FORCYL

Main information

  • Trade name:
  • FORCYL
  • Pharmaceutical form:
  • solution for injection or infusion
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FORCYL
    Netherlands
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • marbofloxacin
  • Therapeutic area:
  • Cattle

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0220/001
  • Authorization date:
  • 27-10-2011
  • EU code:
  • FR/V/0220/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

ForcylSPC–D210–July2012

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Forcyl160mg/mlsolutionforinjectionforcattle

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Marbofloxacin...............................................160mg

Excipients:

Benzylalcohol (E1519)………………...15mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Clearyellowgreenishtoyellowbrownishsolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle.

4.2 Indicationsforuse,specifyingthetargetspecies

Incattle:

-TherapeutictreatmentofrespiratoryinfectionscausedbysensitivestrainsofPasteurellamultocidaand

Mannheimiahaemolytica.

Inlactatingcows:

-TreatmentofacutemastitiscausedbysensitivestrainsofEscherichiacoli.

4.3 Contraindications

Donotuseinanimalswithknownhypersensitivitytofluoroquinolonesortoanyoftheexcipients.

Donotuseincaseswherethepathogeninvolvedisresistanttootherfluoroquinolones(crossresistance).

4.4 Specialwarnings

TheefficacyoftheproducthasnotbeentestedonmastitiscausedbyGrampositivebacteria .

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhenthisproductisused.

Fluoroquinolonesshouldbereservedforthetreatmentofclinicalconditionswhichhaverespondedpoorly,orare

expectedtorespondpoorly,tootherclassofantimicrobials.Whereverpossible,useoftheproductshouldonlybe

basedonsusceptibilitytesting.

UseoftheproductdeviatingfromtheinstructionsgiveninthisSPCmayincreasetheprevalenceofbacteriaresistant

tothefluoroquinolonesandmaydecreasetheeffectivenessoftreatmentwithotherquinolonesduetothepotential

forcrossresistance.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproducttoanimals

Peoplewithknownhypersensitivityto(fluoro)quinolonesshouldavoidanycontactwiththeproduct.

Iftheproductcomesintocontactwiththeskinoreyes,rinsewithcopiousamountsofwater.

Careshouldbetakentoavoidaccidentalself-injection.Intheeventofaccidentalself-administration,theusershould

immediatelyseekprofessionalmedicalcare.

Accidentalself-injectioncaninduceaslightirritation.

Otherprecautions

None

4..6 Adversereactions(frequencyandseriousness)

Administrationbytheintramuscularroutemaycauseraretransientlocalreactionssuchaspainandswellingat

theinjectionsitewhichmaypersistupto7daysafterinjection.

Fluoroquinolonesareknowntoinducearthropathies.Incattle,suchlesionswereobservedafterathreedays

treatmentwiththe16%marbofloxacinsolution.Theselesionsdidnotinduceclinicalsignsandshouldbereversible,

particularlyiftheyweretobeobservedafterasingleadministration.

Nootheradverseeffectwasobservedoncattle.

4.7 Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimals(rats,rabbits)didnotshowanyevidenceofateratogenic,embryotoxicormaternotoxic

effectassociatedwiththeuseofmarbofloxacin.Safetyoftheproductat10mg/kghasnotbeendeterminedin

pregnantcowsorinsucklingcalveswhenusedincows.Usethereforeaccordingtothebenefit/riskassessment

carriedoutbytheresponsibleveterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

-Therapeutictreatmentofrespiratoryinfections

10mg/kgbodyweighti.e.10ml/160kgbodyweightinasingleintramuscularinjection.

-TreatmentofacutemastitiscausedbysensitivestrainsofEscherichiacoli

10mg/kgbodyweighti.e.10ml/160kgbodyweightinasingleintramuscularorintravenousinjection.

Ifthevolumetobeinjectedintramuscularlyismorethan20ml,itshouldbedividedbetweentwoormoreinjection

sites.

