TRULEVA RTU

Main information

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

Documents

Localization

  • Available in:
  • TRULEVA RTU
    Italy
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Ceftiofur
  • Therapeutic area:
  • Cattle, Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0221/001
  • Authorization date:
  • 30-07-2010
  • EU code:
  • FR/V/0221/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

IT:

TRULEVAFluidsuspension,50mg/ml,suspensionforinjectionforpigsandcattle

DE,BE,FRandUK:

TRULEVAFlow,50mg/ml,suspensionforinjectionforpigsandcattle

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Ceftiofur(ashydrochloride) 50.0mg

Excipient(s):

Forthefulllistofexcipients,seesection6.1

3.PHARMACEUTICALFORM

Suspensionforinjection.

Opaquesuspension,whitetooff-white.

4.CLINICALPARTICULARS

4.1Targetspecies

Pigsandcattle.

4.2Indicationsforuse,specifyingthetargetspecies

Infectionsassociatedwithbacteriasensitivetoceftiofur:

Inpigs:

ForthetreatmentofbacterialrespiratorydiseaseassociatedwithPasteurellamultocida,Actinobacillus

pleuropneumoniaeandStreptococcussuis.

Incattle:

ForthetreatmentofbacterialrespiratorydiseaseassociatedwithMannheimiahaemolytica(former

Pasteurellahaemolytica),PasteurellamultocidaandHistophilussomni(formerHaemophilussomnus).

Forthetreatmentofacuteinterdigitalnecrobacillosis(panaritium,footrot),associatedwith

FusobacteriumnecrophorumandBacteroidesmelaninogenicus(Porphyromonasasaccharolytica).

Fortreatmentofthebacterialcomponentofacutepost-partum(puerperal)metritiswithin10daysafter

calvingassociatedwithEscherichiacoli,ArcanobacteriumpyogenesandFusobacteriumnecrophorum,

sensitivetoceftiofur,wheretreatmentwithanotherantimicrobialhasfailed.

4.3Contraindications

Donotadministertoananimalpreviouslyfoundtobehypersensitivetoceftiofurandother 

-lactam

antibiotics.

Donotinjectintravenously.

Donotuseincaseswhereresistancetoothercephalosporinsorbeta-lactamantibioticshasoccurred.

Donotuseinpoultry(includingeggs)duetoriskofspreadofantimicrobialresistancetohumans.

4.4Specialwarningsforeachtargetspecies

Noneknown.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Shakethebottlewellbeforeusetobringtheproductbackintosuspension.

Incaseoftheoccurrenceofallergicreactionthetreatmentshouldbewithdrawn.

TRULEVAFluidsuspension(orFlow)selectsforresistantstrainssuchasbacteriacarryingextended

spectrumbetalactamases(ESBL)whichmayconstitutearisktohumanhealthifthesestrains

disseminatetohumanse.g.viafood.Forthisreason,TRULEVAFluidsuspension(orFlow)shouldbe

reservedforthetreatmentofclinicalconditionswhichhaverespondedpoorly,orareexpectedto

respondpoorly(referstoveryacutecaseswhentreatmentmustbeinitiatedwithoutbacteriological

diagnosis),tomorenarrowspectrumantimicrobialsfirstlinetreatment.Official,nationalandregional

antimicrobialpoliciesshouldbetakenintoaccountwhentheproductisused.Increaseduse,including

useoftheproductdeviatingfromtheinstructionsgivenintheSPC,mayincreasetheprevalenceof

suchresistancebacteriaresistanttoTRULEVAFluidsuspension(orFlow).Wheneverpossible,

TRULEVAFluidsuspension(orFlow)shouldonlybeusedbasedonsusceptibilitytesting.

Donotuseasprophylaxisincaseofretainedplacenta.

TRULEVAFluidsuspension(orFlow)isintendedfortreatmentofindividualanimals.Donotusefor

diseasepreventionorasapartofherdhealthprogrammes.Treatmentofgroupsofanimalsshouldbe

strictlylimitedtoongoingdiseaseoutbreaksaccordingtotheapprovedconditionsofuse.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincreasetheprevalenceof

bacteriaresistancetoceftiofurandmaydecreasetheeffectivenessoftreatmentwithother

cephalosporins,duetothepotentialforcrossresistance.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductsto

animals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)followinginjection,inhalation,

ingestionorskincontact.Hypersensitivitytopenicillinsmayleadtocrossreactionstocephalosporins

andviceversa.Allergicreactionstothesesubstancesmayoccasionallybeserious.

Donothandlethisproductifyouknowyouaresensitised,orifyouhavebeenadvisednottowork

withsuchpreparations.

Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,youshouldseekmedicaladviceand

showthedoctorthiswarning.

Swellingoftheface,lipsoreyesordifficultywithbreathingaremoreserioussymptomsandrequire

urgentmedicalattention.

4.6Adversereactions(frequencyandseriousness)

Hypersensitivityreactionsunrelatedtodosecanoccur.Allergicreactions(e.g.skinreactions,

anaphylaxia)mayoccasionallyoccur.

Inpigs,mildreactionsattheinjectionsite,suchasdiscolorationofthefasciaorfat,havebeen

observedinsomeanimalsforupto20daysafterinjection.

Incattle,firmnessandswellingwereobservedattheinjectionsiteafterSCinjectionofthetestarticle.

Mildtomoderatelocalchronicinflammationwasobservedinmostanimalsuntil42dayspost

injection.

4.7Useduringpregnancy,lactationorlay

Eventhoughstudiesinlaboratoryanimalsshownoevidenceofteratogenesis,abortionorinfluenceon

reproduction,thereproductivesafetyofceftiofurhasnotbeenspecificallyinvestigatedinpregnant

sowsorcows.

