Veterinary Medicines

Mypravac Suis Suspension for Injection

Authorised
  • Mycoplasma hyopneumoniae, strain J, Inactivated
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Product identification

Medicine name:
Mypravac Suis Suspension for Injection
MYPRAVAC SUIS
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:
  • Germany
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:
  • Paul-Ehrlich-Institut
Authorisation number:
  • PEI.V.02850.01.1
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: 26/06/2025
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Package Leaflet

English (PDF)
Published on: 21/10/2024
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Labelling

English (PDF)
Published on: 21/10/2024
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Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 6/12/2024
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