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 |
| Phone No : 03-7966 0288 |
|
| Manufacturer : Swords Laboratories Unlimited Company t/a Bristol-Myers Squibb Cruiserath Biologics |
Manufacturer Address : CRUISERATH ROAD, MULHUDDART, DUBLIN 15, D15 H5EF, |
| Importer : DKSH MALAYSIA SDN. BHD. |
Importer Address : B-11-01, THE ASCENT, PARADIGM |
Ingredients Information / Maklumat Bahan Aktif
| No | Active Ingredient |
| 1 | NIVOLUMAB |
Packaging Information / Maklumat Bungkusan
| No | Quantity |
| 1 | 12 ml |
| 2 | 4ml mL |
| 3 | 10ml mL |
Label (mock-up) for Immediate Container / Label Terdekat
| No | Attachment |
| 1 | D1 Vial Label 120mg_12ml_2000550-01_RO125085.pdf |
| 2 | D1 MY Opdivo_100mg-LBL_LENC-CRU_1363144A3-01_RO089944_Clean.pdf |
| 3 | D1_Opdivo_40mg4ml_vial_clean1363141A2-01.pdf |
Label (mock-up) for Outer Carton / Label Luar
| No | Attachment |
| 1 | D2 Carton label 120mg_12ml_2000582-04_RO125085.pdf |
| 2 | D2 OPDIVO 100mg_Carton_CRU_1363145A4-01__RO089944.pdf |
| 3 | D2 OPDIVO 40mg_Carton_CRU name_1363090A4-01__RO089944.pdf |
Technical Evaluation Summary
NO INFORMATION DETAIL