COCCIBAL ORAL SOLUTION FOR POULTRY 200 MG /ML

Main information

  • Trade name:
  • COCCIBAL ORAL SOLUTION FOR POULTRY 200 MG /ML
  • Pharmaceutical form:
  • Oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • COCCIBAL ORAL SOLUTION FOR POULTRY 200 MG /ML
    Portugal
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • amprolium
  • Therapeutic area:
  • Chicken, Turkeys

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0230/001
  • Authorization date:
  • 24-01-2012
  • EU code:
  • FR/V/0230/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

[Version7.3,04/2010]

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Coccibal,200mg/mlsolutionforuseindrinkingwaterforchickenandturkeys

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Amprolium(ashydrochloride)200mg

Excipient(s):

Sodiummethylparahydroxybenzoate(E219) 1mg

Sodiumpropylparahydroxybenzoate(E217) 0.2mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforuseindrinkingwater.

Clearyellowsolution

4. CLINICALPARTICULARS

4.1Targetspecies

Chickens(broilers,pullets,layers,breederhens)andturkeys

4.2Indicationsforuse,specifyingthetargetspecies

Chickens(broilers,pullets,layers,breederhens)andturkeys:treatmentofintestinal

coccidiosiscausedbyEimeriasppsusceptibletoamprolium.

4.3Contraindications

Noneknown

4.4Specialwarningsforeachtargetspecies

Aswithanyantiparasiticide,frequentandrepeateduseofantiprotozoalsfromthesame

classmayleadtothedevelopmentofresistance.

Incaseofdetectionalackofefficacyduringtreatment,communicateittothenational

competentauthorities.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Theproductisnotintendedforapreventiveuse.

Thisproductshouldbereservedincaseofcoccidiosisoutbreaksduetonon-availability

ofvaccine,incaseoflackofefficacyofvaccineandinvaccinatedflocksifasevere

coccidialchallengeisdiagnosedbeforeimmunityhasfullydeveloped.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Thisisanirritantandcorrosiveproduct.Itcouldcauseairway,eyeandskinirritation.

Wearimperviousglovesandprotectiveglasseswhenhandlingtheproduct.

TheselectedprotectivegloveshavetosatisfythespecificationsofEUDirective

89/686/EECandthestandardEN374derivedfromit.

Avoidinhalationofvapours.

Avoidcontactwiththeskinandeyes.Inthecaseofcontactwithskinoreyes,washthe

affectedareawithcleanrunningwaterimmediatelyandremoveanycontaminated

clothes.Ifirritationpersists,seekmedicaladviceandshowthepackageleaflettothe

doctor.

Thisproductisharmfulwheningested.Incaseofaccidentalingestion,rinsethemouth

withfreshwater,seekmedicaladviceimmediatelyandshowthelabeltothedoctor..

Personwithknownhypersensitivitytotheactivesubstanceortoanyofexcipients,

shouldavoidcontactwiththeproduct.

Washhandsandexposedskinafteruse.

4.6Adversereactions(frequencyandseriousness)

Noneknown

4.7Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimalshavenotproducedanyevidenceofteratogeniceffects.

Thesafetyofamproliumhasnotbeeninvestigatedinlayingbirds.Useonlyaccordingto

therisk/benefitassessmentbytheresponsibleveterinarian.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Amproliumisathiamineanalogue.Therefore,theefficacyofamproliummaybe

reducedduringasimultaneousadministrationofproductscontainingvitaminB-complex.

4.9Amountstobeadministeredandadministrationroute

Indrinkingwateruse..

Posologyforeachtargetspeciesis20mgamprolium/kgb.w.adayfor5-7

consecutivedays

Forthepreparationofmedicatedwaterthebodyweightoftheanimalstobetreatedand

theiractualdailywaterconsumptionshouldbetakenintoaccount.Consumptionmay

varydependingonfactorslikeage,stateofhealth,breed,husbandrysystem.Toprovide

therequiredamountofveterinarymedicinalproductinmlperlitredrinkingwaterthe

followingcalculationshouldbemade:

0.1mltheproductperaveragebodyweight(kg)numberof

kgbodyweight Xoftheanimalstobe Xanimals

daily treated

--------------------------------------------------------------------------------------=mltheproduct

perlitre

Totalwaterconsumption(l)oftheherdatthepreviousdaydrinking

water

Sufficientaccesstothesystemofwatersupplyshouldbeavailablefortheanimalstobe

treatedtoensureadequatewaterconsumption.Noothersourceofdrinkingwater

shouldbeavailableduringthemedicationperiod.Medicateddrinkingwatershouldbe

replacedevery24hours.

