Vidalta 15 mg tablets for Oral Use for Cats

Main information

  • Trade name:
  • Vidalta 15 mg tablets for Oral Use for Cats
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Vidalta 15 mg tablets for Oral Use for Cats
    Malta
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • carbimazole
  • Therapeutic area:
  • Cats

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0408/002
  • Authorization date:
  • 26-10-2011
  • EU code:
  • UK/V/0408/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:January2012

AN:02007/2010

Page1of8

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Vidalta15mgprolonged-releasetabletsforcats

BE,NO:VidaltaVet15mgprolongedreleasetabletsforcats

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachprolonged-releasetabletcontains:

Activesubstance:

Carbimazole 15,00mg

Excipients:

Redferricoxide(E172) 0.75mg

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Prolonged-releasetablet

Rounddarkpinktabletwithlittlespots

4. CLINICALPARTICULARS

4.1 Targetspecies

Cat

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofhyperthyroidismandhyperthyroidism-associatedclinicalsignsincats

4.3 Contraindications

Donotuseincatssufferingfromconcurrentsystemicdiseases,suchassevereprimary

liverdiseaseordiabetesmellitus.

Donotuseincatsshowingsignsofauto-immunediseasesand/oralteredredorwhite

bloodcellcounts,suchasanaemia,neutropaeniaorlymphopaenia.

Donotuseincatswithplateletdisorders(particularlythrombocytopaenia)or

coagulopathies.

Revised:January2012

AN:02007/2010

Page2of8

Donotuseincatswithhypersensitivitytomercaptoimidazoles(carbimazoleor

thiamazole(methimazole))Pleaserefertosection4.7.

4.4 Specialwarningsforthetargetspecies

Thiamazole(methimazole),theactivemetaboliteofcarbimazole,inhibitsthyroid

hormoneproductionandthereforecessationoftreatmentwithcarbimazolewillresultin

arapid(within48hours)returntopre-treatmentthyroidhormonelevels.Chronic

administrationisthereforenecessaryunlesssurgicalorradiation-inducedthyroidectomy

isperformed.

Asmallproportionofcatswiththyroidadenomamayfailtorespondorhaveapoor

responsetotreatment.

Thyroidcarcinomaisararecauseofhyperthyroidisminthecatandmedical

managementaloneisnotrecommendedinsuchcasesasitisnotcurative.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Treatmentshouldbeadjustedaccordingtotherisk:benefitassessmentfortheindividual

case.

Treatmentofhyperthyroidismmayresultinareductionintheglomerularfiltrationrate.

Thiscanleadtounmaskingofpre-existentrenaldysfunction.Treatmentof

hyperthyroidismmayalsoinduceanelevationofliverenzymesoraworseningofpre-

existinghepaticdisorders.Renalandliverfunctionshouldthereforebemonitored

beforeandduringtreatment

Duetoriskofleucopaeniaorhaemolyticanaemia,haematologyparametersshouldbe

monitoredonaregularbasisbeforeandduringtreatment,preferablyateachvisitofthe

doseadjustmentphaseandmaintenancephase(seesection4.9).

Anyanimalthatsuddenlyappearsunwellduringtherapy,particularlyiftheyarefebrile,

shouldhaveabloodsampletakenforroutinehaematologyandbiochemistry.

Neutropenicanimals(neutrophilcounts<2.5x10 9

/l)shouldbetreatedprophylactically

withbactericidalantibioticsandsupportivetherapy.

Dosesabove20mghaveonlybeentrialledinasmallnumberofcats.Therefore,

carefulmonitoringisrecommendedandthedoseshouldbeadjustedaccordingtothe

risk:benefitassessmentfortheindividualcase.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Washhandswithsoapandwaterafteruseandwhenhandlinglitterusedbytreated

animals.

Donothandlethisproductifyouareallergictoantithyroidproducts.

Pregnantwomenshouldweargloveswhenhandlingtheproduct.

Revised:January2012

AN:02007/2010

Page3of8

Donoteat,drinkorsmokewhilehandlingthetabletorusedlitter.

Inthecaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthe

packageinsertorthelabeltothephysician.Carbimazole,asaprodrugofthiamazole

(methimazole),maycausevomiting,epigastricdistress,headache,fever,arthralgia,

pruritusandpancytopaenia.Treatmentissymptomatic.

Ascarbimazoleisasuspectedhumanteratogen,womenofchild-bearingageshould

weargloveswhenhandlinglitterorvomitoftreatedcats.

4..6Adversereactions(frequencyandseriousness)

Mostfrequentcommonadversereactionsencompassvomiting,diarrhoea,reduced

appetite,lossofcondition,lethargy,tachycardia,polydipsia,dehydration,andpolyuria.

Dermatologicalsigns(pruritus,moistdermatitis,erythema,alopecia)havealsobeen

reported.Theseclinicalsignsareusuallymild,adequatelycontrolledbysymptomatic

therapyanddonotrequiretreatmentdiscontinuation.However,ifmoresevereclinical

signsoccurthatdonotrespondtosymptomatictherapy,thedoseshouldbereducedor

treatmentstoppedaccordingtorisk:benefitevaluation.Incasesofseriousadverse

reactions,mortality,possiblyduetotheproduct,mightoccuriftreatmentisnot

discontinued.

Insomecases,signsofgastrointestinalbleedingsuchasbloodyvomit,oral

haemorrhageordarkfaecescanbeobserved.Thesesignsshouldbeconsideredas

seriousandrequireimmediateaction(dosereductionortreatmentdiscontinuation).

Weightloss,dyspnoea,aggressiveness,disorientation,ataxiaorpyrexiahavealso

beenreportedinrarecases.

Treatmentofhyperthyroidismmayresultinareductionintheglomerularfiltrationrate.

Inseverecases,whereazotaemiadevelops,temporaryorpermanenttreatment

discontinuationmayberequired.

Thetreatmentmayinduceincreaseofliverenzymes.Severecasesmayrequire

temporaryorpermanenttreatmentdiscontinuation.However,theseelevationsare

usuallyreversiblefollowingdrugdiscontinuation,althoughsymptomatictherapy

(nutritionalandfluidsupport)mayberequired.

Anaemia, increase or decrease in white blood cell count, neutrophilia,

thrombocytopaenia,eosinophiliaand/orlymphopaeniamayalsooccur,inparticular

duringthefirst4-6weeksoftreatment.Treatmentdiscontinuationmayberequiredin

caseofpersistentandmarkeddisorder.Inmostofthecases,theabnormalitywill

resolvespontaneouslywithin1monthaftertreatmentdiscontinuation.

Positiveantinuclearantibodytitreshavealsobeenreported.

Itappearsthatadversereactionsarereversibleoncessationoftreatment.

Revised:January2012

AN:02007/2010

Page4of8

4.7 Useduringpregnancy,lactationorlay

Laboratorystudiesinratsandmicehaveshownevidenceofteratogenicand

embryotoxiceffectsofthiamazole.Thesafetyoftheproductwasnotassessedin

pregnantorlactatingcats.Furthermore,thiamazolecrossestheplacenta,distributes

intomilkandreachesapproximatelythesameconcentrationasinmaternalserum.

Donotuseinpregnantorlactatingfemales.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Concomitanttreatmentwithphenobarbitalmayreducetheclinicalefficacyof

carbimazole.

Theconcomitantuseofbenzimidazoleanthelmintics(fenbendazoleormebendazole)

hasbeenshowntoreducethehepaticoxidationofthistherapeuticclassandmay

thereforeinduceanincreaseoftheircirculatingrates.Accordingly,co-administrationof

carbimazolewithabenzimidazoleisnotrecommended.

Thiamazolemaydisplayimmunomodulatingproperties.Thisshouldbetakeninto

accountwhenconsideringvaccinationofthecat.

4.9 Amountstobeadministeredandadministrationroute

Fororaluseonly.

Administrationwithfoodenhancesbioavailability.Thetimingoftreatmentandits

relationtofeedingshouldbekeptconsistentfromdaytoday.

DonotbreakorcrushVidaltatabletsasthiswillaffectthesustainedreleaseproperty.

