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01 3Adcock Ingram

02 8Baxter Healthcare Corporation

03 1Vantive Belgium SRL

04 1Vantive Gmbh

05 1Vivisol Srl

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PharmaCompass

01

ASPEN
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ASPEN
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Icodextrin

Brand Name : Extraneal

Dosage Form : SOL

Dosage Strength : 75g/1000ml

Packaging : 2000X1g/1000ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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02

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Icodextrin

Brand Name : Extraneal 2L

Dosage Form : SOL

Dosage Strength : 75g

Packaging : 1X2000g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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03

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Icodextrin

Brand Name : Extraneal

Dosage Form : SOL

Dosage Strength : 75g/1000ml

Packaging : 2000X1g/1000ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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04

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

ICODEXTRIN

Brand Name : EXTRANEAL

Dosage Form : SOLUTION;INTRAPERITONEAL

Dosage Strength : 7.5GM/100ML

Packaging :

Approval Date : 2002-12-20

Application Number : 21321

Regulatory Info : RX

Registration Country : USA

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05

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Icodextrin

Brand Name : Extraneal Clear Flex

Dosage Form : Solution For Peritoneal Dialysis

Dosage Strength : 7.5%W/V

Packaging :

Approval Date : 2015-07-23

Application Number :

Regulatory Info : Withdrawn

Registration Country : Malta

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06

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Icodextrin; Sodium chloride; Sodium lactate, D-; Calcium chloride; Magnesium chloride hexahydrate

Brand Name : Extraneal

Dosage Form : Dialysis Solution

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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07

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Icodextrin; Sodium chloride; Sodium lactate, D-; Calcium chloride; Magnesium chloride hexahydrate

Brand Name : Extraneal

Dosage Form : Dialysis Solution

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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08

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Icodextrin; Sodium chloride; Sodium lactate, D-; Calcium chloride; Magnesium chloride hexahydrate

Brand Name : Extraneal

Dosage Form : Dialysis Solution

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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09

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Icodextrin; Sodium chloride; Sodium lactate, D-; Calcium chloride; Magnesium chloride hexahydrate

Brand Name : Extraneal

Dosage Form : Dialysis Solution

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

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10

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

ICODEXTRIN

Brand Name : EXTRANEAL

Dosage Form : SOLUTION

Dosage Strength : 75G/L

Packaging :

Approval Date :

Application Number : 2240806

Regulatory Info : Ethical

Registration Country : Canada

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11

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Icodextrin

Brand Name : Extraneal

Dosage Form : Dialysis Solution

Dosage Strength : 75mg/ml

Packaging :

Approval Date : 19-08-1997

Application Number : 28101876197

Regulatory Info : Prescription

Registration Country : Denmark

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12

Vantive Gmbh

Country
ASPEN
Not Confirmed
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Vantive Gmbh

Country
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ASPEN
Not Confirmed

Icodextrin; Sodium; Calcium; Magnesium; Chloride; Lactose

Brand Name : Extraneal

Dosage Form : Dialysis Solution

Dosage Strength :

Packaging :

Approval Date : 02/09/1997

Application Number : 53631

Regulatory Info : Allowed

Registration Country : Switzerland

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13

Vantive Belgium SRL

Country
ASPEN
Not Confirmed
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Vantive Belgium SRL

Country
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ASPEN
Not Confirmed

Calcium Chloride; Icodextrin; Magnesium Chloride; Sodium Lactate; Sodium Chloride

Brand Name : Extraneal (Icodextrin

Dosage Form : Solution For Peritoneal Dialysis

Dosage Strength : 0.257G/L; 75G/L; 0.051G/L; 4.5G/L; 5.4G/L

Packaging :

Approval Date : 2005-12-29

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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14

Vivisol Srl

Country
ASPEN
Not Confirmed
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Vivisol Srl

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ASPEN
Not Confirmed

Calcium Chloride Dihydrate; Icodextrin; Magnesium Chloride Hexahydrate; Sodium (S) Lactate; Sodium Chloride

Brand Name : Polithera

Dosage Form : Dialysis Solution

Dosage Strength : 7.5%w/v

Packaging :

Approval Date : 18-09-2024

Application Number : 28106452620

Regulatory Info : Prescription

Registration Country : Denmark

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