Veterinary Medicines

SYMPAGESIC 500 MG/ML + 4 MG/ML SOLUTION FOR INJECTION FOR HORSES, CATTLE, PIGS AND DOGS

Authorised
  • Metamizole sodium monohydrate
  • Hyoscine butylbromide
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Product identification

Medicine name:
SYMPAGESIC 500 MG/ML + 4 MG/ML SOLUTION FOR INJECTION FOR HORSES, CATTLE, PIGS AND DOGS
Sympagesic 500+4 mg/ml injektionsvæske, opløsning
Active substance:
  • Metamizole sodium monohydrate
  • Hyoscine butylbromide
Target species:
  • Cattle
  • Pig
  • Dog
  • Horse
  • Horse (mare)
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Metamizole sodium monohydrate
    500.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Hyoscine butylbromide
    4.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        28
        day
      • Milk
        no withdrawal period
    • Pig
      • Meat and offal
        15
        day
    • Dog
  • Intravenous use
    • Cattle
      • Meat and offal
        18
        day
      • Milk
        no withdrawal period
    • Pig
      • Meat and offal
        15
        day
    • Horse
      • Meat and offal
        15
        day
    • Horse (mare)
      • Milk
        no withdrawal period
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA03DB04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Package description:
  • Cardboard box with vial of 100 ml
  • Cardboard box with 5 vials of 100 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:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Genera d.d.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 61295
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0354/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

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Danish (PDF)
Published on: 29/06/2023
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