Benazepril hydrochloride 20 mg tablets for dogs

Main information

  • Trade name:
  • Benazepril hydrochloride 20 mg tablets for dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Benazepril hydrochloride 20 mg tablets for dogs
    Greece
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • benazepril
  • Therapeutic area:
  • Dogs Non Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0125/003
  • Authorization date:
  • 07-07-2011
  • EU code:
  • NL/V/0125/003
  • Last update:
  • 09-08-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

PartIB1Summaryofproductcharacteristics

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

NL:Benazeprilhydrochloride20mgtablettenvoorhonden

DE:Benakor20mg

DK:Benakorvet.20mg

EL:BenakorF20mgταμπλέταγιασκύλους

HU:BenakorF20mgtablettakutyarészéreA.U.V.

SE:Benakorvet.20mgtablet

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstance:

18.42mgbenazepril(equivalentto20mgbenazeprilhydrochloride)

Excipient(s):

Colourant:Ironoxides(E172)8mg

Forafulllistofexcipients,seesection6.1.

3.PHARMACEUTICALFORM

Orangeoblongdivisibletablets,withabreakmarkononeside.

4.CLINICALPARTICULARS

4.1Targetspecies

Dog

4.2Indicationsforuse,specifyingthetargetspecies

Symptomatictreatmentofcongestiveheartfailurewithorwithoutadjuncttherapyusedinthetreatmentof

heartfailure.

4.3Contraindications

Donotuseinanydogthathasevidenceofcardiacoutputfailureduetoaorticstenosis,mitralvalve

stenosisorpulmonarystenosisorincaseofhypotension.

DonotuseincaseofknownhypersensitivitytoACEinhibitorsortoanyoftheingredientsoftheproduct.

Seeparagraph4.7

4.4Specialwarningsforeachtargetspecies

None

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Noevidenceofrenaltoxicitytotheproducthasbeenobservedindogsduringclinicaltrials.

However,asisroutineincasesofrenalinsufficiency,itisrecommendedtomonitorplasmaureaand

creatininelevels.

Donotabruptlystoporreducetherapy.

Specialprecautionstobetakenbythepersonadministeringthemedicinalproductto

animals

Washhandsafteruse.

Pregnantwomenshouldtakespecialcaretoavoidaccidentalexposure,becauseACEinhibitorshavebeen

foundtoaffecttheunbornchildduringpregnancyinhumans.

Incaseofaccidentalingestionbychildren,seekmedicaladviceimmediatelyandshowthepackageleaflet

orthelabeltothephysician.

4.6Adversereactions(frequencyandseriousness)

-Atthestartoftreatmentadecreaseofbloodpressuremayoccur.

-inrarecasesfatigueordrowsinessmaybeobserved.

-benazeprilhydrochloridemayleadtoincreasedplasmacreatinineconcentrations.

-onrareoccasionstransientsignsofhypotension,suchaslethargyandataxiamayoccur.

4.7Useduringpregnancyorlactation

Donotuseinpregnantornursingbitchesorinbitchesintendedforbreeding.Safetyofthisproducthas

notbeentestedinpregnantorlactatingdogs.Laboratorystudiesinratshaveshownembryotoxiceffectsof

Benazeprilatnon-maternotoxicdoses(urinarytractabnormalitiesinfoetus).Inhumans,ACEinhibitors

havebeenfoundtobeteratogenicduringpregnancy.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Indogswithheartfailure,benazeprilhasbeengivenincombinationwithdigoxin,diureticsandanti-

arrhythmicdrugswithoutdemonstrableadverseinteractions.Inman,thecombinationofACEinhibitors

andNSAIDscanleadtoreducedantihypertensiveefficacyorimpairedrenalfunction.Thecombinationof

benazeprilandotherantihypertensiveagents(e.g.calciumchannelblockers,beta-blockersordiuretics),

anaestheticsorsedativesmayleadtoadditivehypotensiveeffects.ThereforeconcurrentuseofNSAIDsor

othermedicationwithahypotensiveeffectshouldbeconsideredwithcare.Renalfunctionandsignsof

hypotension(lethargy,weakness,etc.)shouldbemonitoredcloselyandtreatedasnecessary.

Interactionswithpotassiumpreservingdiureticslikespironolactone,triamterenoramiloridcannotbe

ruledout.Itisrecommendedtomonitorplasmapotassiumlevelswhenusingbenazeprilincombination

withapotassiumsparingdiureticaslifethreateningreactionsareapossibility.

4.9Amountstobeadministeredandadministrationroute

Therecommendedoraldoseis0.25mgbenazeprilhydrochloride/kgbodyweightoncedaily.Thedose

maybedoubled(stilladministeredoncedaily),ifjudgedclinicallynecessaryandadvisedbythe

veterinarysurgeon.

