Anaemia, Renal impairment, Insurance issue +4
Drugs: OLAPARIB
- Safetyreportversion
- 1
- Safetyreportid
- 27325192
- Primarysourcecountry
- US
- Occurcountry
- US
- Transmissiondateformat
- 102
- Transmissiondate
- 20261008
- Reporttype
- 2
- Serious
- 1
- Seriousnessdeath
- 2
- Seriousnesslifethreatening
- 2
- Seriousnesshospitalization
- 1
- Seriousnessdisabling
- 2
- Seriousnesscongenitalanomali
- 2
- Seriousnessother
- 1
- Receivedateformat
- 102
- Receivedate
- 20260930
- Receiptdateformat
- 102
- Receiptdate
- 20260930
- Fulfillexpeditecriteria
- 1
- Companynumb
- US-ASTRAZENECA-202608NAM025511US
- Primarysource
- Reportercountry
- US
- Qualification
- 5
- Sender
- Sendertype
- 6
- Senderorganization
- ALEXION PHARMACEUTICALS
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientagegroup
- 6
- Patientsex
- 2
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Anaemia
- Reactionoutcome
- 1
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Renal impairment
- Reactionoutcome
- 6
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Insurance issue
- Reactionoutcome
- 6
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Dyspepsia
- Reactionoutcome
- 3
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Fatigue
- Reactionoutcome
- 3
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Arthralgia
- Reactionoutcome
- 3
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- X-ray limb abnormal
- Reactionoutcome
- 6
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- OLAPARIB
- Drugauthorizationnumb
- 208558
- Drugstructuredosagenumb
- 300
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugdosagetext
- 300 MILLIGRAM, BID
- Drugadministrationroute
- 061
- Drugindication
- Ovarian cancer
- Drugstartdateformat
- 602
- Drugstartdate
- 2023
- Actiondrug
- 2
- Drugrecurreadministration
- 3
- Drugadditional
- 1
- Activesubstance
- Activesubstancename
- OLAPARIB
- Harmonized identifiers (openFDA)
- Application number
- NDA208558
- Brand name
- LYNPARZA
- Generic name
- OLAPARIB
- Manufacturer name
- AstraZeneca Pharmaceuticals LP
- Product NDC
- 0310-0569, 0310-0668, 0310-0679, 0310-0578
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- OLAPARIB
- RxCUI
- 1942482, 1942485, 1942487, 1942489
- SPL ID
- 0142c57f-6211-4638-8c48-c215686871b8
- SPL set ID
- 741ff3e3-dc1a-45a6-84e5-2481b27131aa
- Package NDC
- 0310-0668-60, 0310-0668-12, 0310-0668-95, 0310-0679-60, 0310-0679-12, 0310-0679-95, 0310-0569-60, 0310-0569-12, 0310-0578-60, 0310-0578-12
- Nui
- N0000191623, N0000191622
- Pharm class epc
- Poly(ADP-Ribose) Polymerase Inhibitor [EPC]
- Pharm class moa
- Poly(ADP-Ribose) Polymerase Inhibitors [MoA]
- UNII
- WOH1JD9AR8
- Drugcharacterization
- 1
- Medicinalproduct
- OLAPARIB
- Drugauthorizationnumb
- 208558
- Drugstructuredosagenumb
- 200
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugdosagetext
- 200 MILLIGRAM, BID
- Drugadministrationroute
- 061
- Actiondrug
- 2
- Drugrecurreadministration
- 3
- Drugadditional
- 1
- Activesubstance
- Activesubstancename
- OLAPARIB
- Harmonized identifiers (openFDA)
- Application number
- NDA208558
- Brand name
- LYNPARZA
- Generic name
- OLAPARIB
- Manufacturer name
- AstraZeneca Pharmaceuticals LP
- Product NDC
- 0310-0569, 0310-0668, 0310-0679, 0310-0578
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- OLAPARIB
- RxCUI
- 1942482, 1942485, 1942487, 1942489
- SPL ID
- 0142c57f-6211-4638-8c48-c215686871b8
- SPL set ID
- 741ff3e3-dc1a-45a6-84e5-2481b27131aa
- Package NDC
- 0310-0668-60, 0310-0668-12, 0310-0668-95, 0310-0679-60, 0310-0679-12, 0310-0679-95, 0310-0569-60, 0310-0569-12, 0310-0578-60, 0310-0578-12
- Nui
- N0000191623, N0000191622
- Pharm class epc
- Poly(ADP-Ribose) Polymerase Inhibitor [EPC]
- Pharm class moa
- Poly(ADP-Ribose) Polymerase Inhibitors [MoA]
- UNII
- WOH1JD9AR8
- Drugcharacterization
- 1
- Medicinalproduct
- OLAPARIB
- Drugauthorizationnumb
- 208558
- Drugstructuredosagenumb
- 200
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugdosagetext
- 200 MILLIGRAM, BID
- Drugadministrationroute
- 061
- Drugstartdateformat
- 610
- Drugstartdate
- 202608
- Actiondrug
- 2
- Drugrecurreadministration
- 3
- Drugadditional
- 1
- Activesubstance
- Activesubstancename
- OLAPARIB
- Harmonized identifiers (openFDA)
- Application number
- NDA208558
- Brand name
- LYNPARZA
- Generic name
- OLAPARIB
- Manufacturer name
- AstraZeneca Pharmaceuticals LP
- Product NDC
- 0310-0569, 0310-0668, 0310-0679, 0310-0578
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- OLAPARIB
- RxCUI
- 1942482, 1942485, 1942487, 1942489
- SPL ID
- 0142c57f-6211-4638-8c48-c215686871b8
- SPL set ID
- 741ff3e3-dc1a-45a6-84e5-2481b27131aa
- Package NDC
- 0310-0668-60, 0310-0668-12, 0310-0668-95, 0310-0679-60, 0310-0679-12, 0310-0679-95, 0310-0569-60, 0310-0569-12, 0310-0578-60, 0310-0578-12
- Nui
- N0000191623, N0000191622
- Pharm class epc
- Poly(ADP-Ribose) Polymerase Inhibitor [EPC]
- Pharm class moa
- Poly(ADP-Ribose) Polymerase Inhibitors [MoA]
- UNII
- WOH1JD9AR8