File downloaded on 2025-12-31
Source URL: https://medicines.health.europa.eu/veterinary/en/600000097087
Authorised

Product identification

Medicine name:
FARMOLISINA, 500 mg/ ml, soluzione iniettabile per bovini, equini, suini e cani
Active substance:
  • Metamizole sodium
Target species:
  • Cattle
  • Horse
  • Pig
  • Dog
Route of administration:
  • Intramuscular and intravenous use

Product details

Active substance and strength:
  • Metamizole sodium
    500.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular and intravenous use
    • Cattle
      • Meat and offal
        9
        day
      • Milk
        48
        hour
    • Horse
      • Meat and offal
        16
        day
    • Pig
      • Meat and offal
        7
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN02BB02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Ceva Salute Animale S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Vetem S.p.A.
  • Ceva Sante Animale
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 101524
Date of authorisation status change:

Documents

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Italian (PDF)
Published on: 1/08/2023
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