Incaseofusinghalvedtablets:Puttheremaininghalfofadividedtabletbackintheblisterpocketand

storeitinadryplacebelow25ºC.Usetheremainingtablethalfforthenextadministration.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Morphologicalchangessuchashypertrophyandhyperplasiaofthejuxtaglomerularapparatus,increaseof

ureaandloweredheartweightinhealthydogsduetoinvolutionhasbeenobservedafterdosesofmore

than10mg/kg.

Transientreversiblehypotensionmayoccurincasesofaccidentaloverdosage.Symptomatictreatment

consistsofintravenousinfusionofwarmisotonicsalinesolution.

4.11Withdrawalperiod(s)

Notapplicable.

5.PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:ACEinhibitors,plain

ATCvetcode:QC09AA07

5.1Pharmacodynamicproperties

Benazeprilhydrochlorideisapro-drughydrolysedinvivotobenazeprilate.Benazeprilateisahighly

potentandselectiveinhibitorofangiotensinconvertingenzyme(ACE),thuspreventingtheconversionof

inactiveangiotensinItoactiveangiotensinII.Therefore,itblockseffectsmediatedbyangiotensinII,

includingvasoconstrictionofbotharteriesandveins,retentionofsodiumandwaterbythekidneyand

modellingeffects(includingpathologicalcardiahypertrophyanddegenerativerenalchanges).

Theproductcauseslong-lastinginhibitionofplasmaACEactivityindogs,withmorethan95%inhibition

atpeakeffectandsignificantactivity(>80%indogs)persisting24hoursafterdosing.

Itreducesthebloodpressureandvolumeloadontheheartindogswithheartfailure.

Onsetofclinicalefficacycanbeexpectedinapproximately1weekafterinitiationoftherapywith

benazeprilhydrochloride.

5.2Pharmacokineticparticulars

Afteroraladministrationofbenazeprilhydrochloride,peaklevelsofbenazeprilareattainedrapidly(tmax

1.1hindogs)anddeclinequicklyasthedrugispartiallymetabolisedbyliverenzymestobenazeprilate.

Indogs,unchangedbenazeprilandhydrophilicmetabolitesaccountfortheremainder.Indogs,peak

benazeprilateconcentrations(Cmaxof384.16ng/mlafteradoseof1.6mg/kgoftheproduct)are

achievedwithatmaxof1.1h.Thesystemicbioavailabilityisincomplete(~13%indogs)dueto

incompleteabsorption(38%indogs).

Benazeprilateiseliminatedwithat1/2valueof2.8h.Benazeprilandbenazeprilateareextensivelybound

toplasmaproteins,andintissuesarefoundmainlyintheliverandthekidney.

Thereisnosignificantdifferenceinthepharmacokineticsofbenazeprilatewhenbenazeprilhydrochloride

isadministeredtofedorfasteddogs.

Benazeprilateisexcreted54%viathebiliaryand46%viatheurinaryrouteindogs.Theclearanceof

benazeprilateisnotaffectedindogswithimpairedrenalfunctionandthereforenoadjustmentofthedose

isrequiredincasesofrenalinsufficiency.

6.PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Silicacolloidalanhydrous(E551)

Microcrystallinecellulose(E460)

Lactoseanhydrous

ColorconPigmentOrange23069(Ironoxides,E172)

Sodiumcyclamate(E952)

SodiumstarchglycolateTypeA

Magnesiumstearate(E470b).

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:

PVC/PE/PVDC-Aluminiumblister:15months.

Aluminium/Aluminiumblister:18months.

6.4.Specialprecautionsforstorage

Donotstoreabove25ºC

Storeintheoriginalpackage.

6.5Natureandcompositionofimmediatepackaging

1cartoncontains:

1,2,3,4,5,6or7PVC/PE/PVDC/Alu-foilblistersof14tabletseach

or

1,2,3,4,5,6,7Alu/Alu-foilblistersof14tabletseach.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7.MARKETINGAUTHORISATIONHOLDER

LeVetB.V.

Willeskop212

3421GWOudewater

TheNetherlands

8.MARKETINGAUTHORISATIONNUMBER

<localrequirement>

9.DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

<localrequirement>

10DATEOFREVISIONOFTHETEXT

<localrequirement>

PartIB2 Proposalforpackaging,labellingandpackageinsert

1.Labelling

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Benazeprilhydrochloride20mgtabletsfordogs

benazeprilhydrochloride

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

18.42mgbenazepril(equivalentto20mgbenazeprilhydrochloride)

Colouringaid:Ironoxides(E172)8mg

3. PHARMACEUTICALFORM

Tablet

4. PACKAGESIZE

14,28,42,56,70,84or98tablets

5. TARGETSPECIES

Dog

6. INDICATION(S)

Symptomatictreatmentofcongestiveheartfailurewithorwithoutadjuncttherapyusedinthetreatment

ofheartfailure.

