Orbax Oral Suspension 3%

Main information

  • Trade name:
  • Orbax Oral Suspension 3%
  • Pharmaceutical form:
  • Oral suspension
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Orbax Oral Suspension 3%
    Italy
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Orbifloxacin
  • Therapeutic area:
  • Cats, Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0254/001
  • Authorization date:
  • 21-04-2011
  • EU code:
  • UK/V/0254/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:October2012

AN:00697/2012

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Noroclav500mgPalatableTabletsforDogs

NoroclavTablets400mg/100mgforDogs(Sweden)

NoroclavComprimés400mg/100mgpourChiens(France)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

ActiveIngredients:

Amoxicillin(asamoxicillintrihydrate) 400mg

Clavulanicacid(aspotassiumclavulanate) 100mg

ColouringAgent:

CarmoisineLake(E122) 2.45mg

Forafulllistofexcipients,seeSection6.1.

3. PHARMACEUTICALFORM

Tablet.Pinkdivisiblecirculartabletwithscorelineononefaceandfigure500

embossedonopposingface.Thetabletcanbedividedintoequalhalves.

4. CLINICALPARTICULARS

4.1 TargetSpecies

Dogs

4.2 IndicationsforUse,SpecifyingtheTargetSpecies

Treatmentofthefollowinginfectionscausedbybeta-lactamaseproducingstrainsof

bacteriasensitivetoamoxicillinincombinationwithclavulanicacid:

-Skininfections(includingsuperficialanddeeppyodermas)causedby

susceptibleStaphylococci.

-UrinarytractinfectionscausedbysusceptibleStaphylococciorEscherichiacoli.

-RespiratoryinfectionscausedbysusceptibleStaphylococci.

-EnteritiscausedbysusceptibleEscherichiacoli.

Itisrecommendedtocarryoutsuitabletestsforsensitivitywheninitiatingthe

treatment.Thetreatmentshouldonlyproceedifsensitivityisproventothe

combination.

Revised:October2012

AN:00697/2012

4.3 Contraindications

Donotuseinanimalswithknowncasesofhypersensitivitytopenicillinsorother

substancesofthebeta-lactamgroup.

Donotuseinrabbits,guineapigs,hamstersorgerbils.

Donotuseinanimalswithseriousdysfunctionofkidneysaccompaniedbyanuriaor

oliguria.

Donotusewhereresistancetothecombinationisknowntooccur

4.4 Specialwarningsforeachtargetspecies

None.

4.5 SpecialPrecautionsforUse

i. Specialprecautionsforuseinanimals:

Inappropriateuseoftheproductmayincreasetheprevalenceofbacteria

resistanttoamoxicillin/clavulanicacid.

Inanimalswithhepaticandrenalfailure,thedosingregimenshouldbe

carefullyevaluated.

Useoftheproductshouldbebasedonsusceptibilitytestingandtakeinto

accountofficialandlocalantimicrobialpolicies.Narrowspectrum

antibacterialtherapyshouldbeusedforfirstlinetreatmentwhere

susceptibilitytestingsuggestslikelyefficacyofthisapproach.

Cautionisadvisedintheuseinsmallherbivoresotherthanthosein4.3.

Donotadministertohorsesandruminatinganimals.

ii. Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals:

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)following

injection,inhalation,ingestionorskincontact.Hypersensitivitytopenicillins

mayleadtocrossreactionstocephalosporinsandviceversa.Allergic

reactionstothesesubstancesmayoccasionallybeserious.

Handlethisproductwithgreatcaretoavoidexposure,takingall

recommendedprecautions.

Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,youshould

seekmedicaladviceandshowthepackageleafletorthelabeltothe

physician.Swellingoftheface,lipsoreyesordifficultywithbreathingare

moreserioussymptomsandrequireurgentmedicalattention.

Washhandsafteruse.

4.6 Adversereactions(frequencyandseriousness)

Hypersensitivityunrelatedtodosecanoccurwiththeseagents.

Gastrointestinalsymptoms(diarrhoea,vomiting)mayoccurafteradministrationof

theproduct.

