Pharmasin 200 mg/ml Solution for injection

Main information

  • Trade name:
  • Pharmasin 200mg/ml
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Pharmasin 200mg/ml
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • tylosin
  • Therapeutic area:
  • Cattle, Goats, Pigs, Sheep

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0239/001
  • Authorization date:
  • 21-12-2012
  • EU code:
  • FR/V/0239/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

[Version7.3.2,10/2011]

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PHARMASIN200mg/mlsolutionforinjectionforcattle,sheep,goatsandpigs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Tylosin200000IU/ml

Excipients:

Benzylalcohol(E1519) 40mg/ml.

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Apaleyellowtoamber-colouredliquid.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle,sheep,goats,pigs.

4.2 Indicationsforuse(specifyingthetargetspecies)

Infectionscausedmymicroorganismssusceptibletotylosin.

Cattle(adult):

- Treatmentofrespiratoryinfections,metritiscausedbyGram-positive

micro-organisms,mastitiscausedbyStreptococcusspp.,Staphylococcusspp.

orMycoplasmaandinterdigitalnecrobacillosis”,i.e.panaritumorfootrot.

Calves:

- Treatmentofrespiratoryinfectionsandnecrobacillosis.

Pigs:

- Treatmentofenzooticpneumonia,haemorrhagicenteritis,erysipelasand

metritis.

- TreatmentofarthritiscausedbyMycoplasmaandStaphylococcusspp.

Sheepandgoats:

Treatmentofrespiratoryinfections,metritiscausedbyGram-positive

microorganisms,mastitiscausedbyGram+microorganismsorMycoplasmaspp.

4.3 Contraindications

Donotadministertohorses.Intramuscularinjectioncanbefatalinchickensand

turkeys.

Donotadministertoanimalswithaknownhypersensitivitytotylosinorother

macrolides.

4.4 Specialwarnings(foreachtargetspecies)

None.

4.5 Specialprecautionsforuse

4.5i) Specialprecautionsforuseinanimals

Duetolikelyvariability(time,geographical)insusceptibilityofbacteriato

tylosin,bacteriologicalsamplingandsusceptibilitytestingare

recommended.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmay

increasetheprevalenceofbacteriaresistanttotylosinandmaydecreasethe

effectivenessoftreatmentwithothermacrolideantibioticsduetothe

potentialforcrossresistance

Whererepeatinjectionsaretobeadministered,usedifferentsitesforeach

injection.

4.5ii) Specialprecautionsforthepersonadministeringtheveterinary

medicinalproducttoanimals

Careshouldbetakentoavoidaccidentalself-injection.

Ifaccidentalself-injectionoccurs,seekmedicalattentionimmediately.

Intheeventofaccidentalskincontact,washthoroughlywithsoapand

water.Incaseofaccidentaleyecontact,flushtheeyeswithplentyofclean,

runningwater.

Washhandsafteruse.

Tylosinmayinduceirritation.Macrolides,suchastylosin,mayalsocause

hypersensitivity(allergy)followinginjection,inhalation,ingestionor

contactwithskinoreye.Hypersensitivitytotylosinmayleadtocross

reactionstoothermacrolidesandviceversa.Allergicreactionstothese

substancesmayoccasionallybeseriousandthereforedirectcontactshould

beavoided.

Donothandletheproductifyouareallergictoingredientsintheproduct.

Ifyoudevelopsymptomsfollowingexposure,suchasskinrash,youshould

seekmedicaladviceandshowthephysicianthiswarning.Swellingofthe

face,lipsandeyesordifficultyinbreathingaremoreserioussymptomsand

requireurgentmedicalattention.

4.6 Adversereactions(frequencyandseriousness)

Blemishesmayoccuratthesiteofinjectionandcanpersistforupto21days

followingadministration.

