Skin discolouration, Pigmentation disorder
Drugs: PEMETREXED DISODIUM, CARBOPLATIN
- Safetyreportversion
- 1
- Safetyreportid
- 27325173
- Primarysourcecountry
- CN
- Occurcountry
- CN
- Transmissiondateformat
- 102
- Transmissiondate
- 20261008
- 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
- CN-Hansoh-20262190018394
- Duplicate
- 1
- Reportduplicate
- Duplicatesource
- NMPACDR
- Duplicatenumb
- 15498093432332615681541
- Primarysource
- Reportercountry
- CN
- Qualification
- 1
- Sender
- Sendertype
- 6
- Senderorganization
- JIANGSU HANSOH PHARMACEUTICAL GROUP CO., LTD.
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientonsetage
- 66
- Patientonsetageunit
- 801
- Patientagegroup
- 6
- Patientweight
- 56
- Patientsex
- 1
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Skin discolouration
- Reactionoutcome
- 3
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Pigmentation disorder
- Reactionoutcome
- 3
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- PEMETREXED DISODIUM
- Drugbatchnumb
- 1
- Drugstructuredosagenumb
- 800
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugdosagetext
- 800 MG, QD
- Drugdosageform
- Injection
- Drugadministrationroute
- 041
- Drugindication
- Lung neoplasm malignant
- Drugstartdateformat
- 102
- Drugstartdate
- 20260711
- Drugenddateformat
- 102
- Drugenddate
- 20260711
- Drugtreatmentduration
- 1
- Drugtreatmentdurationunit
- 804
- Actiondrug
- 1
- Drugrecurreadministration
- 3
- Drugadditional
- 2
- Activesubstance
- Activesubstancename
- PEMETREXED DISODIUM
- Harmonized identifiers (openFDA)
- Application number
- ANDA214073, ANDA204890, NDA021462, ANDA208696, ANDA209085, NDA215179, ANDA215460, ANDA211899, ANDA209851, ANDA202596, NDA214657, ANDA090384, ANDA215479, ANDA203774
- Brand name
- PEMETREXED, ALIMTA, PEMRYDI RTU, PEMETREXED DISODIUM
- Generic name
- PEMETREXED DISODIUM
- Manufacturer name
- Zydus Lifesciences Limited, Qilu Pharmaceutical Co., Ltd., Eli Lilly and Company, Meitheal Pharmaceuticals Inc., BluePoint Laboratories, Amneal Pharmaceuticals LLC, Camber Pharmaceuticals, Inc., Waverley Pharma Inc, NorthStar RxLLC, Dr. Reddys Laboratories Inc, Somerset Therapeutics LLC, Sandoz Inc., Fresenius Kabi USA, LLC, Shilpa Medicare Limited
- Product NDC
- 70771-1691, 70771-1692, 70771-1693, 67184-0503, 67184-0504, 0002-7623, 0002-7640, 71288-166, 71288-167, 68001-546, 68001-538, 68001-539, 70121-2453, 70121-2461, 70121-2462, 31722-336, 31722-337, 72338-100, 72338-101, 68001-545, 72603-325, 72603-425, 43598-370, 43598-386, 43598-387, 70069-834, 70069-835, 0781-3518, 0781-3519, 0781-3520, 63323-134, 63323-450, 63323-621, 63323-622, 71288-145, 71288-146, 71288-147, 71288-148, 63759-3048, 63759-3049 +3 more
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- PEMETREXED DISODIUM, PEMETREXED DISODIUM HEMIPENTAHYDRATE, PEMETREXED DISODIUM HEPTAHYDRATE