Allergicreactions(e.g.skinreactions,anaphylaxia)mayoccasionallyoccur.

Incaseofoccurrenceofallergicreaction,thetreatmentshouldbewithdrawn.

Revised:October2012

AN:00697/2012

4.7 UseDuringPregnancy,LactationorLay

Studiesinlaboratoryanimalshavenotproducedanyevidenceofteratogenic

effects.Useonlyaccordingtotherisk/benefitassessmentbytheresponsible

veterinarian.

4.8 InteractionswithOtherMedicinalProductsandOtherFormsofInteraction

Chloramphenicol,macrolides,sulfonamidesandtetracyclinesmayinhibitthe

antibacterialeffectofpenicillinbecauseoftherapidonsetofbacteriostaticaction.

Thepotentialforallergiccross-reactivitywithotherpenicillinsshouldbeconsidered.

Penicillinsmayincreasetheeffectsofaminoglycoside.

4.9 AmountstobeAdministeredandAdministration

Toensureacorrectdosage,bodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

Administrationisviatheoralroute.Thedosagerateis12.5mgcombined

actives/kgbodyweighttwicedaily.Thetabletsmaybecrushedandaddedtoalittle

food.

Thefollowingtableisintendedasaguidetodispensingtheproductatthestandard

doserateof12.5mg/kgtwicedaily.

Bodyweight(kg) Numberoftablets(500mg)perdosetwice

daily

20kg ½

40kg 1

60kg 1½

80kg 2

Durationoftherapy:

Routinecasesinvolvingallindications:Themajorityofcasesrespondtobetween5

and7daystherapy.

Chronicorrefractorycases:Inthesecaseswherethereisconsiderabletissue

damage,alongercourseoftherapymayberequiredinthatitallowssufficienttime

fordamagedtissuetorepair.

4.10Overdose(Symptoms,EmergencyProcedures,Antidotes)ifnecessary

Noadverseeffectshavebeenreportedafterthedailyadministrationof3timesthe

recommendeddosefor8days,andafterthedailyadministrationofthe

recommendeddosefor21days.

4.11WithholdPeriod(s)

Notapplicable

Revised:October2012

AN:00697/2012

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Anti-infectiveforsystemicuse:amoxicillinand

enzymeinhibitor.

ATCvetcode:QJ01CR02

5.1 Pharmacodynamicproperties

Amoxicillinisabeta-lactamantibioticanditsstructurecontainsthebeta-lactamring

andthiazolidineringcommontoallpenicillins.Amoxicillinshowsexcellentactivity

againstsusceptibleGram-positivebacteriaandGram-negativebacteria.

Beta-lactamantibioticspreventthebacterialcellwallfromformingbyinterfering

withthefinalstageofpeptidoglycansynthesis.Theyinhibittheactivityof

transpeptidaseenzymes,whichcatalysecross-linkageoftheglycopeptidepolymer

unitsthatformthecellwall.Theyexertabactericidalactionbutcauselysisof

growingcellsonly.

Clavulanicacidisoneofthenaturallyoccurringmetabolitesofthestreptomycete

Streptomycesclavuligerus.Ithasastructuralsimilaritytothepenicillinnucleus,

includingpossessionofabeta-lactamring.Clavulanicacidisabeta-lactamase

inhibitoractinginitiallycompetitivelybutultimatelyirreversibly.Clavulanicacidwill

penetratethebacterialcellwallbindingtobothextracellularandintracellularbeta-

lactamases.

Amoxicillinissusceptibletobreakdownby 

-lactamaseandthereforecombination

withaneffectiveß-lactamaseinhibitor(clavulanicacid)extendstherangeof

bacteriaagainstwhichitisactivetoinclude 

-lactamaseproducingspecies.

Invitropotentiatedamoxicillinisactiveagainstawiderangeofclinicallyimportant

aerobicandanaerobicbacteriaincluding:

Gram-positive:Staphylococci(in cludingβ-lactamaseproducingstrains),Clostridia,

Streptococci.

Gram-negative:Escherichiacoli (includingmostβ-lactamaseproducingstrains),

Campylobacterspp,Pasteurellae,Proteusspp.

