Brain natriuretic peptide increased, Cardiac failure
Drugs: SKYCLARYS
- Safetyreportversion
- 1
- Safetyreportid
- 26940053
- Primarysourcecountry
- EU
- Occurcountry
- EU
- Transmissiondateformat
- 102
- Transmissiondate
- 20260709
- Reporttype
- 1
- Serious
- 1
- Seriousnessdeath
- 2
- Seriousnesslifethreatening
- 2
- Seriousnesshospitalization
- 2
- Seriousnessdisabling
- 2
- Seriousnesscongenitalanomali
- 2
- Seriousnessother
- 1
- Receivedateformat
- 102
- Receivedate
- 20260630
- Receiptdateformat
- 102
- Receiptdate
- 20260630
- Fulfillexpeditecriteria
- 1
- Authoritynumb
- EU-AFSSAPS-RS2026000507
- Primarysource
- Reportercountry
- EU
- Qualification
- 1
- Sender
- Sendertype
- 6
- Senderorganization
- BIOGEN
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientonsetage
- 77
- Patientonsetageunit
- 801
- Patientsex
- 1
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Brain natriuretic peptide increased
- Reactionoutcome
- 3
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Cardiac failure
- Reactionoutcome
- 3
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- SKYCLARYS
- Drugstructuredosagenumb
- 150
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugindication
- Friedreich^s ataxia
- Drugstartdateformat
- 102
- Drugstartdate
- 20260401
- Drugenddateformat
- 102
- Drugenddate
- 20260512
- Drugtreatmentduration
- 41
- Drugtreatmentdurationunit
- 804
- Actiondrug
- 1
- Drugrecurreadministration
- 3
- Drugadditional
- 2
- Activesubstance
- Activesubstancename
- OMAVELOXOLONE
- Harmonized identifiers (openFDA)
- Application number
- NDA216718
- Brand name
- SKYCLARYS
- Generic name
- OMAVELOXOLONE
- Manufacturer name
- Biogen
- Product NDC
- 64406-250
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- OMAVELOXOLONE
- RxCUI
- 2631936, 2631942
- SPL ID
- 4fa5df55-d5bf-44d1-856e-937b48e69bb0
- SPL set ID
- 2709e870-df3d-f30f-e063-6394a90aeda1
- Package NDC
- 64406-250-90
- Nui
- N0000185506, N0000187063
- Pharm class moa
- Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA]
- UNII
- G69Z98951Q
- Summary
- Narrativeincludeclinical
- CASE EVENT DATE: 20260401
