Veterinary Medicines

Synchromate 250 micrograms/ml solution for injection

Authorised
  • Cloprostenol sodium
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Product identification

Medicine name:
Synchromate 250 micrograms/ml solution for injection
Synchromate 0,25mg/ml roztwór do wstrzykiwań dla bydła, świń i koni
Active substance:
  • Cloprostenol sodium
Target species:
  • Cattle (cow)
  • Pig (sow)
  • Horse (mare)
  • Cattle (heifer)
  • Pig (sow, nullipar)
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
    • Cattle (heifer)
      • Meat and offal
        2
        day
      • Milk
        0
        day
    • Pig (sow, nullipar)
      • Meat and offal
        2
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG02AD90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
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:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 3219
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

Combined File of all Documents

English (PDF)
Published on: 24/07/2025
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Summary of Product Characteristics

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Polish (PDF)
Published on: 29/12/2025
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Package Leaflet

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Polish (PDF)
Published on: 29/12/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 29/12/2025
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