PRILIUM 300 MG

Main information

  • Trade name:
  • PRILIUM 300 MG
  • Pharmaceutical form:
  • Powder for oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PRILIUM 300 MG
    Italy
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Imidapril
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0133/003
  • Authorization date:
  • 20-02-2008
  • EU code:
  • FR/V/0133/003
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

11836 Prilium300 mg/FINALSPCRenewal

PRILIUM300mgpowderfororalsolution

Powderfororalsolution

SUMMARYOFPRODUCTCHARACTERISTICS

11836 Prilium300 mg/FINALSPCRenewal

SUMMARYOFPRODUCTCHARACTERISTICS

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

PRILIUM300 mgpowderfororalsolutionfordogs

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Powder/vial

Imidaprilhydrochloride 300 mg

Sodiumbenzoate(E211) 30 mg

Excipientto 1.030 g

Solutionafterreconstitution

Imidaprilhydrochloride 10.0 mg

Sodiumbenzoate(E211) 1.0 mg

Excipientto 1 ml

Forfulllistofexcipients, see6.1.

3.PHARMACEUTICALFORM

Powderfororalsolution

Vialcontainingawhitepowder. Afterreconstitution, thesolutionislimpid and colourless.

4.CLINICALPARTICULARS

4.1. Targetspecies

Dogsweighingover8 kg

4.2. Indicationsforuse, specifyingthetargetspecies

Indogs:treatmentofmoderateto severeheartfailurecaused bymitralregurgitationorbydilated cardiomyopathy.

4.3. Contraindications

Do notuseindogswithlowblood pressure.

Do notuseindogswithacuterenalinsufficiency.

Do notuseindogswithcongenitalheartdisease

Do notuseindogshypersensitiveto anACEinhibitor

Do notuseindogswithhemodynamicallyrelevantstenoses(aorticstenosis, mitralvalvestenosis, pulmonalstenosis)

Do notuseindogswithobstructivehypertrophiccardiomyopathy

4.4. Specialwarningsforeachtargetspecies

None

11836 Prilium300 mg/FINALSPCRenewal

4.5. Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

TheuseofACEinhibitorsindogswithhypovolaemia/dehydrationcanlead to

acutehypotension. Insuchcasesthefluid and electrolytebalanceshould be

restored immediatelyand treatmentsuspended untilithasbeenstabilised.

Parametersused formonitoringrenalfunctionshould bechecked atthe

beginningofthetreatmentand atregulartimeintervalsthereafter.

ii)Specialprecautionsto betakenbythepersonadministeringthemedicinalproductto animals

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthepackageinsertorthelabeltothe

physician.

Washhandsafterhavingadministeredtheveterinarymedicinalproduct.Incaseofcontactwitheyes,rinseimmediately

withplentyofwater.

Thevialmustbeclosed usingthechild proofstopperbeforebeingstored inthefridge.

iii)Otherprecautions

4.6.Adversereactions(frequencyand seriousness)

Diarrhoea, hypotensionand relatedsymptomssuchasfatigue,dizzinessoranorexiacanoccurinrarecases.Vomiting

canalsooccurinveryrarecases.Insuchcasestreatmentshouldbediscontinueduntilthepatient’sconditionhas

returned to normal.

4.7. Useduringpregnancy, lactationorlay

Laboratorystudiesinratsand rabbitsdid notproduceanyevidenceof

teratogenic, embryotoxicormaternotoxiceffects, oreffectsonreproductive

performances, whenimidaprilwasadministered atthetherapeuticdose.

Intheabsenceofdata, do notuseinpregnantorlactatingbitchesorin

breedingdogs.

4.8. Interactionwithothermedicinalproductsand otherformsofinteraction

Intheclinicaltrial,theveterinarymedicinalproducthasbeenusedwithfurosemideanddigoxinandnosafetyconcerns

werenoted.

However, diureticsand alowsodiumdietpotentiatetheeffectofACEinhibitorsbyactivatingtherenin-angiotensin-

aldosteronesystem(RAAS). Diureticsused athighdosesandalowsodiumdietarethusnotrecommendedduringa

treatmentwithACEinhibitorsinordertoavoidhypotensionwithclinicalsignssuchasapathy,ataxia,raresyncopeand

kidneyfailure. Incaseofjointadministrationwithpotassiumretainingdiuretics,potassiummustbemonitoredbecause

thereisarisk ofhyperkaliemia.

4.9. Amount(s)to beadministered and administrationroute

Therecommended doseofimidaprilis0.25 mg/kgonceadayperoralroute, ie:

0.025 ml/kgofPRILIUM®300 mgfordogsweighingmorethan8 kg(1ml/40kg).

