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Search results for "EMA EPAR|DISEASES" in comments (approximate match)
Status:
US Previously Marketed
Source:
Xigris
(2001)
Source URL:
First approved in 2001
Source:
Xigris
Source URL:
Class:
PROTEIN
Status:
US Previously Marketed
Source:
Refludan
(1998)
Source URL:
First approved in 1998
Source:
Refludan
Source URL:
Class:
PROTEIN
Conditions:
Lepirudin is a direct thrombin inhibitor obtained by recombinant technology from the medicinal leech and used for treatment of heparin-induced thrombocytopenia (HIT). Lepirudin was the first direct thrombin inhibitor approved and most frequently used for the treatment of patients with HIT. The efficacy of lepirudin for HIT has been shown to improve general outcomes in patients with HIT, reducing a primary composite endpoint of new thrombosis, all-cause amputation, and all-cause death. Lepirudin forms a stable non-covalent complex with alpha-thrombin, thereby abolishing its ability to cleave fibrinogen and initiate the clotting cascade. It is a highly potent, selective, and essentially irreversible inhibitor of thrombin and clot-bond thrombin. Lepirudin is identical to natural hirudin except for substitution of leucine for isoleucine at the N-terminal end of the molecule and the absence of a sulfate group on the tyrosine at position 63.
Status:
US Previously Marketed
Source:
Infergen
(1997)
Source URL:
First approved in 1997
Source:
Infergen
Source URL:
Class:
PROTEIN
Status:
Possibly Marketed Outside US
Source:
Nuwiq by Octapharma Pharmazeutika Produktionsges M B H [Canada]
Source URL:
First approved in 2015
Source:
BLA125555
Source URL:
Class:
PROTEIN
Status:
Possibly Marketed Outside US
Source:
NCT02552576: Phase 4 Interventional Completed Von Willebrand Disease
(2015)
Source URL:
First approved in 2009
Source:
BLA125251
Source URL:
Class:
PROTEIN
Status:
Possibly Marketed Outside US
Source:
NCT03051516: Phase 4 Interventional Terminated High Grade Anal Canal Intraepithelial Neoplasia
(2017)
Source URL:
First approved in 2006
Source:
BLA125126
Source URL:
Class:
PROTEIN
Status:
Possibly Marketed Outside US
Source:
NCT03051516: Phase 4 Interventional Terminated High Grade Anal Canal Intraepithelial Neoplasia
(2017)
Source URL:
First approved in 2006
Source:
BLA125126
Source URL:
Class:
PROTEIN
Status:
Possibly Marketed Outside US
Class:
PROTEIN
Status:
Possibly Marketed Outside US
Class:
PROTEIN
Status:
Possibly Marketed Outside US
Class:
PROTEIN