Veterinary Medicines

Spasmalgan compositum 500 mg/ml + 4 mg/ml Solution for injection for horses, cattle, pigs and dogs

Authorised
  • Hyoscine butylbromide
  • Metamizole sodium monohydrate
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Product identification

Medicine name:
Spasmalgan compositum 500 mg/ml + 4 mg/ml Solution for injection for horses, cattle, pigs and dogs
Spasmalgan compositum 500 mg/ml + 4 mg/ml Injekčný roztok pre kone, hovädzí dobytok, ošípané a psy
Active substance:
  • Hyoscine butylbromide
  • Metamizole sodium monohydrate
Target species:
  • Cattle
  • Dog
  • Horse
  • Pig
Route of administration:
  • Intravenous use
  • Intramuscular use

Product details

Active substance and strength:
  • Hyoscine butylbromide
    4.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Metamizole sodium monohydrate
    500.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Cattle
      • Milk
        96
        hour
      • Meat and offal
        12
        day
    • Horse
      • Meat and offal
        12
        day
      • Milk
        no withdrawal period
  • Intramuscular use
    • Pig
      • Meat and offal
        15
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA03DB04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovakia
Available in:
  • Slovakia
Package description:
  • (ID2) 100 millilitre(s): Box (board) with 1 Bottle (clear glass) with 100 millilitre(s), closed with Stopfen (bromobutyl rubber) and Cap`` (aluminium)
  • (ID1) 10 millilitre(s): Box (board) with 1 Bottle (clear glass) with 10 millilitre(s), closed with Stopfen (bromobutyl rubber) and Cap`` (aluminium)

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:
  • Veyx Pharma GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Veyx Pharma GmbH
  • Veyx-Pharma B.V.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/024/DC/20-S
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0323/001
Concerned member states:
  • Austria
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Estonia
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Malta
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Spain

Documents

Combined File of all Documents

English (PDF)
Published on: 4/12/2025
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Slovak (PDF)
Published on: 10/08/2023
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