Theveterinarymedicinalproductcanbeadministeredeitherdirectlyintothemouthoftheanimalonanemptystomach

orduringthemeals, oronfood.

11836 Prilium300 mg/FINALSPCRenewal

Preparationoftheoralsolution:Removethenippleand thestopperofthevialcontainingthepowderandfillwithtap

waterup to themark (30ml), placethechild proofcap and screwontightly.

Administration:Unscrewthechildproofcap, introducethegraduated syringeinto theapplicator, turntheassembly

upsidedownand measurethequantityto administerusingthesyringegraduatedinkg.Oncetheveterinarymedicinal

producthasbeenadministered,replacethechildproofcapontothevialandrinsethesyringewithwater.Storethevial

inthefridge.

4.10. Overdose(symptoms, emergencyprocedures, antidotes)

Oraldosesup to 5 mg/kgofimidapril(20-timestherecommended dose)havebeenwelltolerated inhealthydogs.

Hypotensionmayoccurasasymptomofoverdosagewithsignsofapathyandataxia.Thetreatmentissymptomatic.

5.1.Withdrawalperiod

Notapplicable.

5.PHARMACOLOGICALPROPERTIES

Imidaprilisanangiotensin-convertingenzyme(ACE)inhibitor.

AtcVetcode:QC09AA16

5.1. Pharmacodynamicproperties:

Imidaprilisapro-drugwhichishydrolysedin vivoto formanactivemetabolite, imidaprilat. Imidaprilatinhibitsthe

angiotensin-convertingenzyme(ACE). ThisenzymecatalysestheconversionofangiotensinIto angiotensinIIinthe

bloodplasmaandtissuesandinhibitsthebreakdownofbradykinin. AsangiotensinIIhasapotentvasoconstrictive

action,whilebradykininisavasodilator,thereducedformationofangiotensinIIandtheinhibitionofbradykinin

breakdownlead to vasodilation.

Imidaprilreducesheartpreloadandafterloadanddecreasesbloodpressurewithoutanycompensatoryincreaseinthe

heartrate.

5.2 Pharmacokineticproperties:

Followingoraladministrationinthedog,imidaprilisrapidlyabsorbedbythegastrointestinaltractandreachesits

maximumplasmaconcentrationwithinlessthanonehour. Thehalf-lifeofimidaprilisabout2 hours.

Imidaprilismainlyhydrolysedintheliverandkidneytoitsactivemetabolite,imidaprilat.Maximumplasma

concentrationsofimidaprilatarereached withinabout5 hoursand declinewithahalf-lifeofmorethan10 hours.

Thebioavailabilityofimidapriland imidaprilatisdecreased bythejointadministrationoffood.

Theproteinbindingofimidapriland imidaprilatismoderate(85%and 53%, respectively).

Afteroraladministrationoftheradio-labelledcompound,about40%oftotalradioactivityisexcretedinurineandabout

60%inthefaeces.

Aftermultipledosing,theplasmaimidaprilatconcentrationsareabout3timeshigherafterthesecondadministrationthan

afterthefirstadministration, butno additionalincreaseisobserved afterfurtheradministrations.

6.PHARMACEUTICALPARTICULARS

6.1. Listofexcipients

Mannitol,

11836 Prilium300 mg/FINALSPCRenewal

Sodiumbenzoate

6.2. Incompatibilities(majorcases)

Noneknown

6.3. Shelf-life

36 months

Afterreconstitutionaccordingto directions:77 days

6.4. Specialprecautionsforstorage

Beforereconstitution:do notstoreabove25°C

Afterreconstitution:storeat2°C-8°C(inarefrigerator)

6.5. Natureand compositionofimmediatepackaging

Primarypackaging:

amberglassvialoftypeII

bromobutylstopper

polypropylenemauvegraduated syringe

polyethylenesyringeapplicator

highdensitypolyethylene/polyethylenechild proofcap

Salespresentation(s):

boxcontainingone1.030 gpowdervialand one2 mlgraduated syringe

6.6 Specialprecautionsforthedisposalofunused veterinarymedicinalproductorwastematerialsderived from

theuseofsuchproducts, ifappropriate

Anyunused productorwastematerialshould bedisposed ofinaccordancewithnationalrequirements.

7.MARKETINGAUTORISATIONHOLDER

VETOQUINOL

8.MARKETINGAUTHORISATIONNUMBER(S):

9.DATEOFTHEFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION:

10.DATEOFREVISIONOFTHETEXT:

<PROHIBITIONOFSALE, SUPPLYAND/ORUSE>

11836 Prilium300 mg/FINALSPCRenewal

OUTERPACKAGE

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PRILIUM300 mgpowderfororalsolutionfordogs

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Powder/vial

Imidaprilhydrochloride 300 mg

Sodiumbenzoate(E211) 30 mg

Excipientto 1.030 g

Solutionafterreconstitution

Imidaprilhydrochloride 10.0 mg

Sodiumbenzoate(E211) 1.0 mg

Excipientto 1 ml

3. PHARMACEUTICALFORM

Powderfororalsolution

4. PACKAGESIZE

Boxcontainingone1.030 gpowdervialand one2 mlgraduated syringe.