Aftertheendofthemedicationperiodthewatersupplysystemshouldbecleaned

appropriatelytoavoidintakeofsub-therapeuticamountsoftheactivesubstance.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Prolongedusescanproducethiaminedeficiencies

Shouldsymptomsappear,thiaminemustbeadministered.

4.11Withdrawalperiod(s)

Chickens(broilers,

pullets, layers,

breederhens): Meatandoffal: Zerodays

Eggs: Zerodays

Turkeys: Meatandoffal: Zerodays

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:antiprotozoals;agentsagainstprotozoaldisease,

amprolium

ATCvetcode:QP51AX09.

5.1Pharmacodynamicproperties

Amproliumisananticoccidialagentthatactsascompetitiveinhibitorofthiamineinthe

parasitemetabolism,andinterfereswiththemetabolismofglucidesnecessariesfor

coccidianmultiplicationandsurvival.

Inin-vitrostudiesitwasshownthattheuptakeofthiaminebyschizontsofEimeriatenella

andbyhostintestinalcellscanoccurthroughpassivediffusionorbyanactive,energy-

andph-dependentprocess.Amproliumcompetitivelyinhibitedbothsystems,however,

theparasitewasshowntobemoresensitivetoamproliumthanthehost.

AsshownwithEimeriamaximainoculatedchicken,theadministrationofAmprolium

resultedinaproportionofmorphologicallyabnormalmacrogametesandoocystswhich

maybeconsideredthereasonforareducedsporulationrate.

5.2Pharmacokineticparticulars

Afteroraladministrationabsorptionislow,reachingthemaximumconcentration4hours

later.Itisexcretedmainlythroughfaeces

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Propyleneglycol

Sodiummethylparahydroxybenzoate(E219)

Sodiumpropylparahydroxybenzoate(E217)

Purifiedwater

6.2Incompatibilities

Inabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixed

withotherveterinarymedicinalproduct.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelf-lifeafterfirstopeningtheimmediatepackaging:6months

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:24hours

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5Natureandcompositionofimmediatepackaging

100mland1litrecontainers:white,opaquehighdensitypolyethylenebottlessealedby

inductionandwithscrew-oncap.

5litrescontainer:white,opaquehighdensitypolyethylenebarrelssealedbyinduction

andwithscrew-oncap.

Presentations:1L,5L,12x1Lincardboardbox,4x5Lincardboardbox,10x100

mlincardboardboxwithleaflet

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements

7. MARKETINGAUTHORISATIONHOLDER

SPVETERINARIASA

CtraReusVinyolskm4.1

Riudoms(43330)

Spain

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

<{DD/MM/YYYY}><{DDmonthYYYY}>…

10 DATEOFREVISIONOFTHETEXT

{MM/YYYY}or<monthYYYY>

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

ANNEXIII

LABELLINGANDPACKAGELEAFLET

A.LABELLING

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

100mlandouterpackage

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Coccibal,200mg/mlsolutionforuseindrinkingwaterforchickenandturkeys

Amprolium(ashydrochloride)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachmlcontains:

Amprolium(ashydrochloride)200mg/ml

Sodiummethylparahydroxybenzoate(E219)

Sodiumpropylparahydroxybenzoate(E217)

3. PHARMACEUTICALFORM

Solutionforuseindrinkingwater.

Clearyellowsolution

4. PACKAGESIZE

100ml

5. TARGETSPECIES

Chickens(broilers,pullets,layers,breederhens)andturkeys

6. INDICATION(S)

Chickens(broilers,pullets,layers,breederhens)andturkeys:treatmentofintestinal

coccidiosiscausedbyEimeriasppsusceptibletoamprolium.

7. METHODANDROUTE(S)OFADMINISTRATION

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Chickens(broilers,

pullets, layers,

breederhens): Meatandoffal: Zerodays

Eggs: Zerodays

Turkeys: Meatandoffal: Zerodays

9. SPECIALWARNING(S),IFNECESSARY

Seepackageleafletforfullinstructions,includinguserwarnings

10.EXPIRYDATE

<EXP{month/year}>

Onceopened,useby…>

Shelf-lifeafterfirstopeningtheimmediatepackaging:6months

11.SPECIALSTORAGECONDITIONS

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTS

ORWASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly-tobesuppliedonlyonveterinaryprescription.

