COVID-19
Drugs: FABRAZYME
- Safetyreportversion
- 1
- Safetyreportid
- 27325229
- Primarysourcecountry
- US
- Occurcountry
- US
- Transmissiondateformat
- 102
- Transmissiondate
- 20261010
- Reporttype
- 1
- Serious
- 2
- Seriousnessdeath
- 2
- Seriousnesslifethreatening
- 2
- Seriousnesshospitalization
- 2
- Seriousnessdisabling
- 2
- Seriousnesscongenitalanomali
- 2
- Seriousnessother
- 2
- Receivedateformat
- 102
- Receivedate
- 20260930
- Receiptdateformat
- 102
- Receiptdate
- 20260930
- Fulfillexpeditecriteria
- 2
- Companynumb
- US-SA-2026SA0220702
- Primarysource
- Reportercountry
- US
- Qualification
- 5
- Sender
- Sendertype
- 6
- Senderorganization
- SANOFI AVENTIS
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientonsetage
- 14
- Patientonsetageunit
- 801
- Patientsex
- 2
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- COVID-19
- Reactionoutcome
- 1
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- FABRAZYME
- Drugauthorizationnumb
- 103979
- Drugseparatedosagenumb
- 1
- Drugindication
- Fabry^s disease
- Actiondrug
- 5
- Drugrecurreadministration
- 3
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- AGALSIDASE BETA
- Harmonized identifiers (openFDA)
- Application number
- BLA103979
- Brand name
- FABRAZYME
- Generic name
- AGALSIDASE BETA
- Manufacturer name
- Genzyme Corporation
- Product NDC
- 58468-0040, 58468-0041
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- AGALSIDASE BETA
- RxCUI
- 1804755, 1804758, 1804760, 1804762
- SPL ID
- 9b786f81-f4d8-4bc6-8f5f-68adbbfb60d1
- SPL set ID
- 988513ab-b06f-4dd0-93f7-d2d4531dcce4
- Package NDC
- 58468-0041-1, 58468-0040-1
- Nui
- M0000794, N0000175822
- Pharm class cs
- alpha-Glucosidases [CS]
- Pharm class epc
- Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC]
- UNII
- RZD65TSM9U