Search | HMA-EMA Catalogues of real-world data sources and studies

Evaluation of the effectiveness of Penthrox® (methoxyflurane) educational tools adopted as additional risk minimisation measures: Healthcare professional and Patient Survey (Penthrox-Survey)

United Kingdom

EU PAS number:

EUPAS13034

First published:

05/04/2016

Last updated 03/06/2026

Study Finalised

Myozyme (alglucosidase alfa) Safety Information Packet effectiveness evaluation: a health care professional survey

France

Germany

Italy

Poland

Spain

United Kingdom

EU PAS number:

EUPAS10301

First published:

15/07/2015

Last updated 03/06/2026

Study Finalised

Evaluation of the effectiveness of the belatacept (Nulojix®) Patient Alert Card in patients following renal transplantation in European Economic Area countries.

Austria

France

Germany

Sweden

EU PAS number:

EUPAS10046

First published:

24/06/2015

Last updated 03/06/2026

Study Finalised

Evaluation of the effectiveness of the abatacept (ORENCIA®) intravenous and subcutaneous formulation Patient Alert Cards in patients with rheumatoid arthritis in a sample of European Economic Area countries

France

Germany

Spain

Sweden

United Kingdom

EU PAS number:

EUPAS10122

First published:

30/06/2015

Last updated 03/06/2026

Study Finalised

Post Authorisation Safety Study (PASS) to Evaluate the Risks of Hepatotoxicity and Nephrotoxicity from Administration of Methoxyflurane (Penthrox®) for Pain Relief in Hospital Accident & Emergency Departments in the United Kingdom (Penthrox-PASS)

United Kingdom

EU PAS number:

EUPAS13040

First published:

05/04/2016

Last updated 03/06/2026

Study Finalised

Non-interventional study with Binosto 70 mg effervescent tablets once weekly investigating gastro-intestinal events and medication errors (Gastro-PASS)

Italy

Spain

EU PAS number:

EUPAS10888

First published:

04/09/2015

Last updated 03/06/2026

Study Finalised

Characterising the safety profile of lurasidone in clinical practice: A drug utilisation and safety study using a United Kingdom primary care database

United Kingdom

EU PAS number:

EUPAS18536

First published:

07/04/2017

Last updated 03/06/2026

Study Planned

A prospective study to evaluate the safety, effectiveness and impact of the RTS, S/AS01E vaccine in young children in sub-Saharan Africa (EPI-MALARIA-003 VS AME) (115056)

Ghana

Kenya

Malawi

EU PAS number:

EUPAS28541

First published:

20/03/2019

Last updated 03/06/2026

Study Finalised

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Sweden

First published:

24/03/2010

Last updated 02/06/2026

Institution Educational Institution Laboratory/Research/Testing facility Not-for-profit ENCePP partner

Yale University Medical School Department of Neurosurgery (Yale)

United States

First published:

02/06/2026

Last updated 02/06/2026

Institution Hospital/Clinic/Other health care facility

Maternal and Postnatal Outcomes: A worldwide decentralized observational registry to evaluate the safety in women with Fabry disease and their infants after exposure to Elfabrio (pegunigalsidase alfa-iwxj/pegunigalsidase alfa) during pregnancy and/or lactation

Germany

Italy

Spain

United Kingdom

United States

EU PAS number:

EUPAS1000000957

First published:

02/06/2026

Last updated 02/06/2026

Study Ongoing

A Non-Interventional Post-Approval Safety Study of Pfizer-BioNTech COVID-19 Vaccine in the United States

United States

EU PAS number:

EUPAS43468

First published:

19/10/2021

Last updated 02/06/2026

Study Finalised

International Registries for Rare Conditions Affecting Sex Development & Maturation (SDMregistries; formerly known as I-DSD/I-CAH/I-TS /I-HH)

