Mastication disorder
Drugs: DYSPORT
- Safetyreportversion
- 1
- Safetyreportid
- 26942692
- Primarysourcecountry
- US
- Occurcountry
- US
- Transmissiondateformat
- 102
- Transmissiondate
- 20260709
- Reporttype
- 1
- Serious
- 2
- Seriousnessdeath
- 2
- Seriousnesslifethreatening
- 2
- Seriousnesshospitalization
- 2
- Seriousnessdisabling
- 2
- Seriousnesscongenitalanomali
- 2
- Seriousnessother
- 2
- Receivedateformat
- 102
- Receivedate
- 20260630
- Receiptdateformat
- 102
- Receiptdate
- 20260630
- Fulfillexpeditecriteria
- 2
- Companynumb
- US-IPSEN Group, Research and Development-2026-14224
- Primarysource
- Reportercountry
- US
- Qualification
- 5
- Sender
- Sendertype
- 6
- Senderorganization
- IPSEN BIOPHARMACEUTICALS, INC.
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientonsetage
- 67
- Patientonsetageunit
- 801
- Patientagegroup
- 6
- Patientweight
- 77.11
- Patientsex
- 1
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Mastication disorder
- Reactionoutcome
- 3
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- DYSPORT
- Drugbatchnumb
- 033010
- Drugstructuredosagenumb
- 1500
- Drugstructuredosageunit
- 025
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 12
- Drugintervaldosagedefinition
- 803
- Drugdosagetext
- INJECT 1500 UNITS INTO THE MUSCLES, INTO THE MUSCLES OF THE HEAD AND NECK
- Drugdosageform
- Powder for solution for injection
- Drugadministrationroute
- 030
- Drugindication
- Torticollis
- Drugstartdateformat
- 102
- Drugstartdate
- 20260504
- Actiondrug
- 5
- Drugrecurreadministration
- 3
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- ABOBOTULINUMTOXINA
- Harmonized identifiers (openFDA)
- Application number
- BLA125274
- Brand name
- DYSPORT
- Generic name
- BOTULINUM TOXIN TYPE A
- Manufacturer name
- Galderma Laboratories, L.P., Ipsen Biopharmaceuticals, Inc.
- Product NDC
- 0299-5962, 15054-0500, 15054-0530
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAMUSCULAR
- Substance name
- BOTULINUM TOXIN TYPE A
- RxCUI
- 1789956, 1789958, 1789950, 1789953
- SPL ID
- 253b9c91-ded3-b0b3-e063-6294a90a669a, 44512f6b-6a35-4db5-ba17-fe2fe3ec5170
- SPL set ID
- 71313a04-1349-4c26-b840-a39e4a3ddaed, 97513722-8426-4ce3-b85d-0e08e436a140
- Package NDC
- 0299-5962-30, 0299-5962-01, 15054-0500-1, 15054-0500-2, 15054-0500-9, 15054-0530-6
- Nui
- N0000175771, N0000193962, N0000175731, N0000175770
- Pharm class epc
- Acetylcholine Release Inhibitor [EPC], Neuromuscular Blocker [EPC]
- Pharm class pe
- Neuromuscular Blockade [PE]
- Pharm class moa
- Acetylcholine Release Inhibitors [MoA]
- UNII
- E211KPY694
- Summary
- Narrativeincludeclinical
- CASE EVENT DATE: 20260101