Opdivo 40mg/4ml Inj 40 mg/4ml

国: ヨルダン

言語: 英語

ソース: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

有効成分:

Nivolumab 40 mg/4ml

から入手可能:

مستودع أدوية الشرق شخشير - ORIENT DRUG STORE CO

ATCコード:

L01XC17

INN（国際名）:

Nivolumab 40 mg/4ml

投薬量:

40 mg/4ml

パッケージ内のユニット:

1Vial (4ml)

製:

Bristol Myers Squibb Holdings Pharma ,Ltd.Liability Company (امريكا)

情報リーフレット

Front
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I_10000225051
BRISTOL-MYERS SQUIBB:
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Susan Stewart
Brian Dangel
Galina Laufer
5/20/2019
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DEVELOPMENTAL COPY VERSION:
 Utilizes correct specification (drawing)
 Revisions correct per text provided
 Drug potency correct & consistent
 NDC on component verified ??
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Reason for Change: Submission
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INITIAL HERE
Susan Stewart
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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