Angola

Argentina

Armenia

Australia

Austria

Bangladesh

Belgium

Bosnia and Herzegovina

Brazil

Bulgaria

Cameroon

Canada

China

Croatia

Cyprus

Czechia

Denmark

Egypt

France

Georgia

Germany

Greece

Hong Kong

Hungary

India

Indonesia

Ireland

Israel

Italy

Japan

Jordan

Kenya

Kuwait

Lithuania

Malaysia

Mexico

Montenegro

Morocco

Netherlands

Nigeria

Norway

Oman

Pakistan

Philippines

Poland

Portugal

Romania

Russian Federation

Serbia

Singapore

Slovakia

South Africa

Spain

Sri Lanka

Sudan

Sweden

Switzerland

Taiwan

Tanzania, United Republic of

Thailand

Türkiye

Uganda

Ukraine

United Arab Emirates

United Kingdom

United States

Uzbekistan

Viet Nam

First published:

01/06/2026

Last updated 01/06/2026

Data source

Human

Disease registry

Record completeness: 96%

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Interim Analysis of Myocarditis and Pericarditis Associated with COMIRNATY in Persons Less Than 21 Years of Age

Canada

United States

EU PAS number:

EUPAS1000000600

First published:

21/08/2025

Last updated 01/06/2026

Study Discontinued

Post-marketing study to assess serotype-specific effectiveness of Reassortant Rotavirus Vaccine, Live, Oral, Pentavalent (Vero Cell) (ROTATEQ®) in China (V260-077)

China

EU PAS number:

EUPAS36666

First published:

03/09/2020

Last updated 01/06/2026

Study Finalised

Additional risk minimisation measures for Ruconest - European survey of educational materials

European Union

United Kingdom

EU PAS number:

EUPAS1000000680

First published:

21/07/2025

Last updated 01/06/2026

Study Finalised

A Post-Marketing Safety Study using a Pregnancy Registry to Evaluate the Safety of Respiratory Syncytial Virus Vaccine (ABRYSVO™) Exposure During Pregnancy (C3671041)

United States

EU PAS number:

EUPAS1000000179

First published:

07/06/2024

Last updated 01/06/2026

Study Ongoing

Real-world Retrospective Study of RSV Hospital Care Burden, HCRU, and Costs in a Multi-country Hospital Database (REACH)

Netherlands

Spain

United Kingdom

EU PAS number:

EUPAS1000000941

First published:

29/05/2026

Last updated 29/05/2026

Study Ongoing

Dutch Haemophilia Registry

Netherlands

First published:

01/02/2024

Last updated 29/05/2026

Data source

Human

Disease registry

Record completeness: 96%

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German Dementia Registry (DEMREG)

Germany

EU PAS number:

EUPAS1000000913

First published:

29/05/2026

Last updated 29/05/2026

Study Ongoing

TARGET-EU: Dapagliflozin and major adverse cardiovascular events in type 2 diabetes

Netherlands

Spain

United Kingdom

EU PAS number:

EUPAS1000000979

First published:

29/05/2026

Last updated 29/05/2026

Study Planned

TARGET-EU: Rivaroxaban and risk of major gastrointestinal bleeding in elderly patients with non-valvular atrial fibrillation

Denmark

Netherlands

Spain

EU PAS number:

EUPAS1000001001

First published:

29/05/2026

Last updated 29/05/2026

Study Planned

US Open Claims

United States

First published:

01/02/2024

Last updated 28/05/2026

Data source

Human

Administrative healthcare records (e.g., claims)

Record completeness: 80%

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Oncology EMR - OMOP

United States

First published:

01/02/2024

Last updated 28/05/2026

Data source

Human

Hospital inpatient records Hospital outpatient visit records Specialist ambulatory care records

Record completeness: 90%

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Ambulatory EMR - OMOP

United States

First published:

01/02/2024

Last updated 28/05/2026

Data source

Human

Primary care medical records Specialist ambulatory care records

Record completeness: 97%

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Lithuanian National Data Lake

