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01 29Amgen Inc

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PharmaCompass

01

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ROMIPLOSTIM

Brand Name : NPLATE

Dosage Form : INJECTABLE; SUBCUTANEOUS

Dosage Strength : 250MCG/0.5ML; 500MCG/1ML.

Packaging :

Approval Date :

Application Number : 125268

Regulatory Info :

Registration Country : USA

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02

ASPEN
Not Confirmed
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ASPEN
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Su 5416

Brand Name : Nplate

Dosage Form : Romiplostim 250Mcg 0.72Ml 1 Units Parenteral Use

Dosage Strength : 1 vial 250 mcg groun + solv

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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03

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Su 5416

Brand Name : Nplate

Dosage Form : Romiplostim 500Mcg 1,2Ml 1 Unit Parenteral Use

Dosage Strength : 1 vial 500 mcg groun + solv

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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04

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Romiplostim

Brand Name : Nplate

Dosage Form : Solution For Injection

Dosage Strength : 250mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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05

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Romiplostim

Brand Name : Nplate

Dosage Form : Solution For Injection

Dosage Strength : 500mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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06

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Romiplostim

Brand Name : Nplate

Dosage Form : Powder For Solution For Injection

Dosage Strength : 125mcg

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

Romiplostim

Brand Name : Nplate

Dosage Form : Powder For Solution For Injection

Dosage Strength : 250mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

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08

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Romiplostim

Brand Name : Nplate

Dosage Form : Powder For Solution For Injection

Dosage Strength : 500mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

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09

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Romiplostim

Brand Name : Nplate

Dosage Form : Powder For Solution For Injection

Dosage Strength : 125mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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10

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Romiplostim

Brand Name : Nplate

Dosage Form : Powder For Solution For Injection

Dosage Strength : 250mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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11

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Romiplostim

Brand Name : Nplate

Dosage Form : Solution For Injection

Dosage Strength : 250mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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12

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Romiplostim

Brand Name : Nplate

Dosage Form : Solution For Injection

Dosage Strength : 500mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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13

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Romiplostim

Brand Name : Nplate

Dosage Form : Powder For Solution For Injection

Dosage Strength : 500mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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14

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Romiplostim

Brand Name : Nplate

Dosage Form : Powder And Solvent For Injectable Solution

Dosage Strength : 250MCG

Packaging :

Approval Date : 08-04-2010

Application Number : 8497005

Regulatory Info : Authorized

Registration Country : Spain

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15

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Romiplostim

Brand Name : Nplate

Dosage Form : Powder And Solvent For Injectable Solution

Dosage Strength : 500MCG

Packaging :

Approval Date : 08-04-2010

Application Number : 8497007

Regulatory Info : Authorized

Registration Country : Spain

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16

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Romiplostim

Brand Name : Nplate

Dosage Form : Powder For Injectable Solution

Dosage Strength : 250MCG

Packaging :

Approval Date : 10-02-2009

Application Number : 8497001

Regulatory Info : Authorized

Registration Country : Spain

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17

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Romiplostim

Brand Name : Nplate

Dosage Form : Powder For Injectable Solution

Dosage Strength : 500MCG

Packaging :

Approval Date : 10-02-2009

Application Number : 8497002

Regulatory Info : Authorized

Registration Country : Spain

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18

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

ROMIPLOSTIM

Brand Name : NPLATE

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 375MCG/VIAL

Packaging : 0.5ML

Approval Date :

Application Number : 2322854

Regulatory Info : Schedule D

Registration Country : Canada

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19

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

ROMIPLOSTIM

Brand Name : NPLATE

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 625MCG/VIAL

Packaging : 1ML

Approval Date :

Application Number : 2322862

Regulatory Info : Prescription

Registration Country : Canada

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20

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Romiplostim

Brand Name : Nplate 250 µg

Dosage Form : INJ

Dosage Strength : 250µg/0.5ml

Packaging : 0.5X1µg/0.5ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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