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Approved Marketing Authorisations (MA) containing Dexmedetomidine in Europe. Original Data : EMA Website

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$ API Ref.Price (USD/KG) : 892,458Xls
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01 1Orion Corporation

02 4Orion Corporation - Espoo

03 1Grindeks AS

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PharmaCompass

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AAPS 2024
Not Confirmed

dexmedetomidine hydrochloride

Brand Name : Dexdor

Dosage Form : CONCENTRATE FOR SOLUTION FOR INFUSION

Dosage Strength : 100 MICROGRAM / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Fermion Orion Company Banner

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AAPS 2024
Not Confirmed

Dexmedetomidine

Brand Name : Dexdor

Dosage Form : Concentrate to the infusion fluid, resolution

Dosage Strength : 100 mcg/ml

Packaging : Ampoule

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Fermion Orion Company Banner

03

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AAPS 2024
Not Confirmed

Dexmedetomidine

Brand Name : Dexdor

Dosage Form : Concentrate to the infusion fluid, resolution

Dosage Strength : 100 mcg/ml

Packaging : Hood glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Fermion Orion Company Banner

04

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AAPS 2024
Not Confirmed

Dexmedetomidine

Brand Name : Dexdor

Dosage Form : Concentrate to the infusion fluid, resolution

Dosage Strength : 100 mcg/ml

Packaging : Hood glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Fermion Orion Company Banner

05

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AAPS 2024
Not Confirmed

Dexmedetomidine

Brand Name : Dexdor

Dosage Form : Concentrate to the infusion fluid, resolution

Dosage Strength : 100 mcg/ml

Packaging : Ampoule

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Fermion Orion Company Banner

06

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Dexmedetomidine

Brand Name :

Dosage Form : INJECTION

Dosage Strength : 100MCG/ML

Packaging : 4 ml (in vials) and 10 ml (in vials)

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Latvia

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