Possibleadversereactionsattributedtotheproductwhenusedasrecommended

andtheirfrequencyare:Inveryrarecasesthefollowinghavebeenobserved;

swelling/inflammationatthesiteofinjection,vulvularswellingincattle,oedema

oftherectalmucosa,partialanalprotrusion(‘rosebudding’),erythemaand

pruritusinpigs.Anaphylacticshockanddeath.

4.7 Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimalshavenotproducedanyevidenceofteratogenic,

foetotoxicormaternotoxiceffects.Nostudieshavebeenconductedinthetarget

species.Useonlyaccordingtothebenefit/riskassessmentbytheresponsible

veterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amount(s)tobeadministeredandadministrationroute

Intramuscularorslowintravenousinjection(onlyincattle)

Cattle:

5-10mgtylosin/kgbodyweightperdayduring3days(2,5to5mlsolutionfor

injectionper100kgbodyweight)Maximuminjectionvolumeperinjectionsite

shouldnotexceed15ml.

Sheepandgoats:

10mgtylosin/kgbodyweightperdayduring3days(5mlsolutionforinjection

per100kgbodyweight)

Pigs:

5-10mgtylosin/kgbodyweightperdayduring3days(2,5to5mlsolutionfor

injectionper100kgbodyweight)

Theclosuresshouldnotbebroachedmorethan15times.Inordertoprevent

excessivebroachingofthestopper,asuitablemultipledosingdeviceshouldbe

used.

Toensureacorrectdosage,bodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

4.10 Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Inpigsandcalvesanintramuscularinjectionof30mg/kgperdayduring5

consecutive

daysproducednoadverseeffects.

4.11 Withdrawalperiod(s)

Cattle

Meatandoffal:28days.

Milk:108hours.

Sheepandgoats:

Meatandoffal:42days.

Milk:108hours

Pigs:

Meatandoffal:14days.

5. PHARMACOLOGICALORIMMUNOLOGICALPROPERTIES

ATCVetCode:

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,macrolides,tylosin

ATCvetcode:QJ01FA90

5.1 Pharmacodynamicproperties

TylosinisamacrolideantibioticwithapKaof7.1.Tylosinisstructurallysimilarto

erythromycin.ItisproducedbyStreptomycesfradiae.Tylosinhasalowsolublilityin

water.Tylosinexertsitsantibioticactivitybyasimilarmechanismtoother

macrolides,i.e.bybindingthe50Sfractionoftheribosomesresulting,inan

inhibitionofthesynthesisofproteins.Tylosinhasmainlyabacteriostaticactivity.

TylosinhasanantibioticeffectagainstGrampositivecocci(Staphylococci,

Streptococci),Grampositivebacilli(Arcanobacteriumspp.,Clostridiumspp.,

Erysipelothrix,Actinomyces),certainGram-negativebacilles(Haemophilusspp.,

Pasteurellaspp.,Mannheimiaspp.)andMycoplasma.Theantibioticspectrumof

tylosincoversthemajorityofmicroorganismresponsibleforprimaryinfectionsin

younglivestock.

5.2 Pharmacokineticproperties

Absorption:

Followingintramuscularinjectionthetylosinconcentrationreachesitsmaximum

at3-4hoursfollowingadministration.

Distribution:

Themaximumconcentrationinmilkofcattleandsowsis3-6timeshigherthanthe

bloodconcentrationabout6hoursfollowinginjection.Inbovineandporcinelungs

maximumtylosinconcentrationsof7-8timeshigherthanthemaximum

concentrationsinserumwerefoundat6-24hoursfollowingintramuscular

injection.Incattle(whetherinheatornot)theMeanResidenceTime(MRT)in

uterussecretionsoftylosininjectedbyintravenousrouteatadoserateof10

mg/kgwasabout6-7timeshigherthantheonemeasuredinserum.This

illustratesthatinuterinesecretionsasingletylosininjectionatadoserateof10

mg/kgduring24hourscanresultinconcentrationsexceedingtheMIC

oftylosinforArcanobacteriumpyogenes,oneofthepathogensfrequentlyisolated

whenmetritisisdiagnosedincattle.

