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.U.
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

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 3/05/2023
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Summary of Product Characteristics

English (PDF)
Published on: 25/12/2023
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Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 3/05/2023
Download

Package Leaflet

English (PDF)
Published on: 25/12/2023
Download

Labelling

English (PDF)
Published on: 25/12/2023
Download

eu-PUAR-esv0143001-mrp-luteosyl-0.075-mg-ml-solution-for-injection-for-cows-and-sows-en.pdf

English (PDF)
Published on: 25/12/2023
Download
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