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01 2Baxter Healthcare Corporation

02 5CSL Behring

03 2Ferrer Internacional

04 2Grifols International

05 1LFB Group

06 1Laboratório Gross

07 1Madras Pharmaceuticals

08 2Octapharma

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PharmaCompass

01

IPPE
Not Confirmed
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IPPE
Not Confirmed

Factor Ix

Brand Name : Immunine

Dosage Form : Powder And Solvent For Injection Or Infusion Solution

Dosage Strength : 1200IU

Packaging :

Approval Date : 19-02-2008

Application Number : 69603

Regulatory Info : Authorized

Registration Country : Spain

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02

IPPE
Not Confirmed
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IPPE
Not Confirmed

Factor Ix

Brand Name : Immunine

Dosage Form : Powder And Solvent For Injection Or Infusion Solution

Dosage Strength : 600IU

Packaging :

Approval Date : 19-02-2008

Application Number : 69602

Regulatory Info : Suspended

Registration Country : Spain

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03

IPPE
Not Confirmed
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IPPE
Not Confirmed

Factor Ix; Water For Injectable Preparations

Brand Name : Mononine

Dosage Form : Powder And Solvent For Injection Solution Or Infusion

Dosage Strength : 100IU

Packaging :

Approval Date : 01-12-1994

Application Number : 60312

Regulatory Info : Cancelled

Registration Country : Spain

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04

IPPE
Not Confirmed
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IPPE
Not Confirmed

Factor Ix; Water For Injectable Preparations

Brand Name : Mononine

Dosage Form : Powder And Solvent For Injection Solution Or Infusion

Dosage Strength : 100IU

Packaging :

Approval Date : 01-12-1994

Application Number : 60311

Regulatory Info : Cancelled

Registration Country : Spain

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05

IPPE
Not Confirmed
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IPPE
Not Confirmed

Factor Ix; Water For Injectable Preparations

Brand Name : Mononine

Dosage Form : Powder And Solvent For Injection Solution Or Infusion

Dosage Strength : 1000IU

Packaging :

Approval Date : 01-12-1994

Application Number : 60312

Regulatory Info : Cancelled

Registration Country : Spain

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06

IPPE
Not Confirmed
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IPPE
Not Confirmed

Factor Ix; Water For Injectable Preparations

Brand Name : Mononine

Dosage Form : Powder And Solvent For Injection Solution Or Infusion

Dosage Strength : 500IU

Packaging :

Approval Date : 01-12-1994

Application Number : 60311

Regulatory Info : Cancelled

Registration Country : Spain

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07

IPPE
Not Confirmed
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IPPE
Not Confirmed

Factor Ix

Brand Name : Berinin P

Dosage Form : Solution For Injection

Dosage Strength : 1200IU

Packaging :

Approval Date : 06-06-2003

Application Number : 65405

Regulatory Info : Cancelled

Registration Country : Spain

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08

IPPE
Not Confirmed
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IPPE
Not Confirmed

Magnesium Glutamate Hydrobromide; Pyridoxine Hydrochloride; Gamma-Aminobutyric Acid; Gamma-Amino-Beta-Hydroxybutyric Acid

Brand Name : Gamalate B

Dosage Form : Oral Solution

Dosage Strength :

Packaging :

Approval Date : 01-03-1965

Application Number : 40544

Regulatory Info : Authorized

Registration Country : Spain

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09

IPPE
Not Confirmed
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IPPE
Not Confirmed

Magnesium Glutamate Hydrobromide; Pyridoxine Hydrochloride; Gamma-Aminobutyric Acid; Gamma-Amino-Beta-Hydroxybutyric Acid

Brand Name : Gamalate B

Dosage Form : Coated Tablet

Dosage Strength :

Packaging :

Approval Date : 01-03-1965

Application Number : 40545

Regulatory Info : Authorized

Registration Country : Spain

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10

IPPE
Not Confirmed
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IPPE
Not Confirmed

Factor Ix; Proteins

Brand Name : Factor Ix Grifols

Dosage Form : Powder And Solvent For Injectable Solution

Dosage Strength : 50IU

Packaging :

Approval Date : 17-02-2004

Application Number : 65916

Regulatory Info : Authorized

Registration Country : Spain

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11

IPPE
Not Confirmed
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IPPE
Not Confirmed

Factor Ix; Proteins

Brand Name : Novix

Dosage Form : Powder And Solvent For Injectable Solution

Dosage Strength : 50IU

Packaging :

Approval Date : 19-02-2004

Application Number : 65917

Regulatory Info : Cancelled

Registration Country : Spain

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12

IPPE
Not Confirmed
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IPPE
Not Confirmed

GABA; Glutamic Acid; Dibasic Calcium Phosphate; Thiamine Nitrate; Pyridoxine Hydrochloride; Cyanocobalamin

Brand Name : Organoneuro Cerebral®

Dosage Form : Tablet

Dosage Strength : 100MG; 100MG; 50MG; 25MG; 10MG; 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Brazil

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13

IPPE
Not Confirmed
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IPPE
Not Confirmed

Factor Ix

Brand Name : Betafact

Dosage Form : Powder And Solvent For Injectable Solution

Dosage Strength : 50IU

Packaging :

Approval Date : 17-09-2012

Application Number : 75941

Regulatory Info : Cancelled

Registration Country : Spain

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14

IPPE
Not Confirmed
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IPPE
Not Confirmed

Gamma-Aminobutyric Acid

Brand Name :

Dosage Form : Capsule

Dosage Strength : 250MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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15

IPPE
Not Confirmed
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IPPE
Not Confirmed

Factor Ix

Brand Name : Factor Ix Octapharma

Dosage Form : Powder And Solvent For Injectable Solution

Dosage Strength : 100IU

Packaging :

Approval Date : 10-03-2020

Application Number : 84956

Regulatory Info : Cancelled

Registration Country : Spain

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16

IPPE
Not Confirmed
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IPPE
Not Confirmed

Factor Ix

Brand Name : Octanine

Dosage Form : Powder And Solvent For Injectable Solution

Dosage Strength : 100IU

Packaging :

Approval Date : 30-12-2010

Application Number : 72466

Regulatory Info : Authorized

Registration Country : Spain

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