Bimectin Plus

Main information

  • Trade name:
  • Bimectin Plus
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Bimectin Plus
    Italy
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • ivermectin, combinations
  • Therapeutic area:
  • Cattle

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0384/001
  • Authorization date:
  • 22-12-2010
  • EU code:
  • UK/V/0384/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:March2011

AN:00092/2010

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

BimectinPlus,10/100mg/mlSolutionforInjectionforCattle-UK,DK,BE,PT,RO

BimectinFluke,10/100mg/ml,SolutionforInjectionforCattle-DE

CevamecD,10/100mg/ml,Solutioninjectablepourbovins-FR

RenomecPlus,10/100mg/ml,Solucioninyectableparabovinos-ES

MaximecPlus,10/100mg/ml,SolutionforinjectionforCattle –PL,IT

IvermectinClorsulon

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstances:

1mlcontains:

Ivermectin 10mg

Clorsulon 100mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection

Aclearcolourlesstopaleyellowsterilenon-aqueoussolution

4. CLINICALPARTICULARS

4.1Targetspecies

Cattle

4.2Indicationsforuse,specifyingthetargetspecies

Theproductisindicatedforthetreatmentofmixedtrematodeandnematodeor

arthropodinfestationsofthefollowingparasites:

Gastrointestinalroundworms(adultandfourth-stagelarvae):

Ostertagiaostertagi(includinginhibitedlarvalstages)

O.lyrata

Haemonchusplacei

Trichostrongylusaxei

T.colubriformis

Cooperiaoncophora

C.punctata

C.pectinata

Bunostomumphlebotomum

Oesophagostamumradiatum

Strongyloidespapillosus(adult)

N.spathiger(adult)

N.helvetianus(adult)

Lungworms(adultandfourth-stagelarvae)

Dictyocaulusviviparous

Revised:March2011

AN:00092/2010

Liverfluke(adult):

Fasciolahepatica

Eyeworms(adult):

Thelaziaspp

Warbles(parasiticstages):

Hypodermabovis

H.lineatum

Mangemites:

Psoroptesbovis

Sarcoptesscabieivar.bovis

Suckinglice:

Linognathusvituli

Haematopinuseurysternus

Solenopotescapillatus.

Theproductmayalsobeusedasanaidinthecontrolofbitinglice(Damaliniabovis)

andthemangemiteChorioptesbovis,butcompleteeliminationmaynotoccur.

Persistentactivity

Theproductgivenattherecommendeddosageof1ml/50kgbodyweightcontrolsre-

infectionwithHaemonchusplacei,Cooperiaspp.andTrichostrongylusaxeiacquired

upto14daysaftertreatment,OstertagiaostertagiandOesophagostomumradiatum

acquiredupto21daysaftertreatmentandDictyocaulusviviparusacquiredupto28

daysaftertreatment.

4.3Contraindications

Thisproductisnottobeusedintramuscularlyorintravenously.

Thisproductisalowvolumeproductauthorisedforuseincattle.Itmustnotbeused

inotherspeciesassevereadversereactions,includingfatalitiesindogs,mayoccur,

especiallyCollies,OldEnglishSheepdogsandrelatedbreedsorcrosses.

4.4Specialwarningsforeachtargetspecies

Careshouldbetakentoavoidthefollowingpracticesbecausetheyincreasetherisk

ofdevelopmentofresistanceandcouldultimatelyresultinineffectivetherapy:

Toofrequentandrepeateduseofanthelminticsfromthesameclass,overan

extendedperiodoftime.

Underdosing,whichmaybeduetounderestimationofbodyweight,

misadministrationoftheproduct,orlackofcalibrationofthedosingdevice(if

any).

Suspectedclinicalcasesofresistancetoanthelminticsshouldbefurtherinvestigated

usingappropriatetests(e.g.FaecalEggCountReductionTest).Wheretheresults

ofthetest(s)stronglysuggestresistancetoaparticularanthelmintic,ananthelmintic

belongingtoanotherpharmacologicalclassandhavingadifferentmodeofaction

shouldbeused.

