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01 2NITISINONE
02 4Nitisinon
03 3Nitisinone
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01 2MENDELIKABS INC
02 7Mendelikabs Europe Limited
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01 2CAPSULE
02 4Capsule
03 3Hard Capsule
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01 110MG
02 110mg
03 120mg
04 22MG
05 12mg
06 25MG
07 15mg
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01 2Canada
02 3Spain
03 4Sweden
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Regulatory Info : Deregistered
Registration Country : Sweden
Dosage Form : Capsule
Brand Name : Nitisinone Mdk
Dosage Strength : 10mg
Packaging :
Approval Date : 24/08/2017
Application Number : 20160310000047
Regulatory Info : Deregistered
Registration Country : Sweden

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Regulatory Info : Deregistered
Registration Country : Sweden
Dosage Form : Capsule
Brand Name : Nitisinone Mdk
Dosage Strength : 2mg
Packaging :
Approval Date : 24/08/2017
Application Number : 20160310000023
Regulatory Info : Deregistered
Registration Country : Sweden

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Regulatory Info : Deregistered
Registration Country : Sweden
Dosage Form : Capsule
Brand Name : Nitisinone Mdk
Dosage Strength : 20mg
Packaging :
Approval Date : 20/12/2021
Application Number : 20200121000024
Regulatory Info : Deregistered
Registration Country : Sweden

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Regulatory Info : Deregistered
Registration Country : Sweden
Dosage Form : Capsule
Brand Name : Nitisinone Mdk
Dosage Strength : 5mg
Packaging :
Approval Date : 24/08/2017
Application Number : 20160310000030
Regulatory Info : Deregistered
Registration Country : Sweden

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Regulatory Info : Authorized
Registration Country : Spain
Dosage Form : Hard Capsule
Brand Name : Nitisinone Mdk
Dosage Strength : 5MG
Packaging :
Approval Date : 2018-02-09
Application Number : 1171217002
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Authorized
Registration Country : Spain
Dosage Form : Hard Capsule
Brand Name : Nitisinone Mdk
Dosage Strength : 10MG
Packaging :
Approval Date : 2018-02-09
Application Number : 1171217003
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Authorized
Registration Country : Spain
Dosage Form : Hard Capsule
Brand Name : Nitisinone Mdk
Dosage Strength : 2MG
Packaging :
Approval Date : 2018-02-09
Application Number : 1171217001
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Prescription
Registration Country : Canada
Dosage Form : CAPSULE
Brand Name : MDK-NITISINONE
Dosage Strength : 2MG
Packaging : 60
Approval Date :
Application Number : 2457717
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
Dosage Form : CAPSULE
Brand Name : MDK-NITISINONE
Dosage Strength : 5MG
Packaging : 60
Approval Date :
Application Number : 2457725
Regulatory Info : Prescription
Registration Country : Canada
