Veterinary Medicines

Mypravac Suis Suspension for Injection

Authorised
  • Mycoplasma hyopneumoniae, strain J, Inactivated
Download as PDF

Product identification

Medicine name:
Mypravac Suis Suspension for Injection
Mypravac Suis, suspensão injectável
Active substance:
  • Mycoplasma hyopneumoniae, strain J, Inactivated
Target species:
  • Pig (piglet)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Mycoplasma hyopneumoniae, strain J, Inactivated
    1.00
    Protective Dose
    /
    1.00
    Dose
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig (piglet)
      • Meat and offal
        2
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AB13
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Portugal
Package description:
  • box containing 12 bottles of 250 doses (500 ml)
  • box containing 12 bottles of 125 doses (250 ml)
  • box containing 1 vial of 50 doses (100 ml)
  • box containing 10 vial of 10 doses (20 ml)
  • box containing 1 vial of 10 doses (20 ml)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known 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:
  • Directorate General For Food And Veterinary
Authorisation number:
  • R721/03 DGV
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0328/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Netherlands
  • Portugal
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 23/03/2023
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."