MEDEDORM

Main information

  • Trade name:
  • MEDEDORM
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MEDEDORM
    France
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0192/001
  • Authorization date:
  • 13-02-2012
  • EU code:
  • FR/V/0192/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Sededormsolutionforinjectionfordogsandcats [FR]

Sededorm1mg/mlsolutionforinjectionfordogsandcats [BE,DE,ES,HU,NL,PL,PT,UK]

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Medetomidinehydrochloride............................................ 1.0mg

(equivalenttomedetomidine............................................ 0.85mg)

Excipients:

Methylparahydroxybenzoate(E218)................................ 1.0mg

Propylparahydroxybenzoate.......................................... 0.2mg

Forthefulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Clearandcolourlesssolution.

4. CLINICALPARTICULARS

4.1. Targetspecies

Dogsandcats.

4.2. Indicationsforuse,specifyingthetargetspecies

Indogsandcats:

-Sedationinordertofacilitatetherestraintofanimalsduringclinicalexaminations.

-Premedicationpriortogeneralanaesthesia.

4.3. Contraindications

Donotuseinanimalswithseriouscardiovasculardisease,respiratorydiseaseorhepaticorrenal

disorders.

Donotuseincaseofmechanicaldisordersofgastrointestinaltract(torsionofthestomach,

imprisonment,obstructionoftheoesophagus).

Donotadministerinconjunctionwithsympathomimeticamines.

Donotuseincaseofknownhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Donotuseinanimalswithdiabetesmellitus.

Donotuseinanimalswithstateofshock,emaciationorseriousdebilitation.

Donotuseinanimalswithocularproblemswhereanincreaseinintraocularpressurewouldbe

detrimental.

SeeSection4.7.

4.4. Specialwarningsforeachtargetspecies

Itispossiblethatmedetomidinedoesnotprovideanalgesiathroughouttheentiresedationperiod.The

useofadditionalanalgesicsshouldbeconsideredduringpainfulsurgicalprocedures.

4.5.Specialprecautionsforuse

Specialprecautionsforuseinanimals

Duringitsuseinpremedication,thedosageofanaestheticwillbereducedinproportionand

establishedaccordingtothereactionoftheanimal,dependingonthevariabilityofresponsebetween

animals.Specialwarningsandcontraindicationsincludedintheliteratureoftheotherproductsshould

berespectedbeforecarryingoutanyassociation.

Medetomidinecanproducerespiratorydepression;insuchcase,manualventilationand

administrationofoxygenmaybeconducted.

Aclinicalexaminationshouldbecarriedoutinallanimalsbeforetheuseofveterinarymedicinal

productsforsedationand/orgeneralanaesthesia.

Higherdosesofmedetomidineshouldbeavoidedinlargebreeddogs.Careshouldbetakenwhen

combiningmedetomidinewithotheranaestheticsorsedativesbecauseofitsmarkedanaesthetic

sparingeffects.Animalsshouldbefasted12hoursbeforeanaesthesia.

Theanimalshouldbeplacedinacalmandquietsurroundingtoletthesedationgainitsmaximum

effect.Thistakesabout10-15minutes.Oneshouldnotstartanyprocedureorgiveothermedicines

beforemaximumsedationisreached.

Treatedanimalsshouldbekeptwarmandataconstanttemperature,bothduringtheprocedureand

recovery.

Theeyesshouldbeprotectedbyasuitablelubricant.

Nervous,aggressiveorexcitedanimalsshouldbegiventhepossibilitytocalmdownbeforeinitiationof

treatment

Sickanddebilitateddogsandcatsshouldonlybepremedicatedwithmedetomidinebeforeinduction

andmaintenanceofgeneralanaesthesiabasedonarisk-benefitassessment.

Careshouldbetakenwithuseofmedetomidineinanimalswithcardiovasculardisease,orwhichare

elderlyoringeneralpoorhealth.Liverandkidneyfunctionshouldbeevaluatedpriortouse.

Inordertoreducetherecoverytimeafteranæsthesiaorsedation,theeffectofmedetomidinecanbe

reversedbytheadministrationofanalpha-2-antagonistsuchasatipemazole.

Atipamezoledoesnotreversetheeffectofketamine.Asketaminealonecanelicitcramps,alpha-2

antagonistsshouldnotbegivenlessthan30-40min.aftertheadministrationofketamine.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Incaseofaccidentaloralintakeorself-injection,seekmedicaladviceimmediatelyandshowthe

packageleafletorthelabeltothephysicianbutDONOTDRIVEassedationandchangesinblood

pressuremayoccur.

Avoidskin,eyeormucosalcontact.

Washtheexposedskinimmediatelyafterexposurewithlargeamountsofwater.

Removecontaminatedclothesthatareindirectcontactwithskin.

Inthecaseofaccidentalcontactoftheproductwitheyes,rinseabundantlywithfreshwater.If

symptomsoccur,seektheadviceofaphysician.

Ifpregnantwomenhandletheproduct,specialcautionshouldbeobservednottoself-injectasuterine

contractionsanddecreasedfoetalbloodpressuremayoccurafteraccidentalsystemicexposure.

