quest3plus.bpfk.gov.my
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https://quest3plus.bpfk.gov.my/pmo2/detail.php?type=product&id=MAL17055001A
Submission: On December 27 via manual from IN — Scanned from DE
Submission: On December 27 via manual from IN — Scanned from DE
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QUEST 3+ Product Search Product Information / Maklumat Produk Product Name : Opdivo 10mg/ml, Concentrate for solution for infusion Registration No : MAL17055001AZ Holder : DKSH MALAYSIA SDN BHD Holder Address : B-11-01, THE ASCENT, PARADIGM NO. 1, JALAN SS7/26A, KELANA JAYA 47301 PETALING JAYA MALAYSIA Phone No : 03-7966 0288 Manufacturer : Swords Laboratories t/a Bristol-Myers Squibb Cruiserath Biologics Manufacturer Address : CRUISERATH ROAD, MULHUDDART DUBLIN 15, IRELAND Importer : DKSH MALAYSIA SDN BHD Importer Address : B-11-01, THE ASCENT, PARADIGM NO. 1, JALAN SS7/26A, KELANA JAYA 47301 PETALING JAYA MALAYSIA Ingredients Information / Maklumat Bahan Aktif No Active Ingredient 1 NIVOLUMAB Packaging Information / Maklumat Bungkusan No Quantity 1 4ml mL 2 10ml mL Consumer Medication Information Leaflet / Risalah Maklumat Ubat Pesakit No Attachment 1 NA.pdf 2 NA.pdf 3 Not_Applicable.pdf 4 Not_Applicable.pdf 5 Not_Applicable.pdf 6 Not_Applicable.pdf Label (mock-up) for Immediate Container / Label Dalam Bekas No Attachment 1 D1_Opdivo_40mg4ml_vial_clean1363141A2-01.pdf 2 D1 MY Opdivo_100mg-LBL_LENC-CRU_1363144A3-01_RO089944_Clean.pdf Label (mock-up) for Outer Carton / Label Luar Bekas No Attachment 1 D2 OPDIVO 40mg_Carton_CRU name_1363090A4-01__RO089944.pdf 2 D2 OPDIVO 100mg_Carton_CRU_1363145A4-01__RO089944.pdf Proposed Package Insert / Sisipan Bungkusan No Attachment 1 D3 MY Proposed PI OPDIVO_new CRU name_Jan22__RO089944.pdf 2 MY Proposed PI OPDIVO 1L RCC(9ER)_IR clean_newCRUname_mono safetyupdate_12Aug22 v2.pdf 3 MY Proposed PI OPDIVO 1L RCC(9ER)_IR annotated_newCRUname_mono safetyupdate_12Aug22 v2.pdf Technical Evaluation Summary NO INFORMATION DETAIL Print