- RxCUI
- 1728072, 1728077, 2601728, 1728075, 1728079, 2637958, 2637964, 2637966, 2637967, 2637968, 2637969, 2602136, 2602363, 2602365, 2602366
- SPL ID
- fc5f4aa1-92c4-444b-8e64-53708c9a67bc, 0dc735ab-c4c9-4e19-bb80-8a439be7208c, 3af0bc84-13d6-46aa-a4c0-c62410b73bc6, 235ded9d-0115-4335-b7fb-e0d4fa85b6f6, fa3ecbbb-86e3-6fca-e053-6394a90a56d9, eed98f1e-acdf-28da-e053-2a95a90a046c, b6a00be1-95d1-4b91-93bf-4430a57eeff6, 31b2e68a-5c70-b490-e063-6294a90aaab0, d0687ba7-a598-4409-8459-0204bcb6d9f3, fa3ecbbb-86e6-6fca-e053-6394a90a56d9, c754c764-7f07-480c-b130-c5ce64cf0b80, ad279b3e-152b-998b-a0d8-f96ecff31439, 34c64c32-89bd-e0a0-e063-6394a90a8ddf, 764ab64b-c642-4314-83a9-efee79fe83a3, c7ff62a1-e697-4a7c-9907-59163f393528, b369ac27-0118-4e53-be05-c9ba2dbf6875, b0e3847a-fdcf-405c-823c-180fa8dad9c2, 0759eb55-d7ae-c87a-e063-6394a90abe08, b38927c4-2b38-4d5c-be9f-86ba95ddc038
- SPL set ID
- 6986de29-b077-48ac-ad2b-0cc478f72d89, 46a9b89d-7135-4e0c-b8e4-52580554769b, f5a860f3-37ec-429c-ae04-9c88d7c55c08, 1ceacc3e-f555-489b-8b16-2baa58b2f5a5, 61588f3c-4c06-4c35-a000-201dd1019093, c9f34c00-1176-4f44-8cff-bae5bdc0c40f, 0f006b06-ab85-423d-ba0c-dfc3fc25844e, 2ca1ce75-5284-4282-b76a-3700d203c714, 95633c32-89a8-4275-94e7-939c9f2e6135, 14974d4e-2f01-4e02-aea2-c28b3ca0781c, 64f4a9ed-26ff-4bc7-bef1-4faa98b35563, 1d8bcf03-e055-a274-7844-ae9a523e3c4c, 39219e4b-80a6-4d4f-96a3-1202e542d050, 7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab3, ae77f00f-d43b-4b75-afd5-a2a9cb7138da, b185f459-5489-4e18-8521-1686b5d16f67, fe432994-e61b-4a87-8c98-cc20b847d0fe, 4cc1574b-3d2f-489b-9ad3-55695bb97200, e0d000a3-b9d2-4fa9-9591-f7acb077481d
- Package NDC
- 70771-1691-1, 70771-1692-1, 70771-1693-1, 67184-0503-1, 67184-0504-1, 0002-7640-01, 0002-7623-01, 71288-166-10, 71288-167-50, 68001-546-41, 68001-538-41, 68001-539-41, 70121-2453-1, 70121-2461-1, 70121-2462-1, 31722-336-31, 31722-337-31, 72338-100-01, 72338-101-01, 68001-545-41, 72603-325-01, 72603-425-01, 43598-386-62, 43598-387-11, 43598-370-74, 70069-834-01, 70069-835-01, 0781-3518-76, 0781-3519-90, 0781-3520-91, 63323-134-10, 63323-450-50, 63323-621-00, 63323-622-00, 71288-145-10, 71288-146-50, 71288-147-50, 71288-148-51, 63759-3048-1, 63759-3049-1 +5 more
- UNII
- 2PKU919BA9, F4GSH45R4C, 9T47E4OM16
- Drugcharacterization
- 2
- Medicinalproduct
- CARBOPLATIN
- Drugbatchnumb
- 1
- Drugstructuredosagenumb
- 300
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugdosagetext
- 300 MG, QD
- Drugdosageform
- injections
- Drugadministrationroute
- 041
- Drugindication
- Lung neoplasm malignant
- Drugstartdateformat
- 102
- Drugstartdate
- 20260711
- Drugenddateformat
- 102
- Drugenddate
- 20260711
- Drugtreatmentduration
- 1
- Drugtreatmentdurationunit
- 804
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- CARBOPLATIN