7. METHODANDROUTE(S)OFADMINISTRATION

Fororaluse

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

9. SPECIALWARNING(S),IFNECESSARY

Washhandsafteruse

Pregnantwomenshouldtakespecialcaretoavoidaccidentalexposure,becauseACEinhibitorshavebeen

foundtoaffecttheunbornchildduringpregnancyinhumans.

Incaseofaccidentalingestionbychildren,seekmedicaladviseimmediatelyandshowthislabeltothe

doctor.

10. EXPIRYDATE

EXP{month/year}

11. SPECIALSTORAGECONDITIONS

Donotstoreabove25ºC.

Storeintheoriginalpackage

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

LeVetB.V.

Willeskop212

3421GWOudewater

TheNetherlands

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Batch{number}

MINIMUMPARTICULARSTOAPPEARONBLISTERSORSTRIPS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Benazeprilhydrochloride20mgtabletsfordogs

benazeprilhydrochloride

2. NAMEOFTHEMARKETINGAUTHORISATIONHOLDER

LeVet

3. EXPIRYDATE

EXP{month/year}

4. BATCHNUMBER

Batch{number}

5. THEWORDS“FORANIMALTREATMENTONLY”

2.Packageinsert

PACKAGELEAFLET

Benazeprilhydrochloride20mgtabletsfordogs

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOF

THEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCH

RELEASE,IFDIFFERENT

Marketingauthorisationholder:

LeVetB.V.

Willeskop212

3421GWOudewater

TheNetherlands

Manufacturerforthebatchrelease:

ProdulabPharmaB.V.

Forellenweg16

4841SJRaamsdonksveer

TheNetherlands

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Benazeprilhydrochloride20mgtablets

benazeprilhydrochloride

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Activeingredient: 18.42mgbenazepril(equivalentto20mgbenazeprilhydrochloride)

Colouringaid: Ironoxides(E172)8mg

4. INDICATION(S)

Symptomatictreatmentofcongestiveheartfailurewithorwithoutadjuncttherapyusedinthetreatmentof

heartfailure.

5. CONTRAINDICATIONS

Donotuseinanydogthathasevidenceofcardiacoutputfailureduetoaorticstenosis,mitralvalve

stenosisorpulmonarystenosisorincaseofhypotension.Donotuseincaseofknownhypersensitivityto

ACEinhibitorsortoanyoftheingredientsoftheproduct.

Seesection12.

6. ADVERSEREACTIONS

- Atthestartoftreatmentadecreaseofbloodpressuremayoccur.

- inrarecasesfatigueordrowsinessmaybeobserved.

- benazeprilhydrochloridemayleadtoincreasedplasmacreatinineconcentrations.

- onrareoccasionstransientsignsofhypotension,suchaslethargyandataxiamayoccur.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Dogs

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Therecommendedoraldoseis0.25mgbenazeprilhydrochloride/kgbodyweightoncedaily.Thedose

maybedoubled(stilladministeredoncedaily),ifjudgedclinicallynecessaryandadvisedbythe

veterinarysurgeon.

Incaseofusinghalvedtablets:Puttheremaininghalfofadividedtabletbackintheblisterpocketand

storeitinadryplacebelow25ºC.Usetheremainingtablethalfforthenextadministration.

9. ADVICEONCORRECTADMINISTRATION

Foranimaltreatmentonly.Fororaluseonly.

10. WITHDRAWALPERIOD

Notapplicable.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Donotstoreabove25ºC.

Storeintheoriginalpackage

DonotuseaftertheexpirydatestatedonthecartonafterEXP.

12. SPECIALWARNING(S)

Noevidenceofrenaltoxicitytotheproducthasbeenobservedindogsduringclinicaltrials.However,as

isroutineincasesofrenalinsufficiency,itisrecommendedtomonitorplasmaureaandcreatininelevels.

Donotabruptlystoporreducetherapy.

Washhandsafteruse.

Pregnantwomenshouldtakespecialcaretoavoidaccidentalexposure,becauseACEinhibitorshavebeen

foundtoaffecttheunbornchildduringpregnancyinhumans.

Incaseofaccidentalingestionbychildren,seekmedicaladviceimmediatelyandshowthepackageleaflet

orthelabeltothephysician.

Donotuseinpregnantornursingbitchesorinbitchesintendedforbreeding.Safetyoftheproducthasnot

beentestedinbreeding,pregnantorlactatingdogs.Laboratorystudiesinratshaveshownembryotoxic

effectsofbenazeprilatnon-maternotoxicdoses(urinarytractabnormalitiesinthefoetus).Inhumans,

ACEinhibitorshavebeenfoundtobeteratogenicduringpregnancy.

