Detogesic 10mg/ml Solution for Injection for Horses

Main information

  • Trade name:
  • Detogesic 10mg/ml Solution for Injection for Horses
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Detogesic 10mg/ml Solution for Injection for Horses
    Slovenia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Detomidine
  • Therapeutic area:
  • Horses

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0226/001
  • Authorization date:
  • 16-02-2012
  • EU code:
  • UK/V/0226/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:August2013

AN:00202/2012

Page1of7

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

DETOGESIC10mg/mlSolutionforInjectionfor

Horses BE,BG,CY,CZ,DE,

EL,ES,FR,IE,IT,LU,

NL,PL,PT,RO,SI,

SK,UK

EQUISEDANvet10mg/mlSolutionforInjectionfor

Horses FI,NO,SE

EQUISEDAN10mg/mlSolutionforInjectionfor

Horses DK,LT.LV

EQUIDOR10mg/mlSolutionforInjectionforHorses AT,HU

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Detomidinehydrochloride10mg/ml(Detomidine8.36mg/ml)

Excipient(s):

Preservative

Methylparahydroxybenzoate(E218) 1mg/ml

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

SolutionforInjection.

Clear,almostcolourlesssolutionforintravenousinjection.

4. CLINICALPARTICULARS

4.1Targetspecies

Horse

4.2Indicationsforuse,specifyingthetargetspecies

Forthesedationandslightanalgesiaofhorses,tofacilitatephysical

examinationsandtreatments,suchasminorsurgicalinterventions.

Theproductcanbeusedfor:

Medicalexaminations (e.g.endoscopic,rectalandgynaecological

examinations,X-rays).

Minorsurgicalprocedures(e.g.treatmentofwounds,dentaltreatment,

tendontreatment,excisionofskintumours,teattreatment).

Beforetreatmentandmedication(e.g.stomachtube,horseshoeing).

Forpre-medicationpriortoadministrationofinjectionorinhalationanaesthetics.

Seesection4.5beforeuse.

Revised:August2013

AN:00202/2012

Page2of7

4.3Contraindications

Donotuseinanimalswithcardiacabnormalitiesorrespiratorydisease.

Donotuseinanimalswithliverinsufficiencyorrenalfailure.

Donotuseinanimalswithgeneralhealthproblems(e.g.dehydratedanimals).

Donotuseinthelast3monthsofpregnancy.

Donotuseincombinationwithbutorphanolinhorsessufferingfromcolic.

Donotuseincombinationwithbutorphanolinpregnantmares.

SeealsoSections4.7and4.8.

4.4Specialwarningsforeachtargetspecies

None.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Assedationbegins,horsesmaystarttoswayandlowertheheadrapidlywhile

theyremainstanding.Topreventinjuriesinhorseandpeoplewhiletreating

horses,thelocationfortreatmentshouldbechosencarefully.Usual

precautionarymeasuresshouldbetakentopreventself-injury.

Animalssufferingfromshockorliverorkidneydiseaseshouldonlybetreated

accordingtothebenefit/riskassessmentbytheresponsibleveterinarysurgeon.

Theproductshouldnotbeusedinanimalssufferingfromcardiacdiseases

(withpre-existingbradycardiaandriskofatrioventricularblock),respiratory,

liverorrenalinsufficienciesoranyotherextraordinarystressconditions.

Itisrecommendedthatfeedshouldbewithheldforatleast12hourspriorto

anaesthesia.

Waterorfoodshouldnotbeofferedtotreatedanimalsuntilthedrugeffecthas

passed.

Inpainfulproceduresdetomidineshouldbeusedonlyincombinationwithan

analgesicoralocalanaesthetic.

Whilewaitingfortheonsetofsedation,animalsshouldremainincalm

surroundings.

Detomidine/butorphanolcombinationsshouldnotbeusedinhorseswitha

historyofliverdiseaseorcardiacirregularities.

Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Thisproductshouldbeadministeredwithcaution,andcaretakentoavoid

accidentalself-injection.