Theaimoftreatmentistomaintaintotalthyroxinconcentrations(TT4)inthelowerend

ofthereferencerange.Accordingly,thefollowingdoserecommendationsfordosing

duringadjustmentandmaintenancephasesaresuggested.Howeverdosingadjustment

shouldbeprimarilybasedupontheclinicalassessmentoftheindividualcat.Monitoring

ofTT4,fullhaematologyandliverandkidneyparametersisadvisedateach

recommendedfollowupvisit(seesections4.5iand4.6).

Adjustmentphase

Thestartingdoseisasingledailyoraladministrationofonetabletof15mgcarbimazole

percat.ConsiderationcouldbegiventoastartingdoseofVidalta10mgdailywherethe

TT4concentrationisonlymildlyincreased,e.g.between50nmol/Land100nmol/L.

WiththerecommendedstartingdoseofoneVidalta15mgtabletoncedaily,total

thyroxinconcentration(TT4)maydecreasetowithintheeuthyroidrange(TT4<50

nmol/L)shortlyaftertreatmentinitiation.Adoseadjustmentmayberequiredasearlyas

10daysoftreatment.

Doseadjustmentshouldbealsoperformed3,5and8weeksafterinitiationof

treatment,dependingonbothclinicalandhormonalresponsestotreatment.

Revised:January2012

AN:02007/2010

Page5of8

Maintenancephase

Follow-upvisitsevery3to6monthsarerecommended.Thedoseshouldbeadjusted

individuallybasedonclinicalsignsandtotalthyroxinconcentration(TT4).Itisadvisable

tocheckTT410-14daysafterdoseadjustment.

ThetherapeuticdoseofVidaltarangesbetween10mg(one10mgtablet)and25mg

(one10mgtabletandone15mgtablet)oncedaily.

Somecatsrequiredosesoflessthan10mgcarbimazoledaily.Everyotherdaydosing

with10mgor15mgofcarbimazolemaybesufficienttocontrolthedisease.

Doseincreasesshouldnotbemadeinincrementsofgreaterthan5mg.

Dosesabove20mghaveonlybeentrialledinasmallnumberofcatsandshouldbe

usedwithcaution.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Incaseofoverdosage,adverseeffectsthatmayappearinclude,butarenotlimitedto,

weightloss,inappetence,vomiting,lethargyandlessfrequentlysignsofgastrointestinal

bleedingsuchashaematemesis,oralhaemorrhageorhaemorrhageoftheintestinal

tract. Coat and skin abnormalities (erythema, alopecia), as well as

haematological/biochemical changes (eosinophilia, lymphocytosis, neutropaenia,

lymphopaenia,slightleucopaenia,agranulocytosis,thrombocytopaeniaorhaemolytic

anaemia)mayalsoappear.Hepatitisandnephritishavebeenreported.Theseadverse

effectsmaybecomesevereincaseofchronicoverdosing.Inmostcases,adverse

effectsarereversibleupontreatmentdiscontinuationandappropriateveterinarycare.

Totalthyroxinconcentrations(TT4)belowthelowerlimitofthereferencerangemaybe

observedduringtreatmentalthoughthisisrarelylinkedtoovertclinicalsigns.

DecreasingthedosewillleadtoanincreaseoftheTT4.Doseadjustmentshouldnotbe

madebasedonTT4only(seesection4.9).

Pleasealsorefertosection4.6

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Activeingredient:carbimazole

Pharmacotherapeuticgroup:sulphur-containingimidazolederivatives

ATCvetcode:QH03BB01

Revised:January2012

AN:02007/2010

Page6of8

5.1 Pharmacodynamicproperties

Carbimazoleistheprodrugofthiamazole(methimazole).Althoughcarbimazolehas

inherentantithyroidactivity,itisalmosttotallyconvertedtothiamazolesoonafteritsoral

administrationinvivoinhumansandcats.

