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Pediatric Studies Characteristics - Detail
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Pediatrics
Pediatric Studies Characteristics
Detail
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Approval Date:
01/02/2008
Trade Name:
EVICEL
Generic or Proper Name (*):
Fibrin Sealant (Human)*
Indications Studied:
Adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques is ineffective or impractical
Therapeutic Category:
Coagulant
Ages Studied:
2-16 years (retroperi-toneal and intra-abdominal surgery)
Study #:
1
Study Type:
Efficacy/Safety
Study Design:
Active Control
No Patients:
4
No Centers:
18
No Countries:
1
BPCA(B), PREA(P):
P
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