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01 3BioCryst Pharmaceuticals

02 1Biocryst Ireland Limited

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BEROTRALSTAT HYDROCHLORIDE

Brand Name : ORLADEYO

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 110MG BASE

Packaging :

Approval Date : 2020-12-03

Application Number : 214094

Regulatory Info : RX

Registration Country : USA

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BEROTRALSTAT HYDROCHLORIDE

Brand Name : ORLADEYO

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 150MG BASE

Packaging :

Approval Date : 2020-12-03

Application Number : 214094

Regulatory Info : RX

Registration Country : USA

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Berotralstatum

Brand Name : Orladeyo

Dosage Form : Hard Capsule

Dosage Strength : 150mg

Packaging :

Approval Date : 07/06/2022

Application Number : 68464

Regulatory Info : Allowed

Registration Country : Switzerland

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04

Biocryst Ireland Limited

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Biocryst Ireland Limited

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Berotralstatdihydroklorid

Brand Name : Orladeyo

Dosage Form : Capsule

Dosage Strength : 150mg

Packaging :

Approval Date : 30/04/2021

Application Number : 2.02003E+13

Regulatory Info : Approved

Registration Country : Sweden

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