste
Hospital 12 de Octubre
Comuniad de Madrid
2020/09/23Active
Asociación entre el uso de fármacos que bloquean el eje reninaangiotensina-aldosterosa (SRAA) y la incidencia y gravedad de la infección del COVID-19: Un estudio caso-población.
Francisco de Abajo Iglesias
Universidad de Alcalá de Henares
2020/03/26Completed
Estudio de incidencia de Herpes Zóster en pacientes con patología de base: DM, Insuficiencia cardiaca, EPOC y Asma. Ana Pilar Javierre Miranda
Centro de Salud Montesa
Comunidad de Madrid
2020/01/23Active
Creación de una herramienta para detectar fragilidad en una base de datos poblacional de atención primaria (BIFAP).María Medina Sampedro
CS Villaviciosa de Odón
Villaviciosa de Odón
Comunidad de Madrid
2020/01/23Active
El efecto del subsidio para parados de larga duración en la salud de los trabajadores de mediana edad.

Manuel Serrano Alarcón
Grupo de Investigación de Economía y Salud (CRES)
Universitat Pompeu Fabra
2020/02/26Completed
Efectos a corto plazo del calor y el frío en el uso de medicamentos respiratorios. Un estudio ecológico de series temporales.

Dominic Royé
Universidad Santiago de Compostela
2020/01/23Completed
Evaluación del riesgo de desarrollar la enfermedad de Alzheimer en personas mayores diagnosticadas de depresión en tratamiento con antidepresivos en monoterapia.

Elena González Burgos
Universidad Complutense de Madrid
2020/03/26Completed

Projects started in 2019

TitlePrincipal InvestigatorScientific Committee ApprovalStatus
Infección del tracto urinario en adultos en atención primaria en España: incidencia, etiología, prescripción y resistencias antibióticas (2009-2018). ESTUDIO ITURA-AP.

Jesús Redondo Sánchez
CS Ramón y Cajal
Alcorcón
Comunidad de Madrid
2019/03/28Completed
Tratamiento del asma: broncodilatadores vs corticoides inhalados.

Miguel Ángel Lobo Álvarez
CEIm-Regional de la Comunidad de Madrid
Miembro del Grupo de Respiratorio de la Sociedad Española de Medicina Familiar y Comunitaria
2019/03/28Completed
Global prescribing trends in antidepressants, opioids and lithium.

María Dolores Montero Corominas
AEMPS
2019/12/04Active
Changes in alternative treatments for pain and cough in children after introduction of risk minimisation measures for codeine.
Miguel Angel Maciá
AEMPS
2019/09/26Completed
Beneficio clínico neto de los antagonistas de la vitamina K versus anticoagulantes orales de acción directa en fibrilación auricular no valvular.Juan Erviti López
Servicio Navarro de Salud
2019/05/08Active
Efecto de la combinación "Triple whammy" en la hospitalización por fallo renal agudo-estudio de casos y controles anidado en una cohorte.Leire Leache Alegría
Servicio Navarro de Salud-Osasunbidea
Sección de Innovación y Organización
2019/07/04Completed
Análisis de la frecuencia de Hacer lo que No hay que hacer (sobreutilización Inadecuada) en atención primaria en España. Estudio SOBRINA.
María Pilar Astier Peña
CS La Jota
Zaragoza
Servicio Aragonés de Salud
2019/03/28Completed
Farmacoepidemiologia del tratamiento psicotrópico en niños y adolescentes.

Diego Pablo Sánchez Martínez
Universidad de Murcia
Facultad de Medicina
2019/10/30Completed
Riesgo De Fracturas Vertebrales Múltiples Tras la Interrupción Del Tratamiento Con Denosumab (Prolia®) en BIFAP.
Maria del Mar Martín Pérez
AEMPS
2019/07/04Active
Estudio de utilización de Fentanilo de liberación inmediata en España.
Diana González Bermejo
AEMPS
2019/02/26Active
Uso concomitante de tramadol y dabigatran y riesgo de sangrado: Estudio epidemiológico utilizando datos secundarios procedentes de BIFAP.
Lucia Cea Soriano
Universidad Complutense de Madrid
2019/08/29Completed
Análisis de la exacerbación en el paciente con EPOC según el tipo de tratamiento inhalatorio en Atención Primaria.

