01 1Biem Ilac San. ve Tic. A.S
02 21GE Healthcare Inc
03 1Jodas Expoim Pvt. Ltd
01 2Gadodiamide 10Mmol 20Ml 1 Units Parenteral Use
02 1Gadodiamide 25Mmol 50Ml 10 Units Parenteral Use
03 2Gadodiamide 5Mmol 10Ml 1 Units Parenteral Use
04 2Gadodiamide 7,5Mmol 15Ml 1 Units Parenteral Use
05 3INJECTABLE;INJECTION
06 1Inj
07 3Injectable Solution
08 1Injectable Solution In Pre-Filled Syringe
09 1Injection
10 3PFS
11 1SOLUTION
12 2Solution For Injection
13 1Solution for IV Injection
01 1Allowed
02 2Cancelled
03 2DISCN
04 1Ethical
05 1Generic
06 4Originator
07 1RX
08 1Suspended
09 2Temporarily Withdrawn
10 8Blank
01 1Gadodiem
02 4OMNISCAN
03 13Omniscan
04 1Omniscan 10 ml
05 1Omniscan 15 ml
06 1Omniscan 20 ml
07 1Omniscan 20Ml Vial
08 1Blank
01 1Canada
02 1India
03 7Italy
04 1Malta
05 4South Africa
06 2Spain
07 2Sweden
08 1Switzerland
09 1Turkey
10 3USA
Regulatory Info :
Registration Country : Turkey
Brand Name : Gadodiem
Dosage Form : Solution for IV Injection
Dosage Strength : 287MG/ML
Packaging : 10, 15, 20ML Vials
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey
Regulatory Info : RX
Registration Country : USA
Brand Name : OMNISCAN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 287MG/ML
Packaging :
Approval Date : 1993-01-08
Application Number : 20123
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : OMNISCAN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 14.35GM/50ML (287MG/ML)
Packaging :
Approval Date : 2007-09-05
Application Number : 22066
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : OMNISCAN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 28.7GM/100ML (287MG/ML)
Packaging :
Approval Date : 2007-09-05
Application Number : 22066
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : Italy
Brand Name : Omniscan
Dosage Form : Gadodiamide 10Mmol 20Ml 1 Units Parenteral Use
Dosage Strength : 1 ampoule EV 20 ml 0.5 mmol/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Omniscan
Dosage Form : Gadodiamide 10Mmol 20Ml 1 Units Parenteral Use
Dosage Strength : 1 syringe EV 20 ml 0.5 mmol/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Omniscan
Dosage Form : Gadodiamide 25Mmol 50Ml 10 Units Parenteral Use
Dosage Strength : 10 VIALS EV 50 ml 0.5 mmol/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Omniscan
Dosage Form : Gadodiamide 5Mmol 10Ml 1 Units Parenteral Use
Dosage Strength : 1 ampoule EV 10 ml 0.5 mmol/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Omniscan
Dosage Form : Gadodiamide 5Mmol 10Ml 1 Units Parenteral Use
Dosage Strength : 1 syringe EV 10 ml 0.5 mmol/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Omniscan
Dosage Form : Gadodiamide 7,5Mmol 15Ml 1 Units Parenteral Use
Dosage Strength : 1 ampoule EV 15 ml 0.5 mmol/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Omniscan
Dosage Form : Gadodiamide 7,5Mmol 15Ml 1 Units Parenteral Use
Dosage Strength : 1 syringe EV 15 ml 0.5 mmol/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : Temporarily Withdrawn
Registration Country : Sweden
Brand Name : Omniscan
Dosage Form : Injectable Solution
Dosage Strength : 0.5mmol/ml
Packaging :
Approval Date : 30/06/1993
Application Number : 19930630000096
Regulatory Info : Temporarily Withdrawn
Registration Country : Sweden
Regulatory Info : Temporarily Withdrawn
Registration Country : Sweden
Brand Name : Omniscan
Dosage Form : Solution For Injection
Dosage Strength : 0.5mmol/ml
Packaging :
Approval Date : 03/03/1999
Application Number : 20050523000067
Regulatory Info : Temporarily Withdrawn
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Omniscan
Dosage Form : Injectable Solution
Dosage Strength : 287mg/ml
Packaging :
Approval Date : 18/07/1994
Application Number : 52537
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Cancelled
Registration Country : Spain
Brand Name : Omniscan
Dosage Form : Injectable Solution
Dosage Strength : 0.5MMOL
Packaging :
Approval Date : 1999-07-01
Application Number : 62699
Regulatory Info : Cancelled
Registration Country : Spain
Regulatory Info : Cancelled
Registration Country : Spain
Brand Name : Omniscan
Dosage Form : Injectable Solution In Pre-Filled Syringe
Dosage Strength : 0.5MMOL
Packaging :
Approval Date : 1994-07-01
Application Number : 60331
Regulatory Info : Cancelled
Registration Country : Spain
Regulatory Info : Suspended
Registration Country : Malta
Brand Name : Omniscan
Dosage Form : Solution For Injection
Dosage Strength : 0.5MMOL/ML
Packaging :
Approval Date : 2006-09-20
Application Number :
Regulatory Info : Suspended
Registration Country : Malta
Regulatory Info : Ethical
Registration Country : Canada
Brand Name : OMNISCAN
Dosage Form : SOLUTION
Dosage Strength : 287MG/ML
Packaging : 5/10/15/20/50 ML
Approval Date :
Application Number : 2172771
Regulatory Info : Ethical
Registration Country : Canada
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Omniscan 10 ml
Dosage Form : PFS
Dosage Strength : 287mg/ml
Packaging : 10X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 0.5MMOL/1ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : India
