Veterinary Medicines Information website

DIB 1.0 g Vaginal Delivery System for Cattle

Authorised
  • Progesterone
Download as PDF

Product identification

Medicine name:
DIB 1.0 g Vaginal Delivery System for Cattle
Active substance:
  • Progesterone
Target species:
  • Cattle
Route of administration:
  • Vaginal use

Product details

Active substance and strength:
  • Progesterone
    1.00
    gram(s)
    /
    1.00
    System
Pharmaceutical form:
  • Vaginal delivery system
Withdrawal period by route of administration:
  • Vaginal use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG03DA04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Available in:
  • Belgium
Package description:
  • The devices are packed in tri-laminar bags consisting of a polyethylene terephthalate (PET) external sheet, an aluminium middle sheet and a polyethylene internal sheet; in units of 10 per bag. Bags are re-sealable (zipper).Package size:Bag with 10 devices.

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:
  • Syn Vet-Pharma Ireland Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Ovejero S.A.U.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V582497
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0400/001
Concerned member states:
  • Belgium
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 16/02/2025
Download
Dutch (PDF)
Published on: 8/07/2026
Download
French (PDF)
Published on: 8/07/2026
Download
German (PDF)
Published on: 8/07/2026
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 8/07/2026
Download
German (PDF)
Published on: 8/07/2026
Download
Dutch (PDF)
Published on: 8/07/2026
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 8/07/2026
Download
German (PDF)
Published on: 8/07/2026
Download
Dutch (PDF)
Published on: 8/07/2026
Download