Veterinary Medicines

Stellamune Once Emulsion for injection

Authorised
  • Mycoplasma hyopneumoniae, strain NL1042, Inactivated
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Product identification

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

Product details

Active substance and strength:
  • Mycoplasma hyopneumoniae, strain NL1042, Inactivated
    4.50
    log10 enzyme-linked immunosorbent assay unit
    /
    2.00
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        0
        day
    • Pig (for fattening)
      • Meat and offal
        0
        day
    • Pig (suckling piglet)
      • 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:
  • Germany
Available in:
  • Germany
Package description:
  • (ID3): 1 Box with 4 Bottle (High Density PolyEthylene) with 250 millilitre(s), 125 ID (1000 millilitre(s), 500 ID)
  • (ID2): 1 Box with 10 Bottle (High Density PolyEthylene) with 100 millilitre(s), 50 ID (1000 millilitre(s), 500 ID)

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:
  • Zoetis Belgium
  • Laboratorios Syva S.A.
Responsible authority:
  • Paul-Ehrlich-Institut
Authorisation number:
  • PEI.V.02633.01.1
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

Combined File of all Documents

English (PDF)
Published on: 6/08/2024
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German (PDF)
Published on: 6/08/2024
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