Linco-Feed 110 mg/g premix for medicated feeding stuff

Main information

  • Trade name:
  • Linco-Feed 110 mg/g premix for medicated feeding stuff
  • Pharmaceutical form:
  • Premix for medicated feed
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Linco-Feed 110 mg/g premix for medicated feeding stuff
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • lincomycin
  • Therapeutic area:
  • Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • HU/V/0110/001
  • Authorization date:
  • 24-11-2010
  • EU code:
  • HU/V/0110/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

Linco-Feed110mg/gpremixformedicatedfeedingstuffforpigs

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachgproductcontains:

Activesubstance:

Lincomycin(ashydrochloride) 110mg

Forafulllistofexcipients,seesection6.1

3.PHARMACEUTICALFORM

Premixformedicatedfeedingstuff.

Whiteoralmostwhitegranules.

4.CLINICALPARTICULARS

4.1Targetspecies

Swine.

4.2Indicationsforuse,specifyingthetargetspecies

FortreatmentofswinedysenterycausedbyBrachyspirahyodysenteriae,mycoplasmalpneumonia

associatedwithMycoplasmahyopneumoniaeandporcineproliferativeenteropathy(ileitis)associatedwith

Lawsoniaintracellularis.

4.3Contraindications

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyoftheexcipient.

Donotuseinhorses,ruminants,rabbits,guineapigsandhamsters.

Donotuseifresistancetolincosamideshasbeendetected.

4.4Specialwarningsforeachtargetspecies

Inappropriateuseoftheproductmayincreasetheprevalenceofbacteriaresistanttolincosamides.

Useoftheproductshouldbebasedonsusceptibilitytestingandtakeintoaccountofficialandlocal

antimicrobialpolicies.Thepresenceoftheindicateddiseasesintheherdshouldbeestablishedbeforeuse.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Medicatedfeedingstuffuptakecanbeaffectedbytheseverityofthedisease.Incaseofinsufficientuptake

offeed,animalsshouldbetreatedparenterally.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproducttoanimals

Peoplewithknownhypersensitivitytolincomycinshouldavoidcontactwiththeveterinarymedicinal

product.

Careshouldbetakennottoinhaleanydust.Thewearingofapproveddustmasks(eitheradisposablehalf-

maskrespiratorconformingtoEuropeanStandardEN149oranon-disposablerespiratortoEuropean

StandardEN140withafiltertoEN143),gloves,overallsandsafetyglassesisrecommendedduringthe

handlingandmixingofthisproduct.

Directcontactoftheproductwiththeskin,eyesandmucousmembranesshouldbeavoided.

Incaseofaccidentalexposurerinseabundantlywithwater.Incaseofallergicreaction(inflammationof

theface,lipsoreyesorrespiratorydifficulties)duringhandlingormixingoftheproduct,seekmedical

adviceimmediatelyandshowthepackageleafletorthelabeltothephysician.

Donotsmoke,eatordrinkwhenhandlingtheproduct.

Washhandsandanyexposedskinwithsoapandwaterimmediatelyafteruse.

Otherprecautions

Whenspreadingthemanureofweanerpigstreatedwiththeveterinarymedicinalproductatadoseof10

mg/kgfor21days,aminimumdistancetosurfacewaterof10mshouldbeapplied.

4.6Adversereactions(frequencyandseriousness)

Lincomycinmayoccasionallycausetransientsoftstoolsand/ormildswellingoftheanuswithinthefirst

twodaysoftreatment.Veryrarelysomepigsmayshowskinreddeningandmildlyirritablebehaviour.

Theseconditionsareusuallyself-correctingwithin5-8dayswithoutdiscontinuinglincomycintreatment.

4.7Useduringpregnancy,lactation

Thesafetyoftheproducthasnotbeenestablishedinpregnantorlactatingsows.Useonlyinaccordance

withrisk/benefitassessmentbytheresponsibleveterinarian.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Co-administrationwithmacrolides(e.g.erythromycin)shouldbeavoided.

4.9Amountstobeadministeredandadministrationroute

Tobeadministeredorally,indrymedicatedfeedingstuff.

Indication Treatment(mg/kgfeed)

Product Lincomycin

Swinedysentery 1000 110

Mycoplasmapneumonia 2000 220

Proliferativeenteropathy 2000 220

Treatmentofswinedysentery:

Feed110mglincomycin/kgcompletefeed(equivalentto5.5mglincomycin/kgbodyweight)asthesole

rationforthreeweeksoruntilclinicalsignsofdisease(watery,mucoidorbloodystools)disappear.

