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01 23Boehringer Ingelheim GmbH

02 1F. Hoffmann-La Roche

03 1Genentech

04 1ORIFARM GROUP AS

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PharmaCompass

01

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Tenecteplasm

Brand Name : Metalyse

Dosage Form : Solution For Injection

Dosage Strength : 50mg/10ml

Packaging :

Approval Date : 29/06/2000

Application Number : 55418

Regulatory Info : Allowed

Registration Country : Switzerland

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02

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Tenecteplasum

Brand Name : Metalyse®

Dosage Form : Powder For Solution For Injection

Dosage Strength :

Packaging :

Approval Date : 03-02-2025

Application Number :

Regulatory Info :

Registration Country : Moldova

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03

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Tenekteplase

Brand Name : Metalyse

Dosage Form : Solution For Injection

Dosage Strength : 10000IE

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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04

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Tenekteplase

Brand Name : Metalyse

Dosage Form : Solution For Injection

Dosage Strength : 8000IE

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

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05

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Tenekteplase

Brand Name : Metalyse

Dosage Form : Powder For Solution For Injection

Dosage Strength : 5000IE

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

Tenecteplase

Brand Name : Metalyse

Dosage Form : Powder For Solution For Injection

Dosage Strength : 5000units

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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07

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Tenecteplase

Brand Name : Metalyse

Dosage Form : Solution For Injection

Dosage Strength : 8000units

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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08

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Tenecteplase

Brand Name : Metalyse

Dosage Form : Solution For Injection

Dosage Strength : 10000units

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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09

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Tenecteplase

Brand Name : Metalyse

Dosage Form : Injectable Solution

Dosage Strength : 25MG

Packaging :

Approval Date : 19-02-2024

Application Number : 1000169007

Regulatory Info : Authorized

Registration Country : Spain

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10

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Tenecteplase

Brand Name : Metalyse

Dosage Form : Injectable Solution

Dosage Strength : 40MG

Packaging :

Approval Date : 21-03-2001

Application Number : 169005

Regulatory Info : Authorized

Registration Country : Spain

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11

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Tenecteplase

Brand Name : Metalyse

Dosage Form : Injectable Solution

Dosage Strength : 50MG

Packaging :

Approval Date : 21-03-2001

Application Number : 169006

Regulatory Info : Authorized

Registration Country : Spain

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12

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Tenecteplase

Brand Name : Metalyse 8 000 U

Dosage Form : INJ

Dosage Strength : 40mg/20ml

Packaging : 8X1mg/20ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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13

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Tenecteplase

Brand Name : Metalyse 10 000 U

Dosage Form : POI

Dosage Strength : 50mg/20ml

Packaging : 10X1mg/20ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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14

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Tenecteplase

Brand Name : Metalyse

Dosage Form : Powder And Solvents For Solution For Injection

Dosage Strength : 10.000 E

Packaging :

Approval Date : 23-02-2001

Application Number : 28103119499

Regulatory Info : Prescription

Registration Country : Denmark

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15

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Tenecteplase

Brand Name : Metalyse

Dosage Form : Powder For Solution For Injection

Dosage Strength : 5000 E

Packaging :

Approval Date : 12-01-2024

Application Number : 28107106423

Regulatory Info : Prescription

Registration Country : Denmark

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16

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Tenecteplase

Brand Name : Metalyse

Dosage Form : Powder And Solvents For Solution For Injection

Dosage Strength : 8000 E

Packaging :

Approval Date : 23-02-2001

Application Number : 28103119399

Regulatory Info : Prescription

Registration Country : Denmark

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17

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Tenecteplase

Brand Name : Tenecteplase Boehringer Ingelheim Pharma Gmbh & Co. Kg

Dosage Form : Solution For Injection

Dosage Strength : 6000enheter

Packaging :

Approval Date : 23-02-2001

Application Number : 2.00E+13

Regulatory Info : Deregistered

Registration Country : Sweden

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18

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

TENECTEPLASE

Brand Name : TNKASE

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 50MG/VIAL

Packaging : 10 ML

Approval Date :

Application Number : 2244826

Regulatory Info : Schedule D

Registration Country : Canada

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19

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

TENECTEPLASE

Brand Name : TNKASE

Dosage Form : VIAL

Dosage Strength : 50MG/VIAL

Packaging :

Approval Date :

Application Number : 103909

Regulatory Info :

Registration Country : USA

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20

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Tenekteplase

Brand Name : Metalyse

Dosage Form : Solution For Injection

Dosage Strength : 10000IE

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

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