5. TARGETSPECIES

Dogsweighingover8 kg

6. INDICATIONS

Indogs:treatmentofmoderatetosevereheartfailurecausedbymitralregurgitationorbydilated

cardiomyopathy.

7. METHODANDROUTEOFADMINISTRATION

Theveterinarymedicinalproductcanbeadministered eitherdirectlyinto themouthoftheanimalonanempty

stomachorduringthemeals, oronfood.

8. WITHDRAWALPERIOD

Notapplicable.

9. SPECIALWARNINGS, IFNECESSARY

Read thepackageleafletbeforeuse.

11836 Prilium300 mg/FINALSPCRenewal

11836 Prilium300 mg/FINALSPCRenewal

10.EXPIRYDATE

EXP:

Afterreconstitution:77days

11.SPECIALSTORAGEPRECAUTIONS

Beforereconstitution:do notstoreabove25°C

Afterreconstitution:storeat2°C-8°C(intherefrigerator)

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS, IFANY

Anyunusedtheveterinarymedicinalproductorwastematerialshouldbedisposedofinaccordancewithnational

requirements.

13.THEWORDS“FORANIMALTREATMENTONLY” ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE, ifapplicable

FORANIMALTREATMENTONLY

TOBESUPPLIEDONLYONVETERINARYPRESCRIPTION

14.THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keep outofthereachand sightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

VETOQUINOL

16.MARKETINGAUTHORISATIONNUMBER(S)

BATCHNUMBER:

11836 Prilium300 mg/FINALSPCRenewal

PACKAGELEAFLET

PRILIUM300mgpowderfororalsolutionfordogs

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOFTHE

MANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCHRELEASE,IF

DIFFERENT

Marketing Authorisationholder

VETOQUINOL

Manufacturerforthebatchrelease:

VETOQUINOL

MAGNYVERNOIS

F-70200 LURE

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PRILIUM300 mgpowderfororalsolutionfordogs

3. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Powder/vial

Imidaprilhydrochloride 300 mg

Sodiumbenzoate(E211) 30 mg

Excipientto 1.030 g

Solutionafterreconstitution

Imidaprilhydrochloride 10.0 mg

Sodiumbenzoate(E211) 1.0 mg

Excipientto 1 ml

4. INDICATIONS

Indogs:treatmentofmoderatetosevereheartfailurecausedbymitralregurgitationorbydilated

cardiomyopathy.

5. CONTRAINDICATIONS

Do notuseindogswithlowblood pressure.

Do notuseindogswithacuterenalinsufficiency.

Do notuseindogswithcongenitalheartdisease

Do notuseindogshypersensitiveto anACEinhibitor

11836 Prilium300 mg/FINALSPCRenewal

Donotuseindogswithhemodynamicallyrelevantstenoses(aorticstenosis,mitralvalvestenosis,pulmonal

stenosis)

Do notuseindogswithobstructivehypertrophiccardiomyopathy

11836 Prilium300 mg/FINALSPCRenewal

6. ADVERSEREACTIONS

Diarrhoea,hypotensionand related symptomssuchasfatigue,dizzinessoranorexiacanoccurinrarecases.In

suchcasestreatmentshould bediscontinued untilthepatient’sconditionhasreturned to normal.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyourveterinary

surgeon.

7. TARGETSPECIES

Dogsweighingover8 kg

8. DOSAGEFOREACHSPECIES, ROUTE(S)ANDMETHODOFADMINISTRATION

Therecommended doseofimidaprilis0.25 mg/kgonceadayperoralroute, ie:

0.025ml/kgofPRILIUM®300mgpowderfororalsolutionfordogsweighingmorethan

8 kg(1ml/40kg).

Theveterinarymedicinalproductcanbeadministered eitherdirectlyinto themouthoftheanimalonanempty

stomachorduringthemeals, oronfood.

Preparationoftheoralsolution:Removethenippleandthestopperofthevialcontainingthepowderandfillwith

tap waterup to themark (30ml)placethechild proofcap and screwontightly.

Administration:Unscrewthechildproofcap,introducethegraduatedsyringeintotheapplicator,turnthe

assemblyupsidedownandmeasurethequantitytoadministerusingthesyringegraduatedinkg.Oncethe

veterinarymedicinalproducthasbeenadministered,replacethechildproofcapontothevialandrinsethe

syringewithwater. Storethevialinthefridge.

