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Pediatric Studies Characteristics - Detail
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Pediatrics
Pediatric Studies Characteristics
Detail
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Approval Date:
10/10/2008
Trade Name:
Kogenate FS
Generic or Proper Name (*):
Antihemophilic Factor (Recombinant)*
Indications Studied:
Routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no pre-existing joint damage
Therapeutic Category:
Hematology/Coagulation
Ages Studied:
0 2.5 years
Study #:
1
Study Type:
Efficacy/Safety
Study Design:
Open Label/Single-Blind/Parallel Group
No Patients:
65
No Centers:
14
No Countries:
1
BPCA(B), PREA(P):
P
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