PRILBEN

Main information

  • Trade name:
  • PRILBEN
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PRILBEN
    United Kingdom
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0179/001
  • Authorization date:
  • 02-12-2012
  • EU code:
  • FR/V/0179/001
  • Last update:
  • 09-08-2016

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

PACKAGELEAFLET

PRILBEN ®

vet5 film-coatedtabletfordogsandcats [FR]

PRILBENvet5 mgfilm-coatedtabletfordogsandcats

Benazeprilhydrochloride [DE/PL]

Prilbenvet5 mgfilm-coatedtabletfordogs andcats

Benazeprilhydrochloride [SE]

PRILBEN ®

vet5 mgfilm-coatedtabletfordogsandcats

Benazeprilhydrochloride [BE/DK/EL/ES/FI/IT/NL/PT/UK]

1.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATION

HOLDERANDOFTHEMANUFACTURINGAUTHORISATIONHOLDER

RESPONSIBLEFORBATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder

ChemoIbérica,S.A.

GranVíaCarlosIII,98–7ª

08028 Barcelona

SPAIN

Manufacturerforthebatchrelease

LaboratoriosLICONSA, S.A

Avda.Miralcampo,7, Pol.Ind.Miralcampo

AzuquecadeHenares,19200 Guadalajara

SPAIN

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PRILBEN ®

vet5 film-coatedtabletfordogsandcats [FR]

PRILBENvet5 mgfilm-coatedtabletfordogsandcats [PL]

PRILBENvet5 mgfilm-coatedtabletfordogsandcats

Benazeprilhydrochloride [DE]

Prilbenvet5 mgfilm-coatedtabletfordogsandcats

Benazeprilhydrochloride [SE]

PRILBEN ®

vet5 mgfilm-coatedtabletfordogsandcats

Benazeprilhydrochloride [BE/DK/EL/ES/FI/IT/NL/PT/UK]

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER

INGREDIENT(S)

Eachdivisibletabletcontains:

Benazepril..........................................4.6 mg

(equivalentto BenazeprilHydrochloride5 mg)

Excipients:

Titaniumdioxide(E171).....................1.929mg

Ironoxideyellow(E172)....................0.117 mg

Ironoxidered(E172).........................0.014 mg

Ironoxideblack(E172).....................0.004 mg

4. INDICATION(S)

Prilbenvet5mgbelongstoagroupofmedicinescalledAngiotensinConverting

Enzyme(ACE)inhibitors.Itisprescribedbytheveterinarysurgeonforthetreatmentof

congestiveheartfailureindogsandforreductionofproteinuriaassociatedwithchronic

kidneydiseaseincats.

5.CONTRAINDICATIONS

Donotuseincaseofhypersensitivitytotheactivesubstancebenazeprilhydrochloride

ortoanyingredientofthetablets.

Donotuseincasesofhypotension(lowbloodpressure),hypovolemia(lowblood

volume)oracuterenalfailure.

Donotuseincasesofcardiacoutputfailuredueto aorticorpulmonarystenosis.

Donotuseinpregnantorlactatingdogsorcatsbecausethesafetyofbenazepril

hydrochloridehasnotbeenestablishedduringpregnancyorlactationinthesespecies.

.

6.ADVERSEREACTIONS

Somedogswithcongestiveheartfailuremayexhibitvomitingorfatigueduring

treatment.

Indogsandcatswithchronickidneydiseasetheremaybeamoderateincreaseinlevels

ofcreatinine,anindicatorofkidneyfunction,intheblood.Thisislikelyduetothe

effectofthemedicationinreducingthebloodpressurewithinthekidneyandis

thereforenotnecessarilyareasonfortreatmenttobestopped,unlesstheanimalis

showingotheradversereactions.

Theproductmayincreasefoodconsumptionandbodyweightincats.Vomiting,poor

appetite,dehydration,lethargyanddiarrhoeahavebeenreportedonrareoccasionsin

cats.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,please

informyourveterinarysurgeon.

7. TARGETSPECIES

Dogsandcats

8.DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Theproductshouldbegivenorallyoncedaily,withorwithoutfood.Thedurationof

treatmentisunlimited.