Morphologicalchangessuchashypertrophyandhyperplasiaofthejuxtaglomerularapparatus,increaseof

ureaandloweredheartweightinhealthydogsduetoinvolutionhasbeenobservedafterdosesofmore

than10mg/kg.

Transientreversiblehypotensionmayoccurincasesofaccidentaloverdosage.Symptomatictreatment

consistsofintravenousinfusionofwarmisotonicsalinesolution.

Indogswithheartfailure,benazeprilhasbeengivenincombinationwithdigoxin,diureticsandanti-

arrhythmicdrugswithoutdemonstrableadverseinteractions.Inman,thecombinationofACEinhibitors

andNSAIDscanleadtoreducedantihypertensiveefficacyorimpairedrenalfunction.Thecombinationof

benazeprilandotherantihypertensiveagents(e.g.calciumchannelblockers,beta-blockersordiuretics),

anaestheticsorsedativesmayleadtoadditivehypotensiveeffects.Inman,thecombinationofACE

inhibitorsandNSAIDscanleadtoreducedantihypertensiveefficacyorimpairedrenalfunction.Therefore

concurrentuseofNSAIDsorothermedicationwithahypotensiveeffectshouldbeconsideredwithcare.

Renalfunctionandsignsofhypotension(lethargy,weakness,etc.)shouldbemonitoredcloselyandtreated

asnecessary.

Interactionswithpotassiumpreservingdiureticslikespironolactone,triamterenoramiloridcannotbe

ruledout.Itisrecommendedtomonitorplasmapotassiumlevelswhenusingbenazeprilincombination

withapotassiumsparingdiureticaslifethreateningreactionsareapossibility.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinalproducts

shouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

<localrequirement>

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Europe - EMA - European Medicines Agency

12-7-2018

Econor (Elanco Europe Ltd)

Econor (Elanco Europe Ltd)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4580 of Thu, 12 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Active substance: duloxetine hydrochloride) - Centralised - Withdrawal - Commission Decision (2018)4515 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency

3-7-2018

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4254 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/896/T/90

Europe -DG Health and Food Safety

3-7-2018

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4249 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1235/T/77

Europe -DG Health and Food Safety

3-7-2018

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4252 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/862/T/93

Europe -DG Health and Food Safety

3-7-2018

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4251 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/861/T/90

Europe -DG Health and Food Safety

29-6-2018

A past diagnosis of asthma is also associated with #COPD in 20% of the cases. Visit  https://bit.ly/1xErH2t  to learn more. #FactFridaypic.twitter.com/JWK672XtdI

A past diagnosis of asthma is also associated with #COPD in 20% of the cases. Visit https://bit.ly/1xErH2t  to learn more. #FactFridaypic.twitter.com/JWK672XtdI

A past diagnosis of asthma is also associated with #COPD in 20% of the cases. Visit https://bit.ly/1xErH2t  to learn more. #FactFriday pic.twitter.com/JWK672XtdI

FDA - U.S. Food and Drug Administration

30-5-2018

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Active substance: emtricitabine / rilpivirine (as hydrochloride) / tenofovir disoproxil (as fumarate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3453 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2312/T/91

Europe -DG Health and Food Safety

30-5-2018

Vokanamet (Janssen-Cilag International NV)

Vokanamet (Janssen-Cilag International NV)

Vokanamet (Active substance: canagliflozin / metformin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)3463 of Wed, 30 May 2018

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Active substance: Ambroxol hydrochloride) - Orphan designation - Commission Decision (2018)3384 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/236/17

Europe -DG Health and Food Safety

24-5-2018

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3261 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3262 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Janumet (Merck Sharp and Dohme Limited)

Janumet (Merck Sharp and Dohme Limited)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3260 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Efficib (Merck Sharp and Dohme Limited)

Efficib (Merck Sharp and Dohme Limited)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3276 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

21-5-2018

EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Active substance: Mexiletine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)3134 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/074/14/T/03

Europe -DG Health and Food Safety

21-5-2018

EU/3/14/1421 (Incyte Biosciences Distribution B.V.)

EU/3/14/1421 (Incyte Biosciences Distribution B.V.)

EU/3/14/1421 (Active substance: Ponatinib hydrochloride) - Transfer of orphan designation - Commission Decision (2018)3141 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/212/14/T/02

Europe -DG Health and Food Safety

15-5-2018

Votrient (Novartis Europharm Limited)

Votrient (Novartis Europharm Limited)

Votrient (Active substance: Pazopanib hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3062 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1141/T/46

Europe -DG Health and Food Safety

21-3-2018

EU/3/11/919 (Monopar Therapeutics SARL)

EU/3/11/919 (Monopar Therapeutics SARL)

EU/3/11/919 (Active substance: Clonidine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)1817 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/11/T/02

Europe -DG Health and Food Safety