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01 1Abbvie Deutschland Gmbh & Co Kg

02 2Abbvie Deutschland Gmbh & Co. Kg

03 1Accord Healthcare Bv

04 1Accord Healthcare Slu

05 1Adalvo Limited

06 1Anfarm Hellas S.A.

07 1Baxter Holding B.V.

08 1Baxter Holding Bv

09 1BioARS Therapeutics S.A.

10 1Bioglan Ab

11 1DURATA THERAPEUTICS INT.B.V.

12 1Elpen Pharmaceutical Co. Inc.

13 1Galenicum Health Slu

14 2Galenicum Health, S.L.U

15 1Reig Jofre Laboratory, Sa

16 2Teva Bv

17 2Zentiva Ks

18 1Zentiva k.s.

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PharmaCompass

01

Dalbavancin

Brand Name : Xydalba

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500mg

Packaging :

Approval Date : 19/02/2015

Application Number : 20131130000029

Regulatory Info : Approved

Registration Country : Sweden

Abbvie Company Banner

02

Dalbavancin

Brand Name : Xydalba

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

Abbvie Company Banner

03

Dalbavancina

Brand Name : Xydalba

Dosage Form : Powder For Concentrate And Solution For Infusion

Dosage Strength : 500MG

Packaging :

Approval Date : 27-06-2015

Application Number : 114986001

Regulatory Info : Authorized

Registration Country : Spain

Abbvie Company Banner

04

IPPE
Not Confirmed
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IPPE
Not Confirmed

Dalbavancin Hydrochloride

Brand Name : Dalbavancin Accord

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500mg

Packaging :

Approval Date : 11/06/2024

Application Number : 20230223000066

Regulatory Info : Approved

Registration Country : Sweden

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05

IPPE
Not Confirmed
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IPPE
Not Confirmed

Dalbavancin

Brand Name : Deirate

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 500MG

Packaging :

Approval Date : 2024-06-21

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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06

IPPE
Not Confirmed
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IPPE
Not Confirmed

Dalbavancin Hydrochloride

Brand Name : Dalbavancin Baxter

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500mg

Packaging :

Approval Date : 08/07/2024

Application Number : 20230227000031

Regulatory Info : Approved

Registration Country : Sweden

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07

IPPE
Not Confirmed
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IPPE
Not Confirmed

Dalbavancin Hydrochloride

Brand Name : Dalbavancin Bioglan

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500mg

Packaging :

Approval Date : 26/04/2024

Application Number : 20230223000011

Regulatory Info : Approved

Registration Country : Sweden

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08

IPPE
Not Confirmed
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IPPE
Not Confirmed

Zeven

Brand Name : Xydalba

Dosage Form : Dalbavancina 500Mg 1 Unit Parenteral Use

Dosage Strength : 1 bottle groun EV 500 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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09

IPPE
Not Confirmed
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IPPE
Not Confirmed

Dalbavancin Hydrochloride

Brand Name : Dalbavancin Teva

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500mg

Packaging :

Approval Date : 08/07/2024

Application Number : 20230901000074

Regulatory Info : Approved

Registration Country : Sweden

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10

IPPE
Not Confirmed
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IPPE
Not Confirmed

Dalbavancin Hydrochloride

Brand Name : Dalbavancin Zentiva

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500mg

Packaging :

Approval Date : 21/07/2025

Application Number : 20230801000099

Regulatory Info : Approved

Registration Country : Sweden

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