Revised:March2011

AN:00092/2010

4.5Specialprecautionsforuse

i) Specialprecautionsforuseinanimals

Thisproductdoesnotcontainanyantimicrobialpreservative.Swabseptumbefore

removingeachdose.

ii) Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Donotsmokeoreatwhilsthandlingtheproduct.

Washhandsafteruse.

Wearglovesandglasseswhenhandlingtheveterinarymedicinalproduct.Direct

contactwiththeskinshouldbeavoided.

Takecaretoavoidself-injection:theproductmaycauselocalirritationand/orpainat

theinjectionsite.Incaseofaccidentalselfinjection,seekmedicaladviceandshow

thelabeltothedoctor.

iii)Otherprecautions

Theproductisverytoxictoaquaticorganismsanddunginsects.Treatedcattle

shouldnothavedirectaccesstoponds,streamsorditchesfor14daysafter

treatment.Longtermeffectsondunginsectscausedbycontinuousorrepeateduse

cannotbeexcluded.Thereforerepeattreatmentsonapasturewithinaseason

shouldonlybegivenontheadviceofaveterinarian.

4.6Adversereactions(frequencyandseriousness)

Transitorydiscomforthasbeenobservedinsomecattlefollowingsubcutaneous

administration.Alowincidenceofsofttissueswellingattheinjectionsitehasbeen

observed.Thesereactionsdisappearedwithouttreatment.

4.7Useduringpregnancy,lactationorlay

Canbeusedinpregnancyandlactation.

Canbeusedinbreedinganimals.

Seesection4.11.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

Revised:March2011

AN:00092/2010

4.9Amountstobeadministeredandadministrationroute

Dosageanddurationoftreatment

200μgivermectinand2mgclorsulonperkgbodyweightcorrespondingtoasingle

doseof1mlper50kgbodyweight.

Methodofadministration

Theproductshouldbeadministeredonlybysubcutaneousinjectionundertheloose

skininfrontoforbehindtheshoulder.

Dividedosesinexcessof10mlbetweendifferentinjectionsitesandusedifferent

sitestothoseusedforotherparenteralmedications.

Asterile17gauge½inch(15-20mm)needleisrecommended.Replacewithafresh

sterileneedleafterevery10-12animalsorsooneriftheneedlebecomessoiled.

Whenthetemperatureoftheproductisbelow5°C,difficultyinadministrationmaybe

encounteredduetoincreasedviscosity.Warmingtheproductandinjection

equipmenttoabout15°Cwillgreatlyincreasetheeasewithwhichtheproductcanbe

injected.

Whenusingthe500mlpacksizeuseonlyautomaticsyringeequipment.Forthe

50mlpacksize,useofamultidosesyringeisrecommended.

Thetimingoftreatmentshouldbebasedonepidemiologicalfactorsandshouldbe

customisedforeachindividualfarm.Adosingprogramshouldbeestablishedbya

qualifiedprofessionalperson.

Toensureacorrectdosage,bodyweightshouldbedeterminedasaccuratelyas

possible;accuracyofthedosingdeviceshouldbechecked.

Ifanimalsaretobetreatedcollectivelyratherthanindividually,toavoidunder-or

over-dosing,theyshouldbegroupedaccordingtotheirbodyweightanddosed

accordingly.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Adoseof25mlproductper50kgbodyweight(25timestherecommendeddoselevel)

mayresultinaninjectionsitelesion,includingtissuenecrosis,oedema,fibrosisand

inflammation.Nootherdrug-relatedreactionshavebeenobserved.

4.11Withdrawalperiod(s)

Meatandoffal: 66days

Milk: Donotuseincattleproducingmilkforhumanconsumption.

Donotuseinnon-lactatingdairycowsincludingpregnant

heiferswithin60daysofcalving.

