Veterinary Medicines

Synchromate 0.25mg/ml solution for injection for cattle, pigs and horses

Authorised
  • Cloprostenol sodium
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Product identification

Medicine name:
Synchromate 0,25 mg/ml oldatos injekció szarvasmarhák, sertések és lovak számára A.U.V.
Synchromate 0.25mg/ml solution for injection for cattle, pigs and horses
Active substance:
  • Cloprostenol sodium
Target species:
  • Cattle (cow)
  • Pig (sow)
  • Horse (mare)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Cloprostenol sodium
    0.26
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle (cow)
      • Meat and offal
        2
        day
      • Milk
        0
        day
    • Pig (sow)
      • Meat and offal
        2
        day
    • Horse (mare)
      • Meat and offal
        28
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG02AD90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Hungary
Package description:
  • Cardboard box containing 12 vials of 20ml
  • Cardboard box containing 5 vials of 20ml
  • Cardboard box containing 1 vial of 20ml
  • Cardboard box containing 12 vials of 10ml
  • Cardboard box containing 5 vials of 10ml
  • Cardboard box containing 1vial of 10ml
  • Cardboard box containing 1 vial of 100 ml
  • Cardboard box containing 1 vial of 50 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:
  • Alivira Animal Health Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bremer Pharma GmbH
Responsible authority:
  • Directorate Of Veterinary Medicinal Products
Authorisation number:
  • 4342/X/22 NÉBIH ÁTI (1 db 10 ml-es injekciós üvege
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0411/001
Concerned member states:
  • Belgium
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Romania

Documents

Summary of Product Characteristics

English (PDF)
Published on: 24/03/2023
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eu-PUAR-synchromate-0.25mg-ml--solution-for-injection-for-cattle--pigs-and-horses-en.pdf

English (PDF)
Published on: 12/04/2023
Download
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