Pharmasin 2% Oral Granules

Main information

  • Trade name:
  • Pharmasin 2% Oral Granules
  • Pharmaceutical form:
  • Granules
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Pharmasin 2% Oral Granules
    Austria
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • tylosin
  • Therapeutic area:
  • Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0129/001
  • Authorization date:
  • 28-04-2011
  • EU code:
  • NL/V/0129/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PHARMASIN 20mg/gOralGranulesforpigs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Tylosin(astylosinphosphate):20mgperg(equivalentto20000IU)

Forafulllistofexcipientsseesection6.1

3. PHARMACEUTICALFORM

Granules

Lighttancoloured,freeflowinggranules.

4. CLINICALPARTICULARS

4.1 Targetspecies

Pigs.

4.2 Indicationsforuse(specifyingthetargetspecies)

Pigs:Treatmentandpreventionofclinicalsignsofporcineproliferativeenteritis(porcine

intestinaladenomatosis,proliferativehemorrhagicenteropathy,ileitis)associatedwith

Lawsoniaintracellulariswhenthediseasehasbeendiagnosedatthegrouplevel.

4.3 Contraindications

Donotuseinanimalswithknownhypersensitivitytotheactivesubstanceand/ortoanyof

theexcipientsoftheproduct.

Donotuseinanimalswithknownhypersensitivitytotylosinandothermacrolides.

Donotusewherecross-resistancetoothermacrolides(MLSresistance)issuspected.

Donotuseinanimalsvaccinatedwithtylosin-sensitivevaccineseitheratthesametimeor

within1weekpreviously.

Donotuseinanimalswithhepaticdisorders.

Donotuseinhorses–dangerofinflammationofthececum.

4.4 Specialwarnings(foreachtargetspecies)

None.

4.5 Specialprecautionsforuse

4.5.1 Specialprecautionsforuseinanimals

Thisproductisonlyforadministrationinsmallquantitiesoffeedforimmediate

consumption,toindividualanimals.Animalswithacuteinfectionsmayhavea

reducedfeedintakeandshouldbetreatedwithasuitableinjectableproductfirst.The

sensitivityofbacteriatotylosinmayhavechangedovertimeorgeographically.Itis

soundclinicalpracticetobasetreatmentonsusceptibilitytesting.

4.5.2 Specialprecautionsforthepersonadministeringtheveterinarymedicinalproductto

animals

Tylosinmayinduceirritation.Macrolides,suchatylosin,mayalsocause

hypersensitivity(allergy)followinginjection,inhalation,ingestionorcontactwith

skinoreye.Hypersensitivitytotylosinmayleadtocrossreactionstoother

macrolidesandviceversa.Allergicreactionstothesesubstancesmayoccasionally

beseriousandthereforedirectcontactshouldbeavoided.

Toavoidexposureduringmixingandhandlingoftheveterinarymedicinalproduct

wearsafetyglasses,imperviousgloves,andweareitheradisposablehalfmask

respiratorconformingtoEuropeanStandardEN149oranon-disposablerespiratorto

EuropeanStandardEN140withafiltertoEN143.Washhandsafteruse.

Intheeventofaccidentalskincontact,washthoroughlywithsoapandwater.Incase

ofaccidentaleyecontact,flushtheeyeswithplentyofclean,runningwater.

Donothandletheproductifyouareallergictoingredientsintheproduct.

Ifyoudevelopsymptomsfollowingexposure,suchasskinrash,youshouldseek

medicaladviceandshowthephysicianthiswarning.Swellingoftheface,lipsand

eyesordifficultyinbreathingaremoreserioussymptomsandrequireurgentmedical

attention.

4.6 Adversereactions(frequencyandseriousness)

Inpigs,adversereactionshavebeenobserved,includingdiarrhoea,pruritus,erythema,rectal

oedemaandprolapse.

4.7 Useduringpregnancy,lactationorlay

Noadverseeffectstotylosinhavebeenseeninfertility,multi-generationteratologystudies.

Useonlyaccordingtothebenefit/riskassessmentbytheresponsibleveterinarian

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Lincosamidesandaminoglycosideantibioticsantagonizetheactivityoftylosin.

4.9 Amount(s)tobeadministeredandadministrationroute

Foruseinindividualpigsonfarmswhereonlyasmallnumberofpigsaretoreceivethe

medicine.Largergroupsshouldbetreatedwithmedicatedfeedingstuffcontainingthe

premix.

Individualpigsshouldreceive5mgtylosinperkgbodyweight,correspondingto250mg

Pharmasin2%OralGranules/kgbodyweight,onceadayfor3weeks.Thisisachievedby

thoroughlymixingtheproductintothedailyrationforeachindividualpig.Therequired

amountofproductshouldbeaddedtotheestimatedquantityofdailyrationforeachpigina

bucketorsimilarreceptacleandthoroughlymixed.Theproductshouldonlybeaddedtodry

non-pelletedfeed.