Antonio Luis Aguilar Shea.
Centro de salud Puerta de Madrid.
Alcalá de Henares.
Comunidad de Madrid
2019/12/04Completed
Contemporary trends in use of antiplatelets, anticoagulants and statins in three european countries.Francisco de Abajo Iglesias
Universidad de Alcalá de Henares
2019/09/26Completed
Incidencia de arritmias e IC en pacientes tratados con Venlafaxina, Desvenlafaxina y Vortioxetina. Muestra en la vida real. (BIFAP)José Seijas Amigo
Hospital Clínico Universitario de Santiago
2019/09/26Completed
Desarrollo y validación de una Escala de Predicción de fracturas Implementable en historia Clínica electrónica: EPIC.

Daniel Martínez Laguna
CAP Sant Martí de Provençals
Institut Català de la Salut
2019/05/08Completed

Projects started in 2018

TitlePrincipal InvestigatorScientific Committee Approval Status
Use of hydrochlorothiazide and risk of skin cancer.

Luz María León Muñoz
AEMPS
2018/09/27Completed
Use of flecainide and risk of skin cancer.

Luz María León Muñoz
AEMPS
2018/03/01Active
The prevalence and incidence rate of overweight and obesity among children and adolescents (0 to 17 years) in the BIFAP database.Talita Duarte Salles
IDIAP Jordi Gol
2018/06/28Completed
Asociación entre el uso de estatinas y sangrado mayor y accidente cerebrovascular isquémico en pacientes en tratamiento con anticoagulantes de acción directa por fibrilación auricular.
Consuelo Huerta Alvarez
AEMPS/EMA
2017/11/30Active
Creación y validación de un algoritmo de clasificación de términos médicos en la base de datos BIFAP.

Jesús Santamaría Martínez de la Casa
CNIO (Centro Nacional de Investigaciones Oncológicas)
2017/11/30Completed
Evolución de la prescripción de neurolépticos en personas con demencia en España.

Francisco Javier Olazarán Rodríguez
Hospital General Universitario Gregorio Marañón
Comunidad de Madrid
2018/03/01Completed
Relación entre la duración del tratamiento con doble antiagregación tras un infarto agudo de miocardio y eventos trombóticos y hemorrágicos en pacientes anticoagulados por fibrilación auricular.
Ana Fernández Vega
Hospital Clínico San Carlos.
Comunidad de Madrid
2018/09/27Active
Prescripción clínica de antibióticos.


 Javier Arranz Izquierdo
CS Arquitecte Bennassar
Palma de Mallorca
2018/05/24Completed
Control de factores riesgo y prevención secundaria en pacientes con muy alto riesgo cardiovascular.

Ana Fernández Vega
Hospital Clínico San Carlos.
Comunidad de Madrid
2018/01/25Completed
Estimación indirecta de la prevalencia de demencia en canarias mediante los datos de consumo de fármacos específicos para la demencia.Norberto Rodríguez Espinosa
Hospital Universitario Ntra. Señora de Candelaria
Tenerife
2018/07/19Completed
La Depresión en Atención Primaria y su Tratamiento Farmacológico.

Miguel Ángel Mayer Pujadas
Instituto Hospital del Mar de Investigaciones Médicas (IMIM) y Universitat Pompeu Fabra
Barcelona
2018/06/28Completed
El impacto de ayudas públicas a las familias sobre la salud infantil.

 Ana Mari Costa Ramón
Universtitat Pompeu Fabra
Barcelona
2018/11/29Completed

Projects started in 2017

TitlePrincipal InvestigatorScientific Committee Approval Status
Estudio EPOC-ATB - R1

Antonio Luis Aguilar Shea.
Centro de salud Puerta de Madrid.
Alcalá de Henares.
Comunidad de Madrid
2017/09/28Completed
Estudio multicéntrico en Atención Primaria sobre la prescripción antibiótica en otitis media y externa en adultos.

Cruz Bartolomé Moreno
Médico de familia.
Centro de salud Parque Goya.
Zaragoza.
Servicio Aragonés de Salud.
2017/09/28Completed
Estudio de utilización de medicamentos en población pediatriática en España.

