Veterinary Medicines

Spasmipur 20 mg/ml solution for injection for horses, cattle, sheep and pigs

Authorised
  • Hyoscine butylbromide
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Product identification

Medicine name:
Spasmipur 20 mg/ml solution for injection for horses, cattle, sheep and pigs
SPASMIPUR SOLUTION INJECTABLE POUR CHEVAUX, BOVINS, OVINS ET PORCINS
Active substance:
  • Hyoscine butylbromide
Target species:
  • Horse
  • Cattle
  • Sheep
  • Pig
Route of administration:
  • Intravenous use
  • Intramuscular use

Product details

Active substance and strength:
  • Hyoscine butylbromide
    20.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA03BB01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Available in:
  • France
Package description:
  • cardboard box containing 1 vial of 50 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Vetviva Richter GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Vetviva Richter GmbH
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/0410560 4/2019
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0298/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 7/06/2023
Updated on: 9/06/2023
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French (PDF)
Published on: 3/10/2024
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Package Leaflet

English (PDF)
Published on: 7/06/2023
Updated on: 9/06/2023
Download

Labelling

English (PDF)
Published on: 7/06/2023
Updated on: 9/06/2023
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Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 15/10/2025
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Combined File of all Documents

English (PDF)
Published on: 24/07/2025
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eu-PUAR-spasmipur-20-mg-ml-en.pdf

English (PDF)
Published on: 12/04/2023
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