Thepigtobetreatedshouldbeweighedtopreventunderdosing.

Shouldtherebenoclearresponsetotreatmentwithin3daysthetreatmentapproachshould

bereconsidered.

4.10 Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Theproducthasbeenshowntoproducenoadverseeffectswhenfedtopigsat600ppmin

thefeed(threetosixtimestherecommendeddoselevel)for28days.Athighlevels

diarrhoea,apathy,convulsionsmayoccur.Thetherapyissymptomatic

4.11 Withdrawalperiod(s)

Pigs(meat)–1day

5. PHARMACOLOGICALORIMMUNOLOGICALPROPERTIES

ATCVetCode:

Pharmacotherapeuticgroup:macrolideantibiotic,ATCvetcode:QJ01FA90

5.1 Pharmacodynamicproperties

TylosinisamacrolideantibioticproducedbyastrainofStreptomycesfradiae.Itexertsits

antimicrobialeffectbyinhibitingproteinsynthesisofsusceptiblemicro-organisms.

ThetylosinspectrumofactivityincludesGram-positivebacteria,someGram–negative

strainssuchasPasteurella,andMycoplasmaspp..

5.2 Pharmacokineticproperties

Absorption:tylosinreachesmaximalbloodlevelsbetween1and3hoursafteranoraldose.

Distribution:afteroraldosesweregiventopigs,tylosinwasfoundinalltissuesbetween30

minutesand2hoursafteradministration,exceptforthebrainandspinalcord.Comparedto

plasmalevelsclearlyhighertissueconcentrationshavebeenobserved.

Metabolismandexcretion:mostofthematerialexcretedthroughthefaecesconsistsof

tylosin(factorA),relomycine(factorD)anddihydrodesmycosin.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Wheatmeal

Dipotassiumphosphate

Pregelatinisedstarch(potato)

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixed

withotherveterinarymedicinalproducts.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:3months.

6.4 Specialprecautionsforstorage

Storeinadryplace.Storebelow30°C.Donotrefrigerateorfreeze.Protectfromfrost.Store

intheoriginalcontainerinordertoprotectfromlight.

6.5 Natureandcompositionofimmediatepackaging

1kgand5kgLDPEinouterpaperbagwithsuturedcrimp.

Notallpacksizemaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinaryproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7.1 MARKETINGAUTHORISATIONHOLDER

HuvepharmaNV

Uitbreidingstraat80

2600Antwerpen

Belgium

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10. DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

LABEL

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PHARMASIN20mg/gOralGranulesforpigs

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Tylosin(astylosinphosphate):20mgperg.(equivalentto20000IU)

3. PHARMACEUTICALFORM

Granules

4. PACKAGESIZE

1kgand5kgHDPEinanouterpaperbagwithsuturedcrimp.

5. TARGETSPECIES

Pigs.

6. INDICATION(S)

Seepackageleaflet.

7. METHODANDROUTE(S)OFADMINISTRATION

Oraladministrationtotheindividualpig.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Pigs(meat):1day

9. SPECIALWARNING(S),IFNECESSARY

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

UserWarnings:

Tylosinmayinduceirritation.Macrolides,suchatylosin,mayalsocausehypersensitivity(allergy)

followinginjection,inhalation,ingestionorcontactwithskinoreye.Hypersensitivitytotylosinmay

leadtocrossreactionstoothermacrolidesandviceversa.Allergicreactionstothesesubstancesmay

occasionallybeseriousandthereforedirectcontactshouldbeavoided.

Toavoidexposureduringmixingandhandlingoftheveterinarymedicinalproductwearsafety

glasses,imperviousgloves,andweareitheradisposablehalfmaskrespiratorconformingtoEuropean

StandardEN149oranon-disposablerespiratortoEuropeanStandardEN140withafiltertoEN143.

Washhandsafteruse.

Intheeventofaccidentalskincontact,washthoroughlywithsoapandwater.Incaseofaccidentaleye

contact,flushtheeyeswithplentyofclean,runningwater.

Donothandletheproductifyouareallergictoingredientsintheproduct.

Ifyoudevelopsymptomsfollowingexposure,suchasskinrash,youshouldseekmedicaladviceand

showthephysicianthiswarning.Swellingoftheface,lipsandeyesordifficultyinbreathingaremore

serioussymptomsandrequireurgentmedicalattention.

10. EXPIRYDATE

<EXP{month/year}>

11. SPECIALSTORAGECONDITIONS

Storeinadryplace.Storebelow30°C.Donotrefrigerateorfreeze.Protectfromfrost.Storeinthe

originalcontainerinordertoprotectfromlight.

