Veterinary Medicines Information website

ReproCyc PRRS EU lyophilisate and solvent for suspension for injection for pigs

Authorised
  • Porcine reproductive and respiratory syndrome virus, type 1, strain PRRS 94881, Live
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Product identification

Medicine name:
ReproCyc PRRS EU lyophilisate and solvent for suspension for injection for pigs
Active substance:
  • Porcine reproductive and respiratory syndrome virus, type 1, strain PRRS 94881, Live
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
    10000000.00
    50% tissue culture infectious dose
    /
    1.00
    Dose
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:
  • Netherlands
Available in:
  • Netherlands
Package description:
  • Lyophilisate:Type I amber glass vials with bromobutyl rubber stopper and aluminium seal.Solvent:High density polyethylene (HDPE) vials with a bromo- or chlorobutyl rubber stopper and aluminium seal. Cardboard box of 1 lyophilisate vial of 20 ml and 1 solvent vial of 20 ml (10 doses).
  • Lyophilisate:Type I amber glass vials with bromobutyl rubber stopper and aluminium seal.Solvent:High density polyethylene (HDPE) vials with a bromo- or chlorobutyl rubber stopper and aluminium seal. Cardboard box of 1 lyophilisate vial of 100 ml and 1 solvent vial of 100 ml (50 doses).
  • Lyophilisate:Type I amber glass vials with bromobutyl rubber stopper and aluminium seal.Solvent:High density polyethylene (HDPE) vials with a bromo- or chlorobutyl rubber stopper and aluminium seal. Cardboard box of 1 lyophilisate vial of 200 ml and 1 solvent vial of 200 ml (100 doses).
  • Lyophilisate:Type I amber glass vials with bromobutyl rubber stopper and aluminium seal.Solvent:High density polyethylene (HDPE) vials with a bromo- or chlorobutyl rubber stopper and aluminium seal. Cardboard box of 12 lyophilisate vials of 20 ml (10 doses) and Cardboard box of 12 solvent vials of 20 ml (10 doses).
  • Lyophilisate:Type I amber glass vials with bromobutyl rubber stopper and aluminium seal.Solvent:High density polyethylene (HDPE) vials with a bromo- or chlorobutyl rubber stopper and aluminium seal. Cardboard box of 12 lyophilisate vials of 100 ml (50 doses) and Cardboard box of 12 solvent vials of 100 ml (50 doses).
  • Lyophilisate:Type I amber glass vials with bromobutyl rubber stopper and aluminium seal.Solvent:High density polyethylene (HDPE) vials with a bromo- or chlorobutyl rubber stopper and aluminium seal. Cardboard box of 12 lyophilisate vials of 200 ml (100 doses) and Cardboard box of 12 solvent vials of 200 ml (100 doses).
  • Lyophilisate:Type I amber glass vials with bromobutyl rubber stopper and aluminium seal.Solvent:High density polyethylene (HDPE) vials with a bromo- or chlorobutyl rubber stopper and aluminium seal. Cardboard box of 25 lyophilisate vials of 20 ml (10 doses) and Cardboard box of 25 solvent vials of 20 ml (10 doses).
  • Lyophilisate:Type I amber glass vials with bromobutyl rubber stopper and aluminium seal.Solvent:High density polyethylene (HDPE) vials with a bromo- or chlorobutyl rubber stopper and aluminium seal. Cardboard box of 25 lyophilisate vials of 100 ml (50 doses) and Cardboard box of 25 solvent vials of 100 ml (50 doses).
  • Lyophilisate:Type I amber glass vials with bromobutyl rubber stopper and aluminium seal.Solvent:High density polyethylene (HDPE) vials with a bromo- or chlorobutyl rubber stopper and aluminium seal. Cardboard box of 25 lyophilisate vials of 200 ml (100 doses) and Cardboard box of 25 solvent vials of 200 ml (100 doses).

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
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 115087
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0444/001
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

Combined File of all Documents

English (PDF)
Published on: 30/11/2025
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Dutch (PDF)
Published on: 15/10/2025
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Summary of Product Characteristics

English (PDF)
Published on: 30/11/2025
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