PL:Wyłączniedlazwierząt.Wydawanyzprzepisulekarza–Rp

Dopodawaniapodnadzoremlekarzaweterynarii

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

SPVETERINARIASA

CtraReusVinyolskm4.1

Riudoms(43330)

Spain

16.MARKETINGAUTHORISATIONNUMBER(S)

EU/0/00/000/000

17. MANUFACTURER’SBATCHNUMBER

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

Labelfor:1Land5L

Coccibal,200mg/mlsolutionforuseindrinkingwaterforchickenandturkeys

Amprolium(ashydrochloride)

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

AND OF THE MANUFACTURING AUTHORISATION HOLDER

RESPONSIBLEFORBATCHRELEASE,IFDIFFERENT

Marketingauthorisationholderandmanufacturer:

SPVETERINARIASA

CtraReusVinyolskm4.1

Riudoms(43330)

Spain

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Coccibal,200mg/mlsolutionforuseindrinkingwaterforchickenandturkeys

Amprolium(ashydrochloride)

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER

INGREDIENT(S)

Eachmloftheclearyellowsolutioncontains:

Amprolium(ashydrochloride)200mg

Excipient(s):

Sodiummethylparahydroxybenzoate(E219)1mgSodiumpropylparahydroxybenzoate

(E217)0.2mg

4. INDICATION(S)

Chickens(broilers,pullets,layers,breederhens)andturkeys:treatmentofintestinal

coccidiosiscausedbyEimeriasppsusceptibletoamprolium.

5. CONTRAINDICATIONS

Noneknown

6. ADVERSEREACTIONS

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,please

informyourveterinarysurgeon.

7. TARGETSPECIES

Chickens(broilers,pullets,layers,breederhens)andturkeys

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

ADMINISTRATION

Indrinkingwateruse..

Posologyforeachtargetspeciesis20mgamprolium/kgb.w.adayfor5-7

consecutivedays

Forthepreparationofmedicatedwaterthebodyweightoftheanimalstobetreatedand

theiractualdailywaterconsumptionshouldbetakenintoaccount.Consumptionmay

varydependingonfactorslikeage,stateofhealth,breed,husbandrysystem.Toprovide

therequiredamountofveterinarymedicinalproductinmlperlitredrinkingwaterthe

followingcalculationshouldbemade:

0.1mltheproductperaveragebodyweight(kg)numberof

kgbodyweight Xoftheanimalstobe Xanimals

daily treated

--------------------------------------------------------------------------------------=mltheproduct

perlitre

Totalwaterconsumption(l)oftheherdatthepreviousdaydrinking

water

Sufficientaccesstothesystemofwatersupplyshouldbeavailablefortheanimalstobe

treatedtoensureadequatewaterconsumption.Noothersourceofdrinkingwater

shouldbeavailableduringthemedicationperiod.Medicateddrinkingwatershouldbe

replacedevery24hours.

Aftertheendofthemedicationperiodthewatersupplysystemshouldbecleaned

appropriatelytoavoidintakeofsub-therapeuticamountsoftheactivesubstance.

9. ADVICEONCORRECTADMINISTRATION

10.WITHDRAWALPERIOD

Chickens(broilers,

pullets, layers,

breederhens): Meatandoffal: Zerodays

Eggs: Zerodays

Turkeys: Meatandoffal: Zerodays

11.SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions

Shelf-lifeafterfirstopeningthecontainer:6months

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:24hours

Donotuseaftertheexpirydatestatedonthelabel.

12.SPECIALWARNING(S)

Specialwarningsforeachtargetspecies

Aswithanyantiparasiticide,frequentandrepeateduseofantiprotozoalsfromthesame

classmayleadtothedevelopmentofresistance.

Incaseofdetectionalackofefficacyduringtreatment,communicateittothenational

competentauthorities.

Specialprecautionsforuse

Specialprecautionsforuseinanimals

Theproductisnotintendedforapreventiveuse.

Thisproductshouldbereservedincaseofcoccidiosisoutbreaksduetonon-availability

ofvaccine,incaseoflackofefficacyofvaccineandinvaccinatedflocksifasevere

coccidialchallengeisdiagnosedbeforeimmunityhasfullydeveloped.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Thisisanirritantandcorrosiveproduct.Itcouldcauseairway,eyeandskinirritation.

Wearimperviousglovesandprotectiveglasseswhenhandlingtheproduct.

TheselectedprotectivegloveshavetosatisfythespecificationsofEUDirective

89/686/EECandthestandardEN374derivedfromit.

Avoidinhalationofvapours.

Avoidcontactwiththeskinandeyes.Inthecaseofcontactwithskinoreyes,washthe

affectedareawithcleanrunningwaterimmediatelyandremoveanycontaminated

clothes.Ifirritationpersists,seekmedicaladviceandshowthepackageleaflettothe

doctor.

