01 24Bristol Myers Squibb
02 2Clinigen Group
01 1INF
02 1INJECTABLE; IV (INFUSION)
03 1Injectable Solution In Pre-Filled Pen
04 1Injectable Solution In Pre-Filled Syringe
05 1PFS
06 1POWDER FOR SOLUTION
07 2Powder For Concentrate For Solution For Infusion
08 1Powder For Solid Concentrate For Perfusion
09 1SOLUTION
10 6Solution For Injection
11 3injection
12 7Blank
01 3Allowed
02 5Approved
03 3Authorized
04 2Originator
05 1Prescription
06 1Schedule D
07 11Blank
01 3ORENCIA
02 1ORENCIA 125 mg
03 18Orencia
04 1Orencia 250mg
05 3Orencia ClickJect
01 10Australia
02 2Canada
03 2South Africa
04 3Spain
05 5Sweden
06 3Switzerland
07 1USA
Regulatory Info :
Registration Country : USA
Brand Name : ORENCIA
Dosage Form : INJECTABLE; IV (INFUSION)
Dosage Strength : 250MG
Packaging :
Approval Date :
Application Number : 125118
Regulatory Info :
Registration Country : USA
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Orencia
Dosage Form : Solution For Injection
Dosage Strength : 125mg
Packaging :
Approval Date : 2015-04-23
Application Number : 20150131000029
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Orencia
Dosage Form : Solution For Injection
Dosage Strength : 125mg
Packaging :
Approval Date : 2012-10-04
Application Number : 20110825000049
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Orencia
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 250mg
Packaging :
Approval Date : 2007-05-21
Application Number : 20060201000043
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Orencia
Dosage Form : Solution For Injection
Dosage Strength : 50mg
Packaging :
Approval Date : 2019-04-08
Application Number : 20180312000012
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Orencia
Dosage Form : Solution For Injection
Dosage Strength : 87.5mg
Packaging :
Approval Date : 2019-04-08
Application Number : 20180312000029
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Orencia
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 250mg
Packaging :
Approval Date : 2007-08-03
Application Number : 57769
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Orencia
Dosage Form : Solution For Injection
Dosage Strength : 125mg/ml
Packaging :
Approval Date : 2012-02-27
Application Number : 62141
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Orencia
Dosage Form : Solution For Injection
Dosage Strength : 125mg/ml
Packaging :
Approval Date : 2016-03-15
Application Number : 65833
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : ORENCIA
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 250MG/VIAL
Packaging : 1VIAL
Approval Date :
Application Number : 2282097
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ORENCIA
Dosage Form : SOLUTION
Dosage Strength : 125MG/ML
Packaging : 01-Apr
Approval Date :
Application Number : 2402475
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info :
Registration Country : Australia
Brand Name : Orencia ClickJect
Dosage Form :
Dosage Strength :
Packaging : 4
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Orencia ClickJect
Dosage Form :
Dosage Strength :
Packaging : 4
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Orencia
Dosage Form : injection
Dosage Strength : 125 mg/mL
Packaging : 4
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Orencia
Dosage Form : injection
Dosage Strength : 125 mg/mL
Packaging : 4
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Orencia
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Orencia
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Orencia
Dosage Form : injection
Dosage Strength : 125 mg/mL
Packaging : 4
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Orencia 250mg
Dosage Form : INF
Dosage Strength : 250mg/10ml
Packaging : 10X1mg/10ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : ORENCIA 125 mg
Dosage Form : PFS
Dosage Strength : 125mg/1ml
Packaging : 1X4mg/1ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
