tempora

Main information

  • Trade name:
  • Tempora 10 mg chewable tablets for dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Tempora 10 mg chewable tablets for dogs
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • spironolactone
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0235/001
  • Authorization date:
  • 24-05-2012
  • EU code:
  • FR/V/0235/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

TEMPORA10MGCHEWABLETABLETSFORDOGS

TEMPORAVET(NO)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Onetabletcontains

Activesubstance:

Spironolactone............................................................10mg

Excipient(s):

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Chewabletablet

Oblongscoredbeigetablet.Thetabletscanbedividedintoequalhalves

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs

4.2 Indicationsforuse,specifyingthetargetspecies

Foruseincombinationwithstandardtherapy(includingdiureticsupport,wherenecessary)

forthetreatmentofcongestiveheartfailurecausedbydegenerativemitralvalvediseasein

dogs.

4.3 Contraindications

Donotuseinanimalsusedfororintendedforuseinbreeding.

Donotusetheproductindogssufferingfromhypoadrenocorticism,hyperkalaemiaor

hyponatraemia.

DonotadministerspironolactoneinconjunctionwithNSAIDstodogswithrenalinsufficiency.

Donotuseinthecaseofhypersensitivitytospironolactoneoranyoftheexcipients

Seesection4.7

4.4Specialwarningsforeachtargetspecies

None

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Kidneyfunctionandplasmapotassiumlevelsshouldbeevaluatedbeforeinitiatingcombined

treatmentwithspironolactoneandACEinhibitors.Unlikeinhumans,anincreasedincidence

ofhyperkalaemiawasnotobservedinclinicaltrialsperformedindogswiththiscombination.

However,indogswithrenalimpairment,regularmonitoringofrenalfunctionandplasma

potassiumlevelsisrecommended astheremaybeanincreasedriskofhyperkalaemia.

DogstreatedconcomitantlywithspironolactoneandNSAIDsshouldbecorrectlyhydrated.

Monitoringoftheirrenalfunctionandplasmapotassiumlevelsisrecommendedbefore

initiationandduringtreatmentwithcombinedtherapy(see4.3).

Asspironolactonehasanantiandrogeniceffect,itisnotrecommendedtoadministerthe

producttogrowingdogs.

Asspironolactoneundergoesextensivehepaticbiotransformation,careshouldbetaken

whenusingtheproducttotreatdogswithhepaticdysfunction.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Maycauseskinsensitisation:personsknowntobeallergictospironolactoneorother

componentsoftheformulation,shouldnothandlethisproduct.

Handlethisproductwithgreatcaretoavoidunnecessaryexposure,takingallrecommended

precautions.

Washhandsafteruse.

Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,youshouldseekmedical

adviceandshowthedoctorthiswarning.Swellingoftheface,lipsoreyesordifficultywith

breathingaremoreserioussymptomsandrequireurgentmedicalattention.

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthepackage

leafletorthelabeltothephysician.

4.6Adversereactions(frequencyandseriousness)

Areversibleprostaticatrophyisoftenobservedinentiremaledogs.Vomitinganddiarrhoea

maycommonlyoccur.

4.7Useduringpregnancy,lactationorlay

Spironolactonehaddevelopmentaltoxicityinlaboratoryanimals.

Thesafetyoftheproducthasnotbeenassessedinpregnantandlactatingbitches.

Donotuseduringpregnancyandlactation.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Inclinicalstudies,theproductwasco-administeredwithACE-inhibitors,furosemideand

pimobendanwithoutevidenceofassociatedadversereactions.

Spironolactonedecreasesdigoxineliminationandhenceraisesdigoxinplasma

concentration.Asthetherapeuticindexfordigoxinisverynarrow,itisadvisabletomonitor

closelydogsreceivingbothdigoxinandspironolactone.

TheadministrationofeitherdeoxycorticosteroneorNSAIDswithspironolactonemayleadto

amoderatereductionofthenatriureticeffects(reductionofurinarysodiumexcretion)of

spironolactone.

ConcomitantadministrationofspironolactonewithACE-inhibitorsandotherpotassium-

sparingdrugs(asangiotensinreceptorblockers,ß-blockers,calciumchannelsblockers,

etc..)maypotentiallyleadtohyperkalaemia(see4.5).

SpironolactonemaycausebothinductionandinhibitionofcytochromeP450enzymesand

couldthereforeaffectthemetabolismofotherdrugsutilizingthesemetabolicpathways.