Elimination:

Tylosiniseliminatedinunchangedforminbileandurine.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Benzylalcohol(E1519)

Propyleneglycol

Waterforinjections

6.2 Incompatibilities

Inabsenceofcompatibilitystudiesthisveterinaryproductmustnotbemixedwith

otherveterinarymedicinalproducts.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:18months.

Shelflifeafterfirstopeningoftheimmediatepackaging:28days.Discardany

productremaininginthecontaineratthistime.

6.4 Specialprecautionsforstorage

Protectfromlight.Storeintheoriginalcontainer.Donotstoreabove25°C.

Donotfreeze.

6.5 Natureandcompositionofimmediatepackaging

Theproductispresentedin50ml,100mlor250mlTypeIIcolourlessglassvials,

sealedwithabromobutylstopperandaluminiumcapsuppliedinacarton.One

vialpercarton.

Notallpacksizesmaybemarketed

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7.1 MARKETINGAUTHORISATIONHOLDER

HuvepharmaN.V.

Uitbreidingsstraat80

2600Antwerpen

Belgium

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10. DATEOFREVISIONOFTHETEXT

ANNEXIII

LABELLINGANDPACKAGELEAFLET

A.LABELLING

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

50/100/250mlglassvial

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PHARMASIN200mg/mlsolutionforinjectionforcattle,sheep,goatsandpigs

Tylosin

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Activesubstance:

Tylosin200000IU/ml

Excipients:

Benzylalcohol(E1519) 40mg/ml.

3. PHARMACEUTICALFORM

Solutionforinjection.

4. PACKAGESIZE

50(100and250ml)

5. TARGETSPECIES

Cattle,sheep,goats,pigs.

6. INDICATION(S)

Readthepackageleafletbeforeuse

7. METHODANDROUTE(S)OFADMINISTRATION

Forintramuscularorintravenous(cattleonly)use

Readthepackageleafletbeforeuse

8. WITHDRAWALPERIOD

Meatandoffal:

Cattle:28days

Sheepandgoats:42days

Pigs:14days

Milk:108hours

9. SPECIALWARNING(S),IFNECESSARY

Seepackageleafletbeforeuse.

10.EXPIRYDATE

EXP{month/year}

Oncebroachedusewithin28days.Discardanyproductremaininginthecontaineratthis

time.

Onceopened,useby

11.SPECIALSTORAGECONDITIONS

Protectfromlight.Storeintheoriginalcontainer.Donotstoreabove25 C.Donot

freeze.

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Seepackageleaflet.

13.THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.Tobesuppliedonlyonveterinaryprescription.

14.THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

HuvepharmaNV

Uitbreidingstraat80

2600Antwerpen

Belgium

Tel:+3232881849

Fax:+3232897845

E-mail: customerservice@huvepharma.com

16.MARKETINGAUTHORISATIONNUMBER(S)

17.MANUFACTURER’SBATCHNUMBER

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

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

50/100/250mlglassvial

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PHARMASIN200mg/mlsolutionforinjectionforcattle,sheep,goatsandpigs

Tylosin

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Activesubstance:

Tylosin200000IU/ml

Excipients:

Benzylalcohol(E1519) 40mg/ml.

3. PHARMACEUTICALFORM

Solutionforinjection.

4. PACKAGESIZE

50(100and250ml)

5. TARGETSPECIES

Cattle,sheep,goats,pigs.

6. INDICATION(S)

Readthepackageleafletbeforeuse

7. METHODANDROUTE(S)OFADMINISTRATION

Forintramuscularorintravenous(cattleonly)use

Readthepackageleafletbeforeuse

8. WITHDRAWALPERIOD

Meatandoffal:

Cattle:28days

Sheepandgoats:42days

Pigs:14days

Milk:108hours

9. SPECIALWARNING(S),IFNECESSARY

Seepackageleafletbeforeuse.

