Spontaneous reports of suspected adverse drug reactions
The Eplontersen Pregnancy and Lactation Outcomes Study: A Descriptive Safety Study of Pregnant and Lactating Individuals and Their Offspring Exposed to Eplontersen (EPPRO)
Argentina
Armenia
Australia
Austria
Belgium
Brazil
Bulgaria
Canada
China
Croatia
Czechia
Denmark
Estonia
European Union
Finland
France
Georgia
Germany
Greece
Greenland
Hungary
Iceland
India
Indonesia
Ireland
Israel
Italy
Japan
Korea, Democratic People's Republic of
Latvia
Lithuania
Luxembourg
Netherlands
New Zealand
Norway
Other
Poland
Portugal
Romania
Singapore
South Africa
Spain
Sweden
Switzerland
Türkiye
Ukraine
United Arab Emirates
United Kingdom
United Kingdom (Northern Ireland)
United States
EU PAS number:
EUPAS1000000736
First published:
17/09/2025
Study
Planned
Post-marketing study to assess the risk of intussusception after immunization with GlaxoSmithKline (GSK) Biologicals’ oral live-attenuated human rotavirus vaccine in infants less than 1 year old in Latin America (212329)
Argentina
Colombia
Dominican Republic
Honduras
Mexico
Panama
EU PAS number:
EUPAS1000000701
First published:
01/10/2025
Study
Planned
Investigating risk of cancer with Sodium-glucose cotransporter 2 inhibitors: a Case/Non-Case Study in the WHO Global Pharmacovigilance Database Vigibase
France
EU PAS number:
EUPAS1000000311
First published:
03/09/2024
Study
Finalised
Clinical validation study of a CAD system with artificial intelligence algorithms for early non-invasive detection of in vivo cutaneous melanoma. (LEGIT_MC_EVCDAO_2019)
Spain
EU PAS number:
EUPAS108254
First published:
01/07/2025
Study
Finalised
Pilot study for the clinical validation of an artificial intelligence algorithm to optimize the appropriateness of dermatology referrals. (LEGIT.HEALTH_DAO_Derivation_O_2022)
Spain
EU PAS number:
EUPAS108167
First published:
01/07/2025
Study
Ongoing
Clinical Validation of a Computer-Aided Diagnosis (CAD) System Utilizing Artificial Intelligence Algorithms for Continuous and Remote Monitoring of Patient Condition Severity in an Objective and Stable Manner. (LEGIT_COVIDX_EVCDAO_2022.)
Spain
EU PAS number:
EUPAS108260
First published:
01/07/2025
Study
Finalised
Thromboembolic events reported in association with idarucizumab and andexanet alfa: disproportionality analysis of the Food and Drugs Administration Adverse Eventr Resporting System (FAERS) database (Idarucizumab/andexanet alfa & thromboembolism)
Italy
EU PAS number:
EUPAS107330
First published:
02/04/2024
Study
Ongoing
Prospective non-interventional cohort study to assess safety and tolerability of 3Fluart 2023/2024 trivalent seasonal influenza vaccine in children, adolescents, adults and elderly subjects (3Fluart-H-34)
Hungary
EU PAS number:
EUPAS105039
First published:
02/05/2024
Study
Finalised
Monitoring of pregnancy outcomes in women treated with inclisiran: a non-interventional study
Switzerland
EU PAS number:
EUPAS42905
First published:
31/07/2024
Study
Ongoing
Evaluation of pregnancy and infant outcomes in Kesimpta patients using PRegnancy outcomes Intensive Monitoring (PRIM) data - The Kesimpta-PRIM study. (The Kesimpta PRIM study.)
Switzerland
EU PAS number:
EUPAS49855
First published:
08/08/2024
Study
Ongoing