Veterinary Medicines Information website

Stellamune Once Emulsion for injection

Authorised
  • Mycoplasma hyopneumoniae, strain NL1042, Inactivated
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Product identification

Medicine name:
Stellamune Once Emulsion for injection
Active substance:
  • Mycoplasma hyopneumoniae, strain NL1042, Inactivated
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Mycoplasma hyopneumoniae, strain NL1042, Inactivated
    4.50
    log10 relative potency
    /
    1.00
    Dose
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:
  • Belgium
Available in:
  • Belgium
Package description:
  • (ID2) 500 Dose: Box (cardboard) with 10 Bottle (high-density polyethylene) each with 50 Dose, closed with Stopper (chlorobutyl rubber)
  • (ID3) 500 Dose: Box (cardboard) with 4 Bottle (high-density polyethylene) each with 125 Dose, closed with Stopper (chlorobutyl rubber)

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:
  • Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Syva S.A.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V239933
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0281/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Denmark
  • France
  • Greece
  • Iceland
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Portugal
  • Romania
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 24/10/2025
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Dutch (PDF)
Published on: 23/10/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 23/10/2025
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German (PDF)
Published on: 24/10/2025
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Dutch (PDF)
Published on: 24/10/2025
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Combined File of all Documents

English (PDF)
Published on: 13/02/2026
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Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 23/10/2025
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German (PDF)
Published on: 23/10/2025
Download
Dutch (PDF)
Published on: 23/10/2025
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