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01 7Axim Pharmaceuticals (Pty) Ltd

02 4GE Healthcare (Pty) Ltd

03 12Guerbet South Africa (Pty) Ltd

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PharmaCompass

01

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

GADOTERIC ACID

Brand Name : Dotarem Prefilled Syringes

Dosage Form : PFS

Dosage Strength : 98g/100g

Packaging : 15X1g/100ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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02

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

GADOTERIC ACID

Brand Name : Dotarem 10Ml

Dosage Form : INJ

Dosage Strength : 320MG/ML

Packaging : 10X1027G/100ML/10ML

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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03

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

Gadoteric acid

Brand Name : Dotarem 10Ml

Dosage Form : INJ

Dosage Strength : 320MG/ML

Packaging : 10X1g/100ml/10ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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04

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

GADOTERIC ACID

Brand Name : Dotarem 15Ml

Dosage Form : INJ

Dosage Strength : 320MG/ML

Packaging : 10X1027G/100ML/10ML

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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05

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

Gadoteric acid

Brand Name : Dotarem 15Ml

Dosage Form : INJ

Dosage Strength : 320MG/ML

Packaging : 15X1g/100ml/15ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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06

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

GADOTERIC ACID

Brand Name : Dotarem 20Ml

Dosage Form : INJ

Dosage Strength : 320MG/ML

Packaging : 10X1027G/100ML/10ML

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

Gadoteric acid

Brand Name : Dotarem 20Ml

Dosage Form : INJ

Dosage Strength : 320MG/ML

Packaging : 20X1g/100ml/20

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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08

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

gadoteric acid

Brand Name : CLARISCAN

Dosage Form : PFS

Dosage Strength : 0,5 mmol/mlml

Packaging : 10X10ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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09

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

gadoteric acid

Brand Name : CLARISCAN

Dosage Form : PFS

Dosage Strength : 0,5 mmol/mlml

Packaging : 15X10ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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10

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

gadoteric acid

Brand Name : CLARISCAN

Dosage Form : PFS

Dosage Strength : 0,5 mmol/mlml

Packaging : 20X10ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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