Veterinary Medicines

Suvaxyn MH-One Emulsion for injection for pigs

Authorised
  • Mycoplasma hyopneumoniae, strain P-5722-3, Inactivated
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Product identification

Medicine name:
Suvaxyn MH-One Emulsion for injection for pigs
Suvaxyn MH-One - Emulsion zur Injektion für Schweine
Active substance:
  • Mycoplasma hyopneumoniae, strain P-5722-3, Inactivated
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Mycoplasma hyopneumoniae, strain P-5722-3, Inactivated
    1.00
    relative unit(s)
    /
    2.00
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AB13
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Austria
Available in:
  • Austria
Package description:
  • (ID1): 1 Box with 1 Bottle (High Density PolyEthylene) with 20 millilitre(s) (20 millilitre(s))
  • (ID6): 1 Box with 10 Bottle (High Density PolyEthylene) with 250 millilitre(s) (2500 millilitre(s))
  • (ID2): 1 Box with 10 Bottle (High Density PolyEthylene) with 20 millilitre(s) (200 millilitre(s))
  • (ID3): 1 Box with 1 Bottle (High Density PolyEthylene) with 100 millilitre(s) (100 millilitre(s))
  • (ID4): 1 Box with 1 Bottle (High Density PolyEthylene) with 250 millilitre(s) (250 millilitre(s))
  • (ID5): 1 Box with 10 Bottle (High Density PolyEthylene) with 100 millilitre(s) (1000 millilitre(s))

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Immunological veterinary medicinal product application (Article 13d of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Zoetis Osterreich GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Manufacturing & Research Spain S.L.
Responsible authority:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 8-20313
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0248/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • France
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 7/10/2025
Updated on: 28/10/2025
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Summary of Product Characteristics

English (PDF)
Published on: 28/01/2022
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German (PDF)
Published on: 12/02/2024
Updated on: 28/10/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 12/02/2024
Updated on: 28/10/2025
Download

Combined File of all Documents

English (PDF)
Published on: 1/02/2024
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2603675-paren-20250201.pdf

English (PDF)
Published on: 8/12/2025
Download