EXCENEL RTU

Main information

  • Trade name:
  • EXCENEL RTU
  • Pharmaceutical form:
  • Suspension for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EXCENEL RTU
    Slovenia
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Cattle, SWINE

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0102/001
  • Authorization date:
  • 13-02-2012
  • EU code:
  • FR/V/0102/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

BG,CY,EL,ITandRO:

EXCENELFluidsuspension,50mg/ml,suspensionforinjectionforpigsandcattle

AT,DE,BE,LU,NL,FR,IE,SIandUK:

EXCENELFlow,50mg/ml,suspensionforinjectionforpigsandcattle

EE,LV,LT,PTandES:

EXCENELEvo,50mg/ml,suspensionforinjectionforpigsandcattle

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Ceftiofur(ashydrochloride) 50.0mg

Excipient(s):

Forthefulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Suspensionforinjection.

Opaquesuspension,whitetooff-white.

4. CLINICALPARTICULARS

4.1 Targetspecies

Pigsandcattle.

4.2 Indicationsforuse,specifyingthetargetspecies

Infectionsassociatedwithbacteriasensitivetoceftiofur:

Inpigs:

ForthetreatmentofbacterialrespiratorydiseaseassociatedwithPasteurellamultocida,Actinobacillus

pleuropneumoniaeandStreptococcussuis.

Incattle:

ForthetreatmentofbacterialrespiratorydiseaseassociatedwithMannheimiahaemolytica(former

Pasteurellahaemolytica),PasteurellamultocidaandHistophilussomni(formerHaemophilus

somnus).

Forthetreatmentofacuteinterdigitalnecrobacillosis(panaritium,footrot),associatedwith

FusobacteriumnecrophorumandBacteroidesmelaninogenicus(Porphyromonasasaccharolytica).

Fortreatmentofthebacterialcomponentofacutepost-partum(puerperal)metritiswithin10daysafter

calvingassociatedwithEscherichiacoli,ArcanobacteriumpyogenesandFusobacterium

necrophorum,sensitivetoceftiofur,weretreatmentwithanotherantimicrobialhasfailed.

4.3 Contraindications

Donotadministertoananimalpreviouslyfoundtobehypersensitivetoceftiofurandother 

-lactam

antibiotics.

Donotinjectintravenously.

Donotuseinpoultry(includingeggs)duetoriskofspreadofantimicrobialresistanceto

humans.

4.4 Specialwarningsforeachtargetspecies

Noneknown.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Shakethebottlewellbeforeusetobringtheproductbackintosuspension.

Incaseoftheoccurrenceofallergicreactionthetreatmentshouldbewithdrawn.

EXCENELFluidsuspension(orEXCENELFloworEvo)selectsforresistantstrainssuchasbacteria

carryingextendedspectrumbetalactamases(ESBL)whichmayconstitutearisktohumanhealthif

thesestrainsdisseminatetohumanse.g.viafood.Forthisreason,EXCENELFluidsuspension(or

EXCENELFloworEvo)shouldbereservedforthetreatmentofclinicalconditionswhichhave

respondedpoorly,orareexpectedtorespondpoorly(referstoveryacutecaseswhentreatmentmust

beinitiatedwithoutbacteriologicaldiagnosis),tomorenarrowspectrumantimicrobialsfirstline

treatment.Official,nationalandregionalantimicrobialpoliciesshouldbetakenintoaccountwhenthe

productisused.Increaseduse,includinguseoftheproductdeviatingfromtheinstructionsgiveninthe

SPC,mayincreasetheprevalenceofsuchresistancebacteriaresistanttoEXCENELFluidsuspension

(orEXCENELFloworEvo).Wheneverpossible,EXCENELFluidsuspension(orEXCENELFlow

orEvo)shouldonlybeusedbasedonsusceptibilitytesting.

Donotuseasprophylaxisincaseofretainedplacenta.

EXCENELFluidsuspension(orEXCENELFloworEvo)isintendedfortreatmentofindividual

animals.Donotusefordiseasepreventionorasapartofherdhealthprogrammes.Treatmentof

groupsofanimalsshouldbestrictlylimitedtoongoingdiseaseoutbreaksaccordingtotheapproved

conditionsofuse.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)followinginjection,inhalation,

ingestionorskincontact.Hypersensitivitytopenicillinsmayleadtocrossreactionstocephalosporins

andviceversa.Allergicreactionstothesesubstancesmayoccasionallybeserious.

Donothandlethisproductifyouknowyouaresensitised,orifyouhavebeenadvisednottowork

withsuchpreparations.

Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,youshouldseekmedicaladviceand

showthedoctorthiswarning.

Swellingoftheface,lipsoreyesordifficultywithbreathingaremoreserioussymptomsandrequire

urgentmedicalattention.