Thiamazoleresultsindose-dependentinhibitionofthethyroidperoxidase-catalysed

reactionsinvolvedinthyroidhormonesynthesis,includingoxidationofiodideand

iodinationoftyrosylresiduesinthyroglobulin,therebyinhibitingneosynthesisofthyroid

hormones.Thiamazolealsointerfereswiththecouplingofiodotyrosinesto

iodothyroninesviainhibitionofthyroidperoxidaseorbybindingandalteringthe

structureofthyroglobulin,thisreactionbeingmoresensitivetoinhibitionthanthe

formationofiodotyrosines.Theinhibitoryactionofthiamazoleisreversible.

Thiamazoledoesnotinhibittheactionofthyroidhormonesalreadyformedandpresent

inthethyroidglandsorbloodstream,orinterferewiththeeffectivenessofadministered

exogenousthyroidhormone(iatrogenichyperthyroidism).Thisexplainswhythelength

ofthelatencyperioduntilnormalisationofserumconcentrationsofthyroxineand

triiodothyronine,andthustoclinicalimprovement,differsbetweenindividuals.

5.2 Pharmacokineticparticulars

Carbimazoleisrapidlyabsorbedfromthegastrointestinaltractafteroraladministration

andhydrolysedinthegastrointestinaltract(orimmediatelyafterenteringintothe

circulation)totheactivemetabolitethiamazole.Theabsolutebioavailabilityof

thiamazolefromcarbimazoleinVidalta15mgtabletsis88%.

FollowingoraladministrationofonetabletofVidalta10mgtohealthyfastedcats,

maximumthiamazoleconcentrationsareobserved3-4hoursafteradministration,witha

meanpeakconcentrationofthiamazoleof0.54-0.87µg/mL.Followingoral

administrationofonetabletofVidalta15mgtohealthyfastedcats,maximum

thiamazoleconcentrationsareobserved5-7hoursafteradministration,withamean

peakconcentrationofthiamazoleof0.72-1.13µg/mL.Forbothstrengths,the

thiamazoleconcentration/timeprofileisdevoidofpronouncedpeakandthiamazole

persistsinthecirculationatleast20and24hoursforVidalta10mgandVidalta15mg,

respectively.

Thepresenceoffoodinthegastrointestinaltractatthetimeofadministrationhasbeen

showntoincreasethebioavailabilityofthiamazole.Whentabletsareadministeredwith

food,bothC

andAUC

last maybeincreasedwhereast

isnotexpectedtochange.

Nocumulativeeffectsareobserveduponrepeatedadministration.

Thetissuedistributionofmercaptoimidazoleshasnotbeenspecificallystudiedincats

buthasbeenfullydescribedinrodents.Thiamazoleismainlyconcentratedinthe

thyroidandadrenalglands,andcanbefoundtoalesserextentinthethymus,

diaphragm,kidneys,brain,liver,colon,testes,smallintestine,stomachandplasma.

Mercaptoimidazoleshavealsobeenshowntocrosstheplacentalbarrier.

Inrats,thiamazoleisexcretedmainlyviatheurine,andtoalesserextentinthefaeces.

Revised:January2012

AN:02007/2010

Page7of8

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

-Hypromellose

-Microcrystallinecellulose

-Redferricoxide(E172)

-Silica,colloidalanhydrous

-Magnesiumstearate

-Talc

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductsaspackagedforsale:

24months.

6.4.Specialprecautionsforstorage

Donotstoreabove25°C.

Storeintheoriginalcontainer.

Keepthecontainertightlyclosedtoprotectfrommoisture.

Donotremovethedessicant.

6.5Natureandcompositionofimmediatepackaging

Highdensitypolyethylenecontainerof30or100tabletsclosedwithpolypropylene

tamper-evident,child-resistant,screwcapbearingadesiccant.

Packsof1or6containers.

Notallpacksizesmaybemarketed.

Revised:January2012

AN:02007/2010

Page8of8

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproduct

orwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

IntervetUKLtd

WaltonManor

Walton

MiltonKeynes

Buckinghamshire

MK77AJ

8. MARKETINGAUTHORISATIONNUMBER

Vm01708/4530

9. DATEOFFIRSTAUTHORISATION

21December2007

10. DATEOFREVISIONOFTHETEXT

January2012

7-12-2018

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Published on: Thu, 06 Dec 2018 The present scientific opinion deals with the assessment of the bioavailability of magnesium, from the proposed nutrient source, magnesium citrate malate (MgCM), when added for nutritional purposes to food supplements. MgCM is a mixed salt consisting of magnesium cations and citrate and malate anions, and with a magnesium content of 12–15%. MgCM is proposed to be used in food supplements that are intended to provide up to 300–540 mg/day magnesium. The data provided demonst...