4.9 Amountstobeadministeredandadministrationroute

2mgofspironolactoneperkgofbodyweightoncedaily,i.e.1tabletper5kgofbodyweight,

byoralroute.Theproductshouldbeadministeredwithmeal.

Dogweight(kg) TEMPORA10mg

Numberoftabletsperday

>1to2.5 ½

>2.5to5 1

>5to7.5 1½

>7.5to10 2

Thetabletsareflavoured.Ifthedogdoesnotacceptthetabletfromhandorbowl,thenthe

tabletsmaybemixedwithasmallamountoffoodofferedpriortothemainmeal,or

administereddirectlyintothemouthafterfeeding.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Afteradministrationofupto5timestherecommendeddose(10mg/kg)tohealthydogs,

dose-dependentadverseeffectswerenoted,seesection4.6.

Incaseofanaccidentalmassiveingestionbyadog,thereisnospecificantidoteor

treatment.Itisthereforerecommendedtoinducevomiting,lavagethestomach(depending

onriskassessment)andmonitorelectrolytes.Symptomatictreatment,e.g.,fluidtherapy,

shouldbeprovided.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Aldosteroneantagonist.

ATCvetcode:QC03DA01

5.1 Pharmacodynamicproperties

Spironolactoneanditsactivemetabolites(including7 α-thiomethyl-spironolactoneand

canrenone)actasspecificantagonistsofaldosterone,andexerttheireffectsbybinding

competitivelytothemineralocorticoidreceptorlocatedinthekidneys,heartandblood

vessels.

Spironolactoneisanatriureticdrug(historicallydescribedasasoftdiuretic).Inthekidney,

spironolactoneinhibitsthealdosterone-inducedsodiumretentionleadingtoincreasein

sodiumandsubsequentlywaterexcretion,andpotassiumretention.Therenaleffectsof

spironolactoneanditsmetabolitesleadtoadecreaseinextracellularvolumeand

consequentlyinadecreaseofcardiacpreloadandleftatrialpressure.Theresultisan

improvementinheartfunction.

Inthecardiovascularsystem,spironolactonepreventsthedetrimentaleffectsofaldosterone.

Althoughtheprecisemechanismofactionisnotyetclearlydefined,aldosteronepromotes

myocardialfibrosis,myocardialandvascularremodellingandendothelialdysfunction.

Inexperimentalmodelsindogs,itwasshownthatlongtermtherapywithanaldosterone

antagonistpreventsprogressiveleftventricledysfunctionandattenuatesleftventricle

remodellingindogswithchronicheartfailure.

WhenusedincombinationwithACE-inhibitors,spironolactonemaycounteracttheeffectsof

“aldosteroneescape”.

Aslightincreaseinaldosteronebloodlevelsmaybeobservedinanimalsontreatment.This

isthoughttobeduetoactivationoffeedbackmechanismswithoutadverseclinical

consequence.Theremaybeadoserelatedhypertrophyoftheadrenalzonaglomerulosaat

highdoserates.

5.2Pharmacokineticparticulars

Thepharmacokineticsofspironolactonearebasedonitsmetabolites,astheparent

compoundisrapidlymetabolised.

Absorption

Indogs,oralbioavailabilityofspironolactoneasmeasuredbycanrenoneAUCswas83%

relativetotheivroute.Ithasbeenshownthatfeedingsignificantlyincreasestheoral

bioavailabilityofallmeasuredmetabolitesresultingfromdosingdogswithspironolactone.

Aftermultipleoraldosesof2mgspironolactoneperkgfor5consecutivedays,steady-state

conditionsarereachedbyday3andonlyaslightaccumulationofcanrenoneisobserved.

Afteroraladministrationofspironolactoneindogsat2mg/kg,meanCmaxof41ng/mLare

achievedfortheprimarymetabolites,canrenoneand7α-thiomethyl-spironolactone,after4

hours,respectively.

Distribution

Themeanapparentvolumeofdistributionduringeliminationphaseafteroraldosingindogs

was41L/kgforcanrenone.

Themeanresidencetimeofthemetabolitesrangesfrom11hours.

Theproteinbindingisabout90%.

Metabolism

Spironolactoneisrapidlyandcompletelymetabolisedbytheliverintoitsactivemetabolites,

canrenon e,7α-thiomethyl-spironolactoneand6β-hydroxy-7 

-thiomethyl-spironolactone,

whicharetheprimarymetabolitesinthedog.