Treatmentofmycoplasmalpneumonia:

Feed220mglincomycin/kgcompletefeed(equivalentto11mglincomycin/kgbodyweight)asthesole

rationforthreeweeksoruntilclinicalsignsofdiseasedisappear.

Treatmentofporcineproliferativeenteropathy:

Feed220mglincomycin/kgcompletefeed(equivalentto11mglincomycin/kgbodyweight)asthesole

rationforthreeweeks.

Medicatedfeedmaybepelletedattemperaturesnotexceeding85 o C.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Inpigstreatedwith2-10timestherecommendeddoseorallyfor14daysalteredthestoolconsistency,

fromloosestooltodiarrhoea,withoutthelossofappetite.

Ifsuspectedtoxicreactionsoccurduetooverdose,themedicationshouldbediscontinuedandappropriate

symptomatictreatmentshouldbeinitiatedifnecessary.

4.11Withdrawalperiod(s)

Swine:Meatandoffal:5days.

5.PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:lincosamides,ATCvetcode:QJ01FF02.

5.1Pharmacodynamicproperties

LincomycinisalincosamideantibioticproducedbyStreptomyceslincolensis.Lincomycinisbacteriostatic

inactioninhibitingtheproteinsynthesispredominantlybybindingtothe50Sribosomalsubunitsof

bacteria.

Dependingonthesensitivityofmicro-organisms,andontheconcentrationoftheactivesubstancethe

proteinsynthesisinhibitionantibacterialactioncaneitherbebacteriostaticorbactericide.

LincomycinisactiveagainstawiderangeofGram-positivebacteria,suchasstaphylococci,streptococci,

β-haemolyticstreptococci, corynebacteria,Erysipelothrixspp.,andanaerobicbacteria,suchasclostridia,

Bacteroidesspp.,Brachyspiraspp.,aswellasLeptospiraspp.andMycoplasmaspp.

LincomycinhasnoactivityagainstGram-negativebacteria,suchasKlebsiellaspp.,Pasteurellaspp.,and

Salmonellaspp.

Theresistancerateagainstlincomycinisslow,multiple-steptype.Plasmidmediatedinfectiousresistance

isalsodescribed.

Nocross-resistancehasbeendescribedwithpenicillin,ampicillin,cephalosporins,tetracyclines,or

novobiocin.

LincomycinMIC

(µg/ml)valuesarethefollowings:

Mycoplasmahyopneumoniae:MIC

(µg/ml)=0.25

Brachyspirahyodysenteriae:MIC

(µg/ml)=100

5.2 Pharmacokineticparticulars

Systemicbioavailabilityoflincomycinisapproximately53%afteroraladministrationinpigs

Lincomycinisrapidlyabsorbedorallyandreachestherapeuticplasmaconcentration.

Afterasingle,oraladministrationofapproximately4.4mg/kgand11mg/kglincomycintopigs

resultedtherapeuticplasmaconcentrationfor12-16hours,reachingpeakplasmaconcentrationafter4

hours.Afterasingle,oraldoseof10mg/kglincomycintopigsthemaximumplasmaconcentration

)of1.45mg/kgwasreachedat3.6hours(T

).Theeliminationhalflife(T

1/2β )isabout3.36

hours.Theoraladministrationof22mg/kglincomycinfor3daystopigsdidnotresultindrug

accumulationafter24hoursofadministrationandtherewasnotherapeuticplasmaconcentration.

Afteroraladministrationtheabsorbedlincomyciniseliminatedthroughthebileandfaecesinactive

formorasmetabolites.

Lincomycinisalsoexcretedinthemilk.

Lincomycinreachestheinflammationsitebypolymorfneutrophilgranulocytesthatexplainsitsfast

absorptionanddistribution,efficientpenetrationandtargetedactivityindifficulttoreachtissues.

6.PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate.

6.2Incompatibilities

Inabsenceofcompatibilitystudiesthisproductmustnotbemixedwithotherveterinaryproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:3months.

Shelf-lifeafterincorporationintofeed:3months.

6.4.Specialprecautionsforstorage

Storebelow25ºC.Storeinadryplace.

Storeintheoriginalcontainertightlyclosedafteruseinordertoprotectfrommoisture.

6.5Natureandcompositionofimmediatepackaging

5kgmultiwalled,polyethylenelayeredpaperbag.

10kgmultiwalled,polyethylenelayeredpaperbag.

25kgmultiwalled,polyethylenelayeredpaperbag.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwastematerials

derivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7.MARKETINGAUTHORISATIONHOLDER

LavetPharmaceuticalsLtd.

1161Budapest

Ottóu.14.