Indogstheproductshouldbeadministeredorallyataminimumdoseof0.25mg(range

0.25-0.5)benazeprilhydrochloride/kgbodyweightoncedaily,accordingtothe

followingtable:

Weightofdog(kg) PrilbenVet5 mgFilm-Coated

Tablets

Standarddose Doubledose

5-10 0.5 tablet 1 tablet

10-20 1 tablet 2 tablets

Indogswithcongestiveheartfailure,thedosemaybedoubled,stilladministeredonce

daily,to aminimumdoseof0.5 mg(range0.5-1.0)benazeprilhydrochloride/kgbody

weightifjudgednecessaryandadvisedbytheveterinarysurgeon.Alwaysfollowthe

dosinginstructionsgivenbytheveterinarysurgeon.

Incatstheproductshouldbeadministeredorallyataminimumdoseof0.5mg(range

0.5-1.0)benazeprilhydrochloride/kgbodyweightoncedailyaccordingtothefollowing

table:

Weightofcat(kg) PrilbenVet5 mgFilm-Coated

Tablets

2.5–5 0.5 tablet

> 5-10 1 tablet

9. ADVICEONCORRECTADMINISTRATION

None

10. WITHDRAWALPERIOD

Notapplicable

11. SPECIALSTORAGEPRECAUTIONS

Keep outofthereachandsightofchildren

Donotstoreabove25°C.Storeinadryplace.

Returnanyhalvedtablettotheblisterpackandusewithin1day.Theblisterpack

shouldbeinsertedbackintothecardboardbox.

DonotuseaftertheexpirydatestatedonthecartonafterEXP

12. SPECIALWARNING(S)

Specialwarningsfordogsandcats

Theefficacyandsafetyoftheproducthasnotbeenestablishedindogsandcatsbelow

2.5 kgbodyweight.

Specialprecautionsforuseinanimals

Incasesofchronickidneydisease,yourveterinarianwillcheckthehydrationstatusof

yourpetbeforestartingtherapy,andmayrecommendthatregularbloodtestsarecarried

outduringtherapyinordertomonitorplasmacreatinineconcentrationsandblood

erythrocytecounts.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproductto animals

Washhandsafteruse.

Incaseofaccidentaloralingestion,seekmedicaladviceimmediatelyandshowthelabel

orthepackageleaflettothephysician.

Pregnantwomenshouldtakespecialcaretoavoidaccidentaloralexposurebecause

ACEinhibitorshavebeenfoundtoaffecttheunbornchildduringpregnancyinhumans.

Useduringpregnancy,lactation

Donotuseduringpregnancyorlactation.Thesafetyoftheproducthasnotbeen

establishedinbreeding,pregnantorlactatingdogsorcats.

Interactions

Informtheveterinarysurgeoniftheanimalistaking,orhasrecentlytaken,anyother

medicines.

Indogswithcongestiveheartfailure,theveterinarymedicinalproducthasbeengivenin

combinationwithdigoxin,diuretics,pimobendanandanti-arrhythmicproductswithout

evidenceofassociatedadversereactions.

Inhumans,thecombinationofACEinhibitorsandNSAIDs(Non-SteroidalAnti-

InflammatoryDrugs)canleadtoreducedanti-hypertensiveefficacyorimpairedkidney

function.Thecombinationoftheproductandotheranti-hypertensiveagents(e.g.

calciumchannelblockers,β-blockersordiuretics),anaestheticsorsedativesmayleadto

additivehypotensiveeffects.Therefore,concurrentuseofNSAIDsorothermedications

withahypotensiveeffectshouldbeconsideredwithcare.

Yourveterinarysurgeonmayrecommendtocloselymonitorkidneyfunctionandfor

signsofhypotension(lethargy,weaknessetc)andtreattheseifnecessary.

Interactionswithpotassium-preservingdiureticslikespironolactone,triamtereneor

amiloridecannotberuledout.Yourveterinarysurgeonmayrecommendtomonitor

plasmapotassiumconcentrationswhenusingtheproductincombinationwitha

potassium-sparingdiureticbecauseoftheriskofhyperkalaemia(highbloodpotassium).