Shelf-lifeafterfirstopeningtheimmediatepackaging:3months.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedveterinaryproductorwastematerialsderivedfromsuchveterinarymedicinalproducts

shouldbedisposedofinaccordancewithlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

HuvepharmaNV

Uitbreidingstraat80

2600Antwerpen

Belgium

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

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

PACKAGELEAFLET

PHARMASIN

20mg/gOralGranulesforpigs

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOF

THEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCH

RELEASE,IFDIFFERENT

Marketingauthorisation

HuvepharmaNV,Uitbreidingstraat80,2600Antwerpen,Belgium

Manufacturer

BiovetJSC,39PetarRakovStr,4550Peshtera-Bulgaria

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PHARMASIN 20mg/gOralGranulesforpigs

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Tylosin(astylosinphosphate):20mgperg(equivalentto20000IU).

Lighttancoloured,freeflowinggranules.

4. INDICATION(S)

Pigs:Treatmentandpreventionofclinicalsignsofporcineproliferativeenteritis(porcineintestinal

adenomatosis,proliferativehemorrhagicenteropathy,ileitis)associatedwithLawsoniaintracellularis

whenthediseasehasbeendiagnosedatthegrouplevel

5. CONTRAINDICATIONS

Donotuseinanimalswithknownhypersensitivitytotheactivesubstanceand/ortoanyofthe

excipientsoftheproduct.

Donotuseinanimalswithknownhypersensitivitytotylosinandothermacrolides.

Donotusewherecross-resistancetoothermacrolides(MLSresistance)issuspected.

Donotuseinanimalsvaccinatedwithtylosin-sensitivevaccineseitheratthesametimeorwithin1

weekpreviously.

Donotuseinanimalswithhepaticdisorders.

Donotuseinhorses–dangerofinflammationofthececum.

6. ADVERSEREACTIONS

Inpigs,adversereactionshavebeenobserved,includingdiarrhoea,pruritus,erythema,rectaloedema

andprolapse.Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,please

informyourveterinarysurgeon.

7. TARGETSPECIES

Pigs.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Foruseinindividualpigsonfarmswhereonlyasmallnumberofpigsaretoreceivethemedicine.

Largergroupsshouldbetreatedwithmedicatedfeedingstuffcontainingthepremix.

Individualpigsshouldreceive5mgtylosinperkgbodyweight,correspondingto250mgPharmasin

2%OralGranules/kgbodyweight,onceadayfor3weeks.Thisisachievedbythoroughlymixingthe

productintothedailyrationforeachindividualpig.Therequiredamountofproductshouldbeadded

totheestimatedquantityofdailyrationforeachpiginabucketorsimilarreceptacleandthoroughly

mixed.Theproductshouldonlybeaddedtodrynon-pelletedfeed.

Thepigtobetreatedshouldbeweighedtopreventunderdosing.

Shouldtherebenoclearresponsetotreatmentwithin3daysthetreatmentapproachshouldbe

reconsidered.

9. ADVICEONCORRECTADMINISTRATION

Thisproductisonlyforadministrationinsmallquantitiesoffeedforimmediateconsumption,to

individualanimals.

Animalswithacuteinfectionsmayhaveareducedfeedintakeandshouldbetreatedwithasuitable

injectableproductfirst.Thesensitivityofbacteriatotylosinmayhavechangedovertimeor

geographically.Itissoundclinicalpracticetobasetreatmentonsusceptibilitytesting.

10. WITHDRAWALPERIOD

Pigs(meat):1day

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Storeinadryplacebelow30°C.Donotrefrigerateorfreeze.Protectfromfrost.Storeintheoriginal

containerinordertoprotectfromlight.Shelf-lifeafterfirstopeningtheimmediatepackaging:3

months

DonotuseaftertheexpirydatewhichisstatedonthelabelafterEXP

12. SPECIALWARNING(S)

Tylosinmayinduceirritation.Macrolides,suchastylosin,mayalsocausehypersensitivity(allergy)

followinginjection,inhalation,ingestionorcontactwithskinoreye.Hypersensitivitytotylosinmay

leadtocrossreactionstoothermacrolidesandviceversa.Allergicreactionstothesesubstancesmay

occasionallybeseriousandthereforedirectcontactshouldbeavoided.

Toavoidexposureduringmixingandhandlingoftheveterinarymedicinalproductwearsafety

glasses,imperviousgloves,andweareitheradisposablehalfmaskrespiratorconformingtoEuropean

StandardEN149oranon-disposablerespiratortoEuropeanStandardEN140withafiltertoEN143.

Washhandsafteruse.

Intheeventofaccidentalskincontact,washthoroughlywithsoapandwater.Incaseofaccidentaleye

contact,flushtheeyeswithplentyofclean,runningwater.

Donothandletheproductifyouareallergictoingredientsintheproduct.

