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01 4Pfizer Consumer Healthcare

02 8Pfizer Inc

03 1Wyeth Pharmaceuticals Inc

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PharmaCompass

01

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Gemtuzumab ozogamicin

Brand Name : Mylotarg

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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02

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Gemtuzumab ozogamicin

Brand Name : Mylotarg

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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03

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Gemtuzumab ozogamicin

Brand Name : Mylotarg

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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04

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Gemtuzumab ozogamicin

Brand Name : Mylotarg

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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05

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Gemtuzumab Ozogamicin

Brand Name : Mylotarg

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 5mg

Packaging :

Approval Date : 05/12/2019

Application Number : 66879

Regulatory Info : Allowed

Registration Country : Switzerland

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06

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Gemtuzumabozogamicin

Brand Name : Mylotarg

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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07

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Gemtuzumab ozogamicin

Brand Name : Mylotarg

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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08

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Gemtuzumab Ozogamicin

Brand Name : Mylotarg

Dosage Form : Powder For Concentrate For Infusion Solution

Dosage Strength : 5MG

Packaging :

Approval Date : 25-05-2018

Application Number : 1181277001

Regulatory Info : Authorized

Registration Country : Spain

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09

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

GEMTUZUMAB OZOGAMICIN

Brand Name : MYLOTARG

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 4.5MG/VIAL

Packaging :

Approval Date :

Application Number : 2494388

Regulatory Info : Schedule D

Registration Country : Canada

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10

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Gemtuzumab ozogamicin

Brand Name : Mylotarg

Dosage Form : INJ

Dosage Strength : 5mg

Packaging : 5X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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11

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Gemtuzumab Ozogamicin

Brand Name : Mylotarg

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 5mg

Packaging :

Approval Date : 19-04-2018

Application Number : 28105883016

Regulatory Info : Prescription

Registration Country : Denmark

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12

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Gemtuzumab Ozogamicin

Brand Name : Mylotarg

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 5mg

Packaging :

Approval Date : 19-04-2018

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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13

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

GEMTUZUMAB OZOGAMICIN

Brand Name : MYLOTARG

Dosage Form : VIAL;SINGLE-DOSE

Dosage Strength : 4.5MG

Packaging :

Approval Date :

Application Number : 761060

Regulatory Info :

Registration Country : USA

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