ResistanceisshownamongEnterobacterspp,Pseudomonasaeruginosaand

methicillin-resistantStaphylococcusaureus.DogsdiagnosedwithPseudomonas

infectionsshouldnotbetreatedwiththisantibioticcombination.Atrendin

resistanceofE.coliisreported.

Revised:October2012

AN:00697/2012

5.2 Pharmacokineticproperties

Amoxicilliniswell-absorbedfollowingoraladministration.Indogsthesystemic

bioavailabilityis60-70%.Amoxicillin(pKa2.8)hasarelativelysmallapparent

distributionvolume,alowplasmaproteinbinding(34%indogs)andashortterminal

half-lifeduetoactivetubularexcretionviathekidneys.Followingabsorptionthe

highestconcentrationsarefoundinthekidneys(urine)andthebileandtheninliver,

lungs,heartandspleen.Thedistributionofamoxicillintothecerebrospinalfluidis

lowunlessthemeningesareinflamed.

Clavulanicacid(pKa2.7)isalsowell-absorbedfollowingoraladministration.The

penetrationtothecerebrospinalfluidispoor.Theplasmaproteinbindingis

approximately25%andtheeliminationhalf-lifeisshort.Clavulanicacidisheavily

eliminatedbyrenalexcretion(unchangedinurine).

Afteroraladministrationofthe50mgpresentationattherecommendeddoseof

12.5mgcombinedactives/kgtodogs,thefollowingparameterswereobserved:

Cmaxof6.30+/-0.45µg/ml,Tmaxof1.98+/-0.135handAUCof23.38+/-1.39

µg/ml.hforamoxicillinandCmaxof0.87+/-0.1µg/ml,Tmaxof1.57+/-0.177hrs

andAUCof1.56+/-0.24mg/ml.hforclavulanicacid.

6. PHARMACEUTICALPARTICULARS

6.1 ListofExcipient(s)

SodiumStarchGlycolate(typeA)

Copovidone

MagnesiumStearate

Cellulose,microcrystalline

SiliconDioxide

CalciumCarbonate

MagnesiumCarbonate,heavy

RoastBeefFlavour

LakeCarmosine(E122)

6.2 Incompatibilities

Notapplicable.

6.3 Shelf-Life

Shelf-lifeofveterinaryproductaspackagedforsale:2years.

Shelflifeafterfirstopeningtheimmediatepackaging:24hours.

Anydividedtabletportionremainingafter24hoursshouldbediscarded.

6.4 SpecialPrecautionsforStorage

Donotstoreabove25

C.Storeinadryplace.Dividedtabletsshouldbestoredin

theblisterpack.

Revised:October2012

AN:00697/2012

6.5 NatureandCompositionofImmediatePackaging

Theproductispresentedasfollows:

Aluminium/aluminiumblisterstrips,eachcontaining5tablets.Cartonsof10,20,25

and100tablets.Notallpacksizesmaybemarketed.

6.6 SpecialPrecautionsfortheDisposalofUnusedVeterinaryMedicinalProducts

orWasteMaterialsDerivedfromtheUseofSuchProductsifappropriate

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

NorbrookLaboratoriesLimited

StationWorks

Newry

CountyDown

BT356JP

NorthernIreland

8. MARKETINGAUTHORISATIONNUMBER

Vm

02000/4259

9. DATEOFFIRSTAUTHORISATION

Date:26April2006

10. DATEOFREVISIONOFTEXT

Date:October2012

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

NotApplicable

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31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 EFSA has asked the Panel on Nutrition, Novel Foods and Food Allergens (NDA) to update the guidance on the scientific requirements for health claims related to physical performance published in 2012. The update takes into account the experience gained by the NDA Panel with the evaluation of additional health claim applications, changes introduced to the general scientific guidance for stakeholders for health claims applications and information collected from ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Peer review of the pesticide risk assessment of the active substance methiocarb

Peer review of the pesticide risk assessment of the active substance methiocarb

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance methiocarb 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 use...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

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

18-10-2018

P. East Trading Corp. Issues Alert on Undeclared Sulfites In Fruits Du Sud Golden Seedless Raisins

P. East Trading Corp. Issues Alert on Undeclared Sulfites In Fruits Du Sud Golden Seedless Raisins

P. EAST TRADING CORP. of Bronx, NY is recalling Fruits Du Sud Golden Seedless Raisins (Lot No. FDS T499/18) 30 lbs Box, because they contain undeclared SULFITES. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening reactions if they consume these products.