Ifyoudevelopsymptomsfollowingexposure,suchasskinrash,youshouldseekmedicaladviceand

showthephysicianthiswarning.Swellingoftheface,lipsandeyesordifficultyinbreathingaremore

serioussymptomsandrequireurgentmedicalattention.

Noadverseeffectstotylosinhavebeenseeninfertility,multi-generationteratologystudies.Useonly

accordingtothebenefit/riskassessmentbytheresponsibleveterinarian

Lincosamidesandaminoglycosideantibioticsantagonizetheactivityoftylosin

Theproducthasbeenshowntoproducenoadverseeffectswhenfedtopigsat600ppminthefeed

(threetosixtimestherecommendeddoselevel)for28days.Athighlevelsdiarrhoea,apathy,

convulsionsmayoccur.Thetherapyissymptomatic.

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

Anyunusedveterinaryproductorwastematerialsderivedfromsuchveterinarymedicinalproductsshould

bedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Foranyinformationaboutthisveterinarymedicinalproduct,pleasecontactthelocalrepresentativeof

themarketingauthorisationholder.

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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 and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

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

8-11-2018

Theme event on big data and medicine

Theme event on big data and medicine

The U.S. Food and Drug Administration, FDA, The European Medicines Agency, EMA, and Novo Nordisk are among the speakers when The Danish Medicines Agency on 20 November 2018 puts focus on big data and medicine under the event heading “From Big Data to Real World Evidence”.

Danish Medicines Agency

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

29-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Food allergies have touched the lives of most of us. Thousands of Americans experience life-threatening, food-related reactions each year, and an estimated 20 people die from them annually. In some cases, such reactions occur despite a careful reading of packaged food labels by conscientious consumers. To me, that’s unacceptable. The FDA is committed to advancing our efforts to help ensure that Americans have access to the information they need about common allergens in packaged foods.

FDA - U.S. Food and Drug Administration

24-10-2018

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, of Versailles, OH is recalling all products lots manufactured from February 27, 2018 through July 20, 2018, as a precaution because they have the potential to be contaminated with Listeria monocytogenes

FDA - U.S. Food and Drug Administration

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

4-10-2018

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Samen met de Wereldgezondheidorganisatie (WHO) zal Nederland in april 2019 een wereldwijde ministeriële conferentie organiseren over de strijd tegen antibioticaresistentie. Dat heeft minister Bruno Bruins (Medische Zorg) bekend gemaakt tijdens de G20-bijeenkomst in Argentinië. Bij deze bijeenkomst maakte Bruins afspraken met zijn collega’s uit de grootste 20 economieën van de wereld over een gezamenlijke aanpak van gezondheidsvraagstukken. Mede door jarenlange inzet van Nederland, staat antibioticaresist...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

21-9-2018

Pending EC decision:  Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Pending EC decision: Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Emgality, galcanezumab, Opinion date: 20-Sep-2018

Pending EC decision: Emgality, galcanezumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Pending EC decision: RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Pending EC decision: Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Pending EC decision: Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Gilenya, fingolimod, Opinion date: 20-Sep-2018

Pending EC decision: Gilenya, fingolimod, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Apealea, paclitaxel, Opinion date: 20-Sep-2018

Pending EC decision: Apealea, paclitaxel, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Pending EC decision: Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Pending EC decision: Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Pending EC decision: Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Pending EC decision: Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pifeltro, doravirine, Opinion date: 20-Sep-2018

Pending EC decision: Pifeltro, doravirine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Pending EC decision:  Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Pending EC decision: Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Europe - EMA - European Medicines Agency

11-9-2018

Risk assessment of white willow (Salix alba) in food

Risk assessment of white willow (Salix alba) in food

Published on: Tue, 28 Aug 2018 00:00:00 +0200 This Technical Report contains a description of the activities within the work programme of the EU‐FORA Fellowship on the risk assessment of white willow in food. The bark of different varieties of willow has had a long history of medical use as a means to reduce fever and as a painkiller. Willow bark is also used in weight loss and sports performance food supplements. The labelling of these products usually does not mention any restrictions to the length of...

Europe - EFSA - European Food Safety Authority Publications

5-12-2018

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

The slides from TGA's webinar on Advertising Code Basics have been published

Therapeutic Goods Administration - Australia

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

16-11-2018

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Active substance: lurasidone) - Centralised - Renewal - Commission Decision (2018)7674 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2713/R/20

Europe -DG Health and Food Safety

14-11-2018

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7604 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2788/T/20

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

17-9-2018

Agenda:  Agenda - CHMP agenda of the 17-20 September 2018 meeting

Agenda: Agenda - CHMP agenda of the 17-20 September 2018 meeting

Europe - EMA - European Medicines Agency

4-9-2018

Agenda:  Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda: Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda of CHMP written procedure*20-23 August 2018

Europe - EMA - European Medicines Agency