Veterinary Medicines

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

Authorised
  • D-CLOPROSTENOL SODIUM SALT
Download as PDF

Product identification

Medicine name:
Dalmaprost 0.075 mg/ml solution for injection for cattle, pigs and horses
Dalmazin SYNCH 0,075 mg/ml ενέσιμο διάλυμα για βοοειδή, χοίρους και άλογα
Active substance:
  • D-CLOPROSTENOL SODIUM SALT
Target species:
  • Cattle (cow)
  • Pig (female)
  • Horse (mare)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • D-CLOPROSTENOL SODIUM SALT
    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
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Cyprus
Available in:
  • Cyprus
Package description:
  • box containing 1 HDPE container of 100 ml
  • box containing 1 vial of 20 ml
  • box containing 1 vial of 10 ml
  • box containing 60 vials of 2 ml
  • box containing 15 vials of 2 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:
  • Fatro S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Fatro S.p.A.
Responsible authority:
  • Ministry Of Agriculture Rural Development And Environment
Authorisation number:
  • CY00764V
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.
Greek (PDF)
Published on: 31/05/2022
Download

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
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."