Veterinary Medicines

MASTIBIOVAC Zawiesina do wstrzykiwań

Authorised
  • Streptococcus agalactiae, Inactivated
  • Streptococcus dysgalactiae subsp. dysgalactiae, Inactivated
  • Streptococcus uberis, Inactivated
  • STREPTOCOCCUS PYOGENES
  • STAPHYLOCOCCUS AUREUS
  • Trueperella pyogenes, Inactivated
  • Escherichia coli, serotype O111, strain J5, Inactivated
  • Escherichia coli, strain BOV-10, Inactivated
  • Escherichia coli, serotype K99 (fimbrial adhesin F41), strain BOV-14, Inactivated
  • Escherichia coli, strain BOV-15, Inactivated
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Product identification

Medicine name:
MASTIBIOVAC Zawiesina do wstrzykiwań
Active substance:
  • Streptococcus agalactiae, Inactivated
  • Streptococcus dysgalactiae subsp. dysgalactiae, Inactivated
  • Streptococcus uberis, Inactivated
  • STREPTOCOCCUS PYOGENES
  • STAPHYLOCOCCUS AUREUS
  • Trueperella pyogenes, Inactivated
  • Escherichia coli, serotype O111, strain J5, Inactivated
  • Escherichia coli, strain BOV-10, Inactivated
  • Escherichia coli, serotype K99 (fimbrial adhesin F41), strain BOV-14, Inactivated
  • Escherichia coli, strain BOV-15, Inactivated
Target species:
  • Cattle
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Streptococcus agalactiae, Inactivated
    1.00
    millilitre(s)
    /
    5.00
    millilitre(s)
  • Streptococcus dysgalactiae subsp. dysgalactiae, Inactivated
    1.00
    millilitre(s)
    /
    5.00
    millilitre(s)
  • Streptococcus uberis, Inactivated
    1.00
    relative potency
    /
    5.00
    millilitre(s)
  • STREPTOCOCCUS PYOGENES
    1.00
    millilitre(s)
    /
    5.00
    millilitre(s)
  • STAPHYLOCOCCUS AUREUS
    1.00
    relative potency
    /
    5.00
    millilitre(s)
  • Trueperella pyogenes, Inactivated
    1.00
    relative potency
    /
    5.00
    millilitre(s)
  • Escherichia coli, serotype O111, strain J5, Inactivated
    1.00
    relative potency
    /
    5.00
    millilitre(s)
  • Escherichia coli, strain BOV-10, Inactivated
    1.00
    relative potency
    /
    5.00
    millilitre(s)
  • Escherichia coli, serotype K99 (fimbrial adhesin F41), strain BOV-14, Inactivated
    1.00
    relative potency
    /
    5.00
    millilitre(s)
  • Escherichia coli, strain BOV-15, Inactivated
    1.00
    relative potency
    /
    5.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AB
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Biowet Drwalew Sp. z o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Drwalewskie Zaklady Przemyslu Bioweterynaryjnego S.A.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2153
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Polish (PDF)
Published on: 4/02/2022
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Labelling

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Polish (PDF)
Published on: 4/02/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
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