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01 4Baxter Healthcare Corporation

02 2Baxter Healthcare South Africa (Pty) Ltd

03 2CSL Behring

04 3Grifols International

05 3OMRIX BIOPHARMACEUTICALS LTD

06 3Octapharma

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PharmaCompass

01

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

antithrombin III, human

Brand Name : Antithrombin III Baxalta

Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Dosage Strength : -

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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02

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

THROMBIN (HUMAN)

Brand Name : ARTISS

Dosage Form : SOLUTION

Dosage Strength : 4UNIT/ML

Packaging : 2ML/4ML/10ML (TOTAL VOLUME)

Approval Date :

Application Number : 2326167

Regulatory Info : Prescription

Registration Country : Canada

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03

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

THROMBIN (HUMAN)

Brand Name : TISSEEL

Dosage Form : SOLUTION

Dosage Strength : 500UNIT/ML

Packaging : 2ML/4ML/10ML (TOTAL VOLUME)

Approval Date :

Application Number : 2326175

Regulatory Info : Prescription

Registration Country : Canada

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04

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

THROMBIN (HUMAN)

Brand Name : TISSEEL

Dosage Form : KIT

Dosage Strength : 500UNIT/ML

Packaging : 2ML/4ML/10ML

Approval Date :

Application Number : 2326132

Regulatory Info : Prescription

Registration Country : Canada

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05

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

COAGULATION FACTOR II (HUMAN)

Brand Name : BERIPLEX P/N 500

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 800UNIT

Packaging : 30ML

Approval Date :

Application Number : 2359251

Regulatory Info : Schedule D

Registration Country : Canada

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06

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

COAGULATION FACTOR II (HUMAN)

Brand Name : BERIPLEX P/N 1000

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 1600UNIT

Packaging : 50ML

Approval Date :

Application Number : 2410826

Regulatory Info : Schedule D

Registration Country : Canada

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07

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

THROMBIN (HUMAN)

Brand Name : VISTASEAL

Dosage Form : SOLUTION

Dosage Strength : 500UNIT/1ML

Packaging :

Approval Date :

Application Number : 2514222

Regulatory Info : Schedule D

Registration Country : Canada

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08

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

THROMBIN (HUMAN)

Brand Name : VISTASEAL

Dosage Form : SOLUTION

Dosage Strength : 1000UNIT/2ML

Packaging :

Approval Date :

Application Number : 2514230

Regulatory Info : Schedule D

Registration Country : Canada

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09

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

THROMBIN (HUMAN)

Brand Name : VISTASEAL

Dosage Form : SOLUTION

Dosage Strength : 2500UNIT/5ML

Packaging :

Approval Date :

Application Number : 2514257

Regulatory Info : Schedule D

Registration Country : Canada

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10

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

antithrombin III, human

Brand Name : Atenativ

Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INFUSION

Dosage Strength : 50 IU / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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11

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

COAGULATION FACTOR II (HUMAN)

Brand Name : OCTAPLEX

Dosage Form : KIT

Dosage Strength : 760UNIT/VIAL

Packaging : 20ML

Approval Date :

Application Number : 2294664

Regulatory Info : Schedule D

Registration Country : Canada

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12

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

COAGULATION FACTOR II (HUMAN)

Brand Name : OCTAPLEX

Dosage Form : KIT

Dosage Strength : 1520UNIT/VIAL

Packaging : 40ML

Approval Date :

Application Number : 2434970

Regulatory Info : Schedule D

Registration Country : Canada

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13

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

Thrombin

Brand Name : Evicel

Dosage Form : Clottable Protein Human+Human Thrombin 1Ml 2 Units Use Epilesionale

Dosage Strength : 2 vials epilesionale use 1 ml 50-90 mg/ml + 800-1200 IU/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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14

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

Thrombin

Brand Name : Evicel

Dosage Form : Clottable Protein Human+Human Thrombin 2Ml 2 Units Use Epilesionale

Dosage Strength : 2 vials epilesionale use 2 ml 50-90 mg/ml + 800-1200 IU/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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15

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

Thrombin

Brand Name : Evicel

Dosage Form : Clottable Protein Human+Human Thrombin 5Ml 2 Units Use Epilesionale

Dosage Strength : 2 vials epilesionale use 5 ml 50-90 mg/ml + 800-1200 IU/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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16

Baxter Healthcare South Africa (Pty...

Country
AMWC Asia-TDAC
Not Confirmed
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Baxter Healthcare South Africa (Pty...

Country
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AMWC Asia-TDAC
Not Confirmed

Thrombin

Brand Name : Tisseel

Dosage Form : POW

Dosage Strength : 500IU/ml

Packaging : 2X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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17

Baxter Healthcare South Africa (Pty...

Country
AMWC Asia-TDAC
Not Confirmed
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Baxter Healthcare South Africa (Pty...

Country
arrow
AMWC Asia-TDAC
Not Confirmed

Thrombin

Brand Name : Tisseel

Dosage Form : POW

Dosage Strength : 500IU/ml

Packaging : 4X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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