01 1Olon Spa
02 1Shire Solvay Ireland Limited
03 1Takeda Pharma Ag
04 3Takeda Pharmaceuticals International Ag Ireland Branch
01 4Teduglutide
02 2Teduglutide Recombinant
01 1Lyophilizate
02 1Powder And Solvent For Injectable Solution
03 1Powder and liquid to the injection fluid, resolution
04 3Solution For Injection
01 1Italy
02 1Norway
03 1Spain
04 2Sweden
05 1Switzerland
01 5Revestive
02 1Blank
Regulatory Info : Available Dossier- US
Registration Country : Italy
Brand Name :
Dosage Form : Lyophilizate
Dosage Strength : 5MG
Packaging : Vial
Approval Date :
Application Number :
Regulatory Info : Available Dossier- US
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Revestive
Dosage Form : Powder and liquid to the injection fluid, resolution
Dosage Strength : 5 mg
Packaging : Set
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Revestive
Dosage Form : Solution For Injection
Dosage Strength : 1.25mg
Packaging :
Approval Date : 23/06/2017
Application Number : 20160705000065
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Revestive
Dosage Form : Solution For Injection
Dosage Strength : 5mg
Packaging :
Approval Date : 30/08/2012
Application Number : 20110412000049
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Revestive
Dosage Form : Solution For Injection
Dosage Strength : 5mg/5ml
Packaging :
Approval Date : 01/09/2016
Application Number : 65739
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Revestive
Dosage Form : Powder And Solvent For Injectable Solution
Dosage Strength : 5MG
Packaging :
Approval Date : 2013-05-28
Application Number : 12787001
Regulatory Info : Authorized
Registration Country : Spain