Toensureacorrectdosage,bodyweightshouldbedeterminedasaccuratelyaspossibletoavoidunderdosing.

Wherethereisslightcloudinessorvisibleparticlespresent,suchcloudinessorparticlesdisappearwhen

thebottleisshakenbeforeuse.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Lesionsofthejointcartilagewereobservedinsomeanimalstreatedat10mg/kgor30mg/kgforthreetimes

therecommendedtreatmentduration,butdidnotinduceclinicalsigns.Moreover,nosignofoverdosagewas

observedthroughoutthisstudy.

Overdosagemaycausesignssuchasacuteneurologicaldisorderswhichshouldbetreatedsymptomatically.

4.11Withdrawalperiod(s)

Meatandoffal:5days

Milk:48hours

5. PHARMACOLOGICALPROPERTIES

ATCVetcode:QJ01MA93

Pharmacotherapeuticgroup:antibacterialsforsystemicuse,Fluoroquinolones

5.1 Pharmacodynamicproperties

Marbofloxacinisasynthetic,bactericidalantimicrobial,belongingtothefluoroquinolonegroup,whichactsby

inhibitionofDNAgyrase.TheinvitroactivityofmarbofloxacinhasbeendemonstratedtowardsPasteurella

multocida,MannheimiahaemolyticaandEscherichiacoli.

Themarbofloxacininvitroactivityagainstpathogensisolatedin2007frombovinerespiratorydiseasesisgood:

MICvaluesarecomprisedbetween0.008and0.5µg/mlforM.haemolytica(MIC

=0.139µg/ml;MIC

=0.021

µg/ml),between0.004and0.5µg/mlforP.multocida(MIC

=0.028µg/ml;MIC

=0.012µg/ml).

In2008,themarbofloxacinMIC

forE.coliisolatedfrombovinemastitiswas0.021µg/mlandtheMIC

was

0.038µg/ml.

StrainswithMIC≤1µg/mlaresensitivetomarbofloxacinwhereasstrainswithMIC≥4µg/mlareresistantto

marbofloxacin.

Resistancetofluoroquinolonesoccursbychromosomalmutationwiththreemechanisms:decreaseofthebacterial

wallpermeability,expressionofeffluxpumpormutationofenzymesresponsibleformoleculebinding.

5.2 Pharmacokineticparticulars

Afterasingleintramuscularadministrationincattleattherecommendeddoseof10mg/kgbodyweight,the

maximumplasmaconcentrationofmarbofloxacin(Cmax)is7.915µg/mlreachedin1.28h(Tmax)foranexposure

(AUC

)of52.7µg.h/mL.Bioavailabilityafterintramuscularinjectioniscomplete(morethan90%).Marbofloxacin

isextensivelydistributed.Bindingtoplasmaproteinsisabout30%.

Afterintravenousorintramuscularadministration,marbofloxacinconcentrationsinmilkincreaserapidlyandthe

,TmaxandCmaxvaluesobtainedinplasmaandmilkafterbothadministrationroutesaresimilar.

Marbofloxaciniseliminatedslowly(T1/2  z=17.50h)predominantlyastheactiveforminurineandfaeces.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Benzylalcohol

Glucono-delta-lactone

Waterforinjection

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithotherveterinary

medicinalproducts.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelflifeafterfirstopeningtheimmediatepackaging:28days

6.4. Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5 Natureandcompositionofimmediatepackaging

Detailsoftheprimarypackaging:

AmbertypeIIglassvials

Chlorobutylrubberstopper

Aluminiumcaporflipcap

Packsizes:

Cardboardboxcontainingone50mlvial

Cardboardboxcontainingone100mlvial

Cardboardboxcontainingone250mlvial

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwastematerialsderived

fromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinalproductsshould

bedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

VETOQUINOLSA

MAGNYVERNOIS

F-70200LURE

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

<{DD/MM/YYYY}><{DDmonthYYYY}>…

10 DATEOFREVISIONOFTHETEXT

{MM/YYYY}or<monthYYYY>

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Tobesuppliedonlyonveterinaryprescription.