Revised:August2013

AN:00202/2012

Page3of7

Inthecaseofaccidentaloralintakeorself-injectionseekmedicaladvice

immediatelyandshowthepackageleaflettothedoctorbutDONOT

DRIVEassedationandchangesinbloodpressuremayoccur.

Avoidskin,eyeormucosalcontact.

Washtheexposedskinimmediatelyafterexposurewithlargeamountsof

freshwater.

Removecontaminatedclothesthatareindirectcontactwithskin.

Inthecaseofaccidentalcontactoftheproductwitheyes,rinseabundantly

withfreshwater.Ifsymptomsoccur,seektheadviceofadoctor.

Ifpregnantwomenhandletheproduct,specialcautionshouldbeobserved

nottoself-injectasuterinecontractionsanddecreasedfoetalblood

pressuremayoccurafteraccidentalsystemicexposure.

Advicetodoctors:

Detomidineisanalpha-2-adrenoreceptoragonist.Symptoms afterabsorption

mayinvolveclinicaleffectsincludingdose-dependentsedation,respiratory

depression,bradycardia,hypotension,adrymouth,andhyperglycaemia.

Ventriculararrhythmiashavealsobeenreported.Respiratoryand

haemodynamicsymptomsshouldbetreatedsymptomatically.

4.6Adversereactions(frequencyandseriousness)

Injectionofdetomidinemaycausethefollowingsideeffects:

- Bradycardia.

- Transienthypo-orhypertension.

- Respiratorydepression,rarelyhyperventilation.

- Increaseinbloodglucose.

- Aswithothersedatives,inrarecasesparadoxicalreactions(excitations)

candevelop.

- Ataxia.

-Cardiacarrhythmia,atrioventricularandsino-atrialblock.

-Uterinecontractions.

Atdosesabove40mcg/kgbodyweight,thefollowingsymptomscanalsobe

observed:sweating,pilo-erectionandtremorofmuscles,transientpenis

prolapseinstallionsandgeldings.

Inveryrarecaseshorsesmayshowmildsymptomsofcolicfollowing

administrationofalpha-2sympathomimeticsbecausesubstancesofthisclass

transientlyinhibitthemotilityoftheintestines.Theproductshouldbe

prescribedwithcautioninhorseswhichpresentwithsignsofcolicor

impaction.

Adiureticeffectisusuallyobservedwithin45to60minutesaftertreatment.

4.7Useduringpregnancy,lactationorlay

Donotusetheproductinmaresinthelast3monthsofpregnancy.During

theremainingmonthsuseonlyaccordingtoarisk/benefitanalysisbythe

responsibleveterinarysurgeon.

Useduringlactationshouldalsobethesubjectofrisk/benefitanalysisbythe

responsibleveterinarysurgeon.

Revised:August2013

AN:00202/2012

Page4of7

Donotuseincombinationwithbutorphanolinpregnantmares.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrentuseofothersedativesshouldproceedonlyafterconsultationof

thewarningsandprecautionsfortheproduct(s)concerned.

Detomidineshouldnotbeusedincombinationwithsympathomimeticamines

suchasadrenaline,dobutamineandephedrine,exceptasrequiredin

anaestheticemergencies.

Theconcurrentuseofcertainpotentiatedsulphonamidesmaycausecardiac

arrhythmiawithfataloutcome.Donotuseincombinationwith

sulphonamides.

Detomidineincombinationwithothersedativesandanaestheticsshouldbe

usedcarefullybecauseadditive/synergisticeffectsmaybepossible.Where

anaesthesiaisinducedwithacombinationofdetomidineandketamine,prior

tomaintenancewithhalothane,theeffectsofhalothanemaybedelayedand

caremustbetakentoavoidoverdosage.Whendetomidineisusedasapre-

medicantpriortogeneralanaesthesia,itmaydelaytheonsetofinduction.

4.9 Amountstobeadministeredandadministrationroute

Administrationroute

Forintravenous(IV)useonly.Theproductshouldbeinjectedslowly.Onset

ofeffectismorerapidfollowingintravenoususe.

