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01 16CSL Behring

02 2Takeda Pharmaceutical

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PharmaCompass

01

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

C1-Esterase Inhibitor, Human

Brand Name : Berinert

Dosage Form : Powder And Solvent For Injectable Solution And Infusion

Dosage Strength : 500IU

Packaging :

Approval Date : 2017-01-10

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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02

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

C1-Esterase Inhibitor, Human

Brand Name : Berinert

Dosage Form : Powder And Solvent For Injection Solution

Dosage Strength : 1500IU

Packaging :

Approval Date : 2017-01-10

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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03

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

C1-Esterase Inhibitor, Human

Brand Name : Berinert

Dosage Form : Powder And Solvent For Injection Solution

Dosage Strength : 2000IU

Packaging :

Approval Date : 2018-01-10

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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04

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

C1-Esterase Inhibitor, Human

Brand Name : Berinert

Dosage Form : Powder And Solvent For Injection Solution

Dosage Strength : 3000IU

Packaging :

Approval Date : 2018-01-10

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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05

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

C1 esterase inhibitor, human

Brand Name : Berinert

Dosage Form : Injection/Infusion Solution

Dosage Strength : 500IU

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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06

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

C1 esterase inhibitor, human

Brand Name : Berinert

Dosage Form : Solution For Injection

Dosage Strength : 1500IU

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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07

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

C1 esterase inhibitor, human

Brand Name : Berinert

Dosage Form : Solution For Injection

Dosage Strength : 2000IU

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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08

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

C1 esterase inhibitor, human

Brand Name : Berinert

Dosage Form : Solution For Injection

Dosage Strength : 3000IU

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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09

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

C1 Esterase Inhibitor

Brand Name : Berinert

Dosage Form : Powder And Solvent For Subcutaneous Injection Solution

Dosage Strength : 2000IU

Packaging :

Approval Date : 30-04-2019

Application Number : 82884

Regulatory Info : Authorized

Registration Country : Spain

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10

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

C1 Esterase Inhibitor

Brand Name : Berinert

Dosage Form : Powder And Solvent For Injectable Solution

Dosage Strength : 1500IU

Packaging :

Approval Date : 22-12-2015

Application Number : 79703

Regulatory Info : Authorized

Registration Country : Spain

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11

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

C1 Esterase Inhibitor

Brand Name : Berinert

Dosage Form : Powder And Solvent For Injection And Infusion Solution

Dosage Strength : 500IU

Packaging :

Approval Date : 30-03-2009

Application Number : 70695

Regulatory Info : Authorized

Registration Country : Spain

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12

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

C1 Esterase Inhibitor

Brand Name : Berinert

Dosage Form : Powder And Solvent For Subcutaneous Injection Solution

Dosage Strength : 3000IU

Packaging :

Approval Date : 30-04-2019

Application Number : 82885

Regulatory Info : Authorized

Registration Country : Spain

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13

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

C1 ESTERASE INHIBITOR (HUMAN)

Brand Name : BERINERT 500

Dosage Form : KIT

Dosage Strength : 500UNIT/VIAL

Packaging : 10ML

Approval Date :

Application Number : 2352575

Regulatory Info : SCHEDULE D

Registration Country : Canada

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14

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

C1 ESTERASE INHIBITOR (HUMAN)

Brand Name : BERINERT 1500

Dosage Form : KIT

Dosage Strength : 1500UNIT/VIAL

Packaging : 3ML

Approval Date :

Application Number : 2436078

Regulatory Info : SCHEDULE D

Registration Country : Canada

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15

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

C1 ESTERASE INHIBITOR (HUMAN)

Brand Name : HAEGARDA

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 2000UNIT/VIAL

Packaging : 4ML

Approval Date :

Application Number : 2468069

Regulatory Info : SCHEDULE D

Registration Country : Canada

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16

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

C1 ESTERASE INHIBITOR (HUMAN)

Brand Name : HAEGARDA

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 3000UNIT/VIAL

Packaging :

Approval Date :

Application Number : 2468077

Regulatory Info : SCHEDULE D

Registration Country : Canada

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17

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

C1 esterase inhibitor, human

Brand Name : Cinryze

Dosage Form : Solution For Injection

Dosage Strength : 500IU

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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18

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

C1 Esterase Inhibitor

Brand Name : Cinryze

Dosage Form : Powder And Solvent For Injectable Solution

Dosage Strength : 500UNITS

Packaging :

Approval Date : 01-08-2011

Application Number : 11688001

Regulatory Info : Authorized

Registration Country : Spain

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