Lithuania

First published:

14/08/2025

Last updated 28/05/2026

Data source

Human

Administrative healthcare records (e.g., claims) Birth registry Death registry Diagnostic tests or procedures reimbursement Drug registry Hospital discharge records Hospital inpatient records Hospital outpatient visit records Other Pharmacy dispensing records Population registry Primary care medical records Registration with healthcare system Specialist ambulatory care records Vaccination registry

Record completeness: 81%

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Cancer Registry of Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E

Portugal

First published:

01/02/2024

Last updated 28/05/2026

Data source

Human

Disease registry

Record completeness: 87%

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Children's Memorial Health Institute Database

Poland

First published:

27/11/2025

Last updated 28/05/2026

Data source

Human

Hospital discharge records Hospital inpatient records Hospital outpatient visit records Specialist ambulatory care records

Record completeness: 81%

Compare Compare

Pedianet

Italy

First published:

17/10/2022

Last updated 28/05/2026

Data source

Human

Other Population registry Primary care medical records

Record completeness: 90%

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University Medicine, University Hospital Carl Gustav Carus Dresden

Germany

First published:

19/06/2024

Last updated 28/05/2026

Data source

Human

Hospital inpatient records Hospital outpatient visit records

Record completeness: 81%

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University Hospital Antwerp structured data

Belgium

First published:

01/08/2025

Last updated 28/05/2026

Data source

Human

Cancer registry Hospital discharge records Hospital inpatient records Hospital outpatient visit records Other

Record completeness: 95%

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Patient Experience Data in Non‑Interventional Studies Supporting EMA Marketing Authorisation Applications between 2018 and 2023

Netherlands

EU PAS number:

EUPAS1000001011

First published:

28/05/2026

Last updated 28/05/2026

Study Ongoing

Institute for Medicines and Medical Devices (CInMED)

Montenegro

First published:

27/05/2024

Last updated 28/05/2026

Institution Non-EEA National Competent authority Regulatory Authority ENCePP partner

The Danish Multiple Sclerosis Registry

Denmark

First published:

03/11/2025

Last updated 28/05/2026

Data source

Human

Disease registry

Record completeness: 58%

Compare Compare

212853 - Shingrix for intramuscular injection Drug Use Investigation

Japan

EU PAS number:

EUPAS46662

First published:

26/04/2022

Last updated 28/05/2026

Study Finalised

Real-life Enfortumab Vedotin Outcomes as First-line Urothelial Carcinoma Treatment in the Non-interventional Observational and Nationwide French Study

France

EU PAS number:

EUPAS1000000763

First published:

12/11/2025

Last updated 28/05/2026

Study Ongoing

Non-Interventional Postmarketing Safety Study to Evaluate the COMIRNATY 2024-2025 Formula (monovalent KP.2) in the United States

United States

EU PAS number:

EUPAS1000000476

First published:

21/02/2025

Last updated 28/05/2026

Study Ongoing

Enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer previously treated with chemotherapy and immunotherapy: a multicenter, non-interventional study in Italy (EVIDENCE)

Italy

EU PAS number:

EUPAS107848

First published:

22/01/2024

Last updated 28/05/2026

Study Ongoing

Division of Pharmacoepidemiology & Clinical Pharmacology (PECP), Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University

Netherlands

First published:

01/03/2010

Last updated 27/05/2026

Institution Educational Institution ENCePP partner

A pregnancy exposure registry study to assess clinical follow-up and outcomes of pregnancies exposed to ulipristal acetate 30 mg

Austria

Czechia

Finland

France

Germany

Greece

Ireland

Italy

Liechtenstein

Malta

Netherlands

Norway

Poland

Portugal

Romania

Spain

Switzerland

United Kingdom

EU PAS number:

EUPAS33796

First published:

24/02/2020

Last updated 27/05/2026

Study Ongoing

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