Amount(s)tobeadministered

Usealoneforsedation:dosagetable

Dosage

inmcg/kg Dosage

inml/100kg Levelof

sedation Commencement

ofeffect(min) Durationof

effect

(hrs)

10-20 0.1-0.2 Light 3-5 0.5-1

20-40 0.2-0.4 Moderate 3-5 0.5-1

Whenprolongedsedationandanalgesiaisrequired,dosesof40to80mcg/kg

canbeused.Thedurationofeffectisupto3hours.Itisrecommendedto

wait15minutesafterdetomidineadministrationbeforestartingtheplanned

procedure.

Forcombinationwithotherproductstointensifysedationorforpremedication

priortogeneralanaesthesia,dosesof10to30mcg/kgcanbeused.Priorto

useincombinationwithotherproductssuchasbutorphanolorketamine,

consulttheappropriateproductdetailsfordoseratesAllow5minutesafterthe

administrationofdetomidineforthehorsetobecomedeeplysedatedbefore

anysubsequenttreatment.

Thebodyweightoftheanimaltobetreatedshouldbedeterminedas

accuratelyaspossibletoavoidoverdosing.

Revised:August2013

AN:00202/2012

Page5of7

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Intheeventofanaccidentaloverdose,cardiacarrhythmias,hypotension,

delayedrecoveryandprofoundCNSandrespiratorydepressionmayoccur.

Shouldtheeffectsofdetomidinebecomelife-threatening,administrationofan

alpha-2-adrenergicantagonistisrecommended

4.11Withdrawalperiod(s)

Meatandoffal:2days

Milk:12hours

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup: Sedativeandanalgesic

ATCvetcode: QN05CM90

5.1 Pharmacodynamicproperties

Theactiveingredientoftheproductis4-(2,3-dimethylbenzyl)-imidazole-

hydrochloride(INN:detomidine).Detomidineleadstosedationoftreated

animalsandrelievespain,withdurationandintensityofeffectbeingdose

related.Detomidineactsasanagonistatalpha-2adrenoceptors,and

observedanalgesiceffectsareduetoinhibitionoftransmissionofthepain

impulsewithintheCNS.

Detomidineactsonperipheralalpha-adrenoceptors,thereforeanincreasein

bloodglucoselevelandathigherdosagespiloerection,sweatinganddiuresis

mayoccur.Aninitialincreaseinmeanbloodpressureisobserved,which

returnstonormalorslightlybelowandheartratedecreases.TheECGshows

anenlargedPR-interval,andmildatrio-ventricularblocksmaybeobserved.

Thesechangesaretransient.Respiratoryresponseincludesaninitial

decreaseinrespirationrate,increasingtonormalorslightlyhighervalues

withinafewminutes.

5.2 Pharmacokineticparticulars

Detomidineisabsorbedrapidlyafterintramuscularinjection,withaT

of15-

30minutes.Bioavailabilityafterintramuscularadministrationis66-85%.

Afterrapiddistributionofdetomidineintothetissues,withahalf-lifeof0.15

hourspostintravenousinjection,detomidineisalmostcompletely

metabolized,mainlyintheliver-t

is1to2hours.Thevolumeofdistribution

rangesfrom0.75to1.89l/kg,andproteinbindingis75-85%.Theelimination

half-lifeinthehorsewas1.19hours,withlessthan1%parentcompound

presentinurine.Metabolitesaremainlyexcretedviaurineandfaeces.

Revised:August2013

AN:00202/2012

Page6of7

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Methylparahydroxybenzoate(E218)

Sodiumchloride

Sodiumhydroxide(forpHadjustment)

WaterforInjections

6.2Incompatibilities

Thisveterinarymedicinalproductmustnotbemixedwithotherveterinary

medicinalproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinal

productaspackagedforsale:

3years

Shelf-lifeafterfirstopeningimmediatepackaging: 28days.

6.4. Specialprecautionsforstorage

Donotstoreabove25°C.

Storeintheoriginalcartoninordertoprotectfromlight.

Storeinadryplace.