Hungary

8.MARKETINGAUTHORISATIONNUMBER(S)

9.DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10.DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Considerationshouldbegiventoofficialguidanceontheincorporationofmedicatedpremixesinfinal

feeds.

A.LABELLING

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

5kgmultiwalled,polyethylenelayeredpaperbag.

10kgmultiwalled,polyethylenelayeredpaperbag.

25kgmultiwalled,polyethylenelayeredpaperbag.

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Linco-Feed110mg/gpremixformedicatedfeedingstuffforpigs

Lincomycin(ashydrochloride)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Activesubstance:

Lincomycin(ashydrochloride) 110mg/g

3. PHARMACEUTICALFORM

Premixformedicatedfeedingstuff

4. PACKAGESIZE

5kg

10kg

25kg

5. TARGETSPECIES

Swine

6. INDICATION(S)

Swine:FortreatmentofswinedysenterycausedbyBrachyspirahyodysenteriae,mycoplasmal

pneumoniaassociatedwithMycoplasmahyopneumoniaeandporcineproliferative

enteropathy(ileitis)associatedwithLawsoniaintracellularis.

7. METHODANDROUTE(S)OFADMINISTRATION

Tobeadministeredorally,indrymedicatedfeedingstuff.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Meatandoffal:5days.

9. SPECIALWARNING(S),IFNECESSARY

Userwarnings:

Peoplewithknownhypersensitivitytolincomycinshouldavoidcontactwiththeveterinarymedicinal

product.

Wearprotectivegloves,overalls,safetyglassesanddustmaskwhenhandlingandmixingtheproduct.

Readpackageleafletforfulluserwarnings.

10. EXPIRYDATE

EXP{month/year}

Shelf-lifeafterfirstopeningtheimmediatepackaging:3months.

Shelf-lifeafterincorporationintofeed:3months.

Oncebroached,useby:

11. SPECIALSTORAGECONDITIONS

Storebelow25ºC.Storeinadryplace.

Storeintheoriginalcontainertightlyclosedafteruseinordertoprotectfrommoisture.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS,IFANY

Disposeofwastematerialinaccordancewithlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly-tobesuppliedonlyonveterinaryprescription.

Considerationshouldbegiventoofficialguidanceontheincorporationofmedicatedpremixesinfinal

feeds.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthesightandreachofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

LavetPharmaceuticalsLtd.

1161Budapest

Ottóu.14.

Hungary

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Batch:{number}

PACKAGELEAFLET

Linco-Feed110mg/gpremixformedicatedfeedingstuffforpigs

1.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOFTHE

MANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCHRELEASE,IF

DIFFERENT

Marketingauthorisationholder:

LavetPharmaceuticalsLtd.,1161Budapest,Ottóu.14,Hungary

Manufacturerforbatchrelease:

LavetPharmaceuticalsLtd.,2143Kistarcsa,Batthyányu.6,Hungary

2.NAMEOFTHEVETERINARYMEDICINALPRODUCT

Linco-Feed110mg/gpremixformedicatedfeedingstuffforpigs

Lincomycin(ashydrochloride)

3.STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Eachkgproductcontains:

Activesubstance:

Lincomycin(ashydrochloride) 110g

Whiteoralmostwhitegranules.

4.INDICATION(S)

Swine:FortreatmentofswinedysenterycausedbyBrachyspirahyodysenteriae,mycoplasmalpneumonia

associatedwithMycoplasmahyopneumoniaeandporcineproliferativeenteropathy(ileitis)associatedwith

Lawsoniaintracellularis.

5.CONTRAINDICATIONS

Donotuseincaseofhypersensitivitytotheactivesubstanceortotheexcipient.

Donotuseinhorses,ruminants,rabbits,guineapigsandhamsters.

Donotuseifofresistancetolincosamideshasbeendetected.

6.ADVERSEREACTIONS

Lincomycinmayoccasionallycausetransientsoftstoolsand/ormildswellingoftheanuswithinthefirst

twodaysoftreatment.Veryrarelysomepigsmayshowskinreddeningandmildlyirritablebehaviour.

Theseconditionsareusuallyself-correctingwithin5-8dayswithoutdiscontinuinglincomycintreatment.

7.TARGETSPECIES

Swine.

8.DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Tobeadministeredorally,indrymedicatedfeedingstuff.

Indication Treatment(mg/kgfeed)

Product Lincomycin

Swinedysentery 137,5 110

Mycoplasmapneumonia 275 220

Proliferativeenteropathy 275 220

9.ADVICEONCORRECTADMINISTRATION

Treatmentofswinedysentery:

Feed110mglincomycin/kgcompletefeed(equivalentto5.5mglincomycin/kgbodyweight)asthesole

rationforthreeweeksoruntilclinicalsignsofdisease(watery,mucoidorbloodystools)disappear.