María Amparo Gil López-Oliva
Centro de Farmacovigilancia de la Comunidad de Madrid.
Dirección General de Ordenación e Inspección.
Consejería de Sanidad de la Comunidad de Madrid.
2017/04/28Completed
Impacto de la alerta sanitaria de la metoclopramida en la práctica clínica diaria.Laura Urieta González
Servicio Aragonés de Salud
2017/03/23Completed
Cambios en los hábitos de prescripción de Trimetazidina en Atención Primaria tras las alertas de 2012 y 2016 de la AEMPS.David Idoipe Rubio
Servicio Aragonés de Salud
2017/02/23Completed
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.Consuelo Huerta Alvarez
AEMPS / EMA
2017/01/26Completed
Adaptación española de criterios de Beers. Repercusión en Benzodiazepinas.Josep Pastor Cano
Servicio Murciano de Salud
2017/01/26Completed
Utilidad de la base de datos BIFAP para el estudio de seguridad y eficacia del uso de medicamentos durante el embarazoLucía Cea Soriano
Dpto. Medicina Preventiva y Salud Pública. Facultad de Medicina. UCM
2017/01/26Completed
Aterotrombosis y uso de medicamentos: un programa de estudios epidemiológicos de base poblacional para evaluar problemas emergentes y controversias actuales.Francisco de Abajo Iglesias
Universidad de Alcalá de Henares
2016/05/26Completed

Projects started in 2016

TitlePrincipal InvestigatorScientific Committee Approval Status
Utilización de Benzodiazepinas y riesgo de demencia. Estudio poblacional.Pablo Aldaz Arce
Servicio Navarro de Salud
2016/10/27Completed
Vacunación frente al virus del papiloma humano.Elisa Martín Merino
AEMPS
2016/06/30Active
International study on trends in Clozapine utilization.Francisco de Abajo Iglesias
Universidad de Alcalá de Henares
2016/06/30Completed
La polimedicación en España: estudio sobre características generales y perfiles de riesgo a partir de una base de datos poblacional.Miguel Ángel Hernández Rodríguez
Dirección del Servicio Canario de la Salud
2016/06/30Completed
Combinación de un registro de casos poblacional y una base de datos de atención primaria: una nueva aproximación para los estudios caso-población.Francisco de Abajo Iglesias
Universidad de Alcalá de Henares
2016/06/30Active
ADVANCE – Accelerated development of vaccine benefit-risk collaboration in EuropeMaría Elisa Martín Merino
AEMPS
2016/04/07Completed

Projects started in 2015

TitlePrincipal InvestigatorScientific Committee Approval Status
Estudio de los factores de riesgo asociados a la neumonía adquirida en la comunidad y su tratamiento antibiótico en Atención Primaria.Federico Martinón Torres
Hospital Clínico Universitario
Santiago de Compostela
2015/10/29Completed
Elaboración estructurada de un vademécum personalizado como herramienta didáctica en la enseñanza de la terapéuticaEduardo Puerta del Castillo
Universidad de La Laguna
Servicio Canario de la Salud
2015/07/30Completed
Medicamentos como factores de protección o factores de riesgo del cáncer colorrectal.Francisco J. de Abajo Iglesias
Universidad de Alcalá de Henares
2015/07/30Completed
Efecto del Metilfenidato en la incidencia de valvulopatías e hipertensión arterial pulmonar: un estudio de casos y controles aniadado a una cohorte.Luis Carlos Saíz Fernández
Servicio Navarro de Salud
2015/06/25Completed
Efecto de la exposición a Ácido Valproico en la susceptibilidad a enfermedades causadas por virus con envuelta tipo Herpes.Miguel Gil
AEMPS
Francisco Sobrino
Centro de Biología Molecular Severo Ochoa (UAM-CSIC)
2015/06/25Completed
Tendencia de prescripciones de benzodiacepinas en atención primaria entre 2002-2014. Factores determinantes del inicio del tratamiento, no adherencia primaria y larga duración de tratamiento.Consuelo Huerta Alvarez
AEMPS
2015/04/29Completed
Opioid analgesics for non-cancer pain And RISK OF NONFATAL atherothrombotic events.Francisco J. de Abajo Iglesias
Universidad de Alcalá de Henares
2015/02/04Completed
Risk of non-fatal atherothrombotic events associated with the use of calcium supplements, vitamin D, bisphosphonates and other drugs for osteoporosis.Francisco J. de Abajo Iglesias
Universidad de Alcalá de Henares
2015/02/04Completed
Multiple Imputation Strategies for multi-database drug Safety Studies: the MISS Collaboration. Anti-osteoporosis medications and the risk of thromboembolic events: a multi-database cohort study.Elisa Martín Merino
AEMPS
2015/02/04Completed

Scientific Publications

Address

Agencia Española de Medicamentos y Productos Sanitarios.
División de Farmacovigilancia.
Programa BIFAP
Calle Campezo 1, Edificio 8
Madrid, 28022

Contact

Email: bifap@aemps.es  
Teléfono: +34 918 225 173

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