Europe - EFSA - European Food Safety Authority Publications

1-12-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Trichoderma reesei (strain DP‐Nzd22)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Trichoderma reesei (strain DP‐Nzd22)

Published on: Fri, 30 Nov 2018 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with a genetically modified Trichoderma reesei (strain DP‐Nzd22) by DuPont. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The endo‐1,4‐β‐xylanase is intended to be used in distilled alcohol production, bakery and brewery. Residual amounts of total organic solids (TOS) are removed during the production of dis...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

Published on: Mon, 26 Nov 2018 Abstract In response to the EFSA call New approaches in identifying and characterizing microbial and chemical hazards, the project INNUENDO (https://sites.google.com/site/theinnuendoproject/) aimed to design an analytical platform and standard procedures for the use of whole‐genome sequencing in surveillance and outbreak investigation of food‐borne pathogens. The project firstly attempted to identify existing flaws and needs, and then to provide applicable cross‐sectorial ...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

FDA approves new treatment for patients with acute myeloid leukemia

FDA approves new treatment for patients with acute myeloid leukemia

The FDA approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or who have other chronic health conditions or diseases (comorbidities) that may preclude the use of intensive chemotherapy.

FDA - U.S. Food and Drug Administration

21-11-2018

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Published on: Fri, 16 Nov 2018 The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was e...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Setting of an import tolerance for pyraclostrobin in rice

Setting of an import tolerance for pyraclostrobin in rice

Published on: Thu, 15 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Germany to set an import tolerance for the active substance pyraclostrobin in rice. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for rice. Based on the risk assessment results, EFSA concluded that the short‐term intake of residues resulting from the use of p...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Published on: Thu, 15 Nov 2018 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for pyraclostrobin in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residues trials supporting the existing use of pyraclostrobin on table grapes authorised in southern EU Member States and an analytical method for analysing residues of pyraclostrobin in ...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐a‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐OC by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels recommended, dietary exposure to the food enzyme–...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐SO by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme–total organi...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Published on: Wed, 14 Nov 2018 The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM‐JB by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organi...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

FDA - U.S. Food and Drug Administration

16-10-2018

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

FDA - U.S. Food and Drug Administration

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of white willow (Salix alba) in food

Risk assessment of white willow (Salix alba) in food

Published on: Tue, 28 Aug 2018 00:00:00 +0200 This Technical Report contains a description of the activities within the work programme of the EU‐FORA Fellowship on the risk assessment of white willow in food. The bark of different varieties of willow has had a long history of medical use as a means to reduce fever and as a painkiller. Willow bark is also used in weight loss and sports performance food supplements. The labelling of these products usually does not mention any restrictions to the length of...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

16-8-2018

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

FDA - U.S. Food and Drug Administration

15-8-2018

Enforcement Report for the Week of August 15, 2018

Enforcement Report for the Week of August 15, 2018

Recently Updated Records for the Week of August 15, 2018 Last Modified Date: Monday, August 13, 2018

FDA - U.S. Food and Drug Administration

15-8-2018

G Female Oral Tablets

G Female Oral Tablets

G Female Oral Tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

14-8-2018

Minister-president Rutte bij herdenking capitulatie Japan

Minister-president Rutte bij herdenking capitulatie Japan

Minister-president Rutte neemt woensdagmiddag 15 augustus 2018 deel aan de herdenking van de capitulatie van Japan op 15 augustus 1945. De herdenking vindt plaats bij het Indisch Monument in Den Haag.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

31-7-2018

ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle

ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle

ADM Animal Nutrition, a division of Archer Daniels Midland Company (NYSE: ADM), is recalling 200-pound tubs of Mintrate® 36-15 Breed Right Tub cattle feed, product number 54549AAA6H, because the product may contain elevated levels of non-protein nitrogen, which could be harmful to cattle. Excessive levels of non-protein nitrogen can be toxic to cattle and can cause muscle tremors (especially of face and ears), abdominal pain, bloat, frothy salivation, excessive urination, teeth grinding, incoordination, ...