Administrationbyaveterinarysurgeonorundertheirdirectresponsibility.

ANNEXIII

LABELLINGANDPACKAGELEAFLET

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

BOXOF50ml/100ml/250ml

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

Forcyl160mg/mlsolutionforinjectionforcattle

Marbofloxacin

2.STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachmlcontains:

Marbofloxacin………160mg

Benzylalcohol(E1519)………15mg

3.PHARMACEUTICALFORM

Solutionforinjection

4.PACKAGESIZE

Vialof50ml

Vialof100ml

Vialof250ml

5.TARGETSPECIES

Cattle.

6.INDICATIONS

Notincluded.

7.METHODANDROUTESOFADMINISTRATION

Intramuscularorintravenousroute

Readthepackageleafletbeforeuse.

8.WITHDRAWALPERIOD

Meatandoffal:5days.

Milk:48hours.

9.SPECIALWARNINGS

Thesentence“Readthepackageleafletbeforeuse”isalreadyincludedundersection7.

10.EXPIRYDATE

EXP{month/year}

Shelf-lifeafterfirstopeningthecontainer:28days.

Oncebroached,useby:

11.SPECIALSTORAGECONDITIONS

Notapplicable.

12.SPECIFICPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Disposal:readpackageleaflet.

13.THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly–tobesuppliedonlyonveterinaryprescription.

14.THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

Tobecompletedaccordingtoapplicationformforeachmemberstate.

16.MARKETINGAUTHORISATIONNUMBERS

Cardboardboxwith1vialof50ml:

Cardboardboxwith1vialof100ml

Cardboardboxwith1vialof250ml:

17.MANUFACTURER’SBATCHNUMBER

Lot

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

Labelof100and250mlvials

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

Forcyl160mg/mlsolutionforinjectionforcattle

Marbofloxacin

2.STATEMENTOFACTIVEANDOTHERSUBSTANCES

Marbofloxacin………160mg/ml

3.PHARMACEUTICALFORM

Notrequested.

4.PACKAGESIZE

Vialof100ml

Vialof250ml

5.TARGETSPECIES

Cattle.

6.INDICATIONS

Notrequested.

7.METHODANDROUTESOFADMINISTRATION

Intramuscularorintravenousroute

Readthepackageleafletbeforeuse.

8.WITHDRAWALPERIOD

Meatandoffal:5days.

Milk:48hours.

9.SPECIALWARNINGS

Thesentence“Readthepackageleafletbeforeuse”isalreadyincludedundersection7.

10.EXPIRYDATE

EXP{month/year}

Shelf-lifeafterfirstopeningthecontainer:28days.

Oncebroached,useby:

11.SPECIALSTORAGECONDITIONS

Notapplicable.

12.SPECIFICPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Notrequested.

13.THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly–tobesuppliedonlyonveterinaryprescription.

14.THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Notrequestedontheimmediatelabel.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

Tobecompletedaccordingtoapplicationformforeachmemberstate.

16.MARKETINGAUTHORISATIONNUMBER

Notrequestedontheimmediatelabel.

17.MANUFACTURER’SBATCHNUMBER

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGINGUNITS

Labelof50mlvial

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

Forcyl160mg/mlsolutionforinjectionforcattle

Marbofloxacin

2.QUANTITYOFTHEACTIVESUBSTANCE

Marbofloxacin160mg/ml

3.CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

Vialof 50 ml.

4.ROUTESOFADMINISTRATION

Intramuscularorintravenousroute.

5.WITHDRAWALPERIOD

Meatandoffal:5days.

Milk:48hours.

6.BATCHNUMBER

Lot

7.EXPIRYDATE

EXP{month/year}

Shelf-lifeafterfirstopeningthecontainer:28days.

