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Veterinary Medicines

Dalmaprost 0.075 mg/ml solution for injection for cattle, pigs and horses

Authorised
  • R-Cloprostenol sodium

Product identification

Medicine name:
Dalmaprost 0.075 mg/ml solution for injection for cattle, pigs and horses
Dalmazin SYNCH 0,075 mg/ml injekčný roztok pre hovädzí dobytok, ošípané a kone
Active substance:
  • R-Cloprostenol sodium
Target species:
  • Cattle (cow)
  • Pig (female)
  • Horse (mare)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • R-Cloprostenol sodium
    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
        no withdrawal period
      • Milk
        no withdrawal period
    • Pig (female)
      • Meat and offal
        1
        day
    • Horse (mare)
      • Meat and offal
        2
        day
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG02AD90
Authorisation status:
  • Valid
Authorised in:
  • Slovakia
Available in:
  • Slovakia
Package description:
  • box containing 15 vials of 2 ml
  • box containing 60 vials of 2 ml
  • box containing 1 vial of 10 ml
  • box containing 1 vial of 20 ml
  • box containing 1 HDPE container of 100 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Marketing authorisation holder:
  • Fatro S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Fatro S.p.A.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/041/DC/19-S
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0305/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Sweden
  • 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.
Slovak (PDF)
Published on: 23/05/2022

Summary of Product Characteristics

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

Package Leaflet

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

Labelling

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

eu-PUAR-dalmaprost-0.075-mg-ml-solution-for-injection-for-cattle--pigs-and-horses-en.pdf

English (PDF)
Published on: 24/03/2023
Download
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