FDA - U.S. Food and Drug Administration

17-7-2018

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

FDA - U.S. Food and Drug Administration

29-6-2018

Wish Bone Salad Dressing Issues Allergy Alert On Undeclared Milk and Egg in 15 oz. Wish-Bone House Italian Salad Dressing

Wish Bone Salad Dressing Issues Allergy Alert On Undeclared Milk and Egg in 15 oz. Wish-Bone House Italian Salad Dressing

Pinnacle Foods Inc. is voluntarily recalling a limited quantity of Wish Bone House Italian Salad Dressing 15 oz. with the health and safety of our consumers as our top priority. The recall was initiated after learning from a retail customer that a limited number of bottles were mislabeled. The product contains milk and egg, known allergens not declared on the bottle. People who have an allergy or severe sensitivity to milk or egg may run the risk of a serious or life-threatening allergic reaction if t...

FDA - U.S. Food and Drug Administration

18-6-2018

June 15, 2018: Theranos Founder and Former Chief Operating Officer Charged in Alleged Wire Fraud Schemes

June 15, 2018: Theranos Founder and Former Chief Operating Officer Charged in Alleged Wire Fraud Schemes

June 15, 2018: Theranos Founder and Former Chief Operating Officer Charged in Alleged Wire Fraud Schemes

FDA - U.S. Food and Drug Administration

24-5-2018

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

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

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

FDA - U.S. Food and Drug Administration

23-5-2018

FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit

FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit

OTC oral health products containing benzocaine for the temporary relief of sore gums due to teething in infants or children should no longer be marketed. FDA is asking companies to stop selling these products for such use and requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious risks.

FDA - U.S. Food and Drug Administration

14-5-2018

FDA Approves Mirataz, a New Animal Drug to Manage Undesired Weight Loss in Cats

FDA Approves Mirataz, a New Animal Drug to Manage Undesired Weight Loss in Cats

FDA has approved Mirataz (mirtazapine transdermal ointment), a new animal drug to manage undesired weight loss in cats. Mirataz is the first transdermal product to receive FDA approval for use in cats. FDA-approved drugs have been demonstrated to be safe and effective for their intended use.

FDA - U.S. Food and Drug Administration

20-3-2018

Medicines Safety Update, Volume 9, Number 1, February-March 2018

Medicines Safety Update, Volume 9, Number 1, February-March 2018

First-generation oral sedating antihistamines – use in children, Suvorexant (Belsomra) – next day effects, Desvenlafaxine (Pristiq) recommended dose, Miconazole and potential interaction with warfarin

Therapeutic Goods Administration - Australia

9-3-2015

Warning against Slimex 15 and Slimex 15 New Formula

Warning against Slimex 15 and Slimex 15 New Formula

The Danish Health and Medicines Authority warns against taking the weight-loss products "Slimex 15" and "Slimex 15 New Formula" that are sold on the internet. The weight-loss products contain sibutramine that may cause serious side effects.

Danish Medicines Agency

10-12-2014

New procedure for follow up on adverse drugs reaction reports as of 15 December 2014

New procedure for follow up on adverse drugs reaction reports as of 15 December 2014

The Danish Health and Medicines Authority are by 15 December 2014 implementing a new targeted procedure for collecting additional information to reports on adverse drug reactions.

Danish Medicines Agency

1-4-2014

Danish Pharmacovigilance Update 27 February 2014

Danish Pharmacovigilance Update 27 February 2014

In this issue of Danish Pharmacovigilance Update: Further restrictions on the use of osteoporosis medicine strontium ranelate (Protelos®), Anticoagulant therapy to be stopped before initiating treatment with the new oral anticoagulants (NOACs).

Danish Medicines Agency

2-2-2012

Applications for general reimbursement in 2011

Applications for general reimbursement in 2011

In 2011, we reviewed 21 applications for general reimbursement for 20 different medicinal products. 15 of the applications ended with the granting of general reimbursement or general conditional reimbursement, and the remaining six applications were refused.

