SURAMOX/STABOX

Main information

  • Trade name:
  • SURAMOX/STABOX 50% OSP Pig
  • Pharmaceutical form:
  • Powder for oral suspension
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SURAMOX/STABOX 50% OSP Pig
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • amoxicillin
  • Therapeutic area:
  • Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0120/001
  • Authorization date:
  • 24-07-2011
  • EU code:
  • FR/V/0120/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

[Version7.2,12/2009]

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

SURAMOX/STABOX50%ww/wwPowderforOralSolutionforPigs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachgramcontains:

Activesubstance:

Amoxicillin(astrihydrateform).............................500.00mg

Excipient(s):

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Powderfororalsolution.

Whitetoalmostwhiteandslightlygranularpowder.

4. CLINICALPARTICULARS

4.1 Targetspecies

Pig(pigsafterweaning).

4.2 Indicationsforuse,specifyingthetargetspecies

TreatmentofswinepleuropneumoniaduetoActinobacilluspleuropneumoniae(susceptibleto

amoxicillin).

4.3 Contraindications

Donotuseinanimalswithknownhypersensitivitytopenicillinsorothersubstancesofthe

ß-lactamgroup.

Donotuseinanimalswithseriouskidneymalfunctionincludinganuriaandoliguria.

Presenceofβ-lactamaseproducingbacteria.

Donotuseinlagomorphsandrodentssuchasrabbits,guineapigs,hamstersorgerbils.

Donotuseinruminantsorhorses.

4.4 Specialwarningsforeachtargetspecies

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Theuptakeofmedicationbyanimalscanbealteredasaconsequenceofillness.Incaseofinsufficient

uptakeoffeed/wateranimalsshouldbetreatedparenterally.

Useoftheproductshouldbebasedonsusceptibilitytestingofthebacteriaisolatedfromtheanimal.

Ifthisisnotpossible,therapyshouldbebasedonlocal(regional,farmlevel)epidemiologicalinformation

aboutsusceptibilityofthetargetbacteria.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincreasetheprevalenceof

bacteriaresistanttoamoxicillin.

Narrowspectrumantibacterialtherapyshouldbeusedforfirstlinetreatmentwheresusceptibility

testingsuggestthelikelyefficacyofthisapproach.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)followinginjection,inhalation,

ingestionorskincontact.Hypersensitivitytopenicillinsmayleadtocrossreactionsto

cephalosporinsandviceversa.Allergicreactionstothesesubstancesmayoccasionallybe

serious.

Donothandlethisproductifyouknowyouaresensitised,orifyouhavebeenadvisednottowork

withsuchpreparations.

Handlethisproductwithgreatcaretoavoidexposure,takingallrecommendedprecautions.Ifyou

developsymptomsfollowingexposuresuchasaskinrash,youshouldseekmedicaladviceand

showthedoctorthiswarning.Swellingoftheface,lipsoreyesordifficultywithbreathing,are

moreserioussymptomsandrequireurgentmedicalattention.

Useinhalationprotectionandglovesduringpreparation.

Useglovesduringtheadministrationoftheliquidfeedtothepigs.

Washtheexposedskin.

Avoidintroductionofcontaminationduringtheadministrationoftheproduct.

4.6 Adversereactions(frequencyandseriousness)

Penicillinsandcephalosporinsmaycausehypersensitivityfollowingadministration.Allergicreactionsto

thesesubstancesmayoccasionallybeserious.

4.7 Useduringpregnancy,lactationorlay

StudiesperformedinLaboratoryanimals(rat,rabbit),didnotshowateratogenic,embryotoxicor

maternotoxiceffectofamoxicillin.Safetyoftheproductinthepregnantandlactatingsowswasnot

demonstrated..Useonlyaccordinglytothebenefit/riskassessmentbytheresponsibleveterinarian

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Thebactericidaleffectofamoxicillinisneutralizedbysimultaneoususeofpharmaceuticalswith

bacteriostaticmodeofaction.

Nottobeusedsimultaneouslywithneomycinsinceitblockstheabsorptionoforalpenicillins.

4.9 Amountstobeadministeredandadministrationroute

20mgofamoxicillin(astrihydrate)perkgbodyweightdaily(i.e.400mgoftheproductper10

kgbodyweightperday),administeredfor5consecutivedaysorallyinliquidfeed.

Shaketheproductcontainerwellbeforeuse.

Afterdilutionoftheproductinasmallquantityofwater,thedilutionmustbemixedintheliquid

mealuntilhomogenous.

Wheneverpossible,therequiredamountofproductshouldbeaccuratelyweighedbytheuser.

Thecorrectdoseoftheproductcanalsobemeasuredusingthe5gmeasuringspoonwithpack

sizesof50,100and200gand8gmeasuringspoonwithpacksizesof500,1000,1500and3000

g,accordingtothefollowingrecommendations:

Alevel5gmeasuringspoonholds5gofproduct,i.e.theamountofproducttotreat125kg

ofbodyweightperday.