Elimination

Spironolactoneismainlyexcretedviaitsmetabolites.Plasmaclearanceofcanrenoneis3

L/h/kgforcanrenone,indogs.Afteroraladministrationofradiolabelledspironolactonetothe

dog,66%ofthedoseisrecoveredinfaecesand12%intheurine.74%ofthedoseis

excretedwithin48hours

Environmentalproperties

Notapplicable

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Artificialchickenflavour

Yeast

CrospovidonetypeA

Sodiumlaurylsulfate

Maltodextrine

Magnesiumstearate

Silica,colloidalanhydrous

Silicifiedmicrocrystallinecellulose

Lactosemonohydrate

6.2Incompatibilities

None

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:36months

Shelf-lifeafterfirstopeningtheimmediatepackaging:24hours

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Storeinoriginalpackage

Anypart-usedtabletshouldbereturnedtotheopenedblisterandusedwithin24hours

6.5Natureandcompositionofimmediatepackaging

(PA-AL-PVC –aluminiumheatsealed)containing10 tabletsperblister

Cardboardboxof10tabletscontaining1blisterof10tablets

Cardboardboxof20tabletscontaining2blistersof10tablets

Cardboardboxof30tabletscontaining3blistersof10tablets

Cardboardboxof60tabletscontaining6blistersof10tablets

Cardboardboxof100tabletscontaining10blistersof10tablets

Cardboardboxof180tabletscontaining18blistersof10tablets

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

SOGEVAL

200AVENUEDEMAYENNE

ZONEINDUSTRIELLEDESTOUCHES

53000LAVAL

FRANCE

Tel:33243495151

Fax:33243539700

E-mail: sogeval@sogeval.fr

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Tobecompletedinaccordancewithnationalrequirements

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Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

22-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

17-8-2018

Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of Mortality and Stroke

Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of Mortality and Stroke

FDA has reviewed the final results from the post-approval study conducted by SynCardia Systems, LLC. for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System). These final results indicate a higher mortality rate and higher stroke rate for patients initially supported with the C2 Driver System compared to patients initially supported with the previous generation driver, the Circulatory Support System (CSS) Console.

FDA - U.S. Food and Drug Administration

10-12-2018

Exondys (AVI BioPharma International Ltd)

Exondys (AVI BioPharma International Ltd)

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

Europe -DG Health and Food Safety

10-12-2018

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (JensonR+ Limited)

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

Europe -DG Health and Food Safety

26-11-2018

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

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

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

FDA - U.S. Food and Drug Administration

26-11-2018

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

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

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

FDA - U.S. Food and Drug Administration

23-11-2018

.@US_FDA issues Class I Medical Device Recall, the most serious type of   recall: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to  Connector Separation Causing Potential for Loss of Pacing. Find out  more:  https://go.usa.gov/xPHxF  #FDA #MedicalDe

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to Connector Separation Causing Potential for Loss of Pacing. Find out more: https://go.usa.gov/xPHxF  #FDA #MedicalDe

. @US_FDA issues Class I Medical Device Recall, the most serious type of recall: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to Connector Separation Causing Potential for Loss of Pacing. Find out more: https://go.usa.gov/xPHxF  #FDA #MedicalDevice pic.twitter.com/negJ6HU4x2

FDA - U.S. Food and Drug Administration

22-11-2018

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

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

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

Europe -DG Health and Food Safety

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

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

Europe -DG Health and Food Safety

23-10-2018

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

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

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

Europe -DG Health and Food Safety

22-10-2018

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

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

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

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

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

Europe -DG Health and Food Safety

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

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

Europe -DG Health and Food Safety

19-9-2018

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Eli Lilly Nederland B.V.)

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

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Mylan S.A.S.)

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

Europe -DG Health and Food Safety

10-9-2018

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

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

Europe -DG Health and Food Safety

10-9-2018

Alkindi (Diurnal Limited)

Alkindi (Diurnal Limited)

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

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

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

Europe -DG Health and Food Safety

10-9-2018

Silapo (STADA Arzneimittel AG)

Silapo (STADA Arzneimittel AG)

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

Europe -DG Health and Food Safety

4-9-2018

ACM meeting statement, Meeting 10, 2 August 2018

ACM meeting statement, Meeting 10, 2 August 2018

The Advisory Committee on Medicines meeting statement is now available

Therapeutic Goods Administration - Australia

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

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

Europe -DG Health and Food Safety