Veterinary Medicines

Stellamune Once Emulsion for injection

Authorised
  • Mycoplasma hyopneumoniae, strain NL1042, Inactivated
Download as PDF

Product identification

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

Product details

Active substance and strength:
  • Mycoplasma hyopneumoniae, strain NL1042, Inactivated
    0.72
    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
    • Pigs (for fattening)
      • Meat and offal
        0
        day
    • Pig (sucking 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:
  • Portugal
Available in:
  • Portugal
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)
  • (ID1): 1 Box with 10 Bottles (High Density PolyEthylene) with 20 millilitre(s), 10 ID (200 millilitre(s), 100 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.U.
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • R702/02 DGV
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
  • Ireland
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Portugal
  • Romania
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 10/02/2022
Download

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Portuguese (PDF)
Published on: 19/01/2023
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."