Adverse drug reaction, Malignant lymphoid neoplasm, Product dispensed by unauthorised provider
Drugs: GONADOTROPHIN, CHORIONIC, OZEMPIC, GLOW GHK-CU/BPU 157/ TB 500 100 MG/10 MG/10 MG
- Safetyreportversion
- 1
- Safetyreportid
- 26810736
- Primarysourcecountry
- US
- Transmissiondateformat
- 102
- Transmissiondate
- 20260709
- Reporttype
- 1
- Serious
- 1
- Seriousnessdeath
- 2
- Seriousnesslifethreatening
- 2
- Seriousnesshospitalization
- 2
- Seriousnessdisabling
- 1
- Seriousnesscongenitalanomali
- 2
- Seriousnessother
- 2
- Receivedateformat
- 102
- Receivedate
- 20260527
- Receiptdateformat
- 102
- Receiptdate
- 20260527
- Fulfillexpeditecriteria
- 3
- Authoritynumb
- 822765
- Primarysource
- Reportercountry
- US
- Qualification
- 5
- Sender
- Sendertype
- 6
- Senderorganization
- FDA-CTU
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientonsetage
- 31
- Patientonsetageunit
- 801
- Patientweight
- 96.75
- Patientsex
- 1
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Adverse drug reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Malignant lymphoid neoplasm
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Product dispensed by unauthorised provider
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- GONADOTROPHIN, CHORIONIC
- Drugbatchnumb
- #SP897295
- Drugauthorizationnumb
- 99
- Drugseparatedosagenumb
- -1
- Drugdosagetext
- OTHER QUANTITY : 1 INJECTION(S);?FREQUENCY : AS NEEDED;
- Drugadministrationroute
- 058
- Drugindication
- Blood testosterone decreased
- Drugstartdateformat
- 102
- Drugstartdate
- 20251121
- Drugenddateformat
- 102
- Drugenddate
- 20260107
- Drugadditional
- 2
- Activesubstance
- Activesubstancename
- GONADOTROPHIN, CHORIONIC
- Harmonized identifiers (openFDA)
- Application number
- BLA017016
- Brand name
- NOVAREL
- Generic name
- GONADOTROPHIN, CHORIONIC
- Manufacturer name
- Ferring Pharmaceuticals Inc.
- Product NDC
- 55566-1502
- Product type
- HUMAN PRESCRIPTION DRUG
- RxCUI
- 310587, 1865295
- SPL ID
- dd63b1fd-1f0b-496b-b825-b1f8fb351dbb
- SPL set ID
- ac6918ff-9dc3-40d9-8619-54b26e4bdfc8
- Package NDC
- 55566-1502-1, 55566-1700-0
- Drugcharacterization
- 1
- Medicinalproduct
- OZEMPIC
- Activesubstance
- Activesubstancename
- SEMAGLUTIDE
- Harmonized identifiers (openFDA)
- Application number
- NDA213051
- Brand name
- OZEMPIC
- Generic name
- ORAL SEMAGLUTIDE
- Manufacturer name
- Novo Nordisk Pharmaceutical Industries, LP
- Product NDC
- 0169-1704, 0169-1715, 0169-1709, 0169-4303, 0169-4307, 0169-4314, 0169-4815, 0169-4804, 0169-4809
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- SEMAGLUTIDE
- RxCUI
- 2200644, 2200650, 2200652, 2200654, 2200656, 2200658, 2707547, 2707549, 2707551, 2707553, 2707555, 2707557, 2736944, 2736946, 2736948
- SPL ID
- 6834044a-22f1-4f35-b846-b3448ee84c16
- SPL set ID
- 27f15fac-7d98-4114-a2ec-92494a91da98
- Package NDC
- 0169-1715-30, 0169-1715-90, 0169-1704-30, 0169-1709-30, 0169-4303-01, 0169-4303-13, 0169-4303-90, 0169-4303-93, 0169-4303-30, 0169-4303-99, 0169-4307-01, 0169-4307-13, 0169-4307-30, 0169-4314-01, 0169-4314-13, 0169-4314-30, 0169-4815-30, 0169-4815-90, 0169-4804-30, 0169-4809-30
- Nui
- N0000178480, M0160181, N0000020058
- Pharm class epc
- GLP-1 Receptor Agonist [EPC]
- Pharm class cs
- Glucagon-Like Peptide 1 [CS]
- Pharm class moa
- Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
- UNII
- 53AXN4NNHX
- Drugcharacterization
- 2
- Medicinalproduct
- GLOW GHK-CU/BPU 157/ TB 500 100 MG/10 MG/10 MG
- Summary
- Narrativeincludeclinical
- CASE EVENT DATE: 20260113