01 2Clinigen Group
02 1Dipharma
03 1Eurocept International Bv
04 2Eurocept Pharmaceuticals
05 1Navinta
06 1Novitium Pharma LLC
07 5ORPHAN EUROPE SARL
08 4Recordati
09 5Recordati Rare Diseases
10 1Tillomed Laboratories Ltd
11 4Waymade
01 1Carglumic Acid 200Mg 5 Units' Oral Use
02 1Carglumic Acid 200Mg 60 Units Oral Use
03 2DSP
04 3Dispergerbar Antic-Calc tablet
05 11Dispersible Tablet
06 1Dispersible Tablet Oral Use Blister
07 2Dispersible Tablets
08 1TABLET FOR SUSPENSION
09 3TABLET, FOR SUSPENSION;ORAL
10 1Tablet
11 1Tablet For Oral Suspension
01 1Allowed
02 3Approved
03 6Authorized
04 2Originator
05 1Prescription
06 3RX
07 11Blank
01 1Acido Carglumico Tillomed
02 6CARBAGLU
03 2CARGLUMIC ACID
04 10Carbaglu
05 1Cured
06 1Diglumic
07 1Kargluminsyra Waymade
08 1UCEDANE
09 1Ucedane
10 1WAYMADE CARGLUMIC ACID
11 1WAYMADE CARGLUMIC ACID*
12 1Waymade Carglumic Acid
01 1Canada
02 8Italy
03 3Norway
04 2South Africa
05 6Spain
06 3Sweden
07 1Switzerland
08 3USA
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : CARBAGLU
Dosage Form : DSP
Dosage Strength : 200mg
Packaging : 60X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : Italy
Brand Name : Diglumic
Dosage Form : Tablet
Dosage Strength : 200mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : UCEDANE
Dosage Form : Dispersible Tablet Oral Use Blister
Dosage Strength : 200 mg
Packaging : 60 UNITS 200 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Ucedane
Dosage Form : Dispersible Tablet
Dosage Strength : 200mg
Packaging :
Approval Date : 23/06/2017
Application Number : 20160427000046
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : RX
Registration Country : USA
Brand Name : CARGLUMIC ACID
Dosage Form : TABLET, FOR SUSPENSION;ORAL
Dosage Strength : 200MG
Packaging :
Approval Date : 2022-06-22
Application Number : 213395
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : CARGLUMIC ACID
Dosage Form : TABLET, FOR SUSPENSION;ORAL
Dosage Strength : 200MG
Packaging :
Approval Date : 2021-10-13
Application Number : 213729
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Italy
Brand Name : Carbaglu
Dosage Form : Carglumic Acid 200Mg 60 Units Oral Use
Dosage Strength : 60 cpr dispers 200 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Carbaglu
Dosage Form : Carglumic Acid 200Mg 5 Units' Oral Use
Dosage Strength : 5 cpr dispers 200 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Carbaglu
Dosage Form : Dispergerbar Antic-Calc tablet
Dosage Strength : 200 mg
Packaging : Box
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Carbaglu
Dosage Form : Dispergerbar Antic-Calc tablet
Dosage Strength : 200 mg
Packaging : Box
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Carbaglu
Dosage Form : Dispergerbar Antic-Calc tablet
Dosage Strength : 200 mg
Packaging : Box
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : RX
Registration Country : USA
Brand Name : CARBAGLU
Dosage Form : TABLET, FOR SUSPENSION;ORAL
Dosage Strength : 200MG
Packaging :
Approval Date : 2010-03-18
Application Number : 22562
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Italy
Brand Name : CARBAGLU
Dosage Form : Dispersible Tablet
Dosage Strength : 200 mg
Packaging : 5 UNITS 200 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : CARBAGLU
Dosage Form : Dispersible Tablet
Dosage Strength : 200 mg
Packaging : 60 UNITS 200 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Carbaglu
Dosage Form : Tablet For Oral Suspension
Dosage Strength : 200mg
Packaging :
Approval Date : 2020-07-28
Application Number : 67376
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Carbaglu
Dosage Form : Dispersible Tablet
Dosage Strength : 200mg
Packaging :
Approval Date : 24/01/2003
Application Number : 20030124000024
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : CARBAGLU
Dosage Form : TABLET FOR SUSPENSION
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number : 2439360
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info :
Registration Country : Italy
Brand Name : WAYMADE CARGLUMIC ACID
Dosage Form : Dispersible Tablets
Dosage Strength : 200 mg
Packaging : 5 UNITS 200 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : WAYMADE CARGLUMIC ACID*
Dosage Form : Dispersible Tablets
Dosage Strength : 200 mg
Packaging : 60 UNITS 200 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Kargluminsyra Waymade
Dosage Form : Dispersible Tablet
Dosage Strength : 200mg
Packaging :
Approval Date : 29/12/2017
Application Number : 20150711000036
Regulatory Info : Approved
Registration Country : Sweden
