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01 12Baxter Healthcare Corporation

02 7Bayer AG

03 1Cherubino Limited

04 1EJ Busuttil Ltd

05 1Gedeon Richter

06 2Health Biotech

07 1Hekim Pharmaceuticals

08 1Miller and Miller Chemicals

09 1Mirpharm

10 2Nordic Pharma

11 2VetaPro

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PharmaCompass

01

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Fibrinogen, human; Aprotinin; Thrombin, human; Calcium chloride dihydrate

Brand Name : Artiss

Dosage Form : Tissue Adhesive Solution

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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02

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Fibrinogen, human; Aprotinin; Thrombin, human; Calcium chloride dihydrate

Brand Name : Artiss

Dosage Form : Tissue Adhesive Solution

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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03

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Fibrinogen, human; Aprotinin; Thrombin, human; Calcium chloride dihydrate

Brand Name : Tisseel

Dosage Form : Tissue Adhesive Solution

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

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04

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

APROTININ

Brand Name : TRASYLOL

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 10,000KIU/ML

Packaging :

Approval Date :

Application Number : 20304

Regulatory Info :

Registration Country : USA

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05

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Human Fibrinogen; Aprotinin; Human Thrombin; Calcium Chloride Dihydrate

Brand Name : Tisseel –

Dosage Form : SOLUTION FOR SEALANT

Dosage Strength : 182MG; 6000KALLIKREININACTIVATORUNIT/ML; 1000IU; 80MMOL

Packaging :

Approval Date : 2014-07-29

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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06

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Human Fibrinogen; Aprotinin; Human Thrombin; Calcium Chloride Dihydrate

Brand Name : Tisseel –

Dosage Form : SOLUTION FOR SEALANT

Dosage Strength : 455MG; 1500KALLIKREININACTIVATORUNIT/ML; 2500IU; 200MILLIMOL

Packaging :

Approval Date : 2014-07-29

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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07

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Human Fibrinogen; Factor Xiii; Aprotinin; Human Thrombin; Calcium Chloride

Brand Name : Tisseel Lyo Powder And Solvent For Sealant (2Ml)

Dosage Form : Powder And Solvent For Sealant

Dosage Strength : 91MG/ML; 0.6-5IU/ML; 3000KILOIU; 500IU/ML; 40MICROMOLE/ML

Packaging :

Approval Date : 2025-01-07

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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08

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Human Fibrinogen; Factor Xiii; Aprotinin; Human Thrombin; Calcium Chloride

Brand Name : Tisseel Lyo Powder And Solvent For Sealant (10Ml)

Dosage Form : Powder And Solvent For Sealant

Dosage Strength : 91MG/ML; 0.6-5IU/ML; 3000KILOIU; 500IU/ML; 40MICROMOLE/ML

Packaging :

Approval Date : 2025-01-07

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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09

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Human Fibrinogen; Factor Xiii; Aprotinin; Human Thrombin; Calcium Chloride

Brand Name : Tisseel Lyo Powder And Solvent For Sealant (4Ml)

Dosage Form : Powder And Solvent For Sealant

Dosage Strength :

Packaging :

Approval Date : 2025-01-07

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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10

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Aprotininum

Brand Name : Gordox®

Dosage Form : Injectable Solution

Dosage Strength : 100000 ISK

Packaging :

Approval Date : 26-03-2018

Application Number :

Regulatory Info :

Registration Country : Moldova

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11

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Aprotinin

Brand Name :

Dosage Form : Vial

Dosage Strength : 50000IU

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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12

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Aprotinin

Brand Name :

Dosage Form : Vial

Dosage Strength : 100000IU

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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13

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Amylase A; Basic protease inhibitor; Lipase

Brand Name : Preflat® Capsule

Dosage Form : Capsule

Dosage Strength : 110MG; 60MG; 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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14

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Aprotinin

Brand Name :

Dosage Form : Solution for Intravenous

Dosage Strength : 10000KIE/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Russia

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15

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Apricot

Brand Name : Trasylol

Dosage Form : Solution For Injection/Infusion

Dosage Strength :

Packaging :

Approval Date : 16/03/1977

Application Number : 38837

Regulatory Info : Allowed

Registration Country : Switzerland

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16

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Lipase; Basic protease inhibitor; Amylase A; Saccharomyces Boulardii; Inulin; Folic Acid; Vitamin E; Cyanocobalamin; Lecithin API

Brand Name : Episomal IN

Dosage Form : Sachet

Dosage Strength : 71.400; 390.000; 465.000; 6 BILLION; 1000MG; 100 MCG; 40 MG; 750MCG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Serbia

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17

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Lipase; Basic protease inhibitor; Amylase A; Cyanocobalamin; Lecithin API

Brand Name : Episomal MAIN

Dosage Form : Sachet

Dosage Strength : 71.400; 390.000; 465.000; 750MCG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Serbia

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18

Miller and Miller Chemicals

Country
ASPEN
Not Confirmed
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Miller and Miller Chemicals

Country
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ASPEN
Not Confirmed

Aprotinin

Brand Name : Aprotinin

Dosage Form : Solution For Injection

Dosage Strength : 10000KALLIKREININACTIVATORUNIT/ML

Packaging :

Approval Date : 2019-06-13

Application Number :

Regulatory Info : Invalid

Registration Country : Malta

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19

Cherubino Limited

Country
ASPEN
Not Confirmed
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Cherubino Limited

Country
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ASPEN
Not Confirmed

Aprotinin

Brand Name : Aprotinin

Dosage Form : Solution For Injection

Dosage Strength : 100000KALLIKREININACTIVATORUNIT/ML

Packaging :

Approval Date : 2020-10-14

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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20

EJ Busuttil Ltd

Country
ASPEN
Not Confirmed
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EJ Busuttil Ltd

Country
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ASPEN
Not Confirmed

Aprotinin

Brand Name : Trasylol

Dosage Form : Solution For Infusion

Dosage Strength : 1.4MG/ML

Packaging :

Approval Date : 2025-05-28

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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