4.6 Adversereactions(frequencyandseriousness)

Hypersensitivityreactionsunrelatedtodosecanoccur.Allergicreactions(e.g.skinreactions,

anaphylaxia)mayoccasionallyoccur.

Inpigs,mildreactionsattheinjectionsite,suchasdiscolorationofthefasciaorfat,havebeen

observedinsomeanimalsforupto20daysafterinjection.

Incattle,firmnessandswellingwereobservedattheinjectionsiteafterSCinjectionofthetestarticle.

Mildtomoderatelocalchronicinflammationwasobservedinmostanimalsuntil42dayspost

injection.

4.7 Useduringpregnancy,lactationorlay

Eventhoughstudiesinlaboratoryanimalsshownoevidenceofteratogenesis,abortionorinfluenceon

reproduction,thereproductivesafetyofceftiofurhasnotbeenspecificallyinvestigatedinpregnant

sowsorcows.

Useonlyaccordingtoabenefit/riskassessmentbytheresponsibleveterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Beforeuse,shakethebottlevigorouslyforamaximumof60secondsoruntiltheproductappears

adequatelyresuspended.

Pigs:

3mgceftiofur/kgbw/dayfor3daysviaintramuscularroute,i.e.1ml/16kgbwateachinjection.

Notmorethan4mlshouldbeadministeredperinjectionsite.

Cattle:

Respiratorydisease:1mgceftiofur/kgbw/dayfor3to5daysbysubcutaneousinjection,i.e.1ml/50

kgbwateachinjection.

Acuteinterdigitalnecrobacillosis:1mg/kgbw/dayfor3daysbysubcutaneousinjection,i.e.1ml/50

kgbwateachinjection.

Acutepost-partummetritiswithin10daysaftercalving:1mg/kgbw/dayfor5consecutivedaysby

subcutaneousinjection,i.e.1ml/50kgbwateachinjection.

Notmorethan13mlshouldbeadministeredperinjectionsite.

Subsequentinjectionsmustbegivenatdifferentsites.

50mland100mlvialscanbebroachedamaximumof50times.250mlvialscanbebroacheda

maximumof33times.Otherwise,theuseofamultiple-dosesyringeisrecommended.

Incaseofacutepost-partummetritis,additionalsupportivetherapymightberequiredinsomecases.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Thelowtoxicityofceftiofurhasbeendemonstratedinpigsusingceftiofursodiumatdosesinexcess

of8timestherecommendeddailydoseofceftiofurintramuscularlyadministeredfor15consecutive

days.

Incattle,nosignsofsystemictoxicityhavebeenobservedfollowingsubstantialparenteral

overdosages.

4.11Withdrawalperiod(s)

Pigs:meatandoffal:2days.

Cattle:meatandoffal:6days;milk:zerodays.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,Third-generation

Cephalosporins.

ATCvetcode:QJ01DD90

5.1 Pharmacodynamicproperties

Ceftiofurisalategenerationcephalosporin,whichisactiveagainstmanyGram-positiveandGram-

negativebacteria.Ceftiofurinhibitsthebacterialcellwallsynthesis,therebyexertingbactericidal

properties.

Beta-lactamsactbyinterferingwithsynthesisofthebacterialcellwall.Cellwallsynthesisis

dependentonenzymesthatarecalledpenicillin-bindingproteins(PBP's).Bacteriadevelopresistance

tocephalosporinsbyfourbasicmechanisms:1)alteringoracquiringpenicillinbindingproteins

insensitivetoanotherwiseeffective 

-lactam;2)alteringthepermeabilityofthecellto 

-lactams;3)

producingb-lactamasesthatcleavethe 

-lactamringofthemolecule,or4)activeefflux.

Some 

-lactamases,documentedinGram-negativeentericorganisms,mayconferelevatedMICsto

varyingdegreestothirdandfourthgenerationcephalosporins,aswellaspenicillins,ampicillins, 

-

lactaminhibitorcombinations,andfirstandsecondgenerationcephalosporins.

Ceftiofurisactiveagainstthefollowingmicroorganismswhichareinvolvedinrespiratorydiseasesin

pigs:Pasteurellamultocida,ActinobacilluspleuropneumoniaeandStreptococcussuis.Bordetella

bronchisepticaisintrinsicallynon-susceptibletoceftiofur.

Itisalsoactiveagainstbacteriainvolvedinrespiratorydiseaseincattle:Pasteurellamultocida,

Mannheimiahaemolytica(formerPasteurellahaemolytica),Histophilussomni(formerHaemophilus

somnus);bacteriainvolvedinacutebovinefootrot(interdigitalnecrobacillosis)incattle:

Fusobacteriumnecrophorum,Bacteroidesmelaninogenicus(Porphyromonasasaccharolytica);and

bacteriaassociatedwithacutepost-partum(puerperal)metritisincattle:Escherichiacoli,

ArcanobacteriumpyogenesandFusobacteriumnecrophorum.