Alevel8gmeasuringspoonholds8gofproduct,i.e.theamountofproducttotreat200kg

ofbodyweightperday.

Useincommercialfeedonly

Toensureacorrectdosagebodyweightshouldbedetermniedasaccuratelyaspossibletoavoid

underdosing.Theintakeofmedicatedfeeddependsontheclinicalconditionoftheanimals.Inorderto

obtainthecorrectdosagetheconcentrationofSuramoxhastobeadjustedaccordingly.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Nosideeffectswereobservedafteradministrationat5timestherecommendeddosage.

4.11Withdrawalperiod(s)

Meatandoffal:14days.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Penicillinswithextendedspectrum.

ATCvetcode:QJ01CA04

5.1 Pharmacodynamicproperties

Amoxicillinisasemi-syntheticpenicillinderivedfromthe6APAcore(6amino-penicillicacid).Itisa

broadspectrumantibiotic,bactericidalagainstGram+andGram-bacteria,inparticularActinobacillus

pleuropneumoniae,isolatedinpigs.

Amoxicillinactsbyinhibitionofbacterialcellwallsynthesisoractivationofenzymesdisruptingcell

walls(bactericidalaction).

5.2 Pharmacokineticparticulars

Inpigs,aftertheadministrationoftheproductatadoseof20mg/kginliquidfeed,amoxicillinmaximal

plasmaconcentrationof2.0µg/mlisreached1.8hoursaftertheadministration.Therepeated

administrationofthedrugdoesnotleadtoaccumulation.Theaverageabsolutebioavailabilityof

amoxicillininliquidfeedisestimatedtobe12%.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Sodiumglycinecarbonate,

Colloidalanhydroussilica,

Vanillin,

Sodiumhexametaphospate.

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinaryproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterfirstopeningthecontainer:10days

Shelf-lifeafterdissolutioninliquidfeed:2hours.

6.4.Specialprecautionsforstorage

Thismedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5 Natureandcompositionofimmediatepackaging

1boxwith50ghighdensitypolyethylenejarhermeticallyclosedbythermosealedaluminium

polyethylenesealandoverscrewcap,withaspoon.

1boxwith100ghighdensitypolyethylenejarhermeticallyclosedbythermosealedaluminium

polyethylenesealandoverscrewcap,withaspoon.

200ghighdensitypolyethylenejarhermeticallyclosedbythermosealedaluminiumpolyethylene

sealandoverscrewcap,withaspoon.

500and1000ghighdensitypolyethylenejarshermeticallyclosedbythermosealedaluminium

polyethylenesealandoverscrewcap,withaspoon.

1500and3000ghighdensitypolyethylenebarrelsclosedhermeticallybyscrewcapsequippedwith

aninternalrubbersealandanexternalsecuritycompactsealwithaspoon.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

VIRBACS.A.–1 ère

avenue-2065mL.I.D.-F-06516Carros-France

Tel:+33492087304

Fax:+33492087348

e-mail: dar@virbac.fr

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateofthefirstauthorisation:22February2001.

Dateoflastrenewal:10/01/2005.

10 DATEOFREVISIONOFTHETEXT

ANNEXIII

LABELLINGANDPACKAGELEAFLET

A.LABELLING

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Boxof50gor100g

Jarof200gor500gor1kg

Barrelof1,5kgor3kg

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Suramox/Stabox50%ww/wwPowderforOralSolutionforPigs

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachgramcontains:

Amoxicillin(astrihydrateform).............................500.00 mg

3. PHARMACEUTICALFORM

Powderfororalsolution.

4. PACKAGESIZE

50g

100g

200g

500g

1kg

1,5kg

3kg

5. TARGETSPECIES

Pig.

6. INDICATION(S)

Readthepackageleafletbeforeuse.

Ifyounoticeseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyourveterinary

surgeon.

7. METHODANDROUTE(S)OFADMINISTRATION

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Meatandoffal:14days.

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossibletoavoid

underdosing.Theintakeofmedicatedfeeddependsontheclinicalconditionoftheanimal.Inorderto

obtainthecorrectdosagetheconcentrationofSuramoxhastobeadjustedaccordingly.

10. EXPIRYDATE

EXP:{month/year}

Onceopened,usewithin10days.

Afterdissolutioninliquidfeed,usewithin2hours.

11. SPECIALSTORAGECONDITIONS

Readthepackageleafletbeforeuse.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Readthepackageleafletbeforeuse.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

VIRBACS.A.

ère

avenue-2065m-L.I.D.

F-06516Carros

France

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Batch:{number}

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGING

UNITS

Jarof50gor100g

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Suramox/Stabox50%ww/wwPowderforOralSolutionforPigs

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

Eachgramcontains:

Amoxicillin(astrihydrateform).............................500.00 mg

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

50g

100g

4. ROUTE(S)OFADMINISTRATION

Oraluse.

