Bovilis

Main information

  • Trade name:
  • Bovilis IBR marker Live
  • Pharmaceutical form:
  • Suspension for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Bovilis IBR marker Live
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • bovine rhinotracheitis virus (IBR)
  • Therapeutic area:
  • Cattle

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0105/001
  • Authorization date:
  • 20-12-2011
  • EU code:
  • NL/V/0105/001
  • Last update:
  • 09-08-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

NL/V/0105/001/II/002Day90label-leaflet –10-5-2007ConcurrentUse

1/7

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

BovilisIBRMarkerLive

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Perdose(2ml):

BHV-1,strainGK/D(gE¯):10 5.7

-10 7.3

TCID

.

3. PHARMACEUTICALFORM

Lyophilisateforsuspensionfori.m.injection./intranasalapplication.

4. PACKAGESIZE

1,2,5,10,25,50or100doses/10x1,2,5,10,25,50or100doses

5. TARGETSPECIES

Cattle

6. INDICATION(S)

ActiveimmunisationagainstBHV-1infectionincattle

7. METHODANDROUTE(S)OFADMINISTRATION

I.M./intranasal

1doseof2ml.

Readthepackageleafletbeforeuse.(Thissentencewillonlybementionedonce)

8. WITHDRAWALPERIOD

Withdrawalperiod:zerodays

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.(Thissentencewillonlybementionedonce)

10. EXPIRYDATE

<EXP{month/year}>

Usewithin3hoursafterreconstitution.

NL/V/0105/001/II/002Day90label-leaflet –10-5-2007ConcurrentUse

2/7

11. SPECIALSTORAGECONDITIONS

Storeat2-8°Cinthedark

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Readthepackageleafletbeforeuse.(Thissentencewillonlybementionedonce)

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly

Subjecttomedicalprescription(tobereplacedbythenationalsymbol/abbreviation/text)

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

Thenationalrepresentativeof

IntervetInternationalB.V.

WimdeKörverstraat35

5831ANBoxmeer

TheNetherlands

16. MARKETINGAUTHORISATIONNUMBER(S)

<nationalnumber>

17. MANUFACTURER’SBATCHNUMBER

<Batch><Lot><BN>{number}

NL/V/0105/001/II/002Day90label-leaflet –10-5-2007ConcurrentUse

3/7

MINIMUMPARTICULARSTOAPPEARONIMMEDIATELABEL

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

BovilisIBRMarkerLive

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

BHV-1,strainGK/D(gE¯):10 5.7

-10 7.3

TCID

50 perdose(2ml)

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

1,2,5,10,25,50or100doses

4. ROUTE(S)OFADMINISTRATION

I.M./intranasal

5. WITHDRAWALPERIOD

Withdrawalperiod:zerodays

(notapplicableforMRP/DCP,accordingtotemplate)

6. BATCHNUMBER

<Batch><Lot><BN>{number}

7. EXPIRYDATE

<EXP{month/year}>

usewithin3hoursafterreconstitution

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

NL/V/0105/001/II/002Day90label-leaflet –10-5-2007ConcurrentUse

4/7

PACKAGELEAFLET

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder:

Thenationalrepresentativeof

IntervetInternationalB.V.

WimdeKörverstraat35

5831ANBoxmeer

TheNetherlands

Manufacturerresponsibleforbatchrelease:

IntervetInternationalB.V.

WimdeKörverstraat35

5831ANBoxmeer

TheNetherlands

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

BovilisIBRmarkerLive

Lyophilisateandsolventforsuspensionforintramuscularinjectionorintranasalapplication.

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Perdoseof2mlreconstitutedvaccine(pinkaqueoussuspension):

BovineHerpesVirus-1,strainGK/D(gE¯):10 5.7 -10 7.3 TCID

.

4. INDICATION(S)

Activeimmunisationofcattletoreducetheintensityanddurationoftheclinicalrespiratorysigns

inducedbyaninfectionwithBHV-1andtoreducenasalexcretionoffieldvirus.

Onsetofimmunity:

Anincreaseinimmunitywasdemonstrated4daysafterintranasalvaccinationand14daysafter

intramuscularvaccinationof3montholdseronegativeanimals.

Durationofimmunity:

Afterintranasaladministrationto2weekoldcalveswithoutmaternalantibodies,immunitylastsatleast

untiltheageof3-4months,whentheanimalsshouldberevaccinated.Inthepresenceofmaternally

derivedantibodies,theprotectionofthevaccinemaynotbecompleteuntilthisrevaccination.

Revaccinationat3-4monthsofageresultsinprotectiveimmunitythatlastsforatleast6months.

Singleintranasalorintramuscularvaccinationof3montholdanimalsprovidesprotectiveimmunity

(reductionofclinicalsignsandreductionofviralexcretion),whichwasdemonstratedviachallenge3

weeksaftervaccination.Reductionofviralexcretionismaintainedforatleast6monthsaftersingle

vaccination.

Noinformationisavailableontheefficacyofthevaccinetopreventalatentwildvirusinfectionorto

preventwildvirusre-excretioninthelatentcarrier.

