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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 2Ebb Medical Ab

14 1Ecosse Limited

15 2JV Healthcare Limited

16 1Kalceks As

17 1Macure Pharma ApS

18 2Macure Pharma Aps

19 1Medicem Limited

20 3Medochemie Limited

21 1Medochemie Ltd

22 1NM Pharma Limited

23 2NeoFarma Pharmaceuticals Limited

24 2Nordic Prime Aps

25 1Novumgen Limited

26 3Opel Healthcare Switzerland Ag

27 1Opella Healthcare France SAS

28 2Opella Healthcare France SAS T/A Sanofi

29 1Opella Healthcare France Sas

30 1Opella Healthcare Romania S.R.L.

31 4Opella Healthcare Spain Sl

32 1Remedica Limited

33 1Sunglow Lifescience Private Limited

34 2Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

35 2VetViva Richter GmbH

36 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Regulatory Info : Withdrawn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Regulatory Info : Withdrawn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Regulatory Info : Withdrawn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Regulatory Info : Withdrawn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

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Hyoscinbutylbromid

Brand Name : Hyoscine Butylbromide Kalceks

Dosage Form : Injectable Solution

Dosage Strength : 20mg/ml

Packaging :

Approval Date : 11/10/2021

Application Number : 20210409000011

Regulatory Info : Approved

Registration Country : Sweden

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08

ASPEN
Not Confirmed
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ASPEN
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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09

Aps-Arzneimittel-Parallelimport-Service ...

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

Country
arrow
ASPEN
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
ASPEN
Not Confirmed
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Aurovitas Spain, Sau

Country
arrow
ASPEN
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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