Useonlyaccordingtoabenefit/riskassessmentbytheresponsibleveterinarian.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

ThebactericidalpropertiesofBeta-lactamsareneutralisedbysimultaneoususeofbacteriostatic

antibiotics(macrolides,sulfonamidesandtetracyclines).

4.9Amount(s)tobeadministeredandadministrationroute

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.

Incaseofacutepost-partummetritis,additionalsupportivetherapymightberequiredinsomecases.

Subsequentinjectionsmustbegivenatdifferentsites.

50mland100mlvialscanbebroachedamaximumof50times.250mlvialscanbebroacheda

maximumof33times.Otherwise,theuseofamultiple-dosesyringeisrecommended.

Toensureacorrectdosage,bodyweightshouldbedeterminedasaccuratelyaspossibletoavoid

underdosing.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Thelowtoxicityofceftiofurhasbeendemonstratedinpigsusingceftiofursodiumatdosesinexcess

of8timestherecommendeddailydoseofceftiofurintramuscularlyadministeredfor15consecutive

days.

Incattle,nosignsofsystemictoxicityhavebeenobservedfollowingsubstantialparenteral

overdosages.

4.11Withdrawalperiods

Pigs:meatandoffal:2days.

Cattle:meatandoffal:6days;milk:zerodays.

5.PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,Third-generationCephalosporins.

ATCvetcode:QJ01DD90

5.1Pharmacodynamicproperties

Ceftiofurisalategenerationcephalosporin,whichisactiveagainstmanyGram-positiveandGram-

negativebacteria.Ceftiofurinhibitsthebacterialcellwallsynthesis,therebyexertingbactericidal

properties.

Beta-lactamsactbyinterferingwithsynthesisofthebacterialcellwall.Cellwallsynthesisis

dependentonenzymesthatarecalledpenicillin-bindingproteins(PBP's).Bacteriadevelopresistance

tocephalosporinsbyfourbasicmechanisms:1)alteringoracquiringpenicillinbindingproteins

insensitivetoanotherwiseeffective 

-lactam;2)alteringthepermeabilityofthecellto 

-lactams;3)

producing 

-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

currentlyonthelabelforTRULEVAFluidsuspension(orFlow):

ZoneDiameter(mm) MIC(μg/mL) Interpretation

≥21

2.0 (S)Susceptible

18-20 4.0 (I)Intermediate

17 ≥8.0

(R)Resistant

Nobreakpointshavebeendeterminedtodateforthepathogensassociatedwithfootrotoracutepost-

partummetritisincows.

5.2Pharmacokineticparticulars

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.

6.PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Polysorbate80

TriglyceridesMedium-chain

Waterforinjections

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

6.3Shelf-life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:18month.

Shelf-lifeafterfirstbroachingofthecontainer:28days.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofimmediatepackaging

Cardboardboxwith1glassvial(TypeI)of50,100or250ml.

Cardboardboxwith10glassvials(TypeI)of50or100ml.

50and100mlvialshaveachlorobutylstopperandanaluminiumoversealwithplasticflip-offcap.

250mlvialhasabromobutylstopperandanaluminiumoversealwithapull-offcap.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductsorwaste

materialsderivedfromtheuseofsuchproducts,ifappropriate

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements.

7.MARKETINGAUTHORISATIONHOLDER

{Nameandaddress}

<{tel}>

<{fax}>

<{e-mail}>

8.MARKETINGAUTHORISATIONNUMBER

Tobecompletednationally.

9.DATEOFTHEFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

28September2010

10.DATEOFREVISIONOFTHETEXT

{MM/YYYY}or<monthYYYY>

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

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Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

31-5-2018

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. is voluntarily recalling one (1) lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer level. The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint.

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

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

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

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

19-6-2018

New information about #FDAPrecert and opportunity for public input now available-  https://go.usa.gov/xQJmG  #DigitalHealth #MedicalDevice #mhealth

New information about #FDAPrecert and opportunity for public input now available- https://go.usa.gov/xQJmG  #DigitalHealth #MedicalDevice #mhealth

New information about #FDAPrecert and opportunity for public input now available- https://go.usa.gov/xQJmG  #DigitalHealth #MedicalDevice #mhealth

FDA - U.S. Food and Drug Administration

4-6-2018

Eliquis (Bristol-Myers Squibb/Pfizer EEIG)

Eliquis (Bristol-Myers Squibb/Pfizer EEIG)

Eliquis (Active substance: apixaban) - Centralised - 2-Monthly update - Commission Decision (2018)3616 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2148/II/50

Europe -DG Health and Food Safety

30-5-2018

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  https://go.usa.gov/xQvE9 

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 https://go.usa.gov/xQvE9 

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 https://go.usa.gov/xQvE9 

FDA - U.S. Food and Drug Administration

30-5-2018

#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 & review of their device proposals to prevent and treat opioid use dis

#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 & review of their device proposals to prevent and treat opioid use dis

#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 & review of their device proposals to prevent and treat opioid use disorder. #FDA MedicalDevice

FDA - U.S. Food and Drug Administration

3-5-2018

Perjeta (Roche Registration GmbH)

Perjeta (Roche Registration GmbH)

Perjeta (Active substance: pertuzumab) - Centralised - 2-Monthly update - Commission Decision (2018)2771 of Thu, 03 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2547/II/35

Europe -DG Health and Food Safety

27-4-2018

Pending EC decision:  Perjeta, pertuzumab, Opinion date: 26-Apr-2018

Pending EC decision: Perjeta, pertuzumab, Opinion date: 26-Apr-2018

Europe - EMA - European Medicines Agency