Veterinary Medicine Information website

PROSYL 5 mg/ml SOLUCION INYECTABLE

Authorised
  • Dinoprost
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Product identification

Medicine name:
PROSYL 5 mg/ml SOLUCION INYECTABLE
Active substance:
  • Dinoprost
Target species:
  • Horse (mare)
  • Cattle (cow)
  • Pig (female)
  • Sheep
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Dinoprost
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Horse (mare)
      • Meat and offal
        2
        day
    • Cattle (cow)
      • Meat and offal
        2
        day
      • Milk
        1
        day
    • Pig (female)
      • Meat and offal
        4
        day
    • Sheep
      • Meat and offal
        2
        day
      • Milk
        1
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG02AD01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Available in:
  • Spain
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Labiana Life Sciences S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Labiana Life Sciences S.A.
Responsible authority:
  • Spanish Agency For Medicines And Medical Devices
Authorisation number:
  • 1079 ESP
Date of authorisation status change:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 24/07/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 4/02/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 24/07/2024
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