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01 14Boehringer Ingelheim GmbH

02 1F. Hoffmann-La Roche

03 1Genentech

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PharmaCompass

01

FNCE
Not Confirmed
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FNCE
Not Confirmed

Tenekteplase

Brand Name : Metalyse

Dosage Form : Powder for solution for injection

Dosage Strength : 5,000 E

Packaging : Vials 5000E

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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02

FNCE
Not Confirmed
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FNCE
Not Confirmed

Tenecteplase

Brand Name : Metalysis

Dosage Form : Solution For Injection

Dosage Strength : 10.000units

Packaging :

Approval Date : 23/02/2001

Application Number : 20010223000255

Regulatory Info : Approved

Registration Country : Sweden

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03

FNCE
Not Confirmed
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FNCE
Not Confirmed

Tenecteplase

Brand Name : Metalysis

Dosage Form : Powder For Solution For Injection

Dosage Strength : 5000units

Packaging :

Approval Date : 12/01/2024

Application Number : 20231023000096

Regulatory Info : Approved

Registration Country : Sweden

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04

FNCE
Not Confirmed
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FNCE
Not Confirmed

Tenecteplase

Brand Name : Metalysis

Dosage Form : Solution For Injection

Dosage Strength : 8000units

Packaging :

Approval Date : 23/02/2001

Application Number : 20010223000248

Regulatory Info : Approved

Registration Country : Sweden

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05

FNCE
Not Confirmed
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FNCE
Not Confirmed

Tenecteplase

Brand Name : Metalysis

Dosage Form : Solution For Injection

Dosage Strength : 6000enheter

Packaging :

Approval Date : 23/02/2001

Application Number : 20010223000231

Regulatory Info : Deregistered

Registration Country : Sweden

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06

FNCE
Not Confirmed
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FNCE
Not Confirmed

Tenecteplase

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

Dosage Form : Solution For Injection

Dosage Strength : 10.000units

Packaging :

Approval Date : 23/02/2001

Application Number : 20010223000224

Regulatory Info : Deregistered

Registration Country : Sweden

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07

FNCE
Not Confirmed
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FNCE
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 : 20010223000200

Regulatory Info : Deregistered

Registration Country : Sweden

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08

FNCE
Not Confirmed
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FNCE
Not Confirmed

Tenecteplase

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

Dosage Form : Solution For Injection

Dosage Strength : 8000units

Packaging :

Approval Date : 23/02/2001

Application Number : 20010223000217

Regulatory Info : Deregistered

Registration Country : Sweden

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09

FNCE
Not Confirmed
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FNCE
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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10

FNCE
Not Confirmed
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FNCE
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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11

FNCE
Not Confirmed
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FNCE
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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12

FNCE
Not Confirmed
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FNCE
Not Confirmed

Tenecteplase

Brand Name : Metalyse

Dosage Form : Injectable Solution

Dosage Strength : 25MG

Packaging :

Approval Date : 2024-02-19

Application Number : 1000169007

Regulatory Info : Authorized

Registration Country : Spain

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13

FNCE
Not Confirmed
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FNCE
Not Confirmed

Tenecteplase

Brand Name : Metalyse

Dosage Form : Injectable Solution

Dosage Strength : 40MG

Packaging :

Approval Date : 2001-03-21

Application Number : 00169005

Regulatory Info : Authorized

Registration Country : Spain

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14

FNCE
Not Confirmed
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FNCE
Not Confirmed

Tenecteplase

Brand Name : Metalyse

Dosage Form : Injectable Solution

Dosage Strength : 50MG

Packaging :

Approval Date : 2001-03-21

Application Number : 00169006

Regulatory Info : Authorized

Registration Country : Spain

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15

FNCE
Not Confirmed
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FNCE
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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16

FNCE
Not Confirmed
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FNCE
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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