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01 1BioMarin Pharmaceutical
02 1Biomarin International Limited
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01 1Infusion Solution
02 1Solution
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01 1Approved
02 1Authorized
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01 1Roctavian
02 1Roctavian 2 x
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01 1Spain
02 1Sweden
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Roctavian 2 x
Dosage Form : Solution
Dosage Strength :
Packaging :
Approval Date : 2023-02-03
Application Number : 1221668001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Approved
Registration Country : Sweden
Valoctocogene Roxaparvovec (AAV vector gene therapy for Hemophilia A)
Brand Name : Roctavian
Dosage Form : Infusion Solution
Dosage Strength : 2x10E13vg/ml
Packaging :
Approval Date : 24/08/2022
Application Number : 20210626000023
Regulatory Info : Approved
Registration Country : Sweden
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