Veterinary Medicines

Ingelvac PRRSFLEX EU lyophilisate and solvent for suspension for injection for pigs

Authorised
  • Porcine reproductive and respiratory syndrome virus, type 1, strain PRRS 94881, Live
  • Water for injection
Download as PDF

Product identification

Medicine name:
Ingelvac PRRSFLEX EU lyophilisate and solvent for suspension for injection for pigs
Ingelvac PRRSFLEX EU Lyophilisat und Lösungsmittel zur Herstellung einer Injektionssuspension für Schweine
Active substance:
  • Porcine reproductive and respiratory syndrome virus, type 1, strain PRRS 94881, Live
  • Water for injection
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Porcine reproductive and respiratory syndrome virus, type 1, strain PRRS 94881, Live
    3981070.00
    tissue culture infective dose 50
    /
    1.00
    millilitre(s)
  • Water for injection
    1.00
    other
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Lyophilisate and solvent for suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AD03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Austria
Package description:
  • Solvent:High density polyethylene (HDPE) vials with bromo- or chlorobutyl rubber stopper and aluminium seal. 25 solvent vials of 250 ml packed in a separate cardboard box.
  • Solvent:High density polyethylene (HDPE) vials with bromo- or chlorobutyl rubber stopper and aluminium seal. 25 solvent vials of 100 ml packed in a separate cardboard box.
  • Solvent:High density polyethylene (HDPE) vials with bromo- or chlorobutyl rubber stopper and aluminium seal. 25 solvent vials of 50 ml packed in a separate cardboard box.
  • Solvent:High density polyethylene (HDPE) vials with bromo- or chlorobutyl rubber stopper and aluminium seal. 25 solvent vials of 10 ml packed in a separate cardboard box.
  • Solvent:High density polyethylene (HDPE) vials with bromo- or chlorobutyl rubber stopper and aluminium seal. 12 solvent vials of 250 ml packed in a separate cardboard box.
  • Solvent:High density polyethylene (HDPE) vials with bromo- or chlorobutyl rubber stopper and aluminium seal. 12 solvent vials of 100 ml packed in a separate cardboard box.
  • Solvent:High density polyethylene (HDPE) vials with bromo- or chlorobutyl rubber stopper and aluminium seal. 12 solvent vials of 50 ml packed in a separate cardboard box.
  • Solvent:High density polyethylene (HDPE) vials with bromo- or chlorobutyl rubber stopper and aluminium seal. 12 solvent vials of 10 ml packed in a separate cardboard box.
  • Solvent:High density polyethylene (HDPE) vials with bromo- or chlorobutyl rubber stopper and aluminium seal. 12 solvent vials of 10 ml packed in a separate cardboard box.
  • Solvent:High density polyethylene (HDPE) vials with bromo- or chlorobutyl rubber stopper and aluminium seal. 12 solvent vials of 10 ml packed in a separate cardboard box.
  • Solvent:High density polyethylene (HDPE) vials with bromo- or chlorobutyl rubber stopper and aluminium seal. 12 solvent vials of 10 ml packed in a separate cardboard box.
  • Solvent:High density polyethylene (HDPE) vials with bromo- or chlorobutyl rubber stopper and aluminium seal. 12 solvent vials of 10 ml packed in a separate cardboard box.
  • Solvent:High density polyethylene (HDPE) vials with bromo- or chlorobutyl rubber stopper and aluminium seal. 12 solvent vials of 10 ml packed in a separate cardboard box.
  • Solvent:High density polyethylene (HDPE) vials with bromo- or chlorobutyl rubber stopper and aluminium seal. 12 solvent vials of 10 ml packed in a separate cardboard box.
  • Solvent:High density polyethylene (HDPE) vials with bromo- or chlorobutyl rubber stopper and aluminium seal. 12 solvent vials of 10 ml packed in a separate cardboard box.
  • Solvent:High density polyethylene (HDPE) vials with bromo- or chlorobutyl rubber stopper and aluminium seal. 12 solvent vials of 10 ml packed in a separate cardboard box.
  • Solvent:High density polyethylene (HDPE) vials with bromo- or chlorobutyl rubber stopper and aluminium seal. 12 solvent vials of 10 ml packed in a separate cardboard box.
  • Solvent:High density polyethylene (HDPE) vials with bromo- or chlorobutyl rubber stopper and aluminium seal. 12 solvent vials of 10 ml packed in a separate cardboard box.
  • Solvent:High density polyethylene (HDPE) vials with bromo- or chlorobutyl rubber stopper and aluminium seal. 12 solvent vials of 10 ml packed in a separate cardboard box.
  • Solvent:High density polyethylene (HDPE) vials with bromo- or chlorobutyl rubber stopper and aluminium seal. 12 solvent vials of 10 ml packed in a separate cardboard box.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Boehringer Ingelheim Vetmedica GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Boehringer Ingelheim Vetmedica GmbH
  • Norbrook Laboratories (Ireland) Limited
Responsible authority:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 836148
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0443/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 24/11/2021
Updated on: 6/06/2024
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 24/11/2021
Updated on: 6/06/2024
Download

Summary of Product Characteristics

English (PDF)
Published on: 8/04/2022
Updated on: 28/02/2023
Download
German (PDF)
Published on: 24/11/2021
Updated on: 6/06/2024
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."