Treatmentofmycoplasmalpneumonia:

Feed220mglincomycin/kgcompletefeed(equivalentto11mglincomycin/kgbodyweight)asthesole

rationforthreeweeksoruntilclinicalsignsofdiseasedisappear.

Treatmentofporcineproliferativeenteropathy:

Feed220mglincomycin/kgcompletefeed(equivalentto11mglincomycin/kgbodyweight)asthesole

rationforthreeweeks.

Medicatedfeedmaybepelletedattemperaturesnotexceeding85 o C.

10.WITHDRAWALPERIOD

Meatandoffalofswine:5days.

11.SPECIALSTORAGEPRECAUTIONS

Keepoutofthesightandreachofchildren.

Storebelow25ºC.Storeinadryplace.

Keeptheplasticcontainertightlyclosed,orre-closethepaperbagmechanicallyasmuchaspossible.

Storeintheoriginalcontainertightlyclosedafteruseinordertoprotectfrommoisture.

Shelf-lifeafterfirstopeningtheimmediatepackaging:3months.

Shelf-lifeafterincorporationintofeed:3months.

12.SPECIALWARNING(S)

Specialwarningsforeachtargetspecies

Inappropriateuseoftheproductmayincreasetheprevalenceofbacteriaresistanttolincosamides.

Useoftheproductshouldbebasedonsusceptibilitytestingandtakeintoaccountofficialandlocal

antimicrobialpolicies.Thepresenceoftheindicateddiseasesintheherdshouldbeestablishedbeforeuse.

Specialprecautionsforuseinanimals

Medicatedfeedingstuffuptakecanbeaffectedbytheseverityofthedisease.Incaseofinsufficientuptake

offeed,animalsshouldbetreatedparenterally.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproducttoanimals:

Peoplewithknownhypersensitivitytolincomycinshouldavoidcontactwiththeveterinarymedicinal

product.

Careshouldbetakennottoinhaleanydust.Thewearingofapproveddustmasks(eitheradisposablehalf-

maskrespiratorconformingtoEuropeanStandardEN149oranon-disposablerespiratortoEuropean

StandardEN140withafiltertoEN143),gloves,overallsandsafetyglassesisrecommendedduringthe

handlingandmixingofthisproduct.

Directcontactoftheproductwiththeskin,eyesandmucousmembranesshouldbeavoided.

Incaseofaccidentalexposurerinseabundantlywithwater.Incaseofallergicreaction(inflammationof

theface,lipsoreyesorrespiratorydifficulties)duringhandlingormixingoftheproduct,seekmedical

adviceimmediatelyandshowthepackageleafletorthelabeltothephysician.

Donotsmoke,eatordrinkwhenhandlingtheproduct.

Washhandsandanyexposedskinwithsoapandwaterimmediatelyafteruse.

Pregnancy,lactation

Thesafetyoftheproducthasnotbeenestablishedinpregnantorlactatingsows.Useonlyinaccordance

withrisk/benefitassessmentbytheresponsibleveterinarian.

Interactionwithothermedicinalproductsandotherformsofinteraction

Co-administrationwithmacrolides(e.g.erythromycin)shouldbeavoided.Inabsenceofcompatibility

studiesthisproductmustnotbemixedwithotherveterinaryproducts.

Overdose

Inpigstreatedwith2-10timestherecommendeddoseorallyfor14daysalteredthestoolconsistency,

fromloosestooltodiarrhoea,withoutthelossofappetite.

Ifsuspectedtoxicreactionsoccurduetooverdose,themedicationshouldbediscontinuedandappropriate

symptomatictreatmentshouldbeinitiatedifnecessary.

Otherprecautions

Whenspreadingthemanureofweanerpigstreatedwiththeveterinarymedicinalproductatadoseof10

mg/kgfor21days,aminimumdistancetosurfacewaterof10mshouldbeapplied.

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinalproducts

shouldbedisposedofinaccordancewithlocalrequirements.

14.DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15.OTHERINFORMATION

Foranimaltreatmentonly-tobesuppliedonlyonveterinaryprescription.

Considerationshouldbegiventoofficialguidanceontheincorporationofmedicatedpremixesinfinal

feeds.

Packsizes

5kgmultiwalled,polyethylenelayeredpaperbag.

10kgmultiwalled,polyethylenelayeredpaperbag.

25kgmultiwalled,polyethylenelayeredpaperbag.

