Statements (23)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
pharmacovigilance database
|
| gptkbp:access |
restricted and public access
|
| gptkbp:established |
2001
|
| https://www.w3.org/2000/01/rdf-schema#label |
EudraVigilance (EU)
|
| gptkbp:language |
English
|
| gptkbp:legalBasis |
Regulation (EC) No 726/2004
Directive 2001/83/EC |
| gptkbp:monitors |
human medicines
veterinary medicines |
| gptkbp:notableCollection |
adverse drug reaction reports
|
| gptkbp:operatedBy |
gptkb:European_Medicines_Agency
|
| gptkbp:purpose |
monitoring safety of medicines
|
| gptkbp:regionServed |
gptkb:European_Union
|
| gptkbp:relatedTo |
European Union pharmacovigilance system
|
| gptkbp:type |
individual case safety reports
|
| gptkbp:usedFor |
gptkb:European_Parliament
public healthcare professionals pharmaceutical companies national competent authorities |
| gptkbp:website |
https://www.ema.europa.eu/en/human-regulatory/research-development/pharmacovigilance/eudravigilance
|
| gptkbp:bfsParent |
gptkb:Pfizer–BioNTech_COVID-19_vaccine
|
| gptkbp:bfsLayer |
7
|