10.EXPIRYDATE

EXP{month/year}

Oncebroachedusewithin28days.Discardanyproductremaininginthecontaineratthis

time.

Onceopened,useby

11.SPECIALSTORAGECONDITIONS

Protectfromlight.Storeintheoriginalcontainer.Donotstoreabove25 C.Donotfreeze

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Seepackageleaflet.

13.THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.Tobesuppliedonlyonveterinaryprescription.

14.THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

HuvepharmaNV

Uitbreidingstraat80

2600Antwerpen

Belgium

Tel:+3232881849

Fax:+3232897845

E-mail: customerservice@huvepharma.com

16.MARKETINGAUTHORISATIONNUMBER(S)

17.MANUFACTURER’SBATCHNUMBER

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

B.PACKAGELEAFLET

PACKAGELEAFLET

PHARMASIN200mg/mlSolutionforInjectionforcattle,sheep,goatsandpigs

tylosin

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

AND OF THE MANUFACTURING AUTHORISATION HOLDER

RESPONSIBLEFORBATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder

HuvepharmaNV,Uitbreidingstraat80,2600Antwerpen,Belgium

Manufacturer

BiovetJSC,39PetarRakovStr,4550Peshtera-Bulgaria

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PHARMASIN200mg/mlsolutionforinjectionforcattle,sheep,goatsandpigs.

tylosin

3. STATEMENT OF THE ACTIVESUBSTANCE(S)ANDOTHER

INGREDIENT(S)

Activesubstance:

Tylosin200000IU/ml

Excipients:

Benzylalcohol(E1519) 40mg/ml.

Apaleyellowtoamber-colouredliquid.

4. INDICATION(S)

Infectionscausedbymicroorganismssusceptibletotylosin.

Cattle(adult):

- Treatmentofrespiratoryinfections,metritiscausedbyGram-positivemicro-

organisms,mastitiscausedbyStreptococcusspp.,Staphylococcusspp.orMycoplasma

andinterdigitalnecrobacillosis”,i.e.panaritumorfootrot..

Calves:

- Treatmentofrespiratoryinfectionsandnecrobacillosis.

Pigs:

- Treatmentofenzooticpneumonia,haemorrhagicenteritis,erysipelasandmetritis.

- TreatmentofarthritiscausedbyMycoplasmaandStaphylococcusspp.

Sheepandgoats:

- Treatmentofrespiratoryinfections,metritiscausedbyGram-positive

microorganisms,mastitiscausedbyGram+microorganismsorMycoplasmaspp.

5. CONTRAINDICATIONS

Donotadministertohorses.Intramuscularinjectioncanbefatalinchickensandturkeys.

Donotadministertoanimalswithaknownhypersensitivitytotylosinorothermacrolides.

6. ADVERSEREACTIONS

Blemishesmayoccuratthesiteofinjectionandcanpersistforupto21daysfollowing

administration.

Possibleadversereactionsattributedtotheproductwhenusedasrecommendedandtheir

frequencyare:Inveryrarecasesthefollowinghavebeenobserved;swelling/inflammation

atthesiteofinjection,vulvularswellingincattle,oedemaoftherectalmucosa,partialanal

protrusion(‘rosebudding’),erythemaandpruritusinpigs.Anaphylacticshockanddeath.

7. TARGETSPECIES

Cattle,sheep,goats,pigs.

8. DOSAGE FOR EACH SPECIES, ROUTE(S)ANDMETHODOF

ADMINISTRATION

Amount(s)tobeadministeredandadministrationroute

Intramuscularorslowintravenousinjection(onlyincattle)

Cattle:

5-10mgtylosin/kgbodyweightperdayduring3days(2,5to5mlsolutionforinjection

per100kgbodyweight.Maximuminjectionvolumeperinjectionsiteshouldnotexceed15

ml.