Thisproductisharmfulwheningested.Incaseofaccidentalingestion,rinsethemouth

withfreshwater,seekmedicaladviceimmediatelyandshowthelabeltothedoctor..

Personwithknownhypersensitivitytotheactivesubstanceortoanyofexcipients,

shouldavoidcontactwiththeproduct.

Washhandsandexposedskinafteruse.

Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimalshavenotproducedanyevidenceofteratogeniceffects.

Thesafetyofamproliumhasnotbeeninvestigatedinlayingbirds.Useonlyaccordingto

therisk/benefitassessmentbytheresponsibleveterinarian.

Interactionwithothermedicinalproductsandotherformsofinteraction

Amproliumisathiamineanalogue.Therefore,theefficacyofamproliummaybe

reducedduringasimultaneousadministrationofproductscontainingvitaminB-complex.

Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Prolongedusescanproducethiaminedeficiencies

Shouldsymptomsappear,thiaminemustbeadministered.

Incompatibilities

Inabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixed

withotherveterinarymedicinalproduct.

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements

14.DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15.OTHERINFORMATION

Notallpacksizesmaybemarketed.

Packagesize:100ml,1Land5L

Presentations:1L,5L,12x1Lincardboardbox,4x5Lincardboardbox,10x100

mlincardboardboxwithleaflet

Expirydate:

PL: Terminważności(EXP)

Foranimaltreatmentonly-tobesuppliedonlyonveterinaryprescription.

PL:Wyłączniedlazwierząt.Wydawanyzprzepisulekarza–Rp

Dopodawaniapodnadzoremlekarzaweterynarii

MARKETINGAUTHORISATIONNUMBER(S)

EU/0/00/000/000

MANUFACTURER’SBATCHNUMBER

Onceopened,useby…

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:24hours

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

B.PACKAGELEAFLET

PACKAGELEAFLET

Leafletfor100ml

Coccibal,200mg/mlsolutionforuseindrinkingwaterforchickenandturkeys

Amprolium(ashydrochloride)

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

AND OF THE MANUFACTURING AUTHORISATION HOLDER

RESPONSIBLEFORBATCHRELEASE,IFDIFFERENT

Marketingauthorisationholderandmanufacturer:

SPVETERINARIASA

CtraReusVinyolskm4.1

Riudoms(43330)

Spain

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Coccibal,200mg/mlsolutionforuseindrinkingwaterforchickensandturkeys

Amprolium(ashydrochloride)

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER

INGREDIENT(S)

Eachmloftheclearyellowsolutioncontains:

Activesubstance:

Amprolium(ashydrochloride)200mg

Excipient(s):

Sodiummethylparahydroxybenzoate(E219) 1mg

Sodiumpropylparahydroxybenzoate(E217) 0.2mg

4. INDICATION(S)

Chickens(broilers,pullets,layers,breederhens)andturkeys:treatmentofintestinal

coccidiosiscausedbyEimeriasppsusceptibletoamprolium.

5. CONTRAINDICATIONS

Noneknown

6. ADVERSEREACTIONS

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,please

informyourveterinarysurgeon.

7. TARGETSPECIES

Chickens(broilers,pullets,layers,breederhens)andturkeys

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

ADMINISTRATION

Indrinkingwateruse..

Posologyforeachtargetspeciesis20mgamprolium/kgb.w.adayfor5-7

consecutivedays

Forthepreparationofmedicatedwaterthebodyweightoftheanimalstobetreatedand

theiractualdailywaterconsumptionshouldbetakenintoaccount.Consumptionmay

varydependingonfactorslikeage,stateofhealth,breed,husbandrysystem.Toprovide

therequiredamountofveterinarymedicinalproductinmlperlitredrinkingwaterthe

followingcalculationshouldbemade:

0.1mltheproductperaveragebodyweight(kg)numberof

kgbodyweight Xoftheanimalstobe Xanimals

daily treated

--------------------------------------------------------------------------------------=mltheproduct

perlitre

Totalwaterconsumption(l)oftheherdatthepreviousdaydrinking

water

Sufficientaccesstothesystemofwatersupplyshouldbeavailablefortheanimalstobe

treatedtoensureadequatewaterconsumption.Noothersourceofdrinkingwater

shouldbeavailableduringthemedicationperiod.Medicateddrinkingwatershouldbe

replacedevery24hours.

Aftertheendofthemedicationperiodthewatersupplysystemshouldbecleaned

appropriatelytoavoidintakeofsub-therapeuticamountsoftheactivesubstance.

