NUFLOR SWINE PREMIX

Main information

  • Trade name:
  • NUFLOR SWINE PREMIX
  • Pharmaceutical form:
  • Medicated premix
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NUFLOR SWINE PREMIX
    Greece
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • florfenicol
  • Therapeutic area:
  • Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0174/001
  • Authorization date:
  • 16-02-2012
  • EU code:
  • FR/V/0174/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Nuflor40mg/gPremixforMedicated FeedingStuffforSwine

Nuflor40mg/gPremixforMedicatedFeedingStuffforSwine(EE,IT,LT,LV.FI,NO)

Nuflor40mg/gSwinePremixforMedicatedFeedingStuff(IE,UK)

Nuflor40mg/gPremezclaPorcino(ES)

Nuflor40mg/gΦαρμακούχοπρόμιγμαγιαχοίρους(CY,EL)

Nuflor4%Premix-ArzneimittelvormischungfürSchweine(AT,DE)

Nuflor4%premiksdoprzygotowaniapaszyleczniczejdlaświń(PL)

Nuflor40mg/gpremixsertésekmedikálttakarmányához(HU)

Nuflor40mg/gPredmešanicazapripravozdravilnekrmnemešanicezaprašiče(SI)

Nuflor40mg/gpremixpreošípané(SK)

Nuflor40mg/ggemedicineerdvoormengselvoorvarkens(BE,NL,LU)

Nuflor40mg/gprémélangemédicamenteuxpourlesporcs(BE,NL,LU)

Nuflor40mg/gpré-misturaparaalimentomedicamentosoparasuínos(PT)

NuflorPremixPorc(FR)

NuflorPremixforSwine(DK)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Compositionpergram:

Activesubstance:

Florfenicol 40 mg

Excipients:

PropyleneGlycol(E1520) 10 mg

Ground Limestone qsto 1g

Forafulllistofexcipients, seesection6.1.

3. PHARMACEUTICALFORM

Premixformedicated feedingstuff

Whiteto off-white, freeflowingpowder

4. CLINICALPARTICULARS

4.1 Targetspecies

Pigs(Fatteningpigs)

4.2 Indicationsforuse, specifying thetargetspecies

Forthetreatmentand preventionofswinerespiratorydiseasecaused byPasteurella

multocidasusceptibletoflorfenicolininfected herds. Thepresenceofthediseaseshould be

established intheherd beforeinitiatingpreventivetreatment.

4.3 Contraindications

Do notadministerto boarsintended forbreeding.

Do notuseincaseofhypersensivityto theactivesubstanceoranyoftheexcipients.”

4.4 Specialwarningsforeachtargetspecies

Animalsshowingadecreased appetiteand/orapoorgeneralconditionshould betreated by

theparenteralroute.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Theproductshould beused inconjunctionwithsusceptibilitytestingand takeinto account

officialand localpolicyrelatingto theuseofantimicrobials.

Thispremixisintended forthemanufacturingofsolid medicated feed and cannotbeused as

itis;theincorporationrateofthepremixinfeed cannotbelowerthan5kg/ton.

Thispremixcontainsground limestone, whichcanlead to adecreaseinfood consumption

and to aphosphoruscalciumimbalanceinfeed intake. Careshould thereforebetakento

considerthecalciumcontentofthefinalmedicated feed.

Treatmentshould notexceed 5 days.

Inafield clinicalstudy, withinaweek aftertheadministrationofthelastdose, theincidence

ofpigspresentingeithermild depressionand/ormild dyspneaand/orpyrexia(40°C)

wasapprox. 20 %intheinitiallyseverelyillanimals.

Specialprecautionsto betakenby thepersonadministering themedicinalproduct

to animals

Skinsensitisationmayoccur.

Avoid skincontact.

Do nothandlethisproductincaseofknownsensitizationto activesubstanceoranyofthe

excipients.

Handlethisproductwithcareto avoid exposureduringincorporationofpremixintofeed and

administrationoffeed to animals, takingallrecommended precautions.

Weareitheradisposablehalf-mask respiratorconformingto Europeanstandard EN149 or

anon-disposablerespiratorto EuropeanStandard EN140 withafilterto EN143,

chemicallyresistantgloves, protectivecoverallsand goggleswhileincorporatingthepremix

into feed.

Wearglovesand do notsmoke, eat, ordrink whenhandlingtheproductormedicated feed.

Washhandsthoroughlywithsoap and waterafteruseoftheproductormedicated feed

Rinsethoroughlywithwaterincaseofexposure.

Ifyoudevelop symptomsfollowingexposuresuchasskinrash, youshould seek medical

adviceand takethepackageleafletorthelabelwithyou.

