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01 1Baxter Healthcare Limited

02 1Baxter Medical Ab

03 2Innovata Plc

04 4Vantive AB

05 1Vantive Ab

06 1Vantive Belgium SRL

07 1Vantive Gmbh

08 1Vivisol Srl

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PharmaCompass

01

IPPE
Not Confirmed
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IPPE
Not Confirmed

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

Brand Name : Extraneal

Dosage Form : Dialysis Solution

Dosage Strength :

Packaging :

Approval Date : 22/08/1997

Application Number : 19970822000060

Regulatory Info : Approved

Registration Country : Sweden

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02

IPPE
Not Confirmed
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IPPE
Not Confirmed

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

Brand Name : Extraneal Clear-Flex

Dosage Form : Dialysis Solution

Dosage Strength :

Packaging :

Approval Date : 11/06/2015

Application Number : 20141121000013

Regulatory Info : Deregistered

Registration Country : Sweden

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03

IPPE
Not Confirmed
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IPPE
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Regulatory Info : Withdrawn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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04

IPPE
Not Confirmed
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IPPE
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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05

IPPE
Not Confirmed
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IPPE
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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06

Innovata Plc

Country
IPPE
Not Confirmed
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Innovata Plc

Country
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IPPE
Not Confirmed

Icodextrin; Calcium Chloride Dihydrate; Magnesium Chloride Hexahydrate; Sodium Chloride; Sodium Lactate

Brand Name : Icodial

Dosage Form : Dialysis Solution

Dosage Strength :

Packaging :

Approval Date : 22/11/1996

Application Number : 19961122000041

Regulatory Info : Deregistered

Registration Country : Sweden

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07

Innovata Plc

Country
IPPE
Not Confirmed
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Innovata Plc

Country
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IPPE
Not Confirmed

Icodextrin; Calcium Chloride Dihydrate; Magnesium Chloride Hexahydrate; Sodium Chloride; Sodium Lactate Solution

Brand Name : Dexemel

Dosage Form : Solution For Injection

Dosage Strength : 40g/liter

Packaging :

Approval Date : 16/06/2000

Application Number : 20000616000290

Regulatory Info : Deregistered

Registration Country : Sweden

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08

Vivisol Srl

Country
IPPE
Not Confirmed
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Vivisol Srl

Country
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IPPE
Not Confirmed

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

Brand Name : Polithera

Dosage Form : Dialysis Solution

Dosage Strength :

Packaging :

Approval Date : 31/03/2023

Application Number : 20200528000078

Regulatory Info : Approved

Registration Country : Sweden

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09

Vantive Gmbh

Country
IPPE
Not Confirmed
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Vantive Gmbh

Country
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IPPE
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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10

Vantive Belgium SRL

Country
IPPE
Not Confirmed
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Vantive Belgium SRL

Country
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IPPE
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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