Authorised

Product identification

Medicine name:
DALMARELIN 25 micrograms/ml solution for injection for cattle and rabbits
Dalmarelin, 25 Mikrogramm/ml, Injektionslösung für Rinder und Kaninchen
Active substance:
  • Lecirelin
Target species:
  • Rabbit
  • Cattle
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Lecirelin
    25.00
    microgram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Rabbit
      • Meat and offal
        0
        day
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH01CA92
Legal status of supply:
  • Medicinal product on medical prescription for non-renewable delivery
Authorisation status:
  • Valid
Authorised in:
  • Austria
Available in:
  • Austria
Package description:

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:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 8-00606
Date of authorisation status change:
Reference member state:
  • Italy
Procedure number:
  • IT/V/0112/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Iceland
  • Ireland
  • Luxembourg
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 2/02/2024
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 20/04/2023
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Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 20/04/2023
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Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 20/04/2023
Download
Source URL: https://medicines.health.europa.eu/veterinary/600000056171