FDA.reportPublic FDA data

Cablivi Purple Book BLA 761112

BLA number
761112
Proprietary names
Cablivi
Proper names
caplacizumab-yhdp
Applicant
Ablynx NV
Center
CDER
First observed release
2020-05-01
Latest observed release
2026-06-01
Newest archive release
2026-06-01
FDA patent list
No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage
Present in newest release

Latest Known Product Presentations#

Product, Proprietary name, Proper name table
ProductProprietary nameProper nameLicense typeStrengthDosage formRoutePresentationMarketingLicensureApprovalPatent list provided
001Cablivicaplacizumab-yhdp351(a)11MGFor injectionIntravenous, SubcutaneousSingle-Dose VialRxLicensed2019-02-06

Published Patent List#

No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.

Official Monthly Change Events#

Release, Event, Product table
ReleaseEventProductNameLicense typeStatusApplicant
2021-03-01U001Cablivi351(a)RxAblynx NV
2020-08-01U001Cablivi351(a)RxAblynx N.V.
2020-05-01R001Cablivi351(a)RxAblynx N.V.

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2020-05-01001Cablivi351(a)RxLicensed2019-02-06