8.THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly

PACKAGELEAFLET

Forcyl, solutionforinjection

1.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOF

THEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCH

RELEASE,IFDIFFERENT

VETOQUINOLSA

MAGNYVERNOIS

70200LURE

FRANCE

Tobecompletedaccordingtoapplicationformforeachmemberstate

2.NAMEOFTHEVETERINARYMEDICINALPRODUCT

Forcyl160mg/mlsolutionforinjectionforcattle

Marbofloxacin

3.STATEMENTOFTHEACTIVESUBSTANCEANDOTHERINGREDIENTS

Eachmlcontains:

Marbofloxacin………………..160mg

Benzylalcohol(E1519)………15mg

Clearyellowgreenishtoyellowbrownishsolution.

4.INDICATIONS

Incattle:

-TherapeutictreatmentofrespiratoryinfectionscausedbysensitivestrainsofPasteurellamultocidaand

Mannheimiahaemolytica.

Inlactatingcows:

-TreatmentofacutemastitiscausedbysensitivestrainsofEscherichiacoli.

5.CONTRA-INDICATIONS

Donotuseinanimalswithknownhypersensitivitytofluoroquinolonesortoanyoftheexcipients.

Donotuseincaseswherethepathogeninvolvedisresistanttootherfluoroquinolones(crossresistance).

6.ADVERSEREACTIONS

Administrationbytheintramuscularroutemaycauseraretransientlocalreactionssuchaspainandswellingat

theinjectionsitewhichmaypersistupto7daysafterinjection.

Fluoroquinolonesareknowntoinducearthropathies.Incattle,suchlesionswereobservedafterathreedays

treatmentwiththe16%marbofloxacinsolution.Theselesionsdidnotinduceclinicalsignsandshouldbe

reversible,particularlyiftheyweretobeobservedafterasingleadministration.

Nootheradverseeffectwasobservedoncattle.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyourveterinary

surgeon.

7.TARGETSPECIES

Cattle.

8.DOSAGEFOREACHSPECIES,ROUTESANDMETHODOFADMINISTRATION

-Therapeutictreatmentofrespiratoryinfections

10mg/kgbodyweighti.e.10ml/160kgbodyweightinasingleintramuscularinjection.

-TreatmentofacutemastitiscausedbysensitivestrainsofEscherichiacoli

10mg/kgbodyweighti.e.10ml/160kgbodyweightinasingleintramuscularorintravenousinjection.

Ifthevolumetobeinjectedintramuscularlyismorethan20ml,itshouldbedividedbetweentwoormore

injectionsites.

Toensureacorrectdosage,bodyweightshouldbedeterminedasaccuratelyaspossibletoavoidunderdosing.

Wherethereisslightcloudinessorvisibleparticlespresent,suchcloudinessorparticlesdisappearwhen

thebottleisshakenbeforeuse.

9.ADVICEONCORRECTADMINISTRATION

None.

10.WITHDRAWALPERIOD

Meatandoffal:5days

Milk:48hours

11.SPECIALSTORAGEPRECAUTIONS

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Keepoutofthereachandsightofchildren.

Shelf-lifeafterfirstopeningthecontainer:28days.

Whenthecontainerisbroached(opened)forthefirsttime,usingthein-useshelf-lifewhichisspecifiedonthis

packageleaflet,thedateonwhichanyproductremaininginthecontainershouldbediscardedshouldbeworked

out.Thisdiscarddateshouldbewritteninthespaceprovidedonthelabel.

DonotuseaftertheexpirydatestatedonthecartonandvialafterEXP.

12.SPECIALWARNINGS

Specialwarningsforeachtargetspecies

TheefficacyoftheproducthasnotbeentestedonmastitiscausedbyGrampositivebacteria.

Specialprecautionsforuseinanimals

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhenthisproductisused.

Fluoroquinolonesshouldbereservedforthetreatmentofclinicalconditionswhichhaverespondedpoorly,orare

expectedtorespondpoorly,tootherclassofantimicrobials.Whereverpossible,useoftheproductshouldonly

bebasedonsusceptibilitytesting.

