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01 2Cipla Medpro (Pty) Ltd

02 4Equity Pharmaceuticals (Pty) Ltd

03 5Ferring (Pty) Ltd

04 1Takeda (Pty) Ltd

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PharmaCompass

01

Cosmoprof
Not Confirmed
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Mesalazine

Brand Name : Salofalk 500mg

Dosage Form : GRA

Dosage Strength : 500mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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02

Cosmoprof
Not Confirmed
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Cosmoprof
Not Confirmed

Mesalazine

Brand Name : Salofalk 1000mg

Dosage Form : GRA

Dosage Strength : 1000mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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03

Cosmoprof
Not Confirmed
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Cosmoprof
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Mesalazine

Brand Name : Asacol 800

Dosage Form : ECT

Dosage Strength : 800mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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04

Cosmoprof
Not Confirmed
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Cosmoprof
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Mesalazine

Brand Name : Asacol Tablets

Dosage Form : ECT

Dosage Strength : 400mg

Packaging : 90X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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05

Cosmoprof
Not Confirmed
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Cosmoprof
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Mesalazine

Brand Name : Asacol Enema

Dosage Form : ENE

Dosage Strength : 2g/ml

Packaging : 50X1g/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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06

Cosmoprof
Not Confirmed
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Cosmoprof
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Mesalazine

Brand Name : Asacol Suppositories

Dosage Form : SUP

Dosage Strength : 500mg

Packaging : 20X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

Cosmoprof
Not Confirmed
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Cosmoprof
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Mesalazine

Brand Name : Pentasa 1g Suppositories

Dosage Form : SUP

Dosage Strength : 1g

Packaging : 28X1g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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08

Cosmoprof
Not Confirmed
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Cosmoprof
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Mesalazine

Brand Name : Pentasa 1g Enema

Dosage Form : ENE

Dosage Strength : 1g/100ml

Packaging : 100X7g/100ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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09

Cosmoprof
Not Confirmed
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Cosmoprof
Not Confirmed

Mesalazine

Brand Name : Pentasa Sachets 1 g

Dosage Form : SAC

Dosage Strength : 1g

Packaging : 120X1g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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10

Cosmoprof
Not Confirmed
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Cosmoprof
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Mesalazine

Brand Name : Pentasa Sachets 2 g

Dosage Form : SAC

Dosage Strength : 2g

Packaging : 60X1g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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