01 41Novo Nordisk
01 2CAT
02 2Flextouch Injectable Solution In Pre-Filled Pen
03 2Injectable Solution
04 3Injectable Solution In Pre-Filled Pen
05 3Injection fluid, resolution
06 1Injection fluid, resolution in the finished filled pen
07 1Insulin Degludec 300Iu 3Ml 5 Units Parenteral Use
08 2PED
09 2PFP
10 1Penfill Injectable Solution In Cartridge
11 4SOLUTION
12 5SOLUTION;SUBCUTANEOUS
13 13Solution For Injection
01 6Allowed
02 8Approved
03 7Authorized
04 6Originator
05 4Schedule D
06 10Blank
01 1RYZODEG 70/30
02 1Ryzodeg
03 1Ryzodeg FlexTouch
04 1Ryzodeg Flexpen
05 1Ryzodeg Flextouch
06 2Ryzodeg Penfill
07 3Ryzodeg®
08 6TRESIBA
09 9Tresiba
10 2Tresiba 100 U/ml
11 2Tresiba FlexTouch Eml
12 1Tresiba Flexpen
13 2Tresiba Flextouch
14 2Tresiba Penfill
15 1XULTOPHY
16 1XULTOPHY 100/3.6
17 4Xultophy
18 1Xultophy Insulin Degludec Uml und Liraglutide
01 4Canada
02 1Italy
03 4Norway
04 6South Africa
05 7Spain
06 8Sweden
07 6Switzerland
08 5USA
Regulatory Info :
Registration Country : USA
INSULIN ASPART; INSULIN DEGLUDEC
Brand Name : RYZODEG 70/30
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 90 UNITS/3ML;210 UNITS/3ML (30 UNITS/ML;70 UNITS/ML)
Packaging :
Approval Date :
Application Number : 203313
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : TRESIBA
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 300 UNITS/3ML (100 UNITS/ML)
Packaging :
Approval Date :
Application Number : 203314
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : TRESIBA
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 600 UNITS/3ML (200 UNITS/ML)
Packaging :
Approval Date :
Application Number : 203314
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : TRESIBA
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 1000 UNITS/10ML (100 UNITS/ML)
Packaging :
Approval Date :
Application Number : 203314
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : XULTOPHY 100/3.6
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 300 UNITS/3ML;10.8MG/3ML (100 UNITS/ML;3.6MG/ML)
Packaging :
Approval Date :
Application Number : 208583
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : Italy
Brand Name : Tresiba
Dosage Form : Insulin Degludec 300Iu 3Ml 5 Units Parenteral Use
Dosage Strength : FLEXTOUCH SC 5 pens preriemp 3 ml 100 IU/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Tresiba
Dosage Form : Injection fluid, resolution
Dosage Strength : 100 E/ml
Packaging : Finish filled pen, flex touch
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Tresiba
Dosage Form : Injection fluid, resolution
Dosage Strength : 100 E/ml
Packaging : Sylinderampulle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Tresiba
Dosage Form : Injection fluid, resolution
Dosage Strength : 200 E/ml
Packaging : Finish filled pen, flex touch
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Xultophy
Dosage Form : Injection fluid, resolution in the finished filled pen
Dosage Strength : 100 E/ml/3.6 mg/ml
Packaging : Finish filled pen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Tresiba Penfill
Dosage Form : Solution For Injection
Dosage Strength :
Packaging :
Approval Date : 12/03/2013
Application Number : 62562
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Tresiba FlexTouch Eml
Dosage Form : Solution For Injection
Dosage Strength : 100E/ml
Packaging :
Approval Date : 12/03/2013
Application Number : 62563
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Tresiba FlexTouch Eml
Dosage Form : Solution For Injection
Dosage Strength : 200E/ml
Packaging :
Approval Date : 12/03/2013
Application Number : 62563
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Insulin Degludec; Insulin Aspart
Brand Name : Ryzodeg Penfill
Dosage Form : Solution For Injection
Dosage Strength : 420nmol/ml;180nmol/ml
Packaging :
Approval Date : 12/09/2013
Application Number : 62627
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Insulin Degludec; Insulin Aspart
Brand Name : Ryzodeg FlexTouch
Dosage Form : Solution For Injection
Dosage Strength : 420nmol/ml;180nmol/ml
Packaging :
Approval Date : 12/09/2013
Application Number : 62648
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Xultophy Insulin Degludec Uml und Liraglutide
Dosage Form : Solution For Injection
Dosage Strength : 600nmol/ml;3.6mg/ml
Packaging :
Approval Date : 12/09/2014
Application Number : 65041
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Approved
Registration Country : Sweden
Insulin Aspart; Insulin Degludec
Brand Name : Ryzodeg Flexpen
Dosage Form : Solution For Injection
Dosage Strength : 100units/ml
Packaging :
Approval Date : 10/02/2025
Application Number : 20231027000047
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Insulin Aspart; Insulin Degludec
Brand Name : Ryzodeg Flextouch
Dosage Form : Solution For Injection
Dosage Strength : 100units/ml
Packaging :
Approval Date : 21/01/2013
Application Number : 20110929000044
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Insulin Aspart; Insulin Degludec
Brand Name : Ryzodeg Penfill
Dosage Form : Solution For Injection
Dosage Strength : 100units/ml
Packaging :
Approval Date : 21/01/2013
Application Number : 20110929000037
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Tresiba Flexpen
Dosage Form : Solution For Injection
Dosage Strength : 100units/ml
Packaging :
Approval Date : 13/08/2024
Application Number : 20231027000030
Regulatory Info : Approved
Registration Country : Sweden
