Veterinary Medicines

INGELVAC MYCOFLEX SUSPENSION FOR INJECTION FOR PIGS

Authorised
  • Mycoplasma hyopneumoniae, strain J, Inactivated
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Product identification

Medicine name:
INGELVAC MYCOFLEX SUSPENSION FOR INJECTION FOR PIGS
Ingelvac MycoFLEX Zawiesina do wstrzykiwań
Active substance:
  • Mycoplasma hyopneumoniae, strain J, Inactivated
Target species:
  • Pig (for fattening)
  • Pig (for reproduction)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Mycoplasma hyopneumoniae, strain J, Inactivated
    1.00
    enzyme-linked immunosorbent assay unit
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig (for fattening)
      • All relevant tissues
        0
        day
    • Pig (for reproduction)
      • All relevant tissues
        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:
  • Poland
Available in:
  • Poland
Package description:
  • Cardboard box with 1 high density polyethylene bottle of 10 ml (10 doses)
  • Cardboard box with 12 high density polyethylene TwistPak bottles of 250 ml (250 doses)
  • Cardboard box with12 high density polyethylene TwistPak bottles of 100 ml (100 doses)
  • Cardboard box with 12 high density polyethylene TwistPak bottles 50 ml (50 doses)
  • Cardboard box with 12 high density polyethylene TwistPak bottles of 10 ml (10 doses)
  • Cardboard box with 1 density polyethylene TwistPak bottle of 250 ml (250 doses in 250 ml) vaccine
  • Cardboard box with 1 density polyethylene TwistPak bottle of 100 ml (100 doses)
  • Cardboard box with 1 density polyethylene TwistPak bottle of 50 ml (50 doses)
  • Cardboard box with 1 density polyethylene TwistPak bottle of 10 ml (10 doses)
  • Cardboard box with 12 high density polyethylene bottles of 250 ml (250 doses)
  • Cardboard box with 12 high density polyethylene bottles of 100 ml (100 doses)
  • Cardboard box with 12 high density polyethylene bottles of 50 ml (50 doses)
  • Cardboard box with 12 high density polyethylene bottles of 10 ml (10 doses)
  • Cardboard box with 1 high density polyethylene bottle of 250 ml (250 doses)
  • Cardboard box with 1 high density polyethylene bottle of 100 ml (100 doses)
  • Cardboard box with 1 high density polyethylene bottle of 50 ml (50 doses)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Boehringer Ingelheim Vetmedica GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Boehringer Ingelheim Vetmedica GmbH
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 1910
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0203/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • 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.
Polish (PDF)
Published on: 5/05/2022
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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: 12/06/2023
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 12/06/2023
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