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01 35AstraZeneca

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PharmaCompass

01

AAPS
Not Confirmed
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AAPS
Not Confirmed

DURVALUMAB

Brand Name : IMFINZI

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 50MG/ML

Packaging :

Approval Date :

Application Number : 761069

Regulatory Info :

Registration Country : USA

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02

AAPS
Not Confirmed
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AAPS
Not Confirmed

Durvalumab

Brand Name : Imfinzi

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 50mg/ml

Packaging :

Approval Date : 21/09/2018

Application Number : 20170905000017

Regulatory Info : Approved

Registration Country : Sweden

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03

AAPS
Not Confirmed
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AAPS
Not Confirmed

Durvalumabum

Brand Name : Imfinzi

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 120mg/2.4ml

Packaging :

Approval Date : 11/06/2018

Application Number : 66548

Regulatory Info : Allowed

Registration Country : Switzerland

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04

AAPS
Not Confirmed
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AAPS
Not Confirmed

Durvalumabum

Brand Name : Imfinzi

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 500mg/10ml

Packaging :

Approval Date : 11/06/2018

Application Number : 66548

Regulatory Info : Allowed

Registration Country : Switzerland

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05

AAPS
Not Confirmed
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AAPS
Not Confirmed

Durvalumab

Brand Name : Imfinzi

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 50MG

Packaging :

Approval Date : 2020-11-03

Application Number : 1181322001IP

Regulatory Info : Authorized

Registration Country : Spain

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06

AAPS
Not Confirmed
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AAPS
Not Confirmed

Durvalumab

Brand Name : Imfinzi

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 50MG

Packaging :

Approval Date : 2020-11-03

Application Number : 1181322002IP

Regulatory Info : Authorized

Registration Country : Spain

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07

AAPS
Not Confirmed
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AAPS
Not Confirmed

Durvalumab

Brand Name : Imfinzi

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 50MG

Packaging :

Approval Date : 2018-10-31

Application Number : 1181322002

Regulatory Info : Authorized

Registration Country : Spain

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08

AAPS
Not Confirmed
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AAPS
Not Confirmed

Durvalumab

Brand Name : Imfinzi

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 50MG

Packaging :

Approval Date : 2018-10-31

Application Number : 1181322001

Regulatory Info : Authorized

Registration Country : Spain

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09

AAPS
Not Confirmed
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AAPS
Not Confirmed

DURVALUMAB

Brand Name : IMFINZI

Dosage Form : SOLUTION

Dosage Strength : 50MG/ML

Packaging : 2.4ML/10ML

Approval Date :

Application Number : 2468816

Regulatory Info : Schedule D

Registration Country : Canada

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10

AAPS
Not Confirmed
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AAPS
Not Confirmed

Durvalumab

Brand Name : Imfinzi 120 mg

Dosage Form : INF

Dosage Strength : 50mg/ml

Packaging : 2.4X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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11

AAPS
Not Confirmed
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AAPS
Not Confirmed

Durvalumab

Brand Name : Imfinzi 500 mg

Dosage Form : INF

Dosage Strength : 50mg/ml

Packaging : 10X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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12

AAPS
Not Confirmed
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AAPS
Not Confirmed

Durvalumab

Brand Name : Imfinzi

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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13

AAPS
Not Confirmed
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AAPS
Not Confirmed

Durvalumab

Brand Name : Imfinzi

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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14

AAPS
Not Confirmed
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AAPS
Not Confirmed

Durvalumab

Brand Name : Imfinzi

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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15

AAPS
Not Confirmed
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AAPS
Not Confirmed

Durvalumab

Brand Name : Imfinzi

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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16

AAPS
Not Confirmed
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AAPS
Not Confirmed

Durvalumab

Brand Name : Imfinzi

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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17

AAPS
Not Confirmed
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AAPS
Not Confirmed

Durvalumab

Brand Name : Imfinzi

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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18

AAPS
Not Confirmed
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AAPS
Not Confirmed

Durvalumab

Brand Name : Imfinzi

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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19

AAPS
Not Confirmed
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AAPS
Not Confirmed

Durvalumab

Brand Name : Imfinzi

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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20

AAPS
Not Confirmed
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AAPS
Not Confirmed

Durvalumab

Brand Name : Imfinzi

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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