Sheepandgoats:

10mgtylosin/kgbodyweightperdayduring3days(5mlsolutionforinjectionper100kg

bodyweight.

Pigs:

5-10mgtylosin/kgbodyweightperdayduring3days(2,5to5mlsolutionforinjection

per100kgbodyweight.

Toensureacorrectdosage,bodyweightshouldbedeterminedasaccuratelyaspossibleto

avoidunderdosing.

9. ADVICEONCORRECTADMINISTRATION

Theclosuresshouldnotbebroachedmorethan15times.Inordertopreventexcessive

broachingofthestopper,asuitablemultipledosingdeviceshouldbeused.

10. WITHDRAWALPERIOD

Cattle:

Meatandoffal:28days.

Milk:108hours.

Sheepandgoats:

Meatandoffal:42days.

Milk:108hours

Pigs:

Meatandoffal:14days.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Shelflifeafterfirstopeningtheimmediatepackaging:28days.Discardanyproduct

remaininginthecontaineratthistime

Protectfromlight.Storeintheoriginalcontainer.Donotstoreabove25°C.Donotfreeze.

Donotuseaftertheexpirydatestatedonthelabel.

12. SPECIALWARNING(S)

None.

Specialprecautionsforuseinanimals

Duetolikelyvariability(time,geographical)insusceptibilityofbacteriatotylosin,

bacteriologicalsamplingandsusceptibilitytestingarerecommended.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincreasethe

prevalenceofbacteriaresistanttotylosinandmaydecreasetheeffectivenessoftreatment

withothermacrolideantibioticsduetothepotentialforcrossresistance

Whererepeatinjectionsaretobeadministered,usedifferentsitesforeachinjection.

Specialprecautionsforthepersonadministeringtheveterinarymedicinalproductto

animals

Careshouldbetakentoavoidaccidentalself-injection.

Ifaccidentalself-injectionoccurs,seekmedicalattentionimmediately.

Intheeventofaccidentalskincontact,washthoroughlywithsoapandwater.Incaseof

accidentaleyecontact,flushtheeyeswithplentyofclean,runningwater.

Washhandsafteruse.

Tylosinmayinduceirritation.Macrolides,suchastylosin,mayalsocausehypersensitivity

(allergy)followinginjection,inhalation,ingestionorcontactwithskinoreye.

Hypersensitivitytotylosinmayleadtocrossreactionstoothermacrolidesandviceversa.

Allergicreactionstothesesubstancesmayoccasionallybeseriousandthereforedirect

contactshouldbeavoided.

Donothandletheproductifyouareallergictoingredientsintheproduct.

Ifyoudevelopsymptomsfollowingexposure,suchasskinrash,youshouldseekmedical

adviceandshowthephysicianthiswarning.Swellingoftheface,lipsandeyesor

difficultyinbreathingaremoreserioussymptomsandrequireurgentmedicalattention.

Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimalshavenotproducedanyevidenceofteratogenic,foetotoxicor

maternotoxiceffects.Nostudieshavebeenconductedinthetargetspecies.Useonly

accordingtothebenefit/riskassessmentbytheresponsibleveterinarian.

Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Inpigsandcalvesanintramuscularinjectionof30mg/kgperdayduring5consecutive

daysproducednoadverseeffects.

Incompatibilities

Inabsenceofcompatibilitystudiesthisveterinaryproductcannotbemixedwithother

veterinarymedicinalproducts.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Theproductispresentedin50,100or250mlTypeIIcolourlessglassvials,sealedwitha

bromobutylstopperandaluminiumcapsuppliedinacarton.Onevialpercarton.

Notallpacksizesmaybemarketed.

Foranyinformationaboutthisveterinarymedicinalproduct,pleasecontactthelocal

representativeofthemarketingauthorisationholder.