ThefollowingMinimumInhibitoryConcentrations(MIC)havebeendeterminedforceftiofurin

Europeanisolatesoftargetbacteria,isolatedfromdiseasedanimals:

Pigs

Organism(numberofisolates) MICrange(µg/mL) MIC

90 (µg/mL)

A.pleuropneumoniae(28)

0.03 *

0.03

Pasteurellamultocida(37)

0.03-0.13

0.03

Streptococcussuis(495)

0.03-0.25

0.03

Haemophilusparasuis(16)

0.03-0.13

0.03

Cattle

Organism(numberofisolates) MICrange(µg/mL) MIC

90 (µg/mL)

Mannheimiaspp.(87)

0.03 *

0.03

P.multocida(42)

0.03-0.12

0.03

H.somni(24)

0.03 *

0.03

Arcanobacteriumpyogenes(123)

0.03-0.5 0.25

Escherichiacoli(188) 0.13->32.0 0.5

Fusobacterium necrophorum

(67)(isolatesfromcasesoffootrot)

0.06-0.13 ND

Fusobacterium necrophorum

(2)(isolatesfromcasesofacutemetritis)

0.03-0.06 ND

*Norange;allisolatesyieldedthesamevalue.ND:notdetermined.

ThefollowingbreakpointsarerecommendedbyCLSIforbovineandporcinerespiratorypathogens

currentlyonthelabelforEXCENELFluidsuspension(orEXCENELFloworEvo):

ZoneDiameter(mm) MIC(μg/mL) Interpretation

≥21

2.0 (S)Susceptible

18-20 4.0 (I)Intermediate

17 ≥8.0

(R)Resistant

Nobreakpointshavebeendeterminedtodateforthepathogensassociatedwithfootrotoracutepost-

partummetritisincows.

5.2 Pharmacokineticparticulars

Afteradministration,ceftiofurisquicklymetabolisedtodesfuroylceftiofur,theprincipalactive

metabolite.

Desfuroylceftiofurhasanequivalentanti-microbialactivitytoceftiofuragainstthebacteriainvolved

inrespiratorydiseaseinanimals.Theactivemetaboliteisreversiblyboundtoplasmaproteins.Dueto

transportationwiththeseproteins,themetaboliteconcentratesatasiteofinfection,isactiveand

remainsactiveinthepresenceofnecrotictissueanddebris.

Inpigsgivenasingleintramusculardoseof3mg/kgbodyweight(bw),maximumplasma

concentrationsof11.8±1.67µg/mLwerereachedafter1hour;theterminaleliminationhalf-life(t½)

ofdesfuroylceftiofurwas16.7±2.3hours.Noaccumulationofdesfuroylceftiofurhasbeenobserved

afteradoseof3mgceftiofur/kgbw/dayadministereddailyover3days.

Theeliminationoccurredmainlyviatheurine(morethan70%).Averagerecoveriesinfaeces

accountedforapproximately12-15%ofthedrug.

Ceftiofuriscompletelybioavailablefollowingintramuscularadministration.

Afterasingle1mg/kgdosegivensubcutaneouslytocattle,maximumplasmalevelsof2.85±1.11

µg/mLarereachedwithin2hoursafteradministration.Inhealthycows,aCmaxof2.25±0.79µg/mL

wasreachedintheendometrium5±2hoursafterasingleadministration.Maximumconcentrations

reachedincarunclesandlochiaeofhealthycowswere1.11±0.24µg/mLand0.98±0.25µg/mL,

respectively.

Theterminaleliminationhalf-life(t½)ofdesfuroylceftiofurincattleis11.5±2.57hours.No

accumulationwasobservedafteradailytreatmentover5days.Theeliminationoccurredmainlyvia

theurine(morethan55%);31%ofthedosewasrecoveredinthefaeces.

Ceftiofuriscompletelybioavailablefollowingsubcutaneousadministration.

5.3 Environmentalproperties

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Polysorbate80

TriglyceridesMedium-chain

Waterforinjections

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:18month.

Shelf-lifeafterfirstbroachingofthecontainer:28days.

6.4.Specialprecautionsforstorage

Donotstoreabove25°C.

6.5 Natureandcompositionofimmediatepackaging

Cardboardboxwith1glassvial(TypeI)of50,100or250ml.

Cardboardboxwith10glassvials(TypeI)of50or100ml.

50and100mlvialshaveachlorobutylstopperandanaluminiumoversealwithplasticflip-offcap.

