Spontaneous reports of suspected adverse drug reactions

Spontaneous reports of suspected adverse drug reactions

An Observational Case Series to Describe Women Exposed to Repatha During Pregnancy and Infant Outcomes During the First Year of Life (20200408)

United States

EU PAS number:

EUPAS42393

First published:

26/08/2021

Last updated 13/10/2025

Study Ongoing

Ozanimod Real-World Safety - A Post-Authorisation Multi-National Long-term Non-Interventional Study (ORION)

Germany

United States

EU PAS number:

EUPAS44615

First published:

14/12/2021

Last updated 14/08/2025

Study Ongoing

PRJ2215: Assessment of Bupropion Misuse/Abuse 2004-2011 (201235)

United States

EU PAS number:

EUPAS5568

First published:

17/01/2014

Last updated 24/05/2024

Study Finalised

Adakveo (crizanlizumab) PRegnancy outcomes Intensive Monitoring (PRIM) (Adakveo (crizanlizumab) PRIM)

Switzerland

EU PAS number:

EUPAS39412

First published:

18/02/2021

Last updated 08/05/2024

Study Ongoing

Comparative cardiovascular side effects of medications for attention-deficit/hyperactivity disorder: protocol of a case non-case study based on the WHO international pharmacovigilance database

France

EU PAS number:

EUPAS47582

First published:

07/06/2022

Last updated 23/04/2024

Study Planned

A regulatory requirement non-interventional study to monitor the safety and effectiveness of Ofev (Nintedanib, 150mg/100mg, BID) in Korean patients

Korea, Republic of

EU PAS number:

EUPAS41912

First published:

07/07/2021

Last updated 10/12/2024

Study Finalised

Prospective non-interventional cohort study to assess safety and tolerability of 3Fluart 2022/2023 trivalent seasonal influenza vaccine in children, adolescents, adults and elderly subjects (3Fluart-H-31)

Hungary

EU PAS number:

EUPAS47317

First published:

02/06/2022

Last updated 17/04/2024

Study Finalised

Prospective non-interventional cohort study to assess safety and tolerability of 3Fluart 2021/2022 trivalent seasonal influenza vaccine in children, adolescents, adults and elderly subjects (3Fluart-H-30)

Hungary

EU PAS number:

EUPAS41178

First published:

19/05/2021

Last updated 17/04/2024

Study Finalised

Monitoring of the Lenalidomide Pregnancy Prevention Programme (PPP) Implementation and Effectiveness in Germany (Lena-PIE Germany)

Germany

EU PAS number:

EUPAS45747

First published:

14/02/2022

Last updated 02/07/2024

Study Ongoing

Demonstration study 2.5.5 of the ConcePTION project; Validation of primary source pregnancy exposure and outcomes (pharmacovigilance data)

Netherlands

United Kingdom

EU PAS number:

EUPAS44505

First published:

01/12/2021

Last updated 03/03/2022

Study Planned