01 22Pfizer Inc
01 2KIT
02 2POI
03 9POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
04 4POWDER FOR SOLUTION
05 5Trockensub
01 2Originator
02 6Schedule D
03 14Blank
01 9ReFacto AF
02 5ReFacto AF FuseNGo
03 2XYNTHA
04 4XYNTHA SOLOFUSE
05 1Xyntha 1000 I.U.
06 1Xyntha 500 I.U.
01 6Canada
02 2South Africa
03 9Sweden
04 5Switzerland
Regulatory Info :
Registration Country : Sweden
Brand Name : ReFacto AF
Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Dosage Strength : 2000 IU
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : ReFacto AF
Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Dosage Strength : 250 IU
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : ReFacto AF
Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Dosage Strength : 250 IU
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : ReFacto AF
Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Dosage Strength : 1000 IU
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : ReFacto AF
Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Dosage Strength : 500 IU
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : ReFacto AF
Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Dosage Strength : 500 IU
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : ReFacto AF
Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Dosage Strength : 2000 IU
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : ReFacto AF
Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Dosage Strength : 3000 IU
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : ReFacto AF
Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Dosage Strength : 1000 IU
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Switzerland
Brand Name : ReFacto AF FuseNGo
Dosage Form : Trockensub
Dosage Strength : 1000iu
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : ReFacto AF FuseNGo
Dosage Form : Trockensub
Dosage Strength : 2000IE
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : ReFacto AF FuseNGo
Dosage Form : Trockensub
Dosage Strength : 3000IE
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : ReFacto AF FuseNGo
Dosage Form : Trockensub
Dosage Strength : 500IE
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : ReFacto AF FuseNGo
Dosage Form : Trockensub
Dosage Strength : 250IE
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : XYNTHA SOLOFUSE
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 500UNIT/SYR
Packaging :
Approval Date :
Application Number : 2374064
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : XYNTHA SOLOFUSE
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 1000UNIT/SYR
Packaging :
Approval Date :
Application Number : 2374072
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : XYNTHA SOLOFUSE
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 2000UNIT/SYR
Packaging :
Approval Date :
Application Number : 2374080
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : XYNTHA SOLOFUSE
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 3000UNIT/SYR
Packaging :
Approval Date :
Application Number : 2374099
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : XYNTHA
Dosage Form : KIT
Dosage Strength : 250UNIT/VIAL
Packaging : 250IU -4ML DILUENT
Approval Date :
Application Number : 2309483
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : XYNTHA
Dosage Form : KIT
Dosage Strength : 500UNIT/VIAL
Packaging : 500IU-4ML DILUENT
Approval Date :
Application Number : 2309491
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Xyntha 500 I.U.
Dosage Form : POI
Dosage Strength : 500IU
Packaging : 4X1IU
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Xyntha 1000 I.U.
Dosage Form : POI
Dosage Strength : 1000IU
Packaging : 4X1IU
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
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