Movement disorder, Myopathy, Myalgia
Drugs: PITAVASTATIN, ASPIRIN\CLOPIDOGREL, EPLERIUM +3
- Safetyreportversion
- 1
- Safetyreportid
- 26940055
- Primarysourcecountry
- EU
- Transmissiondateformat
- 102
- Transmissiondate
- 20260709
- Reporttype
- 3
- Serious
- 1
- Seriousnessdeath
- 2
- Seriousnesslifethreatening
- 2
- Seriousnesshospitalization
- 2
- Seriousnessdisabling
- 1
- Seriousnesscongenitalanomali
- 2
- Seriousnessother
- 1
- Receivedateformat
- 102
- Receivedate
- 20260630
- Receiptdateformat
- 102
- Receiptdate
- 20260630
- Fulfillexpeditecriteria
- 1
- Authoritynumb
- EU-GREOF-202601020
- Duplicate
- 1
- Reportduplicate
- Duplicatesource
- GREOF
- Duplicatenumb
- EU-GREOF-202601020
- Primarysource
- Reportercountry
- EU
- Qualification
- 3
- Sender
- Sendertype
- 6
- Senderorganization
- KOWA PHARM
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientonsetage
- 59
- Patientonsetageunit
- 801
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Movement disorder
- Reactionoutcome
- 3
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Myopathy
- Reactionoutcome
- 3
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Myalgia
- Reactionoutcome
- 3
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- PITAVASTATIN
- Drugauthorizationnumb
- 022363
- Drugseparatedosagenumb
- 1
- Drugindication
- Product used for unknown indication
- Actiondrug
- 5
- Drugrecurreadministration
- 3
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- PITAVASTATIN
- Harmonized identifiers (openFDA)
- Application number
- ANDA205932, ANDA206070, ANDA205955, ANDA206015, ANDA205961
- Brand name
- PITAVASTATIN, PITAVASTATIN CALCIUM
- Generic name
- PITAVASTATIN CALCIUM, PITAVASTATIN
- Manufacturer name
- Teva Pharmaceuticals, Inc., Mylan Pharmaceuticals Inc., Upsher-Smith Laboratories, LLC, Aurobindo Pharma Limited, Amneal Pharmaceuticals LLC
- Product NDC
- 0480-3631, 0480-3632, 0480-3633, 0378-5055, 0378-5056, 0378-5057, 0832-6048, 0832-6049, 0832-6050, 65862-812, 65862-813, 65862-814, 65162-029, 65162-030, 65162-031
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- PITAVASTATIN CALCIUM
- RxCUI
- 861643, 861648, 861652
- SPL ID
- 191b4856-1662-a7b8-e063-6394a90a2c56, 44bb6612-917c-4457-952a-5751ea607867, 53c2bd9a-c6ee-8b8c-e063-6294a90a5a95, 9a71c5a7-aaf8-4650-aba4-da6ba84d03a7, ab7d1d71-229c-4528-9c2d-59d268c48c25
- SPL set ID
- fac09182-dcf2-1770-e053-6394a90af50c, 26b5e5e8-45cd-4a98-9af4-2d04c1130881, 9ad1ecb9-822d-47c1-9f6f-6f771fa0f924, a52401eb-a822-475b-a40d-7b8acde2ae1a, 7fbfcc0c-9251-456d-a525-e62cfd8abd4b
- Package NDC
- 0480-3632-98, 0480-3633-98, 0480-3631-98, 0378-5055-77, 0378-5056-77, 0378-5057-77, 0832-6049-90, 0832-6048-90, 0832-6050-90, 65862-812-90, 65862-812-05, 65862-813-90, 65862-813-05, 65862-814-90, 65862-814-05, 65162-029-03, 65162-029-09, 65162-029-50, 65162-030-03, 65162-030-09, 65162-030-50, 65162-031-03, 65162-031-09, 65162-031-50
- UNII
- IYD54XEG3W
- Drugcharacterization
- 2
- Medicinalproduct
- ASPIRIN\CLOPIDOGREL
- Drugseparatedosagenumb
- 1
- Drugindication
- Product used for unknown indication
- Actiondrug
- 5
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- ASPIRIN\CLOPIDOGREL
- Drugcharacterization
- 2
- Medicinalproduct
- EPLERIUM
- Drugseparatedosagenumb
- 1
- Drugindication
