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01 9Boehringer Ingelheim GmbH

02 3F. Hoffmann-La Roche

03 3Genentech

04 11ORIFARM GROUP AS

05 1Omnia L?kemedel Ab

06 3Paranova Pharmaceuticals Ab

07 2Pharmachim Ab

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PharmaCompass

01

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

Alteplase

Brand Name : Actilyse

Dosage Form : Injection/Infusion Solution

Dosage Strength : 2mg

Packaging :

Approval Date : 16/12/2010

Application Number : 20100526000080

Regulatory Info : Approved

Registration Country : Sweden

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02

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

Alteplase

Brand Name : Actilyse

Dosage Form : Injection/Infusion Solution

Dosage Strength :

Packaging :

Approval Date : 04/05/1990

Application Number : 19900504000200

Regulatory Info : Approved

Registration Country : Sweden

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03

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

ALTEPLASE

Brand Name : ACTIVASE

Dosage Form : VIAL; SINGLE-USE

Dosage Strength : 100MG/VIAL

Packaging :

Approval Date :

Application Number : 103172

Regulatory Info :

Registration Country : USA

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04

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

ALTEPLASE

Brand Name : ACTIVASE

Dosage Form : VIAL; SINGLE-USE

Dosage Strength : 50MG/VIAL

Packaging :

Approval Date :

Application Number : 103172

Regulatory Info :

Registration Country : USA

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05

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

ALTEPLASE

Brand Name : CATHFLO ACTIVASE

Dosage Form : VIAL

Dosage Strength : 2MG/VIAL

Packaging :

Approval Date :

Application Number : 103172

Regulatory Info :

Registration Country : USA

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06

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

Alteplase

Brand Name : Actilyse

Dosage Form : Injection/Infusion Solution

Dosage Strength :

Packaging :

Approval Date : 09/01/2014

Application Number : 20130904000050

Regulatory Info : Approved

Registration Country : Sweden

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07

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

Alteplase

Brand Name : Actilyse

Dosage Form : Injection/Infusion Solution

Dosage Strength : 2mg

Packaging :

Approval Date : 26/11/2014

Application Number : 20140403000048

Regulatory Info : Deregistered

Registration Country : Sweden

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08

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

Alteplase

Brand Name : Actilyse

Dosage Form : Injection/Infusion Solution

Dosage Strength :

Packaging :

Approval Date : 09/01/2014

Application Number : 20130904000043

Regulatory Info : Deregistered

Registration Country : Sweden

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09

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

Alteplase

Brand Name : Actilyse

Dosage Form : Injection/Infusion Solution

Dosage Strength :

Packaging :

Approval Date : 26/11/2014

Application Number : 20140403000062

Regulatory Info : Deregistered

Registration Country : Sweden

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10

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

Alteplase

Brand Name : Actilyse

Dosage Form : Injection/Infusion Solution

Dosage Strength :

Packaging :

Approval Date : 10/11/2011

Application Number : 20110409000014

Regulatory Info : Deregistered

Registration Country : Sweden

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11

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

Alteplase

Brand Name : Actilyse

Dosage Form : Injection/Infusion Solution

Dosage Strength :

Packaging :

Approval Date : 08/02/2017

Application Number : 20160706000040

Regulatory Info : Deregistered

Registration Country : Sweden

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12

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

Alteplase

Brand Name : Actilyse

Dosage Form : Injection/Infusion Solution

Dosage Strength :

Packaging :

Approval Date : 11/05/2016

Application Number : 20150919000043

Regulatory Info : Deregistered

Registration Country : Sweden

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13

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

Alteplase

Brand Name : Actilyse

Dosage Form : Injection/Infusion Solution

Dosage Strength :

Packaging :

Approval Date : 26/11/2014

Application Number : 20140403000055

Regulatory Info : Deregistered

Registration Country : Sweden

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14

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

Alteplase

Brand Name : Actilyse

Dosage Form : Injection/Infusion Solution

Dosage Strength :

Packaging :

Approval Date : 05/04/2013

Application Number : 20120706000174

Regulatory Info : Deregistered

Registration Country : Sweden

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15

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

Alteplase

Brand Name : Actilyse

Dosage Form : Injection/Infusion Solution

Dosage Strength :

Packaging :

Approval Date : 23/05/2012

Application Number : 20110407000030

Regulatory Info : Deregistered

Registration Country : Sweden

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16

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

Alteplase

Brand Name : Actilyse

Dosage Form : Injection/Infusion Solution

Dosage Strength :

Packaging :

Approval Date : 05/04/2013

Application Number : 20120707000067

Regulatory Info : Deregistered

Registration Country : Sweden

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17

Omnia L?kemedel Ab

Country
BioJapan
Not Confirmed
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Omnia L?kemedel Ab

Country
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BioJapan
Not Confirmed

Alteplase

Brand Name : Actilyse

Dosage Form : Injection/Infusion Solution

Dosage Strength :

Packaging :

Approval Date : 01/03/2012

Application Number : 20110329000057

Regulatory Info : Deregistered

Registration Country : Sweden

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18

Paranova Pharmaceuticals Ab

Country
BioJapan
Not Confirmed
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Paranova Pharmaceuticals Ab

Country
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BioJapan
Not Confirmed

Alteplase

Brand Name : Actilyse

Dosage Form : Injection/Infusion Solution

Dosage Strength :

Packaging :

Approval Date : 02/09/2015

Application Number : 20150123000037

Regulatory Info : Deregistered

Registration Country : Sweden

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19

Paranova Pharmaceuticals Ab

Country
BioJapan
Not Confirmed
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Paranova Pharmaceuticals Ab

Country
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BioJapan
Not Confirmed

Alteplase

Brand Name : Actilyse

Dosage Form : Injection/Infusion Solution

Dosage Strength :

Packaging :

Approval Date : 02/09/2015

Application Number : 20150123000020

Regulatory Info : Deregistered

Registration Country : Sweden

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20

Paranova Pharmaceuticals Ab

Country
BioJapan
Not Confirmed
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Paranova Pharmaceuticals Ab

Country
arrow
BioJapan
Not Confirmed

Alteplase

Brand Name : Actilyse

Dosage Form : Injection/Infusion Solution

Dosage Strength :

Packaging :

Approval Date : 02/09/2015

Application Number : 20150122000038

Regulatory Info : Deregistered

Registration Country : Sweden

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