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01 1Abbott Laboratories

02 97Adcock Ingram

03 1Al-Razi Pharma

04 1Ateco Pharma

05 24B. Braun Medical

06 3B. Braun Melsungen AG

07 121Baxter Healthcare Corporation

08 3Bayer AG

09 6CSL Vifor

10 1Cherubino Limited

11 1DECHRA VETERINARY PRODUCTS AS

12 2DMVET INC

13 1Darnytsia

14 2Demo S.A.

15 26Fresenius Kabi AB Brunna

16 2Fresenius Kabi AG

17 3Fresenius Kabi USA

18 16Fresenius Medical Care

19 42Fresenius Medical Care de Mexico

20 10Fresenius SE & Co. KGaA

21 1Grifols International

22 3Hospira, Inc.

23 2ICU Medical

24 4Igenius Life Sciences

25 2Innovata Plc

26 1Laboratorios ERN

27 1Laphysan Sau

28 2LeBasi Pharmaceuticals CC

29 2MILES

30 1MONICO SpA

31 6NXSTAGE MEDICAL INC

32 6Noridem Enterprises Limited

33 12OTSUKA ICU MEDCL

34 1PROCTER AND GAMBLE

35 18SALF SpA

36 1Tecsolpar Sa

37 6Vantive Belgium SRL

38 2Vantive Gmbh

39 15Vantive Health Sl

40 1Vivisol Srl

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PharmaCompass

01

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

Brand Name : DEXTROSE 5% IN LACTATED RINGERS IN PLASTIC CONTAINER

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML

Packaging :

Approval Date : 1982-01-01

Application Number : 17510

Regulatory Info : DISCN

Registration Country : USA

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02

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

Brand Name : LACTATED RINGERS AND DEXTROSE 5% IN PLASTIC CONTAINER

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML

Packaging :

Approval Date : 1982-01-01

Application Number : 16679

Regulatory Info : RX

Registration Country : USA

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03

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

Brand Name : LACTATED RINGERS IN PLASTIC CONTAINER

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML

Packaging :

Approval Date : 1982-01-01

Application Number : 16682

Regulatory Info : RX

Registration Country : USA

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04

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

SODIUM LACTATE

Brand Name : SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 1.87GM/100ML

Packaging :

Approval Date : 1982-01-01

Application Number : 16692

Regulatory Info : DISCN

Registration Country : USA

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05

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM LACTATE

Brand Name : PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 37MG/100ML;5GM/100ML;30MG/100ML;119MG/100ML;161MG/100ML;94MG/100ML;138MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1982-01-01

Application Number : 17390

Regulatory Info : DISCN

Registration Country : USA

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06

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM LACTATE

Brand Name : PLASMA-LYTE R IN PLASTIC CONTAINER

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 36.8MG/100ML;30.5MG/100ML;74.6MG/100ML;640MG/100ML;496MG/100ML;89.6MG/100ML

Packaging :

Approval Date : 1982-01-01

Application Number : 17438

Regulatory Info : DISCN

Registration Country : USA

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07

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE

Brand Name : DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 5GM/100ML;31MG/100ML;141MG/100ML;20MG/100ML;12MG/100ML;260MG/100ML

Packaging :

Approval Date : 1982-01-01

Application Number : 17484

Regulatory Info : RX

Registration Country : USA

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08

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

Brand Name : DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER

Dosage Form : SOLUTION;INTRAPERITONEAL

Dosage Strength : 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML

Packaging :

Approval Date : 1982-01-01

Application Number : 17512

Regulatory Info : DISCN

Registration Country : USA

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09

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

Brand Name : DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER

Dosage Form : SOLUTION;INTRAPERITONEAL

Dosage Strength : 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML

Packaging :

Approval Date : 1982-01-01

Application Number : 17512

Regulatory Info : DISCN

Registration Country : USA

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10

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

Brand Name : DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER

Dosage Form : SOLUTION;INTRAPERITONEAL

Dosage Strength : 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML

Packaging :

Approval Date : 1982-01-01

Application Number : 17512

Regulatory Info : DISCN

Registration Country : USA

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11

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Glucose Monohydrate; Anhydrous Glucose; Sodium Chloride; Sodium Lactate; Calcium Chloride Dihydrate; Magnesium Chloride Hexahydrate

Brand Name : Capd/Dpca 19

Dosage Form : Solution For Peritoneal Dialysis

Dosage Strength :

Packaging :

Approval Date : 14-07-2000

Application Number : 63235

Regulatory Info : Authorized

Registration Country : Spain

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12

Vantive Health Sl

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SCOPE Summit
Not Confirmed
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Vantive Health Sl

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SCOPE Summit
Not Confirmed

Glucose Monohydrate; Sodium Carbonate; Sodium Chloride; Calcium Chloride Dihydrate; Sodium S-Lactate; Magnesium Chloride Hexahydrate

