Veterinary Medicines

Spasmipur 20 mg/ml

Authorised
  • Hyoscine butylbromide
Download as PDF

Product identification

Medicine name:
Spasmipur 20 mg/ml
Spasmipur Vet. 20 mg/ml injektionsvæske, opløsning
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
Withdrawal period by route of administration:
  • Intravenous use
    • Horse
    • Cattle
    • Sheep
    • Pig
  • Intramuscular use
    • Horse
    • Cattle
    • Sheep
    • Pig
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA03BB01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Available in:
  • Denmark
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:
  • Danish Medicines Agency
Authorisation number:
  • 60983
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
Download
Danish (, INJEKTIONSVÆSKE, OPLØSNING 20 MG-ML)
Published on: 20/01/2025
Download

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
Download

eu-PUAR-spasmipur-20-mg-ml-en.pdf

English (PDF)
Published on: 12/04/2023
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."