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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 1Dechra Regulatory Bv

13 1Ebb Medical AB

14 2Ebb Medical Ab

15 1Ecosse Limited

16 2JV Healthcare Limited

17 1Kalceks As

18 1Macure Pharma ApS

19 2Macure Pharma Aps

20 1Medicem Limited

21 3Medochemie Limited

22 1Medochemie Ltd

23 1NM Pharma Limited

24 2NeoFarma Pharmaceuticals Limited

25 2Nordic Prime Aps

26 1Novumgen Limited

27 3Opel Healthcare Switzerland Ag

28 1Opella Healthcare France SAS

29 2Opella Healthcare France SAS T/A Sanofi

30 1Opella Healthcare France Sas

31 1Opella Healthcare Romania S.R.L.

32 4Opella Healthcare Spain Sl

33 1Remedica Limited

34 1Sunglow Lifescience Private Limited

35 2Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

36 2VetViva Richter GmbH

37 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Regulatory Info : Withdrawn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Regulatory Info : Withdrawn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

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Regulatory Info : Withdrawn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 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

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 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

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 : 2019-08-21

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 : Cancelled

Registration Country : Spain

Metamizol Sodium; Butylscopolamine Bromide

Brand Name : Buscapina Compositum

Dosage Form : Coated Tablet

Dosage Strength : 250MG; 10 MG

Packaging :

Approval Date : 01-06-1959

Application Number : 32174

Regulatory Info : Cancelled

Registration Country : Spain

Sanofi Company Banner

07

BioAsia
Not Confirmed
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BioAsia
Not Confirmed

Scopolamine butyl bromide

Brand Name : Scopolamine butylbromide Kalceks

Dosage Form : Solution For Injection

Dosage Strength : 20mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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08

BioAsia
Not Confirmed
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BioAsia
Not Confirmed

Hyoscinbutylbromid

Brand Name : Hyoscine Butylbromide Kalceks

Dosage Form : Injectable Solution

Dosage Strength : 20mg/ml

Packaging :

Approval Date : 11-10-2021

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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09

Aps-Arzneimittel-Parallelimport-Service ...

Country
BioAsia
Not Confirmed
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Aps-Arzneimittel-Parallelimport-Service ...

Country
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BioAsia
Not Confirmed

Scopolamine Butylbromide

Brand Name : Buscopan

Dosage Form : Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 18/10/2007

Application Number : 56802

Regulatory Info : Allowed

Registration Country : Switzerland

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10

Aurovitas Spain, Sau

Country
BioAsia
Not Confirmed
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Aurovitas Spain, Sau

Country
arrow
BioAsia
Not Confirmed

Butylscopolamine Bromide

Brand Name : Butilescopolamina Aurovitas

Dosage Form : Coated Tablet

Dosage Strength : 10MG

Packaging :

Approval Date : 23-04-2021

Application Number : 85946

Regulatory Info : Authorized

Registration Country : Spain

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