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01 3Novartis Pharmaceuticals Corporation
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01 1CAPSULE;ORAL
02 2Hard Capsule
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01 1Allowed
02 1Authorized
03 1RX
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01 1FABHALTA
02 2Fabhalta
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01 1Spain
02 1Switzerland
03 1USA
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : Allowed
Registration Country : Switzerland
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
Regulatory Info : Authorized
Registration Country : Spain
Iptacopan Hydrochloride Monohydrate
Brand Name : Fabhalta
Dosage Form : Hard Capsule
Dosage Strength : 200MG
Packaging :
Approval Date : 2024-07-11
Application Number : 1241802002
Regulatory Info : Authorized
Registration Country : Spain