Danish Medicines Agency

26-9-2011

Danish Pharmacovigilance Update, 15 September 2011

Danish Pharmacovigilance Update, 15 September 2011

In this issue of Danish Pharmacovigilance Update, read about a significant increase in off-label use of AeroBec® in children under the age of five, and much more.

Danish Medicines Agency

23-11-2018

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more:  https://go.usa.gov/xPHxf   #FDA #MedicalDevice

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more: https://go.usa.gov/xPHxf  #FDA #MedicalDevice

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more: https://go.usa.gov/xPHxf  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

21-11-2018

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (Active substance: Recombinant human interleukin-3 truncated diphtheria toxin fusion protein) - Transfer of orphan designation - Commission Decision (2018)7816 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/064/15/T/02

Europe -DG Health and Food Safety

8-11-2018

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries. pic.twitter.com/WkDNnXqmbw

FDA - U.S. Food and Drug Administration

22-10-2018

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Active substance: Triheptanoin) - Transfer of orphan designation - Commission Decision (2018)6992 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/007/15/T/02

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Active substance: Insulin human) - Transfer of orphan designation - Commission Decision (2018)6985 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

17-10-2018

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review.

Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD.  https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https://go.usa.gov/xPqku  pic.twitter.com/EYNZANlgr9

FDA - U.S. Food and Drug Administration

25-9-2018

Conducting clinical trials & preparing a submission for #FDA review?

Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more!  https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.usa.gov/xPqku . pic.twitter.com/Ktqq9Slx0y

FDA - U.S. Food and Drug Administration

24-9-2018

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

FDA - U.S. Food and Drug Administration

27-7-2018

EU/3/15/1473 (Celgene Europe B.V.)

EU/3/15/1473 (Celgene Europe B.V.)

EU/3/15/1473 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5042 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/284/14/T/01

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Active substance: (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate) - Transfer of orphan designation - Commission Decision (2018)4094 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/184/15/T/02

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1460 (Eisai GmbH)

EU/3/15/1460 (Eisai GmbH)

EU/3/15/1460 (Active substance: Lenvatinib) - Transfer of orphan designation - Commission Decision (2018)4080 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/287/14/T/01

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1590 (Merck Europe B.V.)

EU/3/15/1590 (Merck Europe B.V.)

EU/3/15/1590 (Active substance: Recombinant human monoclonal IgG1 antibody against programmed death ligand-1) - Transfer of orphan designation - Commission Decision (2018)4088 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/150/15/T/02

Europe -DG Health and Food Safety

29-5-2018

EU/3/15/1453 (Roche Registration GmbH)

EU/3/15/1453 (Roche Registration GmbH)

EU/3/15/1453 (Active substance: Chimeric 2'-O-(2-methoxyethyl) modified oligonucleotide targeted to huntingtin RNA) - Transfer of orphan designation - Commission Decision (2018)3401 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/256/14/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/15/1562 (IQVIA RDS Ireland Limited)

EU/3/15/1562 (IQVIA RDS Ireland Limited)

EU/3/15/1562 (Active substance: A highly purified formulation of Staphylococcus aureus protein A) - Transfer of orphan designation - Commission Decision (2018)3144 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/111/15/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/15/1595 (IQVIA RDS Ireland Limited)

EU/3/15/1595 (IQVIA RDS Ireland Limited)

EU/3/15/1595 (Active substance: Live attenuated Listeria monocytogenes bioengineered with a chimeric human epidermal growth factor receptor 2 fused to a truncated form of the Lm protein listeriolysin O) - Transfer of orphan designation - Commission Decision (2018)1819 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/162/15/5T/01

Europe -DG Health and Food Safety

5-3-2018

EU/3/15/1555 (La Jolla Pharmaceutical II BV)

EU/3/15/1555 (La Jolla Pharmaceutical II BV)

EU/3/15/1555 (Active substance: Synthetic hepcidin) - Transfer of orphan designation - Commission Decision (2018)1426 of Mon, 05 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/15/T/02

Europe -DG Health and Food Safety