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01 8Novartis Pharmaceuticals Corporation

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PharmaCompass

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IPTACOPAN HYDROCHLORIDE

Brand Name : FABHALTA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 200MG BASE

Packaging :

Approval Date : 2023-12-05

Application Number : 218276

Regulatory Info : RX

Registration Country : USA

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02

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Iptacopanum

Brand Name : Fabhalta

Dosage Form : Hard Capsule

Dosage Strength : 200mg

Packaging :

Approval Date : 29/08/2024

Application Number : 68603

Regulatory Info : Allowed

Registration Country : Switzerland

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03

ASPEN
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Iptakopanhydrokloridmonohydrat

Brand Name : Fabhalta

Dosage Form : Capsule

Dosage Strength : 200mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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04

ASPEN
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Iptacopan

Brand Name : Fabhalta

Dosage Form : Capsule

Dosage Strength : 200mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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05

ASPEN
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Iptacopan Hydrochloride Monohydrate

Brand Name : Fabhalta

Dosage Form : Hard Capsule

Dosage Strength : 200MG

Packaging :

Approval Date : 11-07-2024

Application Number : 1241802002

Regulatory Info : Authorized

Registration Country : Spain

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06

ASPEN
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IPTACOPAN (IPTACOPAN HYDROCHLORIDE)

Brand Name : FABHALTA

Dosage Form : CAPSULE

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number : 2554313

Regulatory Info : Prescription

Registration Country : Canada

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07

ASPEN
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Iptacopan

Brand Name : Fabhalta

Dosage Form :

Dosage Strength :

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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08

ASPEN
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ASPEN
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Iptacopan Hydrochloride Monohydrate

Brand Name : Fabhalta

Dosage Form : Hard Capsules

Dosage Strength : 200mg

Packaging :

Approval Date : 17-05-2024

Application Number : 28106960523

Regulatory Info : Prescription

Registration Country : Denmark

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