Advicetodoctors:

Medetomidineisanalpha2-adrenoreceptoragonist,symptomsafterabsorptionmayinvolveclinical

effectsincludingdose-dependentsedation,respiratorydepression,bradycardia,hypotension,adry

mouth,andhyperglycaemia.Ventriculararrhythmiashavealsobeenreported.

Respiratoryandhaemodynamicsymptomsshouldbetreatedsymptomatically.

4.6. Adversereactions(frequencyandseriousness)

Thefollowingadversereactionsmayoccur:

- Cardiovasculareffects:bradycardiawithatrioventricularblock(1 st

and2 nd

degree)and

occasionalextrasystoles,vasoconstrictionofcoronaryartery,decreasedcardiacoutput.

- Increaseofbloodpressurejustaftertheadministrationofproductandthenreturntothe

normalvalueorslightlybelow.

- Somedogsandmostcatsvomit5-10minutesafterinjection.Catsmayalsovomiton

recovery.

- Sensitivitytoloudnoiseshasbeenobservedinsomeanimals.

- Anincreaseofdiuresis,hypothermia,respiratorydepression,cyanosis,apainattheinjection

siteandmuscletremorsmayalsooccur.

Thefollowingmayalsobeobserved:

- Casesofreversiblehyperglycaemiaduetoadepressionofinsulinsecretion.

- Casesofpulmonaryoedema.

Incasesofcardiovascularandrespiratorydepression,assistedventilationandadministrationof

oxygenmaybeindicated.Atropinecanincreasethecardiacrate.

Dogsweighinglessthan10kgcanpresentfrequentlywiththeabove-mentionedadversereactions.

4.7. Useduringpregnancy,lactationorlay

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduringpregnancyand

lactation.

Therefore,donotusethedrugduringpregnancyandlactation.

4.8. Interactionwithothermedicinalproductsandotherformsofinteraction

Theconcomitantadministrationofothercentralnervoussystemdepressantsshouldbeexpectedto

potentiatetheeffectofeitherproductandappropriatedoseadjustmentshouldbemade.

Medetomidinehasmarkedanaestheticsparingeffects(seesection4.5oftheSPC).

Theeffectsofmedetomidinecanbeantagonisedbytheadministrationofatipamezole.

Donotadministerconcomitantlywithsympathomimeticsorsulfamidesandtrimethoprim.

4.9. Amountstobeadministeredandadministrationroute

Dogs:intramuscularorintravenousinjection

Forsedation:

Forsedationtheproductshouldbeadministeredattherateof15-80µgofmedetomidine

hydrochlorideperkgofbodyweightI.V.,or20-100µgofmedetomidinehydrochlorideperkgofbody

weightI.M.

Usethetablebelowtodeterminethecorrectdosageonthebasisofbodyweight.

Maximaleffectisobtainedwithin15-20minutes.Clinicaleffectisdose-dependent,lasting30to180

minutes.

Sededormdosage sinmlandcorrespondingamountofmedetomidinehydrochlorideinμg/kgbw:

body

weight

[kg] i.v.-Injection

[ml]

corresp.to

[μg/kgbw] i.m.-Injection

[ml]

corresp.to

[μg/kgbw]

1 0.08 80.0 0.10 100.0

2 0.12 60.0 0.16 80.0

3 0.16 53.3 0.21 70.0

4 0.19 47.5 0.25 62.5

5 0.22 44.0 0.30 60.0

6 0.25 41.7 0.33 55.0

7 0.28 40.0 0.37 52.9

8 0.30 37.5 0.40 50.0

9 0.33 36.7 0.44 48.9

10 0.35 35.0 0.47 47.0

12 0.40 33.3 0.53 44.2

14 0.44 31.4 0.59 42.1

16 0.48 30.0 0.64 40.0

18 0.52 28.9 0.69 38.3

20 0.56 28.0 0.74 37.0

25 0.65 26.0 0.86 34.4

30 0.73 24.3 0.98 32.7

35 0.81 23.1 1.08 30.9

40 0.89 22.2 1.18 29.5

50 1.03 20.6 1.37 27.4

60 1.16 19.3 1.55 25.8

70 1.29 18.4 1.72 24.6

80 1.41 17.6 1.88 23.5

90 1.52 16.9 2.03 22.6

100 1.63 16.3 2.18 21.8

Forpremedication:

10-40µgmedetomidinehydrochlorideperkgbodyweight,correspondingto0.1-0.4mlper10kgbody

weight.Theexactdosedependsonthecombinationofdrugsusedandthedosage(s)oftheother

drug(s).Thedoseshouldfurthermorebeadjustedtothetypeofsurgery,lengthofprocedureand

patienttemperamentandweight.Premedicationwithmedetomidinewillsignificantlyreducethe

dosageoftheinductionagentrequiredandwillreducevolatileanaestheticrequirementsfor

maintenanceanaesthesia.Allanaestheticagentsusedforinductionormaintenanceofanaesthesia

shouldbeadministeredtoeffect.Beforeusinganycombinations,productliteraturefortheother

productsshouldbeobserved.Seealsosection4.5.