Brand Name : Physioneal 35

Dosage Form : Solution

Dosage Strength : 13.6 MG/ML

Packaging :

Approval Date : 31-10-2003

Application Number : 65759

Regulatory Info : Authorized

Registration Country : Spain

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13

Vantive Health Sl

Country
SCOPE Summit
Not Confirmed
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Vantive Health Sl

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SCOPE Summit
Not Confirmed

Glucose Monohydrate; Sodium Bicarbonate; Sodium Chloride; Sodium Lactate; Calcium Chloride Dihydrate; Magnesium Chloride Hexahydrate

Brand Name : Physioneal

Dosage Form : Solution

Dosage Strength : 2.27%

Packaging :

Approval Date : 09-09-2004

Application Number : 66309

Regulatory Info : Authorized

Registration Country : Spain

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14

Vantive Health Sl

Country
SCOPE Summit
Not Confirmed
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Vantive Health Sl

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SCOPE Summit
Not Confirmed

Glucose Monohydrate; Sodium Bicarbonate; Sodium Chloride; Sodium Lactate; Calcium Chloride Dihydrate; Magnesium Chloride Hexahydrate

Brand Name : Physioneal

Dosage Form : Solution

Dosage Strength : 2.27%

Packaging :

Approval Date : 07-09-2004

Application Number : 66307

Regulatory Info : Authorized

Registration Country : Spain

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15

Vantive Health Sl

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SCOPE Summit
Not Confirmed
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Vantive Health Sl

Country
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SCOPE Summit
Not Confirmed

Glucose Monohydrate; Sodium Carbonate; Sodium Chloride; Calcium Chloride Dihydrate; Sodium S-Lactate; Magnesium Chloride Hexahydrate

Brand Name : Physioneal

Dosage Form : Solution

Dosage Strength : 2.27%

Packaging :

Approval Date : 05-11-2003

Application Number : 65760

Regulatory Info : Authorized

Registration Country : Spain

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16

Vantive Health Sl

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SCOPE Summit
Not Confirmed
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Vantive Health Sl

Country
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SCOPE Summit
Not Confirmed

Glucose Monohydrate; Sodium Bicarbonate; Sodium Chloride; Sodium Lactate; Calcium Chloride Dihydrate; Magnesium Chloride Hexahydrate

Brand Name : Physioneal

Dosage Form : Solution

Dosage Strength : 86% W/V; 38.6MG

Packaging :

Approval Date : 29-09-2004

Application Number : 66390

Regulatory Info : Authorized

Registration Country : Spain

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17

Vantive Health Sl

Country
SCOPE Summit
Not Confirmed
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Vantive Health Sl

Country
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SCOPE Summit
Not Confirmed

Glucose Monohydrate; Sodium Bicarbonate; Sodium Chloride; Sodium Lactate; Calcium Chloride Dihydrate; Magnesium Chloride Hexahydrate

Brand Name : Physioneal

Dosage Form : Solution

Dosage Strength : 86% W/V; 38.6MG

Packaging :

Approval Date : 07-09-2004

Application Number : 66310

Regulatory Info : Authorized

Registration Country : Spain

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18

Vantive Health Sl

Country
SCOPE Summit
Not Confirmed
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Vantive Health Sl

Country
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SCOPE Summit
Not Confirmed

Glucose Monohydrate; Sodium Carbonate; Sodium Chloride; Calcium Chloride Dihydrate; Sodium S-Lactate; Magnesium Chloride Hexahydrate

Brand Name : Physioneal

Dosage Form : Solution

Dosage Strength : 86% W/V; 38.6MG

Packaging :

Approval Date : 31-10-2003

Application Number : 65761

Regulatory Info : Authorized

Registration Country : Spain

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19

Vantive Health Sl

Country
SCOPE Summit
Not Confirmed
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Vantive Health Sl

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SCOPE Summit
Not Confirmed

Glucose Monohydrate; Anhydrous Glucose; Sodium Chloride; Sodium Lactate; Calcium Chloride Dihydrate; Magnesium Chloride Hexahydrate

Brand Name : Dianeal Pd

Dosage Form : Solution

Dosage Strength : 13.6 MG/ML

Packaging :

Approval Date : 01-03-1994

Application Number : 60050

Regulatory Info : Suspended

Registration Country : Spain

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20

Vantive Health Sl

Country
SCOPE Summit
Not Confirmed
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Vantive Health Sl

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SCOPE Summit
Not Confirmed

Glucose Monohydrate; Anhydrous Glucose; Sodium Chloride; Sodium Lactate; Calcium Chloride Dihydrate; Magnesium Chloride Hexahydrate

Brand Name : Dianeal Pd4

Dosage Form : Solution

Dosage Strength : 13.6 MG/ML

Packaging :

Approval Date : 01-03-1994

Application Number : 60053

Regulatory Info : Suspended

Registration Country : Spain

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