01 8Bayer AG
01 1Inj Solution
02 1Injection fluid, resolution in the finished filled syringe
03 1SOL
04 1SOLUTION
05 1SOLUTION FOR INJECTION
06 1SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
07 2SOLUTION;INTRAVENOUS
01 1Ethical
02 1Originator
03 2RX
04 4Blank
01 2EOVIST
02 1PRIMOVIST
03 1Primo Shown
04 4Primovist
01 1Canada
02 1Norway
03 1South Africa
04 2Sweden
05 1Switzerland
06 2USA
Regulatory Info : RX
Registration Country : USA
Brand Name : EOVIST
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 1.8143GM/10ML (181.43MG/ML)
Packaging :
Approval Date : 2008-07-03
Application Number : 22090
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : EOVIST
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 2.72145GM/15ML (181.43MG/ML)
Packaging :
Approval Date : 2013-02-04
Application Number : 22090
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Sweden
Brand Name : Primovist
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 0.25 MMOL / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Primovist
Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
Dosage Strength : 0.25 MMOL / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Primo Shown
Dosage Form : Injection fluid, resolution in the finished filled syringe
Dosage Strength : 0.25 mmol/ml
Packaging : Finish filled syringe of glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Brand Name : Primovist
Dosage Form : Inj Solution
Dosage Strength : 0.25mmol/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Ethical
Registration Country : Canada
Brand Name : PRIMOVIST
Dosage Form : SOLUTION
Dosage Strength : 181.43MG/ML
Packaging : 5ML/7.5ML/10ML
Approval Date :
Application Number : 2340666
Regulatory Info : Ethical
Registration Country : Canada
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Primovist
Dosage Form : SOL
Dosage Strength : 600mg
Packaging : 10X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
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