9. ADVICEONCORRECTADMINISTRATION

10.WITHDRAWALPERIOD

Chickens(broilers,

pullets, layers,

breederhens): Meatandoffal: Zerodays

Eggs: Zerodays

Turkeys: Meatandoffal: Zerodays

11.SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions

Shelf-lifeafterfirstopeningthecontainer:6months

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:24hours

Donotuseaftertheexpirydatestatedonthelabel.

12.SPECIALWARNING(S)

Specialwarningsforeachtargetspecies

Aswithanyantiparasiticide,frequentandrepeateduseofantiprotozoalsfromthesame

classmayleadtothedevelopmentofresistance.

Incaseofdetectionalackofefficacyduringtreatment,communicateittothenational

competentauthorities.

Specialprecautionsforuse

Specialprecautionsforuseinanimals

Theproductisnotintendedforapreventiveuse.

Thisproductshouldbereservedincaseofcoccidiosisoutbreaksduetonon-availability

ofvaccine,incaseoflackofefficacyofvaccineandinvaccinatedflocksifasevere

coccidialchallengeisdiagnosedbeforeimmunityhasfullydeveloped.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Thisisanirritantandcorrosiveproduct.Itcouldcauseairway,eyeandskinirritation.

Wearimperviousglovesandprotectiveglasseswhenhandlingtheproduct.

TheselectedprotectivegloveshavetosatisfythespecificationsofEUDirective

89/686/EECandthestandardEN374derivedfromit.

Avoidinhalationofvapours.

Avoidcontactwiththeskinandeyes.Inthecaseofcontactwithskinoreyes,washthe

affectedareawithcleanrunningwaterimmediatelyandremoveanycontaminated

clothes.Ifirritationpersists,seekmedicaladviceandshowthepackageleaflettothe

doctor.

Thisproductisharmfulwheningested.Incaseofaccidentalingestion,rinsethemouth

withfreshwater,seekmedicaladviceimmediatelyandshowthelabeltothedoctor.

Personwithknownhypersensitivitytotheactivesubstanceortoanyofexcipients,

shouldavoidcontactwiththeproduct.

Washhandsandexposedskinafteruse.

Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimalshavenotproducedanyevidenceofteratogeniceffects.

Thesafetyofamproliumhasnotbeeninvestigatedinlayingbirds.Useonlyaccordingto

therisk/benefitassessmentbytheresponsibleveterinarian.

Interactionwithothermedicinalproductsandotherformsofinteraction

Amproliumisathiamineanalogue.Therefore,theefficacyofamproliummaybe

reducedduringasimultaneousadministrationofproductscontainingvitaminB-complex.

Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Prolongedusescanproducethiaminedeficiencies

Shouldsymptomsappear,thiaminemustbeadministered.

Incompatibilities

Inabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixed

withotherveterinarymedicinalproduct.

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements

14.DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15.OTHERINFORMATION

Notallpacksizesmaybemarketed.

Packagesize:100ml,1Land5L

Presentations:1L,5L,12x1Lincardboardbox,4x5Lincardboardbox,10x100

mlincardboardboxwithleaflet

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Health Canada

17-11-2018

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Published on: Fri, 16 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐011 under Regulation (EC) No 1829/2003 from Monsanto Europe, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified soybean MON 89788, for food and feed uses, excluding cultivation within the European Union....

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

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

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

Published on: Fri, 16 Nov 2018 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 tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate 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 St...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Published on: Wed, 14 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐010 under Regulation (EC) No 1829/2003 from Bayer, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified LLCotton25, for food and feed uses, import and processing, excluding cultivation within the EU. The d...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Published on: Wed, 14 Nov 2018 The scope of application EFSA‐GMO‐DE‐2016‐133 is for food and feed uses, import and processing of genetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed to confer tolerance to the herbicidal active substances glyphosate and glufosinate‐ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and com...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

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

20-10-2018

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.03...

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

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

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

Published on: Mon, 01 Oct 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 cyflufenamid. To assess the occurrence of cyflufenamid 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 (in...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

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

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

25-6-2018

FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy

FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy

FDA approved Epidiolex (cannabidiol) oral solution, the first drug comprised of an active ingredient derived from marijuana, to treat two rare and severe forms of epilepsy.

FDA - U.S. Food and Drug Administration

24-5-2018

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

The FDA has approved Semintra (telmisartan oral solution), the first FDA-approved animal drug to control systemic hypertension in cats. Semintra is an oral solution administered either directly into the cat’s mouth or on top of a small amount of food.

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