Veterinary Medicine 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:
  • Denmark
Available in:
  • Denmark
Package description:
  • (ID3) 500 Dose: Box (cardboard) with 4 Bottle (high-density polyethylene) each with 125 Dose, closed with Stopper (chlorobutyl rubber)
  • (ID2) 500 Dose: Box (cardboard) with 10 Bottle (high-density polyethylene) each with 50 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:
  • Danish Medicines Agency
Authorisation number:
  • 33493
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.
Danish (, INJEKTIONSVÆSKE, EMULSION)
Published on: 7/04/2025
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Combined File of all Documents

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