Notallpacksizesmaybemarketed.

InItaly:

Pharmacotherapeuticgroup:lincosamides,ATCvetcode:QJ01FF02.

IntheUnitedKingdom:

Whenthecontainerisopenedforthefirsttime,usingthein-useshelf-lifewhichisspecifiedonthis

packageleaflet,thedateonwhichanyproductremaininginthecontainershouldbediscardedshouldbe

workedout.Thisdiscarddateshouldbewritteninthespaceprovidedonthelabel.

21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Pest categorisation of non‐EU Monochamus spp.

Pest categorisation of non‐EU Monochamus spp.

Published on: Mon, 19 Nov 2018 The Panel on Plant Health performed a pest categorisation of non‐EU Monochamus spp., a well‐defined insect genus in the family Cerambycidae (Insecta: Coleoptera). Species can be identified using taxonomic keys at national and regional level, and DNA barcoding. Two online world catalogues exist for the genus. The genus includes about one hundred species and many subspecies colonising conifers and non‐conifer trees in many areas in the world. The non‐EU species are listed in...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

FDA Warns Two Firms about Monensin Contamination in Horse Feed

FDA Warns Two Firms about Monensin Contamination in Horse Feed

FDA has issued warning letters to two feed mills that mixed horse feed containing monensin, an animal drug that is toxic and potentially lethal to horses. This should be a reminder to all feed manufacturers making medicated feeds that they must remain vigilant about adhering to CGMP requirements.

FDA - U.S. Food and Drug Administration

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

30-7-2018

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

Under the national nutrivigilance scheme, reports of adverse effects likely to be associated with the consumption of food supplements containing melatonin have been brought to the attention of ANSES. A retrospective analysis of these reports, combined with the considerable level of consumption of this type of supplement, led ANSES to conduct an assessment of the potential health risks. In its Opinion of February 2018, the Agency highlighted the existence of populations and situations at risk, for which t...

France - Agence Nationale du Médicament Vétérinaire

8-5-2018

Medicated Feeds

Medicated Feeds

An approved medicated feed mill license is required for facilities that manufacture feed using certain medicated articles/drugs.

FDA - U.S. Food and Drug Administration

21-11-2018

EU/3/18/2085 (Rigenerand S.r.l.)

EU/3/18/2085 (Rigenerand S.r.l.)

EU/3/18/2085 (Active substance: Autologous human adipose perivascular stromal cells genetically modified to secrete soluble tumour necrosis factor-related apoptosis-inducing ligand) - Orphan designation - Commission Decision (2018)7794 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/18

Europe -DG Health and Food Safety

21-10-2018

Although I’ve been focusing on medical products, we're also advancing our food safety and nutrition work, such as our joint advice w/ EPA on making informed choices about eating fish for women who are pregnant, may become pregnant or are breastfeeding  ht

Although I’ve been focusing on medical products, we're also advancing our food safety and nutrition work, such as our joint advice w/ EPA on making informed choices about eating fish for women who are pregnant, may become pregnant or are breastfeeding ht

Although I’ve been focusing on medical products, we're also advancing our food safety and nutrition work, such as our joint advice w/ EPA on making informed choices about eating fish for women who are pregnant, may become pregnant or are breastfeeding https://go.usa.gov/xPnda . pic.twitter.com/nktV9BDAC3

FDA - U.S. Food and Drug Administration

6-8-2018

Tysabri (Biogen Netherlands B.V.)

Tysabri (Biogen Netherlands B.V.)

Tysabri (Active substance: Natalizumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5390 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/603/T/110

Europe -DG Health and Food Safety

27-7-2018

EU/3/06/363 (Telix Pharmaceuticals Holdings Germany GmbH)

EU/3/06/363 (Telix Pharmaceuticals Holdings Germany GmbH)

EU/3/06/363 (Active substance: 4-[131I]iodo-L-phenylalanine) - Transfer of orphan designation - Commission Decision (2018)5036 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/05/T/02

Europe -DG Health and Food Safety

18-7-2018

EU/3/16/1718 (Salzman Group Ltd)

EU/3/16/1718 (Salzman Group Ltd)

EU/3/16/1718 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2018)4807 of Wed, 18 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/16/T/01

Europe -DG Health and Food Safety

27-6-2018

Glivec (Novartis Europharm Limited)

Glivec (Novartis Europharm Limited)

Glivec (Active substance: Imatinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4087 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/406/T/110

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (Active substance: Veliparib) - Transfer of orphan designation - Commission Decision (2018)3021 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/10/T/02

Europe -DG Health and Food Safety