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
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Product identification

Medicine name:
Ingelvac PRRSFLEX EU lyophilisate and solvent for suspension for injection for pigs
Ingelvac PRRSFLEX EU Liofilizat i rozpuszczalnik do sporządzania zawiesiny do wstrzykiwań dla świń
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:
  • Poland
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.
  • Lyophilisate:Type I amber glass vials with bromobutyl rubber stopper and aluminium seal.25 lyophilisate vials of 250 ml (250 doses) packed in a separatecardboard box.
  • Lyophilisate:Type I amber glass vials with bromobutyl rubber stopper and aluminium seal.25 lyophilisate vials of 100 ml (100 doses) packed in a separatecardboard box.
  • Lyophilisate:Type I amber glass vials with bromobutyl rubber stopper and aluminium seal.25 lyophilisate vials of 50 ml (50 doses)packed in a separatecardboard box.
  • Lyophilisate:Type I amber glass vials with bromobutyl rubber stopper and aluminium seal.25 lyophilisate vials of 10 ml (10 doses) packed in a separatecardboard box.
  • Lyophilisate:Type I amber glass vials with bromobutyl rubber stopper and aluminium seal.12 lyophilisate vials of 250 ml (250 doses) packed in a separatecardboard box.
  • Lyophilisate:Type I amber glass vials with bromobutyl rubber stopper and aluminium seal.12 lyophilisate vials of 100 ml (100 doses) packed in a separatecardboard box.
  • Lyophilisate:Type I amber glass vials with bromobutyl rubber stopper and aluminium seal.12 lyophilisate vials of 50 ml (50 doses) packed in a separatecardboard box.
  • Lyophilisate:Type I amber glass vials with bromobutyl rubber stopper and aluminium seal.12 lyophilisate vials of 10 ml (10 doses) packed in a separatecardboard box.
  • Lyophilisate:Type I amber glass vials with bromobutyl rubber stopper and aluminium seal.Solvent:High density polyethylene (HDPE) vials with bromo- or chlorobutyl rubber stopper and aluminium seal. 1 lyophilisate vial of 250 ml (250 doses) and 1 solvent vial of 250 ml packed in one cardboard box.
  • Lyophilisate:Type I amber glass vials with bromobutyl rubber stopper and aluminium seal.Solvent:High density polyethylene (HDPE) vials with bromo- or chlorobutyl rubber stopper and aluminium seal. 1 lyophilisate vial of 100 ml (100 doses) and 1 solvent vial of 100 ml packed in one cardboard box.
  • Lyophilisate:Type I amber glass vials with bromobutyl rubber stopper and aluminium seal.Solvent:High density polyethylene (HDPE) vials with bromo- or chlorobutyl rubber stopper and aluminium seal. 1 lyophilisate vial of 50 ml (50 doses) and 1 solvent vial of 50ml packed in one cardboard box.
  • Lyophilisate:Type I amber glass vials with bromobutyl rubber stopper and aluminium seal.Solvent:High density polyethylene (HDPE) vials with bromo- or chlorobutyl rubber stopper and aluminium seal. 1 lyophilisate vial of 10 ml (10 doses) and 1 solvent vial of 10 ml packed in one 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:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2485
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

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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Polish (PDF)
Published on: 11/05/2022
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 11/05/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 11/05/2022
Download
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