Overdose

Transientreversiblehypotension(lowbloodpressure)mayoccurincasesofaccidental

overdose.Therapyshouldconsistofintravenousinfusionofwarmisotonicsaline.

13. SPECIAL PRECAUTIONS FOR THE DISPOSALOFUNUSED

PRODUCTORWASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

14.DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

Spain:25/02/2008

Portugal:10/01/2008

France:13/02/2008

Italy:Pending

UK:04/03/2008

Finland:21/12/2007

Belgium:10/03/2008

TheNetherlands:11/02/2008

Denmark:02/10/2008

Sweden:Pending

Germany:04/09/2008

Greece:10/11/2008

Poland:04/02/2009

15.OTHERINFORMATION

Benazeprilhydrochlorideisaprodrughydrolysedinvivotoitsactivemetabolite,

benazeprilat.

Benazeprilatisahighlypotentandselectiveinhibitoroftheangiotensinconverting

enzyme(ACE),thuspreventingtheconversionofinactiveangiotensinItoactive

angiotensinIIandtherebyalsoreducingsynthesisofaldosterone.Therefore,itblocks

effectsmediatedbyangiotensinIIandaldosterone,includingvasoconstrictionofboth

arteriesandveins,retentionofsodiumandwaterbythekidneyandremodelingeffects

(includingpathologicalcardiachypertrophyanddegenerativerenalchanges).

Theproductcauseslong-lastinginhibitionofplasmaACEactivityindogsandcats,

withmorethan95%inhibitionatpeakeffectandsignificantactivity(>80%indogsand

>90%incats)persisting24 hoursafterdosing.

Theproductreducesthebloodpressureandvolumeloadontheheartindogswith

congestiveheartfailure.

Incatswithexperimentalrenalinsufficiency,theproductnormalizedtheelevated

glomerularcapillarypressureandreducedthesystemicbloodpressure.Reductionin

glomerularhypertensionmayretardtheprogressionofkidneydiseasebyinhibitionof

furtherdamagetothekidneys.Inaclinicaltrialincatswithchronickidneydisease,The

productsignificantlyreducedproteinlossintheurine;thiseffectisprobablymediated

viareducedglomerularhypertensionandbeneficialeffectsontheglomerularbasement

membrane.Theproductalsoincreasedtheappetiteofthecats,particularlyinmore

advancedcases.

IncontrastwithotherACEinhibitors,benazeprilatisexcretedequallybybothbiliary

andurinaryroutesindogsand85%viathebiliaryand15%viatheurinaryrouteincats,

andthereforenoadjustmentofthedoseofTheproductisnecessaryinthetreatmentof

caseswithrenalinsufficiency.

Boxwith14or140tablets.

Notallpack sizemaybemarketed.

Foranimaltreatmentonly–to besuppliedonlyonveterinaryprescription

4-6-2018

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger.

FDA - U.S. Food and Drug Administration

4-6-2018

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System   by Hospira: Recall - Due to the Potential Presence of Particulate Matter

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira: Recall - Due to the Potential Presence of Particulate Matter

The patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity.

FDA - U.S. Food and Drug Administration

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8038 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/42/T/54

Europe -DG Health and Food Safety

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

1-11-2018

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

26-9-2018

FORTEKOR PLUS (Elanco GmbH)

FORTEKOR PLUS (Elanco GmbH)

FORTEKOR PLUS (Active substance: pimobendan / benazepril) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6321 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2804/T/11

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

23-7-2018

Optruma (Eli Lilly Nederland B.V.)

Optruma (Eli Lilly Nederland B.V.)

Optruma (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4893 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

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

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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

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (Active substance: (R)-1-(3-(aminomethyl) phenyl)-N-(5-((3-cyanophenyl)(cyclopropylmethylamino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide dihydrochloride) - Orphan designation - Commission Decision (2018)4173 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/003/18

Europe -DG Health and Food Safety

14-6-2018

Kuvan (BioMarin International Limited)

Kuvan (BioMarin International Limited)

Kuvan (Active substance: sapropterin dihydrochloride) - Centralised - Yearly update - Commission Decision (2018)3859 of Thu, 14 Jun 2018

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3802 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/152/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3801 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/11/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3799 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/11/T/03

Europe -DG Health and Food Safety

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