Veterinary Medicines

AMERVAC-PRRS LIOFILIZADO Y DISOLVENTE PARA SUSPENSION INYECTABLE PARA PORCINO

Not authorised
  • Porcine reproductive and respiratory syndrome virus, type 1, strain VP-046 BIS, Inactivated
Download as PDF

Product identification

Medicine name:
AMERVAC-PRRS LIOFILIZADO Y DISOLVENTE PARA SUSPENSION INYECTABLE PARA PORCINO
Active substance:
  • Porcine reproductive and respiratory syndrome virus, type 1, strain VP-046 BIS, Inactivated
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Porcine reproductive and respiratory syndrome virus, type 1, strain VP-046 BIS, Inactivated
    3.50
    50% tissue culture infectious dose
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate and solvent for solution 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:
  • Surrendered
Authorised in:
  • Spain
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Laboratorios Hipra S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Hipra, S.A.
Responsible authority:
  • Spanish Agency For Medicines And Medical Devices
Authorisation number:
  • 1220 ESP
Date of authorisation status change:

Documents

Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 8/08/2024
Download

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 8/08/2024
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 8/08/2024
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."