UseoftheproductdeviatingfromtheinstructionsgiveninthisSPCmayincreasetheprevalenceofbacteria

resistanttothefluoroquinolonesandmaydecreasetheeffectivenessoftreatmentwithotherquinolonesdueto

thepotentialforcrossresistance.

Userwarnings

Peoplewithknownhypersensitivityto(fluoro)quinolonesshouldavoidanycontactwiththeproduct.

Iftheproductcomesintocontactwiththeskinoreyes,rinsewithcopiousamountsofwater.

Careshouldbetakentoavoidaccidentalself-injection.Intheeventofaccidentalself-administration,theuser

shouldimmediatelyseekprofessionalmedicalcare.

Accidentalself-injectioncaninduceaslightirritation.

Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimals(rats,rabbits)didnotshowanyevidenceofateratogenic,embryotoxicor

maternotoxiceffectassociatedwiththeuseofmarbofloxacin.Safetyoftheproductat10mg/kghasnotbeen

determinedinpregnantcowsorinsucklingcalveswhenusedincows.Usethereforeaccordingtothebenefit/risk

assessmentcarriedoutbytheresponsibleveterinarian.

Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Lesionsofthejointcartilagewereobservedinsomeanimalstreatedat10mg/kgor30mg/kgforthreetimes

therecommendedtreatmentduration,butdidnotinduceclinicalsigns.Moreover,nosignofoverdosagewas

observedthroughoutthisstudy.

Overdosagemaycausesignssuchasacuteneurologicaldisorderswhichshouldbetreatedsymptomatically.

Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinalproducts

shouldbedisposedofinaccordancewithlocalrequirements.

14.DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15.OTHERINFORMATION

Cardboardboxwith1vialof50ml:

Cardboardboxwith1vialof100ml:

Cardboardboxwith1vialof250ml:

Notallpacksizesmaybemarketed.

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Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Published on: Wed, 10 Oct 2018 00:00:00 +0200 This report provides a review of existing models for predicting the spatial distribution and abundance of wild boar at various scales (global, continental, national and regional) in order to inform the development of a new model to produce estimates of wild boar abundance at European level. The review identifies and discusses a range of models based on a wide variety of data types, corresponding to those targeted by the data collection model set by ENETwild,...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

10-10-2018

Enforcement Report for the Week of October 10, 2018

Enforcement Report for the Week of October 10, 2018

Recently Updated Records for the Week of October 10, 2018 Last Modified Date: Tuesday, October 09, 2018

FDA - U.S. Food and Drug Administration

24-9-2018

FDA Announces Availability of Resources for Animal Drug Sponsors

FDA Announces Availability of Resources for Animal Drug Sponsors

The FDA is making available two pre-recorded webinars and a slide presentation to help drug sponsors understand recent changes to the submission process for new animal drug applications and related submissions. The changes take effect 10/1/2018.

FDA - U.S. Food and Drug Administration

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

FDA - U.S. Food and Drug Administration

11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Update of the Xylella spp. host plant database

Update of the Xylella spp. host plant database

Published on: Mon, 10 Sep 2018 00:00:00 +0200 Following a request from the European Commission, EFSA periodically updates the database on the host plants of Xylella spp. While previous editions of the database (2015 and 2016) dealt with the species Xylella fastidiosa only, this database version addresses the whole genus Xylella, including therefore both species X. fastidiosa and Xylella taiwanensis. The database now includes information on host plants of Xylella spp. retrieved from scientific literature...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

WASHINGTON, Sept. 10, 2018 – U.S. Secretary of Agriculture Sonny Perdue, DVM and U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D. today announced a joint public meeting to be held on Oct. 23-24, 2018 to discuss the use of cell culture technology to develop products derived from livestock and poultry.

