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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Umicore

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    01 Arsenic Trioxide (1)

    02 Calamine (1)

    03 Carboplatin (1)

    04 Cisplatin (1)

    05 Lomustine (1)

    06 Oxaliplatin (2)

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    01 Active (4)

    02 Blank (3)

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    01 Valid (5)

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    01 226MF10121 (1)

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    Carboplatin

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    USDMF

    Found USDMF

    28047
    Active
    CARBOPLATIN
    2014-03-10
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-264 - Rev 03
    Valid
    Carboplatin
    2019-10-24
    Japanese DMF

    Found JDMF

    226MF10121
    Carboplatin at Calle 14, Nr. 229 (L...
    2014-06-18
    Written Confirmation

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    Application Number
    28047
    R1-CEP 2009-264 - Rev 03
    226MF10121
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CARBOPLATIN
    Carboplatin
    Carboplatin at Calle 14, Nr. 229 (L...
    Issue/Submission Date
    2014-03-10
    2019-10-24
    2014-06-18
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    Oxaliplatin

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    USDMF

    Found USDMF

    28043
    Active
    OXALIPLATIN
    2014-03-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-002 - Rev 03
    Valid
    Oxaliplatin
    2020-02-19
    Japanese DMF

    Found JDMF

    227MF10151
    Oxaliplatin at Calle 14, Nr. 229 (L...
    2015-06-01
    Written Confirmation

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    Application Number
    28043
    R1-CEP 2010-002 - Rev 03
    227MF10151
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    OXALIPLATIN
    Oxaliplatin
    Oxaliplatin at Calle 14, Nr. 229 (L...
    Issue/Submission Date
    2014-03-08
    2020-02-19
    2015-06-01
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    Cisplatin

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    USDMF

    Found USDMF

    28046
    Active
    CISPLATIN
    2014-03-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-012 - Rev 00
    Valid
    Cisplatin
    2018-06-01
    Japanese DMF

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    Written Confirmation

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    Application Number
    28046
    R1-CEP 2012-012 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CISPLATIN
    Cisplatin
    Issue/Submission Date
    2014-03-09
    2018-06-01
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    Arsenic Trioxide

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    USDMF

    Found USDMF

    31325
    Active
    ARSENIC TRIOXIDE
    2017-01-31
    CEP/COS

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    Application Number
    31325
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ARSENIC TRIOXIDE
    Issue/Submission Date
    2017-01-31
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    Lomustine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-132 - Rev 00
    Valid
    Lomustine
    2022-11-10
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R0-CEP 2021-132 - Rev 00
    Status
    Valid
     
    Filing Details
    Lomustine
    Issue/Submission Date
    2022-11-10
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    Oxaliplatin

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    USDMF

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    CEP/COS

    Found CEP/COS

    R0-CEP 2022-346 - Rev 00
    Valid
    Oxaliplatin, LB
    2022-11-28
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R0-CEP 2022-346 - Rev 00
    Status
    Valid
     
    Filing Details
    Oxaliplatin, LB
    Issue/Submission Date
    2022-11-28
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    Calamine

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    USDMF

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    CEP/COS

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    Japanese DMF

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