FDA - U.S. Food and Drug Administration

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

25-9-2018

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Harris Teeter is notifying shoppers of a voluntarily recall of Harris Teeter Low Fat Frozen Yogurt Cookies & Cream 1.5 qt laminated cartons, UPC 0 72036 98182 0, with all SELL BY DATES up to 07/30/19 due to undeclared peanut product.

FDA - U.S. Food and Drug Administration

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

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

31-8-2018

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

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

Published on: Thu, 30 Aug 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 Germany for the pesticide active substance 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 cype...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida Facility Due to Possible Microbial Contamination

Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida Facility Due to Possible Microbial Contamination

Product Quest Manufacturing (“Product Quest”) announced its voluntary recall of Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist due to a finding of microbial contamination identified as Pseudomonas aeruginosa.

FDA - U.S. Food and Drug Administration

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

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

28-8-2018

Pfizer, Inc. Issues A Voluntary Nationwide Recall Of One Lot Of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle

Pfizer, Inc. Issues A Voluntary Nationwide Recall Of One Lot Of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle

Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling one lot of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle because of customer complaints that the dosage cup provided is marked in teaspoons and the instructions on the label are described in milliliters (mL).

FDA - U.S. Food and Drug Administration

30-11-2018

Pregabalin Zentiva k.s (Zentiva, k.s.)

Pregabalin Zentiva k.s (Zentiva, k.s.)

Pregabalin Zentiva k.s (Active substance: pregabalin) - Centralised - Yearly update - Commission Decision (2018)8149 of Fri, 30 Nov 2018

Europe -DG Health and Food Safety

15-11-2018

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Active substance: infliximab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7549 of Thu, 15 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4020/T/30

Europe -DG Health and Food Safety

30-10-2018

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Active substance: Phosphorothioate oligonucleotide targeted to transthyretin) - Transfer of orphan designation - Commission Decision (2018)7282 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/098/13/T/01

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Active substance: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant) - Orphan designation - Commission Decision (2018)7281 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/127/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Active substance: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII) - Orphan designation - Commission Decision (2018)7280 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/104/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Active substance: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG) - Orphan designation - Commission Decision (2018)7279 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/091/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Active substance: Melatonin) - Orphan designation - Commission Decision (2018)7278 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/077/18

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

30-10-2018

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Active substance: Gefitinib) - Orphan designation - Commission Decision (2018)7276 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/090/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (Active substance: Avapritinib) - Orphan designation - Commission Decision (2018)7275 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/079/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Active substance: Autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA) - Orphan designation - Commission Decision (2018)7274 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/113/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Active substance: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile) - Orphan designation - Commission Decision (2018)7272 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/125/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate) - Orphan designation - Commission Decision (2018)7273 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/102/18

Europe -DG Health and Food Safety

30-9-2018

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Active substance: edoxaban) - PSUSA - Modification - Commission Decision (2018)5089 of Sun, 30 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10387/201710

Europe -DG Health and Food Safety

17-9-2018

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction.   Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the c

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction. Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the c

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction. Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the concept.

FDA - U.S. Food and Drug Administration

30-8-2018

Steglatro (Merck Sharp and Dohme B.V.)

Steglatro (Merck Sharp and Dohme B.V.)

Steglatro (Active substance: ertugliflozin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5789 of Thu, 30 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4315/T/2

Europe -DG Health and Food Safety

30-8-2018

Fluenz Tetra (AstraZeneca AB)

Fluenz Tetra (AstraZeneca AB)

Fluenz Tetra (Active substance: influenza vaccine (live attenuated, nasal)) - Centralised - Variation - Commission Decision (2018)5815 of Thu, 30 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2617/II/82

Europe -DG Health and Food Safety