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01 1 Cipaglucosidase Alfa
02 1CIPAGLUCOSIDASE ALFA-ATGA
03 1Cipaglucosidase Alfa
04 1Cipaglucosidase Alpha
05 1I Am Lustful.
06 1MIGALASTAT HYDROCHLORIDE
07 1MIGLUSTAT
08 2Migalastat Hydrochloride
09 1Migalastatum
10 1Miglustat
11 1Miglustatum
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01 3AMICUS THERAP US
02 6Amicus Therapeutics Europe Limited
03 3Amicus Therapeutics Switzerland Gmbh
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01 2CAPSULE;ORAL
02 3Capsule
03 3Hard Capsule
04 1INJECTABLE;INJECTION
05 1Powder For Concentrate For Infusion Solution
06 2Powder For Concentrate For Solution For Infusion
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01 2105MG
02 2105mg
03 1123MG
04 2123mg
05 265MG
06 265mg
07 1EQ 123MG BASE
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01 3Spain
02 3Sweden
03 3Switzerland
04 3USA
Regulatory Info : Allowed
Registration Country : Switzerland
Dosage Form : Powder For Concentrate F...
Brand Name : Pombiliti
Dosage Strength : 105mg
Packaging :
Approval Date : 04/07/2024
Application Number : 67804
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Authorized
Registration Country : Spain
Dosage Form : Powder For Concentrate F...
Brand Name : Pombiliti
Dosage Strength : 105MG
Packaging :
Approval Date : 2023-04-25
Application Number : 1221714001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info :
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : POMBILITI
Dosage Strength : 105MG
Packaging :
Approval Date :
Application Number : 761204
Regulatory Info :
Registration Country : USA
Regulatory Info : Approved
Registration Country : Sweden
Dosage Form : Powder For Concentrate F...
Brand Name : Pombiliti
Dosage Strength : 105mg
Packaging :
Approval Date : 20/03/2023
Application Number : 20211108000043
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Dosage Form : Capsule
Brand Name : Opfolda
Dosage Strength : 65mg
Packaging :
Approval Date : 26/06/2023
Application Number : 20211108000036
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : RX
Registration Country : USA
Dosage Form : CAPSULE;ORAL
Brand Name : GALAFOLD
Dosage Strength : EQ 123MG BASE
Packaging :
Approval Date : 2018-08-10
Application Number : 208623
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Approved
Registration Country : Sweden
Dosage Form : Capsule
Brand Name : Galafold
Dosage Strength : 123mg
Packaging :
Approval Date : 26/05/2016
Application Number : 20150626000015
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Authorized
Registration Country : Spain
Dosage Form : Hard Capsule
Brand Name : Galafold
Dosage Strength : 123MG
Packaging :
Approval Date : 2016-08-29
Application Number : 1151082001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Allowed
Registration Country : Switzerland
Dosage Form : Capsule
Brand Name : Galafold
Dosage Strength : 123mg
Packaging :
Approval Date : 28/10/2016
Application Number : 66108
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : RX
Registration Country : USA
Dosage Form : CAPSULE;ORAL
Brand Name : OPFOLDA
Dosage Strength : 65MG
Packaging :
Approval Date : 2023-09-28
Application Number : 215211
Regulatory Info : RX
Registration Country : USA