NL/V/0105/001/II/002Day90label-leaflet –10-5-2007ConcurrentUse

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5. CONTRAINDICATIONS

Donotvaccinateunhealthyanimals.

6. ADVERSEREACTIONS

Aslighttransientriseintemperature(1

C)canoccurupto5dayspostvaccination.

Anincreaseofnasaldischargecanbeobservedafterintranasalvaccination.

At10-foldoverdose,noothereffectshavebeenobserved.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Cattle

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

ReconstitutethevaccinewiththesolventUnisolve

Numberofdosespervial Volume(ml)ofsolventneeded

1 2

2 4

5 10

10 20

25 50

50 100

100 200

Dosage:asingledoseof2mlreconstitutedvaccineperanimal

Methodofadministration:

-fromtheageof3monthsonward:intranasalorintramuscular.

-atanagebetween2weeksand3months:intranasal

Vaccinationschedule:

-Basicvaccination:

Vaccinateeachanimalwithonesingledose.

-Revaccination:

Whenthefirstvaccinationisgivenbetweentheageof2weeksand3months,theanimalsshouldbe

revaccinatedwithasingledoseattheageof3-4months.Afterwards,revaccinateevery6months.

Whenvaccinationisstartedaftertheanimalsare3monthsold,theanimalsshouldberevaccinatedwith

asingledoseevery6months.

9. ADVICEONCORRECTADMINISTRATION

Forintranasaladministration(1mlineachnostril),theuseofanozzleisrecommended.

Usesterilevaccinationequipmentfreefromdisinfectants.Topreventthespreadofanyinfective

agentstheintranasalequipmentshouldbechangedateachanimal.

NL/V/0105/001/II/002Day90label-leaflet –10-5-2007ConcurrentUse

6/7

10. WITHDRAWALPERIOD

Zerodays

11. SPECIALSTORAGEPRECAUTIONS

Freeze-driedvaccine:storeat2-8

Cinthedark.

Solvent:storebelow25

C

Vaccineafterreconstitution:storebelow25°C,usewithin3hours.

Donotuseaftertheexpirydatestatedonthelabel

Keepoutofthereachandsightofchildren.

12. SPECIALWARNING(S)

Thepresenceofmaternalantibodiescaninfluencetheefficacyofthevaccination.Thereforeitis

recommendedtoascertaintheimmunestatusofcalvesbeforevaccinationisstarted.

Animalsbetweentheageof2weeksand3monthsshouldbevaccinatedviatheintranasalrouteonly

andtheanimalsshouldberevaccinatedviatheintranasalorintramuscularroutewhentheanimalsare

3-4monthsold.

Afterintranasaladministration,thevaccinevirusmayspreadtoin-contactcattle.Cattlewhichneedto

remaintotallyfreefromBHV-1antibodiesshouldbeseparatedfromintranasallyvaccinatedanimals.

Canbeusedduringpregnancyandlactation.

Noinformationisavailableontheuseofthisvaccineinbreedingbulls.

Noinformationisavailableonthesafetyandefficacyfromtheconcurrentuseofthisvaccinewithany

other,except-incattlefrom3weeksofageonwards-withIntervetsinactivatedBovipastRSPvaccine

(wherethisproductisauthorised).Itisthereforerecommendedthatnoothervaccinesshouldbe

administeredwithin14daysbeforeandaftervaccinationwiththisproduct.

Onlyreconstitutewiththesolventsuppliedforusewiththeproduct.

Donotmixwithanyothervaccineorimmunologicalproduct.

Donotusetogetherwithimmunosuppressiveagents

Incaseofaccidentalselfinjection,seekmedicaladviceimmediatelyandshowthepackageleafletor

thelabeltothephysician.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIAL,IFANY

Disposeofwastematerialbyboiling,incineration,orimmersioninanappropriatedisinfectantin

accordancewithnationalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

4May2007

15. OTHERINFORMATION

NL/V/0105/001/II/002Day90label-leaflet –10-5-2007ConcurrentUse

7/7

Thevaccinestimulatesactiveimmunityagainstbovineherpesvirustype1(BHV-1).Thevaccinedoes

notelicitantibodiestoglycoproteinEofBHV-1(markervaccine).Thisenablesdiscriminationbetween

cattlevaccinatedwiththisproductandcattleinfectedwithBHV-1fieldvirusorvaccinatedwith

conventionalnon-markerBHV-1vaccines.

ATC-vetcode:QI02AD01,liveherpesvirusvaccine

Presentations:

Freeze-driedvaccine:

Cardboardboxwith1or10vialsofglass(hydrolytictypeI)withrubberstopperandmetalcap.

contentspervial:

1,2,5,10,25,50or100doses

Solvent:

Cardboardboxwith1or10vialsofglass(hydrolytictypeII)orplastic(polyethyleneterephthalate)

withrubberstopperandmetalcap.

contentspervial:

Glass: 2,4,10or20ml

GlassorPET: 50,100or200ml

Notallpacksizesmaybemarketed

1-12-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Trichoderma reesei (strain DP‐Nzd22)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Trichoderma reesei (strain DP‐Nzd22)

Published on: Fri, 30 Nov 2018 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with a genetically modified Trichoderma reesei (strain DP‐Nzd22) by DuPont. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The endo‐1,4‐β‐xylanase is intended to be used in distilled alcohol production, bakery and brewery. Residual amounts of total organic solids (TOS) are removed during the production of dis...

