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01 4AS Kalceks

02 1Aristo Pharma GmbH

03 4As Kalceks

04 8G.L. Pharma Gmbh

05 1GL Pharma Gmbh

06 4Kalceks As

07 2Mundipharma AS

08 14Mundipharma Ab

09 14Mundipharma Medical Company, Hamilton, Bermuda, Basel Branch

10 2Quintian Pharma Limited

11 1Sintetica Sa

12 1Streuli Pharma Ag

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PharmaCompass

01

BePharma
Not Confirmed
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BePharma
Not Confirmed

Hydromorphone Hydrochloride

Brand Name : Hydromorphone Aristo

Dosage Form : Oral Solution

Dosage Strength : 2.6MG

Packaging :

Approval Date : 2025-02-07

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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02

BePharma
Not Confirmed
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BePharma
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Hydromorphone hydrochloride

Brand Name : Hydromorphone hydrochloride Kalceks

Dosage Form : Solution For Injection/Infusion

Dosage Strength : 10mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

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03

BePharma
Not Confirmed
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BePharma
Not Confirmed

Hydromorphone hydrochloride

Brand Name : Hydromorphone hydrochloride Kalceks

Dosage Form : Solution For Injection/Infusion

Dosage Strength : 2mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

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04

BePharma
Not Confirmed
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BePharma
Not Confirmed

Hydromorphone hydrochloride

Brand Name : Hydromorphone hydrochloride Kalceks

Dosage Form : Solution For Injection/Infusion

Dosage Strength : 20mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

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05

BePharma
Not Confirmed
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BePharma
Not Confirmed

Hydromorphone hydrochloride

Brand Name : Hydromorphone hydrochloride Kalceks

Dosage Form : Solution For Injection/Infusion

Dosage Strength : 50mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

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06

BePharma
Not Confirmed
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BePharma
Not Confirmed

Hydromorphone Hydrochloride

Brand Name : Hydromorphone Kalceks

Dosage Form : Solution For Injection/Infusion

Dosage Strength : 2mg/ml

Packaging :

Approval Date : 04-01-2019

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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07

BePharma
Not Confirmed
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BePharma
Not Confirmed

Hydromorphone Hydrochloride

Brand Name : Hydromorphone Kalceks

Dosage Form : Solution For Injection/Infusion

Dosage Strength : 10mg/ml

Packaging :

Approval Date : 04-01-2019

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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08

BePharma
Not Confirmed
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BePharma
Not Confirmed

Hydromorphone Hydrochloride

Brand Name : Hydromorphone Kalceks

Dosage Form : Solution For Injection/Infusion

Dosage Strength : 20mg/ml

Packaging :

Approval Date : 04-01-2019

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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09

BePharma
Not Confirmed
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BePharma
Not Confirmed

Hydromorphone Hydrochloride

Brand Name : Hydromorphone Kalceks

Dosage Form : Solution For Injection/Infusion

Dosage Strength : 50mg/ml

Packaging :

Approval Date : 04-01-2019

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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10

G.L. Pharma Gmbh

Country
BePharma
Not Confirmed
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G.L. Pharma Gmbh

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BePharma
Not Confirmed

Hydromorphone Hydrochloride

Brand Name : Gerodolan

Dosage Form : Solution For Injection/Infusion

Dosage Strength : 2mg/ml

Packaging :

Approval Date : 11-04-2019

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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