- Product used for unknown indication
- Actiondrug
- 5
- Drugadditional
- 3
- Drugcharacterization
- 2
- Medicinalproduct
- JARDIANCE
- Drugseparatedosagenumb
- 1
- Drugindication
- Product used for unknown indication
- Actiondrug
- 5
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- EMPAGLIFLOZIN
- Harmonized identifiers (openFDA)
- Application number
- NDA204629
- Brand name
- JARDIANCE
- Generic name
- EMPAGLIFLOZIN
- Manufacturer name
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Product NDC
- 0597-0152, 0597-0153
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- EMPAGLIFLOZIN
- RxCUI
- 1545658, 1545664, 1545666, 1545668
- SPL ID
- 09daa78d-f417-436c-a29e-029c015ca6d6
- SPL set ID
- faf3dd6a-9cd0-39c2-0d2e-232cb3f67565
- Package NDC
- 0597-0152-90, 0597-0152-07, 0597-0152-70, 0597-0152-37, 0597-0152-30, 0597-0153-37, 0597-0153-30, 0597-0153-90, 0597-0153-07, 0597-0153-70
- Nui
- N0000187059, N0000187058
- Pharm class epc
- Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
- Pharm class moa
- Sodium-Glucose Transporter 2 Inhibitors [MoA]
- UNII
- HDC1R2M35U
- Drugcharacterization
- 2
- Medicinalproduct
- PANTIUM [PACLITAXEL]
- Drugseparatedosagenumb
- 1
- Drugindication
- Product used for unknown indication
- Actiondrug
- 5
- Drugadditional
- 3
- Drugcharacterization
- 2
- Medicinalproduct
- NEBIVOLOL HYDROCHLORIDE
- Drugseparatedosagenumb
- 1
- Drugindication
- Product used for unknown indication
- Actiondrug
- 5
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- NEBIVOLOL HYDROCHLORIDE
- Harmonized identifiers (openFDA)
- Application number
- ANDA203821, NDA021742, ANDA216568, ANDA213830
- Brand name
- NEBIVOLOL, BYSTOLIC, NEBIVOLOL HYDROCHLORIDE
- Generic name
- NEBIVOLOL HYDROCHLORIDE
- Manufacturer name
- AvKARE, Allergan, Inc., Apnar Pharma LP, Glenmark Pharmaceuticals Inc., USA, Unichem Pharmaceuticals (USA), Inc.
- Product NDC
- 42291-871, 42291-872, 42291-873, 42291-874, 0456-1402, 0456-1405, 0456-1410, 0456-1420, 24689-159, 24689-160, 24689-161, 24689-162, 68462-615, 68462-616, 68462-617, 68462-618, 29300-375, 29300-376, 29300-377, 29300-378
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- NEBIVOLOL HYDROCHLORIDE
- RxCUI
- 387013, 751612, 751618, 827073, 751616, 751620, 751623, 827075
- SPL ID
- 48842030-a03d-fb38-e063-6294a90a9dd0, 0096cdf0-43e6-4128-8990-aed7e1fab83f, ffc06b5e-4f7d-4020-8be9-a4e903c1bfa8, 151f00ae-13ed-4174-bf4d-bc30f1fb9d69, 1a80b28a-62f6-443e-8e8d-fc89b74be5ea
- SPL set ID
- 1ce89dc5-018d-db40-e063-6294a90a9722, 8b8ad213-1dc8-454e-a524-075685c0e1a8, 3f5766c0-e1fa-4805-a32c-523182310ad5, cb47560d-9e35-4b0f-b12b-6ea478684a5b, b1762bbb-b5be-48a7-8101-bb736f28845a
- Package NDC
- 42291-871-30, 42291-872-90, 42291-873-90, 42291-874-90, 0456-1402-30, 0456-1402-90, 0456-1402-01, 0456-1402-63, 0456-1405-30, 0456-1405-90, 0456-1405-01, 0456-1405-63, 0456-1410-30, 0456-1410-90, 0456-1410-01, 0456-1410-63, 0456-1420-30, 0456-1420-90, 0456-1420-01, 0456-1420-63, 24689-159-01, 24689-159-02, 24689-160-01, 24689-160-02, 24689-161-01, 24689-161-02, 24689-162-01, 24689-162-02, 68462-615-30, 68462-615-01, 68462-615-11, 68462-616-30, 68462-616-01, 68462-616-11, 68462-617-30, 68462-617-01, 68462-617-11, 68462-618-30, 68462-618-01, 68462-618-11 +12 more
- UNII
- JGS34J7L9I