6.5Natureandcompositionofimmediatepackaging

Multi-dose,clear,Type1glassvial,withpierceablebromobutylrubberstopper

andanaluminiumcollar,containing10ml.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

VetcareLimited

Peltotuentie5

25130Muurla

Finland

Revised:August2013

AN:00202/2012

Page7of7

8. MARKETINGAUTHORISATIONNUMBER

Vm03379/4000

9. DATEOFFIRSTAUTHORISATION

Date:07April2008

10. DATEOFREVISIONOFTHETEXT

Date:August2013

Approved:21/08/2013

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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

10-8-2018

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Active substance: bortezomib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5515 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4207/T/10

Europe -DG Health and Food Safety

7-8-2018

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

FDA - U.S. Food and Drug Administration

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

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

29-5-2018

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Active substance: Para-aminosalicylic acid) - Transfer of orphan designation - Commission Decision (2018)3396 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/072/10/T/02

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

22-5-2018

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: AVOID THE SUN BETWEEN 10 AM-4 PM when UV rays are strongest! Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/mNsFqKTfFk

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: AVOID THE SUN BETWEEN 10 AM-4 PM when UV rays are strongest! Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/mNsFqKTfFk

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: AVOID THE SUN BETWEEN 10 AM-4 PM when UV rays are strongest! Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancer pic.twitter.com/mNsFqKTfFk

FDA - U.S. Food and Drug Administration

21-5-2018

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: WEAR HATS, SUNGLASSES, AND VISORS. Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/WAPabvM811

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: WEAR HATS, SUNGLASSES, AND VISORS. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/WAPabvM811

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: WEAR HATS, SUNGLASSES, AND VISORS. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancer pic.twitter.com/WAPabvM811

FDA - U.S. Food and Drug Administration

21-5-2018

Pls RT: 10 Ways to Keep Athletes Safe While In the Sun: APPLY SUNSCREEN. Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw pic.twitter.com/YRV0lVSRkh

Pls RT: 10 Ways to Keep Athletes Safe While In the Sun: APPLY SUNSCREEN. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw pic.twitter.com/YRV0lVSRkh

Pls RT: 10 Ways to Keep Athletes Safe While In the Sun: APPLY SUNSCREEN. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  pic.twitter.com/YRV0lVSRkh

FDA - U.S. Food and Drug Administration

21-5-2018

RT this: 10 Ways to Keep Athletes Safe While in the Sun: COVER UP! Wear sun-protective clothing and hats. Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw pic.twitter.com/GzY50eEVp9

RT this: 10 Ways to Keep Athletes Safe While in the Sun: COVER UP! Wear sun-protective clothing and hats. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw pic.twitter.com/GzY50eEVp9

RT this: 10 Ways to Keep Athletes Safe While in the Sun: COVER UP! Wear sun-protective clothing and hats. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  pic.twitter.com/GzY50eEVp9

FDA - U.S. Food and Drug Administration

18-5-2018

EU/3/10/778 (Chiesi Farmaceutici S.p.A.)

EU/3/10/778 (Chiesi Farmaceutici S.p.A.)

EU/3/10/778 (Active substance: Cysteamine bitartrate (gastroresistant)) - Transfer of orphan designation - Commission Decision (2018)3137 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/034/10/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/765 (Novartis Europharm Limited)

EU/3/10/765 (Novartis Europharm Limited)

EU/3/10/765 (Active substance: Midostaurin) - Transfer of orphan designation - Commission Decision (2018)3039 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/016/10/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/764 (Novartis Europharm Limited)

EU/3/10/764 (Novartis Europharm Limited)

EU/3/10/764 (Active substance: Everolimus) - Transfer of orphan designation - Commission Decision (2018)3038 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/10/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (Active substance: Veliparib) - Transfer of orphan designation - Commission Decision (2018)3021 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/10/T/02

Europe -DG Health and Food Safety

28-3-2018

EU/3/10/803 (Astellas Pharma Europe B.V.)

EU/3/10/803 (Astellas Pharma Europe B.V.)

EU/3/10/803 (Active substance: Chimeric monoclonal antibody against claudin-18 splice variant 2) - Transfer of orphan designation - Commission Decision (2018)2007 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/083/10/T/01

Europe -DG Health and Food Safety