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Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 26 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Modification of the existing maximum residue level for flonicamid in various crops

Modification of the existing maximum residue level for flonicamid in various crops

Published on: Tue, 25 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Ne...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge is voluntarily initiating a Worldwide recall involving a field correction of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp., for a potential interruption and/or inability to start therapy to the patient regarding the use of certain Intra-Aortic Balloons (IABs) prior to or during the use with Cardiosave IABP for users who are at altitudes above 3200 feet/975 meters. This condition could potentially lead to patient hemodynamic instability.

FDA - U.S. Food and Drug Administration

13-9-2018

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 12 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for sintofen according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for sintofen according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 28 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sintofen. To assess the occurrence of sintofen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 27 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance prochloraz. To assess the occurrence of prochloraz residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for napropamide according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for napropamide according to Article 12 of Regulation (EC) No 396/2005

Published on: Fri, 24 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Published on: Mon, 20 Aug 2018 00:00:00 +0200 Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for myclobutanil according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for myclobutanil according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 13 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance myclobutanil. To assess the occurrence of myclobutanil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Com...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

17-7-2018

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Volgend jaar worden zo’n 650.000 kinderen extra opgeroepen om zich te laten inenten tegen de zeer ernstige infectieziekte meningokokken. Het gaat om kinderen die zijn geboren na 1 januari 2001 en voor mei 2004. Dat laat staatssecretaris Paul Blokhuis (VWS) weten in een brief aan de Tweede Kamer. Reden voor deze maatregel is dat in de afgelopen jaren een stijging te zien is van het aantal mensen dat de infectie meningokokken type W oploopt. Met deze extra vaccinatieronde moet die groei worden ingedamd. He...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

13-7-2018

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira, Inc., a Pfizer company, is voluntarily recalling 8 lots of Hospira’s Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial (NDC 0409-0106-01) to the Hospital/Retail level. The product is being recalled due to adverse event reports indicative of infusion reactions.

FDA - U.S. Food and Drug Administration

29-3-2007

New reimbursement status of lipid lowering medicinal products enters into force on 23 April 2007

New reimbursement status of lipid lowering medicinal products enters into force on 23 April 2007

As of 23 April 2007, the reimbursement status of lipid lowering medicinal products will be changed. The decision includes all lipid lowering medicinal products with marketing authorisations in Denmark on 15 March 2007.

Danish Medicines Agency

26-11-2018

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient https://go.usa.gov/xPHdE 

FDA - U.S. Food and Drug Administration

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration

17-9-2018

Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency

18-4-2018

EU/3/18/2009 (SOTIO a.s)

EU/3/18/2009 (SOTIO a.s)

EU/3/18/2009 (Active substance: Autologous dendritic cells pulsed with killed ovarian cancer cells and matured by TLR3 ligand ex vivo) - Orphan designation - Commission Decision (2018)2405 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/246/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (Active substance: Adeno-associated viral vector serotype 9 encoding miRNA against human superoxide dismutase 1) - Orphan designation - Commission Decision (2018)2404 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/254/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Active substance: Adeno-associated viral vector serotype 8 containing the human acid alpha-glucosidase gene) - Orphan designation - Commission Decision (2018)2403 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/255/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2005 (IQVIA RDS Ireland Limited)

EU/3/18/2005 (IQVIA RDS Ireland Limited)

EU/3/18/2005 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1893 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/222/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2004 (IQVIA RDS Ireland Limited)

EU/3/18/2004 (IQVIA RDS Ireland Limited)

EU/3/18/2004 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1892 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/217/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1891 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/225/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1890 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/224/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2001 (Soligenix UK Ltd)

EU/3/18/2001 (Soligenix UK Ltd)

EU/3/18/2001 (Active substance: Recombinant modified ricin toxin A-chain subunit) - Orphan designation - Commission Decision (2018)1889 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/242/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2006 (IQVIA RDS Ireland Limited)

EU/3/18/2006 (IQVIA RDS Ireland Limited)

EU/3/18/2006 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1894 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/234/17

Europe -DG Health and Food Safety