Revised:March2011

AN:00092/2010

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Endectocides,macrocycliclactones,avermectins,

ivermectin-combinations

ATCvetcode:QP54AA51

5.1Pharmacodynamicproperties

Ivermectinisamemberofthemacrocycliclactoneclassofendectocidesandhasa

uniquemodeofaction.Ithasbroadandpotentantiparasiticactivity.Itbinds

selectivelyandwithhighaffinitytoglutamate-gatedchlorideionchannelswhich

occurininvertebratenerveandmusclecells.Thisleadstoanincreaseinthe

permeabilityofthecellmembranetochlorideionswithhyperpolarisationofthenerve

ormusclecell,resultinginparalysisanddeathoftheparasite.Compoundsofthis

classmayalsointeractwithotherligand-gatedchloridechannelssuchasthose

gatedbytheneurotransmittergamma-amino-butyricacid(GABA).

Themarginofsafetyforcompoundsofthisclassisattributabletothefactthat

mammalsdonothaveglutamate-gatedchloridechannels,thatthemacrocyclic

lactoneshavealowaffinityforothermammalianligand-gatedchloridechannelsand

theydonotreadilycrosstheblood-brainbarrier.

Clorsulonisrapidlyabsorbedinthebloodstream.Itisboundtotheerythrocytesand

plasmawhichareingestedbythefluke.Clorsuloninhibitstheglycolyticenzymesin

theflukeanddeprivesitofitsmainsourceofmetabolicenergy.

5.2Pharmacokineticproperties

Aftersubcutaneousadministrationof2mgclorsulonand0.2mgivermectinperkg

bodyweight,theplasmaprofiledemonstratedaslow,steadyabsorptionofivermectin

whichreachedamaximumplasmaconcentrationatamediantimeof1.50days.In

contrast,clorsulonappearedrapidlyabsorbedwithamaximumplasmaconcentration

atamediantimeof0.25days.Theterminalhalflifeforthetwoactiveingredients

weredeterminedasfollows:Ivermectinapproximately3.79daysandClorsulon

approximately3.58days

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Glycerolformal

Propyleneglycol

Monoethanolamine

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days

Revised:March2011

AN:00092/2010

6.4.Specialprecautionsforstorage

Protectfromlight.

Keepthecontainerintheoutercartoninordertoprotectfromlight.

6.5Natureandcompositionofimmediatepackaging

Containermaterial: Highdensitypolyethylene

Containerclosure: Siliconisedgreybromobutylrubberstopperwithtamperevident

aluminiumoverseal.

Containercolour: Natural

Containervolume: 50ml,250mlor500ml

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

EXTREMELYDANGEROUSTOFISHANDAQUATICLIFE.Donotcontaminate

surfacewatersorditcheswiththeproductorusedcontainer.Anyunusedveterinary

medicinalproductorwastematerialsderivedfromsuchveterinarymedicinalproducts

shouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

CrossVetpharmGroupLtd

BroomhillRoad

Tallaght

Dublin24

Ireland

8. MARKETINGAUTHORISATIONNUMBER

Vm12597/4051

9. DATEOFFIRSTAUTHORISATION

19February2010

10.DATEOFREVISIONOFTHETEXT

March2011

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Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

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

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

28-9-2018

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily." (see pic...

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

20-9-2018

Vacant position at IMA's Quality Assessment Team

Vacant position at IMA's Quality Assessment Team

The Agency advertises vacancy for expert in Quality Assessment Team in Assessment Division. The Agency is looking for strong candidate who are willing to work on challenging and interesting tasks. The vacancy is a full position (100%).

IMA - Icelandic Medicines Agency

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

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

12-12-2018

Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

TGO 100 has been registered on the Federal Register of Legislation. It commences on 8 December 2018, repealing and replacing TGO 98

Therapeutic Goods Administration - Australia

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

21-11-2018

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Active substance: Propagermanium) - Orphan designation - Commission Decision (2018)7810 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/103/18

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

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

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

2-10-2018

NexoBrid (MediWound Germany GmbH)

NexoBrid (MediWound Germany GmbH)

NexoBrid (Active substance: Concentrate of proteolytic enzymes enriched in bromelain) - PSUSA - Modification - Commission Decision (2018)6460 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10028/201712

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

Kadcyla (Roche Registration GmbH)

Kadcyla (Roche Registration GmbH)

Kadcyla (Active substance: Trastuzumab emtansine) - Centralised - Renewal - Commission Decision (2018)6100 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2389/R/39

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