European Health Data & Evidence Network (EHDEN)

This sponsor has funded 8 studies across 22 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
33214 Ongoing Not included in RMP The comparative safety of first-line conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) used for the treatment of rheumatoid... Yes No
34497 Finalised Not included in RMP Hydroxychloroquine safety and potential efficacy as an antiviral prophylaxis in light of potential wide-spread use in COVID-19: a multinational,... Yes No
35296 Finalised Not included in RMP Association of angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARB) on coronavirus disease (COVID-19) incidence... Yes No
36231 Finalised Not included in RMP Association of alpha-1 blocker (ɑ-1B) on coronavirus disease (COVID-19) susceptibility and severity Yes No
37225 Planned Not included in RMP Project Sc(y)lla: SARS-Cov-2 Large-scale Longitudinal Analyses on the comparative safety and effectiveness of treatments under evaluation for... Yes No
41726 Ongoing Not included in RMP Drug utilisation studies using data mapped to the OMOP Common Data Model: a proof of concept study assessing respiratory drug use in patients with... Yes No
106954 Planned Not included in RMP Incidence, prevalence, and characterisation of medicines with suggested drug shortages in Europe Yes No
107015 Planned Not included in RMP Hip fracture information profiling, surveillance and treatment across epidemiological registries (HIPSTAR) Yes No

PAS by Risk Management Plan (RMP) requirement

European Health Data & Evidence Network (EHDEN)

The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.

Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.