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NMPA Approval

Agalsidase Beta for Injection

Approval Number

国药准字SJ20190040

CompanySanofi B.V.

Registration Date

July 4, 2024

Previous Approval Numbers

S20190040

Drug Information

Generic Name

注射用阿加糖酶β

Trade Name

法布赞

Dosage Form

注射剂

Strength

5mg/瓶

Drug Type

生物制品

Registration Date

July 4, 2024

Expiry Date

April 24, 2029

Company Information

Applicant Company

Company NameSanofi B.V.

Company Address

Paasheuvelweg 25,1105 BP Amsterdam, The Netherlands

Manufacturing Company

Company NameGENZYME IRELAND LIMITED

Company Address

IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland

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