- Harmonized identifiers (openFDA)
- Application number
- ANDA077861, ANDA076517, ANDA077059, ANDA207324, NDA219921, ANDA077269, ANDA205487, ANDA206775, ANDA077266
- Brand name
- CARBOPLATIN, KYXATA
- Generic name
- CARBOPLATIN
- Manufacturer name
- Apotex Corp., Hospira, Inc., Gland Pharma Limited, Teyro Labs Private Limited, Avyxa Pharma, LLC, Teva Parenteral Medicines, Inc., Natco Pharma USA LLC, Eugia US LLC, Accord Healthcare, Inc., BPI Labs LLC, Fresenius Kabi USA, LLC
- Product NDC
- 60505-6282, 61703-150, 61703-360, 61703-262, 61703-600, 68083-190, 68083-191, 68083-192, 68083-193, 82511-003, 82511-004, 82511-005, 82511-006, 83831-141, 83831-140, 83831-142, 0703-4239, 0703-4244, 0703-4246, 0703-4248, 69339-364, 69339-365, 69339-366, 69339-367, 61703-339, 55150-333, 55150-334, 55150-335, 55150-386, 16729-295, 54288-164, 54288-165, 54288-166, 54288-167, 63323-172
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- CARBOPLATIN
- RxCUI
- 597195, 2721602
- SPL ID
- 0e68e276-b0df-4f03-e063-6394a90a22b9, 5aa72c15-8033-4559-b257-373371b18958, 5af07c55-5bef-4da3-91fa-9b3d8d1253d3, 2b3f8994-659d-b905-e063-6394a90a3aec, 5c711945-70be-42f4-b153-e1459dd9929c, bed4c1cf-f3ef-4faa-b2a4-24ee9a9879df, 4c89cedc-e48b-445c-ad05-54dbe60e4fb0, 0ddf4411-7138-412a-908a-fadf22bdfb79, 6029d051-ee8d-44cc-8dae-b91c3385d4c3, 35cf6068-f31a-211b-e063-6294a90a6b53, b943761e-6a46-45a0-bdb4-1fec1e101f8c, c0a7463c-d90f-4060-a54e-6a4888e8af0e, 3a1dd588-13b0-4d58-8d46-3a25a4fc6b40, 5abfcb87-bb02-4384-9c9d-7d0e3e809311
- SPL set ID
- 1c275825-0275-4c73-b650-e4c1519f13b8, 47677091-fd20-49af-933c-c9dd2be21de9, 9eb057eb-29ce-40d2-9ac8-ed107f25f5ab, f64a0cbe-7fe3-407e-8933-21c30e1a1ebc, f91c48da-68d1-4aa7-89b8-d84a3e8b629b, f330f5a2-2cad-402f-bcbb-26245a753276, 4c89cedc-e48b-445c-ad05-54dbe60e4fb0, c3ae9880-44bb-4f4e-93d8-8a5e21708a30, f5fe9a20-47a5-45b9-ab06-c6158d9b6aca, 48aa7ef3-9f44-2a08-e054-00144ff88e88, e176b6ef-2ff6-498b-a9d8-7a634d147f37, 5484d2f0-0cc2-4bba-8f26-c7f6539a9606, b4fa7aac-c9d2-4af4-a281-3e6cfc502ff6, 5abfcb87-bb02-4384-9c9d-7d0e3e809311
- Package NDC
- 60505-6282-1, 60505-6282-3, 60505-6282-6, 60505-6282-7, 61703-360-18, 61703-150-05, 61703-262-05, 61703-600-05, 68083-190-01, 68083-191-01, 68083-192-01, 68083-193-01, 82511-004-15, 82511-003-05, 82511-005-45, 82511-006-60, 83831-140-02, 83831-141-08, 83831-142-50, 0703-4244-01, 0703-4246-01, 0703-4248-01, 0703-4239-01, 69339-364-05, 69339-365-15, 69339-366-45, 69339-367-60, 61703-339-18, 61703-339-22, 61703-339-50, 61703-339-56, 55150-333-01, 55150-334-01, 55150-335-01, 55150-386-01, 16729-295-31, 16729-295-33, 16729-295-34, 16729-295-12, 16729-295-38 +11 more
- Nui
- N0000175413, N0000175073
- Pharm class epc
- Platinum-based Drug [EPC]
- UNII
- BG3F62OND5
- Summary
- Narrativeincludeclinical
- CASE EVENT DATE: 20260901