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01 2Italfarmaco S.p.A
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01 1Oral Suspension
02 1SUSPENSION;ORAL
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01 1Approved
02 1RX
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01 1DUVYZAT
02 1Duvyzat
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01 1Sweden
02 1USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DUVYZAT
Dosage Form : SUSPENSION;ORAL
Dosage Strength : EQ 8.86MG BASE/ML
Packaging :
Approval Date : 2024-03-21
Application Number : 217865
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Approved
Registration Country : Sweden
Givinostat Hydrochloride Monohydrate
Brand Name : Duvyzat
Dosage Form : Oral Suspension
Dosage Strength : 8.86mg/ml
Packaging :
Approval Date : 06/06/2025
Application Number : 20230703000012
Regulatory Info : Approved
Registration Country : Sweden