Veterinary Medicines

Dalmazin, 75 micrograms/ml, solution for injection for cattle, buffaloes and pigs

Authorised
  • Cloprostenol
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Product identification

Medicine name:
Dalmazin, 75 micrograms/ml, solution for injection for cattle, buffaloes and pigs
Dalmazin 75 microgrammi/ml soluzione iniettabile per bovine, bufale e scrofe.
Active substance:
  • Cloprostenol
Target species:
  • Cattle (cow)
  • Pig (sow)
  • Buffalo (female)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Cloprostenol
    75.00
    microgram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle (cow)
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Pig (sow)
      • Meat and offal
        1
        day
    • Buffalo (female)
      • Meat and offal
        1
        day
      • Milk
        0
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG02AD90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Package description:
  • Cardboard box containing 1 x 10 ml type II glass vial sealed with a chlorobutyl type I rubber stopper and aluminium overseal
  • Cardboard box containing 4 blister of 15 x 2 ml type I glass vials (60 vials) sealed with a chlorobutyl type I rubber stopper and aluminium overseal
  • Cardboard box containing 1 blister of 15 x 2 ml type I glass vials (15 vials) sealed with a chlorobutyl type I rubber stopper and aluminium overseal
  • Cardboard box containing 10 x 10 ml type II glass vials sealed with a chlorobutyl type I rubber stopper and aluminium overseal
  • Cardboard box containing 5 x 20 ml type II glass vials sealed with a chlorobutyl type I rubber stopper and aluminium overseal
  • Cardboard box containing a 20 ml type II glass vial sealed with a chlorobutyl type I rubber stopper and aluminium overseal
  • Cardboard box with 1 type II glass vial of 50 ml with a chlorobutyl type I rubber stopper and an aluminium overseal
  • Cardboard box with 1 HDPE multidose container of 100 ml with a chlorobutyl type I rubber stopper and an aluminium overseal

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:
  • Fatro S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Fatro S.p.A.
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 101725
Date of authorisation status change:
Reference member state:
  • Italy
Procedure number:
  • IT/V/0105/001
Concerned member states:
  • Austria
  • Belgium
  • France
  • Germany
  • Ireland
  • Luxembourg
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 6/08/2025
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Italian (PDF)
Published on: 7/10/2025
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