FDA - U.S. Food and Drug Administration

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft protocol for the Scientific Opinion on free sugars from all dietary sources, prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel), supported by the ad‐hoc Working Group on Sugars. The draft protocol was endorsed by the Panel for public consultation at its plenary meeti...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food, Inc. of Portland, OR is expanding its voluntary recall to include an additional quantity of Rad Cat Raw Diet across all varieties with Best By dates of 10/19/18 through 12/3/19 because it has the potential to be contaminated with Listeria monocytogenes. Radagast Pet Food is conducting this voluntary recall out of an abundance of caution because of its strong commitment to food safety and quality.

FDA - U.S. Food and Drug Administration

10-8-2018

Enforcement Report for the Week of July 25, 2018

Enforcement Report for the Week of July 25, 2018

Recently Updated Records for the Week of July 25, 2018 Last Modified Date: Friday, August 10, 2018

FDA - U.S. Food and Drug Administration

10-12-2018

Exondys (AVI BioPharma International Ltd)

Exondys (AVI BioPharma International Ltd)

Exondys (Active substance: eteplirsen) - Centralised - Refusal of marketing authorisation - Commission Decision (2018)8620 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4355

Europe -DG Health and Food Safety

10-12-2018

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (Active substance: ivabradine) - Centralised - Withdrawal - Commission Decision (2018)8623 of Mon, 10 Dec 2018

Europe -DG Health and Food Safety

26-11-2018

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware of those technologies.

FDA - U.S. Food and Drug Administration

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

22-11-2018

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Active substance: emtricitabine / tenofovir disoproxil) - Centralised - 2-Monthly update - Commission Decision (2018)7884 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4215/IB/10G

Europe -DG Health and Food Safety

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

Spinraza (Active substance: nusinersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7550 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/T/10

Europe -DG Health and Food Safety

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Active substance: Sildenafil citrate) - Transfer of orphan designation - Commission Decision (2018)6993 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/068/10/T/01

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

Recocam (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6954 of Fri, 19 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2247/T/10

Europe -DG Health and Food Safety

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

19-9-2018

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Active substance: olaratumab) - Centralised - Annual renewal - Commission Decision (2018)6105 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4216/R/10

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 5971 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4078/T/10

Europe -DG Health and Food Safety

10-9-2018

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Active substance: netupitant / palonosetron) - Centralised - Yearly update - Commission Decision (2018)5947 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Alkindi (Diurnal Limited)

Alkindi (Diurnal Limited)

Alkindi (Active substance: hydrocortisone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5945 of Mon, 10 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4416/T/03

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

Retacrit (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5946 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Silapo (STADA Arzneimittel AG)

Silapo (STADA Arzneimittel AG)

Silapo (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5944 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

4-9-2018

ACM meeting statement, Meeting 10, 2 August 2018

ACM meeting statement, Meeting 10, 2 August 2018

The Advisory Committee on Medicines meeting statement is now available

Therapeutic Goods Administration - Australia

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety

10-8-2018

Torisel (Pfizer Europe MA EEIG)

Torisel (Pfizer Europe MA EEIG)

Torisel (Active substance: Temsirolimus) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5521 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/799/T/71

Europe -DG Health and Food Safety

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

10-8-2018

Lymphoseek (Norgine B.V.)

Lymphoseek (Norgine B.V.)

Lymphoseek (Active substance: tilmanocept) - Centralised - Yearly update - Commission Decision (2018)5520 of Fri, 10 Aug 2018

Europe -DG Health and Food Safety

10-8-2018

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Active substance: tedizolid phosphate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5522 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2846/T/28

Europe -DG Health and Food Safety

10-8-2018

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Active substance: Daptomycin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5519 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/637/T/69

Europe -DG Health and Food Safety

10-8-2018

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Active substance: Thalidomide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5524 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/823/T/57

Europe -DG Health and Food Safety

10-8-2018

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Active substance: caspofungin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5517 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/379/T/67

Europe -DG Health and Food Safety

10-8-2018

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5518 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/910/T/65

Europe -DG Health and Food Safety