5. WITHDRAWALPERIOD

Meatandoffal:14days.

6. BATCHNUMBER

Batch:{number}

7. EXPIRYDATE

EXP:{month/year}

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

Readthepackageleafletbeforeuse.

B.PACKAGELEAFLET

PACKAGELEAFLET

SURAMOX/STABOX50%ww/wwPowderforOralSolutionforPigs

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder:

VIRBACS.A.

1èreavenue–2065M–L.I.D.

F-06516Carros

France

Marketingauthorisationmanufacturerforthebatchrelease:

VIRBAC

8-10ruedesAulnaies

95420Magny-En-Vexin

France

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

SURAMOX/STABOX50%ww/wwPowderforOralSolutionforPigs

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Eachgramcontains:

Activesubstance:

Amoxicillin(astrihydrateform).............................500.00 mg

4. INDICATION(S)

TreatmentofswinepleuropneumoniaduetoActinobacilluspleuropneumoniae(susceptibleto

amoxicillin).

5. CONTRAINDICATIONS

Donotuseinanimalswithknownhypersensitivitytopenicillinsorothersubstancesofthe

ß-lactamgroup.

Donotuseinanimalswithseriouskidneymalfunctionincludinganuriaandoliguria.

Presenceofβ-lactamaseproducingbacteria.

Donotuseinlagomorphsandrodentssuchasrabbits,guineapigs,hamstersorgerbils.

Donotuseinruminantsorhorses.

6. ADVERSEREACTIONS

Penicillinsandcephalosporinsmaycausehypersensitivityfollowingadministration.Allergicreactionsto

thesesubstancesmayoccasionallybeserious.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Pig(pigsafterweaning).

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

20mgofamoxicillin(astrihydrate)perkgbodyweightdaily(i.e.400mgoftheproductper10kg

bodyweightperday),administeredfor5consecutivedaysorallyinliquidfeed.

9. ADVICEONCORRECTADMINISTRATION

Shaketheproductcontainerwellbeforeuse.

Afterdilutionoftheproductinasmallquantityofwater,thedilutionmustbemixedintheliquid

mealuntilhomogenous.

Wheneverpossible,therequiredamountofproductshouldbeaccuratelyweighedbytheuser.

Thecorrectdoseoftheproductcanalsobemeasuredusingthe5gmeasuringspoonwithpack

sizesof50,100and200gand8gmeasuringspoonwithpacksizesof500,1000,1500and3000

g,accordingtothefollowingrecommendations:

Alevel5gmeasuringspoonholds5gofproduct,i.e.theamountofproducttotreat125kg

ofbodyweightperday.

Alevel8gmeasuringspoonholds8gofproduct,i.e.theamountofproducttotreat200kg

ofbodyweightperday.

Useincommercialfeedonly

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossibletoavoid

underdosing.Theintakeofmedicatedfeeddependsontheclinicalconditionoftheanimals.Inorderto

obtainthecorrectdosagetheconcentrationofSuramoxhastobeadjustedaccordingly.

10. WITHDRAWALPERIOD

Meatandoffal:14days.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

DonotuseaftertheexpirydatewhichisstatedonthelabelandcartonafterEXP.

Shelf-lifeafterfirstopeningthecontainer:10days

Shelf-lifeafterdissolutioninliquidfeed:2hours.

12. SPECIALWARNING(S)

Specialprecautionsforuseinanimals

Theuptakeofmedicationbyanimalscanbealteredasaconsequenceofillness.Incaseofinsufficient

uptakeoffeed/wateranimalsshouldbetreatedparenterally.

Useoftheproductshouldbebasedonsusceptibilitytestingofthebacteriaisolatedfromtheanimal.If

thisisnotpossible,therapyshouldbebasedonlocal(regional,farmlevelepidemiologicalinformation

aboutsusceptibilityofthetargetbacteria.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincreasetheprevalenceof

bacteriaresistanttoamoxicillin

Narrowspectrumantibacterialtherapyshouldbeusedforfirstlinetreatmentwheresusceptibility

testingsuggestthelikelyefficacyofthisapproach.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)followinginjection,inhalation,

ingestionorskincontact.Hypersensitivitytopenicillinsmayleadtocrossreactionsto

cephalosporinsandviceversa.Allergicreactionstothesesubstancesmayoccasionallybe

serious.

Donothandlethisproductifyouknowyouaresensitised,orifyouhavebeenadvisednottowork

withsuchpreparations.

Handlethisproductwithgreatcaretoavoidexposure,takingallrecommendedprecautions.Ifyou

developsymptomsfollowingexposuresuchasaskinrash,youshouldseekmedicaladviceand

showthedoctorthiswarning.Swellingoftheface,lipsoreyesordifficultywithbreathing,are

moreserioussymptomsandrequireurgentmedicalattention.

