Veterinary Medicines

Luteosyl 0.075 mg/ml Solution for injection for cows and sows

Authorised
  • D-cloprostenol
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Product identification

Medicine name:
Luteosyl 0.075 mg/ml Solution for injection for cows and sows
LUTEOSYL 0,075 mg/ml инжекционен разтвор за говеда и свине
Active substance:
  • D-cloprostenol
Target species:
  • Cattle (cow)
  • Pig (sow)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • D-cloprostenol
    0.08
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle (cow)
      • Meat and offal
        1
        day
      • Milk
        0
        hour
    • Pig (sow)
      • Meat and offal
        1
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG02AD90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Bulgaria
Available in:
  • Bulgaria
Package description:
  • cardboard box containing 5 glass vials of 20 ml
  • cardboard box containing 1 glass vial of 20 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:
  • Laboratorios Syva S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Syva S.A.
Responsible authority:
  • Bulgarian Food Safety Authority
Authorisation number:
  • 0022-2653
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0143/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 30/10/2025
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Bulgarian (PDF)
Published on: 20/09/2024
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Labelling

English (PDF)
Published on: 30/10/2025
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Bulgarian (PDF)
Published on: 20/09/2024
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Package Leaflet

English (PDF)
Published on: 30/10/2025
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Bulgarian (PDF)
Published on: 20/09/2024
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Combined File of all Documents

English (PDF)
Published on: 24/07/2025
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eu-PUAR-esv0143001-mrp-luteosyl-0.075-mg-ml-solution-for-injection-for-cows-and-sows-en_30_10_2025_505.pdf

English (PDF)
Published on: 30/10/2025
Download