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01 5Bayer AG
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01 1INJ
02 1Inj L?s
03 1SOLUTION
04 1SOLUTION FOR INJECTION
05 1SOLUTION;INTRAVENOUS
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01 1Originator
02 1RX
03 1Schedule C
04 2Blank
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01 2XOFIGO
02 3Xofigo
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01 1Canada
02 1South Africa
03 1Sweden
04 1Switzerland
05 1USA
Regulatory Info : RX
Registration Country : USA
Brand Name : XOFIGO
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 162mCi/6ML (27mCi/ML)
Packaging :
Approval Date : 2013-05-15
Application Number : 203971
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Sweden
Brand Name : Xofigo
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 1000 KBQ / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Switzerland
Brand Name : Xofigo
Dosage Form : Inj L?s
Dosage Strength : 1100kBq
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Schedule C
Registration Country : Canada
Brand Name : XOFIGO
Dosage Form : SOLUTION
Dosage Strength : 1100KBq/ML
Packaging : 6ML
Approval Date :
Application Number : 2418398
Regulatory Info : Schedule C
Registration Country : Canada
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Xofigo
Dosage Form : INJ
Dosage Strength : 1100kBq/ml at reference date
Packaging : 1X1kBq/ml at reference date
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa