Drug information for REFLUDAN

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
INJECTABLE; INJECTION	50MG/VIAL	Prescription	(Reference Drug)	LEPIRUDIN RECOMBINANT	lepirudin	BAYER HLTHCARE	20807 2007-03-15 Letter 2006-11-13 Letter 2006-11-09 Label 2003-04-18 Letter 2003-04-04 Review 1998-03-06 Letter 1997-09-08 Other

Drug Adverse Effects information for REFLUDAN

Role code	Indications	Reaction	# Reports
PS	HEPARIN-INDUCED THROMBOCYTOPENIA	EMBOLISM	1
PS	HEPARIN-INDUCED THROMBOCYTOPENIA	HAEMORRHAGE	1
PS	HEPARIN-INDUCED THROMBOCYTOPENIA	THROMBOCYTOPENIA	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	DIALYSIS	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	TRANSPLANT	1
SS	AORTIC THROMBOSIS	ASTHENIA	3
SS	AORTIC THROMBOSIS	HYPOAESTHESIA	3
SS	AORTIC THROMBOSIS	PAIN	3
SS	AORTIC THROMBOSIS	WOUND HAEMORRHAGE	3
C	GASTROOESOPHAGEAL REFLUX DISEASE	ANTEPARTUM HAEMORRHAGE	1
C	GASTROOESOPHAGEAL REFLUX DISEASE	BUDD-CHIARI SYNDROME	1
C	GASTROOESOPHAGEAL REFLUX DISEASE	CHOLECYSTITIS	1
C	GASTROOESOPHAGEAL REFLUX DISEASE	CHOLECYSTITIS CHRONIC	1
C	GASTROOESOPHAGEAL REFLUX DISEASE	CHOLELITHIASIS	1
C	GASTROOESOPHAGEAL REFLUX DISEASE	GALLBLADDER INJURY	1
C	GASTROOESOPHAGEAL REFLUX DISEASE	HEPATIC VEIN THROMBOSIS	1
C	GASTROOESOPHAGEAL REFLUX DISEASE	LIVER INJURY	1
C	HEPATIC VEIN THROMBOSIS	ANTEPARTUM HAEMORRHAGE	1
C	HEPATIC VEIN THROMBOSIS	BUDD-CHIARI SYNDROME	1
C	HEPATIC VEIN THROMBOSIS	CHOLECYSTITIS	1
C	HEPATIC VEIN THROMBOSIS	CHOLECYSTITIS CHRONIC	1
C	HEPATIC VEIN THROMBOSIS	CHOLELITHIASIS	1
C	HEPATIC VEIN THROMBOSIS	GALLBLADDER INJURY	1
C	HEPATIC VEIN THROMBOSIS	HEPATIC VEIN THROMBOSIS	1
C	HEPATIC VEIN THROMBOSIS	LIVER INJURY	1
C	PAIN	ANTEPARTUM HAEMORRHAGE	2
C	PAIN	BUDD-CHIARI SYNDROME	2
C	PAIN	CHOLECYSTITIS	2
C	PAIN	CHOLECYSTITIS CHRONIC	2
C	PAIN	CHOLELITHIASIS	2
C	PAIN	GALLBLADDER INJURY	2
C	PAIN	HEPATIC VEIN THROMBOSIS	2
C	PAIN	LIVER INJURY	2
C	PRODUCT USED FOR UNKNOWN INDICATION	ANTEPARTUM HAEMORRHAGE	5
C	PRODUCT USED FOR UNKNOWN INDICATION	BUDD-CHIARI SYNDROME	5
C	PRODUCT USED FOR UNKNOWN INDICATION	CHOLECYSTITIS	5
C	PRODUCT USED FOR UNKNOWN INDICATION	CHOLECYSTITIS CHRONIC	5
C	PRODUCT USED FOR UNKNOWN INDICATION	CHOLELITHIASIS	5
C	PRODUCT USED FOR UNKNOWN INDICATION	GALLBLADDER INJURY	5
C	PRODUCT USED FOR UNKNOWN INDICATION	HEPATIC VEIN THROMBOSIS	5
C	PRODUCT USED FOR UNKNOWN INDICATION	LIVER INJURY	5

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