250mlvialhasabromobutylstopperandanaluminiumoversealwithapull-offcap.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

{Nameandaddress}

<{tel}>

<{fax}>

<{e-mail}>

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

<{DD/MM/YYYY}><{DDmonthYYYY}>…

10 DATEOFREVISIONOFTHETEXT

{MM/YYYY}or<monthYYYY>

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

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FDA - U.S. Food and Drug Administration

17-7-2018

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FDA - U.S. Food and Drug Administration

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Econor (Elanco GmbH)

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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

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

1-11-2018

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

25-9-2018

Voriconazole Hikma (Hikma FarmacEutica (Portugal), S.A.)

Voriconazole Hikma (Hikma FarmacEutica (Portugal), S.A.)

Voriconazole Hikma (Active substance: voriconazole) - Centralised - Yearly update - Commission Decision (2018)6286 of Tue, 25 Sep 2018

Europe -DG Health and Food Safety

19-9-2018

Targretin (Eisai GmbH)

Targretin (Eisai GmbH)

Targretin (Active substance: bexarotene) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6098 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/326/T/50

Europe -DG Health and Food Safety

18-9-2018

 Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

This third meeting between regulators and representatives of industry stakeholder organisations addresses all areas of product-development support, including scientific advice, specifics for paediatric and orphan medicines and support for innovation. The meeting focuses on the implementation of the orphan notice, ‘histology-independent indications’ in the context of orphan designations, the upcoming rollout of a new tool for orphan designation applications, digital technology proposals in medicine develo...

Europe - EMA - European Medicines Agency

17-9-2018

The #FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development and review of their device proposals to prevent and treat opioid u

The #FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development and review of their device proposals to prevent and treat opioid u

The #FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development and review of their device proposals to prevent and treat opioid use disorder. #FDA

FDA - U.S. Food and Drug Administration

12-9-2018

 Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

This information day will update participants on the Agency’s medicine risk management activities and provide advice to marketing authorisation holders and applicants on drafting a risk management plan (RMP) in view of the full implementation of the second revision of the RMP template after the transitional period has elapsed. It will also provide an opportunity for an exchange of experiences with this template between regulators and industry. A dedicated session will discuss the streamlining of safety s...

Europe - EMA - European Medicines Agency

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

7-8-2018

Research: Software as a Medical Device and Cyber Security for Medical Devices

Research: Software as a Medical Device and Cyber Security for Medical Devices

Opportunity to participate in CSIRO research to inform new Australian medical device industry guidance

Therapeutic Goods Administration - Australia

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

23-7-2018

Optruma (Eli Lilly Nederland B.V.)

Optruma (Eli Lilly Nederland B.V.)

Optruma (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4893 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

16-7-2018

On July 25th, the FDA will host a webinar to provide developers and interested applicants an opportunity to hear from the FDA and answer questions about the #FDAInnovationChallenge. Click the link for more information  http://go.usa.gov/xQvE9 pic.twitter.

On July 25th, the FDA will host a webinar to provide developers and interested applicants an opportunity to hear from the FDA and answer questions about the #FDAInnovationChallenge. Click the link for more information http://go.usa.gov/xQvE9 pic.twitter.

On July 25th, the FDA will host a webinar to provide developers and interested applicants an opportunity to hear from the FDA and answer questions about the #FDAInnovationChallenge. Click the link for more information http://go.usa.gov/xQvE9  pic.twitter.com/kT7EqyTPxr

FDA - U.S. Food and Drug Administration

16-7-2018

#FDA’s comprehensive plan that places nicotine and the issue of addiction at the center of our tobacco efforts. I’m optimistic about the opportunity to forge a new path for a heathier America. Learn more about the plan and how to submit public comments:

#FDA’s comprehensive plan that places nicotine and the issue of addiction at the center of our tobacco efforts. I’m optimistic about the opportunity to forge a new path for a heathier America. Learn more about the plan and how to submit public comments:

#FDA’s comprehensive plan that places nicotine and the issue of addiction at the center of our tobacco efforts. I’m optimistic about the opportunity to forge a new path for a heathier America. Learn more about the plan and how to submit public comments: https://go.usa.gov/xQ7Jb  pic.twitter.com/hQxiKdMZBK

FDA - U.S. Food and Drug Administration

12-7-2018

Econor (Elanco Europe Ltd)

Econor (Elanco Europe Ltd)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4580 of Thu, 12 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Active substance: duloxetine hydrochloride) - Centralised - Withdrawal - Commission Decision (2018)4515 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency

3-7-2018

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4254 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/896/T/90

Europe -DG Health and Food Safety

3-7-2018

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4249 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1235/T/77

Europe -DG Health and Food Safety

3-7-2018

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4252 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/862/T/93

Europe -DG Health and Food Safety

3-7-2018

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4251 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/861/T/90

Europe -DG Health and Food Safety