Europe - EFSA - European Food Safety Authority Publications

28-11-2018

EFSA Scientific Colloquium 24 – 'omics in risk assessment: state of the art and next steps

EFSA Scientific Colloquium 24 – 'omics in risk assessment: state of the art and next steps

Published on: Tue, 27 Nov 2018 In recent years, the development of innovative tools in genomics, transcriptomics, proteomics and metabolomics (designated collectively as 'omics technologies) has opened up new possibilities for applications in scientific research and led to the availability of vast amounts of analytical data. The interpretation and integration of 'omics data can provide valuable information on the functional status of an organism and on the effect of external factors such as stressors. T...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

Published on: Mon, 26 Nov 2018 Abstract In response to the EFSA call New approaches in identifying and characterizing microbial and chemical hazards, the project INNUENDO (https://sites.google.com/site/theinnuendoproject/) aimed to design an analytical platform and standard procedures for the use of whole‐genome sequencing in surveillance and outbreak investigation of food‐borne pathogens. The project firstly attempted to identify existing flaws and needs, and then to provide applicable cross‐sectorial ...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Published on: Fri, 16 Nov 2018 The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was e...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

FDA approves new drug to treat travelers’ diarrhea

FDA approves new drug to treat travelers’ diarrhea

FDA approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool.

FDA - U.S. Food and Drug Administration

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐a‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐OC by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels recommended, dietary exposure to the food enzyme–...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐SO by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme–total organi...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Published on: Wed, 14 Nov 2018 The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM‐JB by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organi...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Published on: Thu, 25 Oct 2018 00:00:00 +0200 A multi-country outbreak of 12 listeriosis cases caused by Listeria monocytogenes sequence type (ST) 8 has been identified through whole genome sequencing (WGS) analysis in three EU/EEA countries: Denmark (6 cases), Germany (5) and France (1). Four of these cases have died due to or with the disease. It is likely that the extent of this outbreak has been underestimated since the outbreak was identified through sequencing and only a subset of the EU/EEA count...

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Published on: Thu, 25 Oct 2018 00:00:00 +0200 The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the gen...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Published on: Thu, 27 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, France, for the pesticide active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Antimicrobial resistance (AMR) represents a major challenge for Public Health and the scientific community, and requires immediate and drastic solutions. Acquired resistance to certain antimicrobials is already widespread to such an extent that their efficacy in the treatment of certain life‐threatening infections is already compromised. To date, the emergence and spread of AMR has been attributed to the use, misuse or indiscriminate use of antibiotics as th...

Europe - EFSA - European Food Safety Authority Publications

1-10-2018

MS-H vaccine (Pharmsure Veterinary Products Europe Ltd)

MS-H vaccine (Pharmsure Veterinary Products Europe Ltd)

MS-H vaccine (Active substance: Mycoplasma synoviae Strain MS-H live attenuated thermosensitive) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6404 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/161/T/11

Europe -DG Health and Food Safety

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety

11-7-2018

ERYSENG (Laboratorios Hipra, S.A.)

ERYSENG (Laboratorios Hipra, S.A.)

ERYSENG (Active substance: Inactivated Erysipelothrix rhusiopathiae, strain R32E11) - Centralised - Yearly update - Commission Decision (2018)4523 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Hiprabovis IBR Marker Live (Laboratorios Hipra, S.A.)

Hiprabovis IBR Marker Live (Laboratorios Hipra, S.A.)

Hiprabovis IBR Marker Live (Active substance: Live gE- tk- double-gene deleted Bovine Herpes Virus type 1 (BoHV-1), strain CEDDEL) - Centralised - Yearly update - Commission Decision (2018)4520 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

4-7-2018

ERYSENG PARVO (Laboratorios Hipra, S.A.)

ERYSENG PARVO (Laboratorios Hipra, S.A.)

ERYSENG PARVO (Active substance: Inactivated porcine parvovirus, strain NADL-2 / Inactivated Erysipelothrix rhusiopathiae, strain R32E11) - Centralised - Yearly update - Commission Decision (2018) 4354 of Wed, 04 Jul 2018

Europe -DG Health and Food Safety

19-6-2018

Aftovaxpur Doe (Merial)

Aftovaxpur Doe (Merial)

Aftovaxpur Doe (Active substance: purified, inactivated foot-and-mouth disease virus strains O1 Manisa, O1 BFS, O Taiwan 3/97, A22 Iraq, A24 Cruzeiro, A Turkey 14/98, Asia 1 Shamir, SAT2 Saudi Arabia) - Centralised - Renewal - Commission Decision (2018)3891 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2292/R/8

Europe -DG Health and Food Safety