Statements (22)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory process
|
| gptkbp:administeredBy |
gptkb:European_Medicines_Agency
|
| gptkbp:appliesTo |
medicines
|
| gptkbp:awardedBy |
conditional marketing authorisation
|
| gptkbp:condition |
public health emergencies
insufficient clinical data unmet medical needs |
| gptkbp:convertedTo |
standard marketing authorisation
|
| https://www.w3.org/2000/01/rdf-schema#label |
EMA (conditional approval)
|
| gptkbp:legalBasis |
Regulation (EC) No 726/2004
|
| gptkbp:purpose |
early access to medicines
|
| gptkbp:region |
gptkb:European_Union
|
| gptkbp:renewable |
yes
|
| gptkbp:requires |
risk management plan
additional data submission annual reassessment |
| gptkbp:usedFor |
gptkb:COVID-19_vaccines
rare disease treatments oncology medicines |
| gptkbp:validOn |
one year
|
| gptkbp:bfsParent |
gptkb:REGEN-COV_(casirivimab_and_imdevimab)
|
| gptkbp:bfsLayer |
7
|