Cats:intramuscularinjection,intravenousinjectionandsubcutaneousinjection

Formoderate-deepsedationandrestraintofcatstheproductshouldbeadministeredatadosageof

50 –150µgmedetomidinehydrochloride/kgbw(corresp.to0.05–0.15ml/kgbw).Thespeedof

inductionisslowerwhensubcutaneousrouteofadministrationisused.

4.10. Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Incasesofoverdosage,theprincipalsignsareprolongedanaesthesiaorsedation.Insomecases,

cardiorespiratoryeffectsmayoccur.Thetreatmentconsistsoftheadministrationofanalpha-2

antagonist,asatipamezole,providedthatreversalofsedationisnotdangerousfortheanimal

(atipamezoledoesnotreversetheeffectsofketamine,whichusedalonecanproduceconvulsionsin

dogsandcrampsincats).Alpha-2-antagonistsshouldnotbegivenlessthan30-40minutesafterthe

administrationofketamine.

Atipamezolehydrochlorideisadministeredbyintramuscularrouteatthefollowingdosage:5timesthe

initialdoseofmedetomidinehydrochlorideadministeredtodogs(µg/kg)and2.5timesforcats.The

volumeofatipamezolehydrochloride5mg/mlisequaltovolumeofdrugadministeredtodogs;forcats

halfofthisvolumeshouldbeused.

Ifitisimperativetoreversebradycardiabuttomaintainsedation,atropinemaybeused.

4.11. Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:sedativeandanalgesic.

ATCvetCode:QN05CM91.

5.1. Pharmacodynamicproperties

Medetomidineisasedativecomponentwhichpresentsanalgesicandmyorelaxantproperties.Itisa

selectiveagonist,specificandparticularlyeffectiveforalpha-2-adrenergicsreceptors.Theactivationof

thesereceptorsinducesadecreaseinthereleaseandturnoverofnoradrenalinincentralnervous

systemwhichisdeclaredbymeansofsedation,analgesiaandbradycardia.Atperipherallevel,

medetomidinecausesvasoconstrictionbystimulationofpost-synapticalpha-2-adrenergicreceptors,

whichproduceatransitoryhypertension.Bloodpressurereturnstonormallevels,eventoamoderate

hypotensionwithin1to2hours.Respiratoryratecanbereducedtemporarily.

Thetimeanddepthofsedationandanalgesiaaredosedependent.Whentheeffectismaximum,the

animalisrelaxedanddoesnotrespondtoexternalstimulation.Medetomidineactsinasynergic

mannerwithketamineoropiates,suchasfentanyl,resultinginabetteranaesthesia.Thenecessary

amountofvolatileanaesthesics(e.g.halothane)isreducedbymedetomidine.Inadditiontoits

sedative,analgesiaandmyorelaxantproperties,medetomidinealsoexertshypothermicandmydriatic

effects,inhibitsthesalivationanddecreasesintestinalmotility.

5.2. Pharmacokineticparticulars

Afterintramuscularinjection,medetomidineisrapidlyandalmostcompletelyabsorbedinthesiteof

injectionandpharmacokineticsisverysimilartothatobservedafterintravenousinjection.Maximum

plasmaconcentrationsarereachedwithin15to20minutes.Estimatedplasmahalf-lifeis1.2hoursfor

dogsand1.5hoursforcats.Medetomidineismainlyoxidisedintheliver,whileasmallamountis

methylatedinthekidney.Metabolitesareprimarilyexcretedinurine.

6. PHARMACEUTICALPARTICULARS

6.1. Listofexcipients

Methylparahydroxybenzoate.(E218)

Propylparahydroxybenzoate.

Sodiumchloride.

Waterforinjections.

6.2. Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts

6.3. Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days

6.4. Specialprecautionsforstorage

Donotrefrigerateorfreeze.

Protectfromlight.

Protectfromfrost.

6.5. Natureandcompositionofimmediatepackaging

TypeIclearglassvialsof10mlcapacity.Vialsarefittedwithabromobutylstopperandsealedwithan

aluminiumcap.Vialsarepackedinacardboardbox.

Packsizes:

-Boxwith1vial

6.6. Specialprecautionsforthedisposalofunusedveterinarymedicinalproductsorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

VETPHARMAANIMALHEALTH,S.L.

LesCorts,23

08028Barcelona

SPAIN

8. MARKETINGAUTHORISATIONNUMBER

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

29-6-2018

Pending EC decision:  Dexdor, dexmedetomidine, Opinion date: 28-Jun-2018

Pending EC decision: Dexdor, dexmedetomidine, Opinion date: 28-Jun-2018

Europe - EMA - European Medicines Agency

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

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

6-8-2018

Dexdor (Orion Corporation)

Dexdor (Orion Corporation)

Dexdor (Active substance: dexmedetomidine) - Centralised - 2-Monthly update - Commission Decision (2018)5377 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2268/II/26

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

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

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

6-6-2018

Cepedex (CP-Pharma Handelsgesellschaft mbH)

Cepedex (CP-Pharma Handelsgesellschaft mbH)

Cepedex (Active substance: dexmedetomidine) - Centralised - Yearly update - Commission Decision (2018)3684 of Wed, 06 Jun 2018

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