Veterinary Medicines

Spasmium comp. 500 mg/ml + 4 mg/ml solution for injection

Authorised
  • Hyoscine butylbromide
  • Metamizole sodium monohydrate
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Product identification

Medicine name:
Spasmium comp. 500 mg/ml + 4 mg/ml solution for injection
Spasmium comp.500 mg/ml + 4 mg/ml oldatos injekció
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
      • Meat and offal
        12
        day
      • Milk
        4
        day
    • Dog
    • Horse
      • Meat and offal
        12
        day
      • Milk
        no withdrawal period
  • Intramuscular use
    • Dog
    • 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:
  • Hungary
Package description:
  • (ID2): 1 unspecified outer container with 5 Vial (Glass) with 100 millilitre(s) (500 millilitre(s))
  • (ID1): 1 unspecified outer container with 1 Vial (Glass) with 100 millilitre(s) (100 millilitre(s))

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:
  • Richter Pharma AG
  • Richter Pharma AG
Responsible authority:
  • Directorate Of Veterinary Medicinal Products
Authorisation number:
  • 3668/X/15 NÉBIH ÁTI
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0159/001
Concerned member states:
  • Austria
  • Bulgaria
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 1/08/2024
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