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01 17Pfizer Inc
02 8Swedish Orphan Biovitrum AB
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01 1KIT
02 2POI
03 5POWDER FOR SOLUTION
04 12Powder And Solvent For Injectable Solution
05 5Powder And Solvent For Injectable Solution In Pre-Filled Syringe
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01 17Authorized
02 2Originator
03 6Schedule D
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01 8Elocta
02 9Refacto Af
03 2XYNTHA
04 4XYNTHA SOLOFUSE
05 1Xyntha 1000 I.U.
06 1Xyntha 500 I.U.
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01 6Canada
02 2South Africa
03 17Spain
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : XYNTHA
Dosage Form : POWDER FOR SOLUTION
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 : 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 : 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
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Refacto Af
Dosage Form : Powder And Solvent For Injectable Solution
Dosage Strength : 500IU
Packaging :
Approval Date : 1999-06-01
Application Number : 99103002
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Refacto Af
Dosage Form : Powder And Solvent For Injectable Solution
Dosage Strength : 250IU
Packaging :
Approval Date : 1999-06-01
Application Number : 99103001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Refacto Af
Dosage Form : Powder And Solvent For Injectable Solution
Dosage Strength : 1000IU
Packaging :
Approval Date : 1999-06-01
Application Number : 99103003
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Refacto Af
Dosage Form : Powder And Solvent For Injectable Solution
Dosage Strength : 2000IU
Packaging :
Approval Date : 2003-03-10
Application Number : 99103004
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Elocta
Dosage Form : Powder And Solvent For Injectable Solution
Dosage Strength : 1000IU
Packaging :
Approval Date : 2016-02-05
Application Number : 1151046004
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Elocta
Dosage Form : Powder And Solvent For Injectable Solution
Dosage Strength : 1500IU
Packaging :
Approval Date : 2016-02-05
Application Number : 1151046005
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Elocta
Dosage Form : Powder And Solvent For Injectable Solution
Dosage Strength : 4000IU
Packaging :
Approval Date : 2019-07-29
Application Number : 1151046008
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Elocta
Dosage Form : Powder And Solvent For Injectable Solution
Dosage Strength : 750IU
Packaging :
Approval Date : 2019-07-29
Application Number : 1151046003
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Elocta
Dosage Form : Powder And Solvent For Injectable Solution
Dosage Strength : 2000IU
Packaging :
Approval Date : 2016-02-08
Application Number : 1151046006
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Elocta
Dosage Form : Powder And Solvent For Injectable Solution
Dosage Strength : 250IU
Packaging :
Approval Date : 2016-02-05
Application Number : 1151046001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Elocta
Dosage Form : Powder And Solvent For Injectable Solution
Dosage Strength : 3000IU
Packaging :
Approval Date : 2016-02-08
Application Number : 1151046007
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Elocta
Dosage Form : Powder And Solvent For Injectable Solution
Dosage Strength : 500IU
Packaging :
Approval Date : 2016-02-08
Application Number : 1151046002
Regulatory Info : Authorized
Registration Country : Spain