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01 1Pharmacare Limited, Woodmead

02 1Accord Healthcare (Pty) Ltd

03 1Kahma Biotech (Pty) Ltd

04 1Lamar International (Pty) Ltd

05 1Mylan (Pty) Ltd

06 1Pfizer Laboratories (Pty) Ltd

07 1Ranbaxy Pharmaceuticals (Pty) Ltd

08 1Teva Pharmaceuticals (Pty) Ltd

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PharmaCompass

01

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Antibody Engineering
Not Confirmed

Dexmedetomidine

Brand Name : Eccladex

Dosage Form : INF

Dosage Strength : 100mcg/ml

Packaging : 2X5mcg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Dexmedetomidine Hydrochloride

Brand Name : Sedalpha 100 µg/ml

Dosage Form : INJ

Dosage Strength : 100mcg/ml

Packaging : 2X5mcg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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03

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Dexmedetomidine Hydrochloride

Brand Name : Sedmedex 100 µg/ml

Dosage Form : INJ

Dosage Strength : 100mcg/ml

Packaging : 2X5mcg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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04

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Dexmedetomidine hydrochloride

Brand Name : Precedex

Dosage Form : INJ

Dosage Strength : 100mcg/ml

Packaging : 2X5mcg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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05

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

DEXMEDETOMIDINE

Brand Name : DEXISUN

Dosage Form : INF

Dosage Strength : 100mcg/ml

Packaging : 2X5mcg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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06

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

Brand Name : DEMETEV

Dosage Form : INF

Dosage Strength : 100mcg/ml

Packaging : 2X5mcg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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07

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Dexmedetomidine hydrochloride

Brand Name : Demodinex

Dosage Form : INJ

Dosage Strength : 100mcg/ml

Packaging : 2X5mcg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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08

Lamar International (Pty) Ltd

Country
Antibody Engineering
Not Confirmed
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Lamar International (Pty) Ltd

Country
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Antibody Engineering
Not Confirmed

Dexmedetomidine

Brand Name : Precia

Dosage Form : INJ

Dosage Strength : 100mcg/ml

Packaging : 2X5mcg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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