Useinhalationprotectionandglovesduringpreparation.

Useglovesduringtheadministrationoftheliquidfeedtothepigs.

Washtheexposedskin.

Avoidintroductionofcontaminationduringtheadministrationoftheproduct.

Useduringpregnancy,lactationorlay

StudiesperformedinLaboratoryanimals(rat,rabbit),didnotshowateratogenic,embryotoxicor

maternotoxiceffectofamoxicillin.Safetyoftheproductinthepregnantandlactatingsowswasnot

demonstrated.Useonlyaccordinglytothebenefit/riskassessmentbytheresponsibleveterinarian

Interactionwithothermedicinalproductsandotherformsofinteraction

Thebactericidaleffectofamoxicillinisneutralizedbysimultaneoususeofpharmaceuticalswith

bacteriostaticmodeofaction.

Nottobeusedsimultaneouslywithneomycinsinceitblockstheabsorptionoforalpenicillins.

Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Nosideeffectswereobservedafteradministrationat5timestherecommendeddosage.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalnationalrequirements.

14. DATEONWICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

1boxwitha50gjar,withaspoon.

1boxwitha100g,jarwithaspoon.

200gjar,withaspoon.

500and1000gjars,withaspoon.

1500and3000gbarrelswithaspoon.

Notallpacksizesmaybemarketed.

Whenthecontainerisopenedforthefirsttime,usingtheinuseshelf-lifewhichisspecifiedonthis

packageleaflet,thedateonwhichanyproductremaininginthecontainershouldbediscardedshould

beworkedout.Thisdiscarddateshouldbewritteninthespaceprovidedonthelabel.”

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7K and Poseidon 4500 by Shoreside Enterprises: Voluntary Recall - Due to Presence of Undeclared Sildenafil and/or Tadalafil

Use of products with the undeclared active ingredients, sildenafil and tadalafil, may pose a threat to consumers because the active ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are the most at risk from these products. These products are considered ta...

FDA - U.S. Food and Drug Administration

18-5-2018

Unauthorized prescription antibiotic drugs seized from Gigi's Market in Ottawa, ON, may pose serious health risks

Unauthorized prescription antibiotic drugs seized from Gigi's Market in Ottawa, ON, may pose serious health risks

Health Canada has seized four unauthorized drugs from Gigi’s Market, 23 Montreal Road, Ottawa, ON. The products (Ampicillin, Kamox, Medampi and Medomox) are labelled to contain antibiotic drugs (ampicillin or amoxicillin) that can only be dispensed by a healthcare professional to a patient with a valid prescription. The products listed below have not been evaluated by Health Canada for safety, effectiveness or quality and may pose serious health risks.

Health Canada

17-5-2018

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil

Shoreside Enterprises, Inc. is voluntarily recalling 7K (Lot specific: Lot #RO) and Poseidon 4500 (Extreme 1000 mg) (Lot specific: Lot #20117BL) to the consumer level. FDA analysis found the samples of these products to contain undeclared Sildenafil and/or Tadalafil. Sildenafil and Tadalafil are active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED).

FDA - U.S. Food and Drug Administration

18-4-2018

ViaGro 500mg Male Enhancement capsules

ViaGro 500mg Male Enhancement capsules

Safety advisory

Therapeutic Goods Administration - Australia

14-4-2018

'Rhino 69 Extreme 50000' Recalled due to Presence of Active Ingredient 'Tadalafil'

'Rhino 69 Extreme 50000' Recalled due to Presence of Active Ingredient 'Tadalafil'

AMA Wholesale Inc. (Distributor/Re-seller), is voluntarily recalling Rhino 69 Extreme 50000 capsules to the consumer level. FDA analysis found the product to be tainted with undeclared tadalafil. Tadalafil is an active ingredient in a FDA-approved prescription drug that is used for erectile dysfunction.

FDA - U.S. Food and Drug Administration

28-3-2018

Public Notification: Rhino 69 Extreme 50000 contains hidden drug ingredient

Public Notification: Rhino 69 Extreme 50000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Rhino 69 Extreme 50000, a product promoted and sold for sexual enhancement on various websites, including www.bonanza.com, and possibly in some retail stores.

FDA - U.S. Food and Drug Administration

25-9-2017

Global operation against illegal medicines

Global operation against illegal medicines

A global operation against illegal medicines has been completed. 123 countries participated, and the operation resulted in 354 arrests or further investigations and the suspension of more than 3,500 websites.

Danish Medicines Agency

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

20-11-2018

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more:  https://go.usa.gov/xP

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xP

. @US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xPAtn  #MedicalDevice #FDA pic.twitter.com/6e064UQ2wg

FDA - U.S. Food and Drug Administration