国: ヨルダン
言語: 英語
ソース: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)
Nivolumab 100 mg/10ml
مستودع أدوية الشرق شخشير - ORIENT DRUG STORE CO
L01XC17
Nivolumab 100 mg/10ml
100 mg/10ml
1 Vial (10ml)
Bristol Myers Squibb Holdings Pharma ,Ltd.Liability Company (امريكا)
Front (Page 1) I_10000225051 BRISTOL-MYERS SQUIBB: LENGTH HATCH LEGEND. ALL HATCHING DENOTES AREAS TO CONTAIN NOTED INFORMATION. 2870.2mm Cut SPECIFIC RULE LEGEND IC Mark Area Page 1: 3/16" from left edge, 4 point width, 100% black Susan Stewart Brian Dangel Galina Laufer 5/20/2019 COMMENTS: GRAPHIC DESIGNER: STRUCTURAL DESIGNER: ENGINEER: DATE OF APPROVAL: STRUCTURE #: Manufacturing Science & Technology Outside Bleed NA 128 Barcode No Text Edge Bar I 2 of 5 Barcode IC Mark Glue (No Ink or Varnish) 3" 76.200mm 39" 990.600mm 3" 76.200mm 3 / 16 " 4.762mm 3 / 16 " 4.762mm 3 / 16 " 4.763mm 17 1 / 2 " 444.500mm 1 5 / 16 " 33.337mm 1 5 / 16 " 33.337mm 1 5 / 16 " 33.337mm 1 5 / 16 " 33.337mm 3 / 16 " 4.762mm 1 / 4 " 6.350mm 3 / 16 " 4.763mm 1 / 4 [ 6.350] 1 / 4 " 6.350mm 1 / 4 " 6.350mm 1 / 4 " 6.350mm 3 / 8 [ 9.525] 1 / 2 " 12.700mm 1 / 2 " 12.700mm 1 1 / 2 " 38.100mm 1 / 16 " 1.588mm 1 / 16 " 1.588mm 3 / 4 " 19.050mm 7 5 / 8 " 193.675mm 9 7 / 8 " 250.825mm 1 / 2 " 12.700mm 1 / 2 " 12.700mm 1 / 2 " 12.700mm 3 / 4 " 19.050mm BLACK PRODUCT: ORIGINATOR: DATE: FILENAME: PR CODE: DEVELOPMENTAL COPY VERSION: Utilizes correct specification (drawing) Revisions correct per text provided Drug potency correct & consistent NDC on component verified ?? Spellcheck Utilizes correct colors Tints, gradations and colors shown as swatches Proofread by Reason for Change: Submission . INITIAL HERE Susan Stewart X X X na X X X 02Nov2021 00 B DV_0059_Opdivo GEM insert Opdivo GEM OPDIVO ® (NIVOLUMAB) 40 MG/4 ML (10 MG/ML) INJECTION 100 MG/10 ML (10 MG/ML) INJECTION FULL PRESCRIBING INFORMATION Note: Some numbered sections and subsections have been omitted from the full prescribing information because they are not applicable. 1 INDICATIONS AND USAGE 1.1 Unresectable or Metastatic Melanoma OPDIVO, as a single agent or in combination with ipilimumab, is indicated for the treatment of patients with unresectable or metastatic melanoma. 1.2 Adjuvant Treatment of Melanoma OPDIVO is indicated for the adjuvant treatmen 完全なドキュメントを読む