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01 18Boehringer 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

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Alteplase (recombinant DNA)

Brand Name : Actilyse

Dosage Form : Injection/Infusion Solution

Dosage Strength : 20mg

Packaging :

Approval Date : 19/09/1988

Application Number : 48313

Regulatory Info : Allowed

Registration Country : Switzerland

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02

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Alteplase (recombinant DNA)

Brand Name : Actilyse

Dosage Form : Injection/Infusion Solution

Dosage Strength : 50mg

Packaging :

Approval Date : 19/09/1988

Application Number : 48313

Regulatory Info : Allowed

Registration Country : Switzerland

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03

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Alteplase (recombinant DNA)

Brand Name : Actilyse

Dosage Form : Injection/Infusion Solution

Dosage Strength : 10mg

Packaging :

Approval Date : 19/09/1988

Application Number : 48313

Regulatory Info : Allowed

Registration Country : Switzerland

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04

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Alteplase (recombinant DNA)

Brand Name : Actilyse Cathflo

Dosage Form : Powder For Solution For Injection

Dosage Strength : 2mg

Packaging :

Approval Date : 10/07/2009

Application Number : 58665

Regulatory Info : Allowed

Registration Country : Switzerland

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05

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Alteplase

Brand Name : Actilyse

Dosage Form : Powder And Solvent For Injectable Solution And Infusion

Dosage Strength : 50MG

Packaging :

Approval Date : 2007-05-16

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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06

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Alteplase

Brand Name : Actilyse

Dosage Form : Powder And Solvent For Injectable Solution And Infusion

Dosage Strength : 10MG

Packaging :

Approval Date : 2019-05-06

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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07

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Alteplase

Brand Name : Actilyse

Dosage Form : Powder And Solvent For Injectable Solution And Infusion

Dosage Strength : 20MG

Packaging :

Approval Date : 2019-05-06

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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08

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Alteplasus

Brand Name : Actilyse®

Dosage Form : Injection/Infusion Solution

Dosage Strength : 50mg

Packaging :

Approval Date : 06-03-2020

Application Number :

Regulatory Info :

Registration Country : Moldova

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09

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Alteplase

Brand Name : Actilyse

Dosage Form : Injection/Infusion Solution

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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10

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Alteplase

Brand Name : Actilyse

Dosage Form : Injection/Infusion Solution

Dosage Strength : 20mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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11

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Alteplase

Brand Name : Actilyse

Dosage Form : Injection/Infusion Solution

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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12

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Alteplase

Brand Name : Actilyse

Dosage Form : Injection/Infusion Solution

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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13

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Alteplase

Brand Name : Actilyse Cathflo

Dosage Form : Powder For Injection And Infusion Solution

Dosage Strength : 2MG

Packaging :

Approval Date : 29-04-2013

Application Number : 76900

Regulatory Info : Authorized

Registration Country : Spain

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14

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Alteplase

Brand Name : Actilyse Powder And Solvent For Injection And Infusion Solution

Dosage Form : Infusion Solution

Dosage Strength :

Packaging :

Approval Date : 01-02-1989

Application Number : 59494

Regulatory Info : Authorized

Registration Country : Spain

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15

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Alteplase

Brand Name : Actilyse

Dosage Form : Injection/Infusion Solution

Dosage Strength :

Packaging :

Approval Date : 08-01-1991

Application Number : 28101415990

Regulatory Info : Prescription

Registration Country : Denmark

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16

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Alteplase

Brand Name : Actilyse

Dosage Form : Injection/Infusion Solution

Dosage Strength :

Packaging :

Approval Date : 04-05-1990

Application Number : 1.99E+13

Regulatory Info : Approved

Registration Country : Sweden

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17

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Alteplase

Brand Name : Actilyse

Dosage Form : Injection/Infusion Solution

Dosage Strength : 2mg

Packaging :

Approval Date : 16-12-2010

Application Number : 2.01E+13

Regulatory Info : Approved

Registration Country : Sweden

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18

BioProcess International
Not Confirmed
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BioProcess International
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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19

BioProcess International
Not Confirmed
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BioProcess International
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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20

BioProcess International
Not Confirmed
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BioProcess International
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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