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01 1Sanofi Aventis Sa

02 3Sanofi Malta Limited

03 1Sanofi S.R.L

04 1ALFRED E TIEFENBACHER GmbH & Co KG

05 1AS Kalceks

06 1Aps-Arzneimittel-Parallelimport-Service Ag

07 1As Kalceks

08 1Aurovitas Spain, Sau

09 2Bilim Ilac Sanayi Ve Ticaret A.?.

10 1Boehringer Ingelheim Limited

11 1Dechra Regulatory BV

12 2Ebb Medical Ab

13 1Ecosse Limited

14 2JV Healthcare Limited

15 1Kalceks As

16 1Macure Pharma ApS

17 1Macure Pharma Aps

18 1Medicem Limited

19 2Medochemie Limited

20 1Medochemie Ltd

21 1NM Pharma Limited

22 2NeoFarma Pharmaceuticals Limited

23 3Opel Healthcare Switzerland Ag

24 1Opella Healthcare France SAS

25 2Opella Healthcare France SAS T/A Sanofi

26 1Opella Healthcare France Sas

27 1Opella Healthcare Romania S.R.L.

28 4Opella Healthcare Spain Sl

29 1Remedica Limited

30 1Sunglow Lifescience Private Limited

31 2Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

32 2VetViva Richter GmbH

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Cancelled

Registration Country : Spain

Metamizol Sodium; Butylscopolamine Bromide

Brand Name : Buscapina Compositum

Dosage Form : Coated Tablet

Dosage Strength : 250MG; 10 MG

Packaging :

Approval Date : 1959-06-01

Application Number : 32174

Regulatory Info : Cancelled

Registration Country : Spain

Sanofi Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Regulatory Info : EU Dossier Readiness-Q1 2019

Registration Country : Germany

Butylscopolamine

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Dossier Readiness-Q1 2019

Registration Country : Germany

Tiefenbacher Compnay Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Withdrawn

Registration Country : Malta

Hyoscine Butylbromide

Brand Name : Buscopan Ampoules

Dosage Form : Solution For Injection

Dosage Strength : 20MG/ML

Packaging :

Approval Date : 2017-08-01

Application Number :

Regulatory Info : Withdrawn

Registration Country : Malta

Sanofi Company Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Withdrawn

Registration Country : Malta

Hyoscine Butylbromide

Brand Name : Buscopan Ibs Relief

Dosage Form : Tablet

Dosage Strength : 10MG

Packaging :

Approval Date : 2017-08-01

Application Number :

Regulatory Info : Withdrawn

Registration Country : Malta

Sanofi Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Withdrawn

Registration Country : Malta

Hyoscine Butylbromide

Brand Name : Buscopan Ampoules

Dosage Form : Solution For Injection

Dosage Strength : 20MG/ML

Packaging :

Approval Date : 2018-12-03

Application Number :

Regulatory Info : Withdrawn

Registration Country : Malta

Sanofi Company Banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Withdrawn

Registration Country : Malta

Hyoscine Butylbromide

Brand Name : Buscopan Ampoules

Dosage Form : Solution For Injection

Dosage Strength : 20mg/ml

Packaging :

Approval Date : 2019-08-21

Application Number :

Regulatory Info : Withdrawn

Registration Country : Malta

Sanofi Company Banner

07

VMX
Not Confirmed
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VMX
Not Confirmed

Hyoscinbutylbromid

Brand Name : Buscopan

Dosage Form : Injectable Solution

Dosage Strength : 20mg/ml

Packaging :

Approval Date : 20/07/2016

Application Number : 20151219000030

Regulatory Info : Approved

Registration Country : Sweden

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08

VMX
Not Confirmed
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VMX
Not Confirmed

Hyoscinbutylbromid

Brand Name : Buscopan

Dosage Form : Injectable Solution

Dosage Strength : 20mg/ml

Packaging :

Approval Date : 20/07/2016

Application Number : 20151219000047

Regulatory Info : Approved

Registration Country : Sweden

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09

VMX
Not Confirmed
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VMX
Not Confirmed

Hyoscinbutylbromid

Brand Name : Bumacor

Dosage Form : Injectable Solution

Dosage Strength : 20mg/ml

Packaging :

Approval Date : 18/08/2022

Application Number : 20201027000019

Regulatory Info : Approved

Registration Country : Sweden

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10

VMX
Not Confirmed
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VMX
Not Confirmed

Hyoscinbutylbromid

Brand Name : Buscopan

Dosage Form : Injectable Solution

Dosage Strength : 20mg/ml

Packaging :

Approval Date : 28/06/1954

Application Number : 19540628000030

Regulatory Info : Approved

Registration Country : Sweden

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