9. ADVICEONCORRECTADMINISTRATION

None.

10.WITHDRAWALPERIOD

Notapplicable.

11.SPECIALSTORAGEPRECAUTIONS

Keep outofthereachand sightofchildren.

Beforereconstitution:do notstoreabove25°C

Afterreconstitution:storeat2°C-8°C(intherefrigerator)

Do notuseaftertheexpirydatestated onthecarton.

Shelf-lifeafterreconstitution:77 days

12.SPECIALWARNINGS

Specialprecautionsforuseinanimals

11836 Prilium300 mg/FINALSPCRenewal

TheuseofACEinhibitorsindogswithhypovolaemia/dehydrationcanleadtoacutehypotension.Insuchcases

thefluidandelectrolytebalanceshouldberestoredimmediatelyandtreatmentsuspendeduntilithasbeen

stabilised.Parametersusedformonitoringrenalfunctionshouldbecheckedatthebeginningofthetreatmentand

atregulartimeintervalsthereafter.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthepackageinsertorthelabeltothe

physician.

Washhandsafterhavingadministeredtheveterinarymedicinalproduct.Incaseofcontactwitheyes,rinse

immediatelywithplentyofwater.

Thevialmustbeclosed usingthechild proofstopperbeforebeingstored inthefridge.

Useduring pregnancy, lactationorlay

Laboratorystudiesinratsandrabbitsdidnotproduceanyevidenceofteratogenic,embryotoxicormaternotoxic

effects,oreffectsonreproductiveperformances,whenimidaprilwasadministeredatthetherapeuticdose.Inthe

absenceofdata, do notuseinpregnantorlactatingbitchesorinbreedingdogs.

Interactionwithothermedicinalproductsandotherformsofinteraction

Intheclinicaltrial, theveterinarymedicinalproducthasbeenused withfurosemideand digoxinand no safety

concernswerenoted.

HoweverdiureticsandalowsodiumdietpotentiatetheeffectofACEinhibitorsbyactivatingtherenin-

angiotensin-aldosteronesystem(RAAS).Diureticsusedathighdosesandalowsodiumdietarethusnot

recommended duringatreatmentwithACEinhibitorsinorderto avoid hypotensionwithclinicalsignssuchas

apathy,ataxia,raresyncopeandkidneyfailure.Incaseofjointadministrationwithpotassiumretainingdiuretics,

potassiummustbemonitored becausethereisarisk ofhyperkaliemia.

Overdose(symptoms, emergency procedures, antidotes)

Repeated oraldosesup to 5 mg/kg/d ofimidaprilhavebeenwelltolerated inhealthydogs.

Hypotensionmayoccurasasymptomofoverdosagewithsignsofapathyandataxia.Thetreatmentis

symptomatic.

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS, IFANY

Anyunusedtheveterinarymedicinalproductorwastematerialshouldbedisposedofinaccordancewithnational

requirements.

Medicinesshould notbedisposed ofviawastewaterorhousehold waste

Askyouveterinarysurgeonhowtodisposeofmedicinesno longerrequired. Thesemeasuresshould help to

protecttheenvironment.

14.DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

11836 Prilium300 mg/FINALSPCRenewal

DECEMBER2006

15.OTHERINFORMATION

Foranimaltreatmentonly.

Boxcontainingone1.030 gwhitepowdervialand one2 mlgraduated mauvesyringe. Afterreconstitution,

thesolutionislimpid and colourless.

11836 Prilium300 mg/FINALSPCRenewal

LABEL

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PRILIUM300 mgpowderfororalsolutionfordogs

2. QUANTITYOFTHEACTIVESUBSTANCE

Imidaprilhydrochloride……………………………..300 mg

3. CONTENTSBYWEIGHT, BYVOLUMEORBYNUMBEROFDOSES

Boxcontainingone1.030 gpowdervialand one2 mlgraduated syringe

4. ROUTE(S)OFADMINISTRATION

Theveterinarymedicinalproductcanbeadministered eitherdirectlyinto themouthoftheanimalonanempty

stomachorduringthemeals, oronfood.

5. WITHDRAWALPERIOD

Notapplicable.

6. BATCHNUMBER

7. EXPIRYDATE

EXP:

Shelf-lifeafterreconstitution:77 days

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

KEEPOUTOFREACHANDSIGHTOFCHILDREN

Beforereconstitution:do notstoreabove25°C

Afterreconstitution:storeat2°C-8°C(intherefrigerator)

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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

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

27-6-2018

Yondelis (Pharma Mar S.A.)

Yondelis (Pharma Mar S.A.)

Yondelis (Active substance: Trabectedin) - PSUSA - Modification - Commission Decision (2018)4096 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/3001/201709

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