Otherprecautions

Manurefromtreated swinemustbestored foraminimumofonemonthbeforebeingspread

and incorporated infields.

4.6 Adversereactions(frequency andseriousness)

Commonlyobserved adverseeffectsarediarrhoeaperianalinflammationand rectaleversion.

Increased serumcalciummayalso beobserved. Theseeffectsaretransient, resolvingon

cessationoftreatment.

4.7 Useduring pregnancy, lactationorlay

Thesafetyoftheproductduringpregnancyand lactationhasnotbeenstudied insows. Use

oftheproductduringpregnancyand lactationisthereforenotrecommended.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amount(s)to beadministeredandadministrationroute

To beadministered orally, inmedicated feedingstuff.

Dosage:

10 mgofflorfenicolperkgbodyweight(bw)(equivalentto 250 mgNuflorswinepremix)

perdayadministered for5 consecutivedays.

Administration:

Foradailyfeed intakeof50g/kgbodyweight, thisdosagecorrespondsto arateof

incorporationof5 kgofpremixpertonoffeed, i.e. 200 ppmofflorfenicol.

Therateofincorporationofthemedicated premixinthefeed maybeincreased inorderto

achievetherequired dosageonamg/kgbodyweightbasisand to takeinto accounttheactual

feed intake. Thus, theinclusionlevelmayneed adjustingasfollowsto givethecorrectdose.

250 mgNuflorSwinepremix

perkgbodyweightand day x Averagepigbody

weight(kg) = mgNUFLORSWINE

PREMIXperkgoffeed

Averagedailyfeed intake(kg/animal)

Themaximumrateofincorporationis12.5 kg/ton(500 ppmofflorfenicol), higherratesof

inclusionmaylead to poorpalatabilityand decreased food consumption.

Undernocircumstancesshould theincorporationrateofthepremixbebelow5 kg/tonof

feed.

Inallcasestherecommended doseof10mgofflorfenicolperkgofbodyweightperday, for

5 consecutivedayshasto berespected.

To ensureacorrectdosagebodyweightshould bedetermined asaccuratelyaspossibleto

avoid underdosing. Therequired dosesshould bemeasured bysuitablycalibrated weighing

equipment.

Ahorizontalribbonmixershould beused to incorporatetheproductinto thefeedingstuff. It

isrecommended thattheproductisadded to themixercontainingthefeedingstuff

ingredientsand mixed thoroughlyto produceahomogeneousmedicated feedingstuff.

Medicated feed mayalso thenbepelleted. Pelletingconditionsincludeapre-conditioning

stepwithsteamand thenthemixtureispassed throughapelleterorextruderundernormal

conditions.

4.10 Overdose(symptoms, emergency procedures, antidotes), ifnecessary

Intheeventofoverdose, areductioninfood and waterconsumption, togetherwitha

decreaseinbodyweightmaybeobserved. Theremaybeanincreaseinrefused feed and an

increaseinserumcalcium

4.11 Withdrawalperiods

Meatand offal:14 days

5. PHARMACOLOGICALPROPERTIES

PharmacotherapeuticGroup:Antibiotic, memberofthephenicolfamily

ATCvetcode:QJ01BA90

5.1 Pharmacodynamicproperties

Florfenicolisabroad-spectrumsyntheticantibioticinthephenicolgroup thatisactiveagainst

mostGram-positiveand Gram-negativebacteriaisolated fromdomesticanimals. Florfenicol

actsbyinhibitionofproteinsynthesisattheribosomalleveland isbacteriostatic. However,

bactericidalactivityhasbeendemonstratedin-vitroagainstPasteurella multocidawhen

florfenicolispresentatconcentrationsabovetheMICfor4 to 12 hours.

In-vitrotestinghasshownthatflorfenicolisactiveagainstthebacterial

pathogensmostcommonlyisolated inrespiratorydiseasesinpigs, includingPasteurella

multocida.

Atotalof193Pasteurella multocidaisolatesfromtherespiratorytractofswinewere

collected between2002 and 2003 inFrance, Spain, Greece, Germany, theUnited Kingdom

and Belgium. TheMinimalInhibitoryConcentration(MIC)offlorfenicolagainstthetarget

pathogenrangesfrom0.25 to 1µg/mlwithaMIC

of0.5µg/ml.

Theonlymechanismsofchloramphenicolresistancethatareknownto havesignificantclinical

relevanceareCAT ( ChloramphenicolAcetylTransferase)-mediatedinactivationandefflux-

pumpresistance.Ofthese,onlysomeoftheeffluxmediatedresistancewouldalsoconfer

resistancetoflorfenicolandthushavethepotentialtobeaffectedbyflorfenicolusein

animals.

5.2 Pharmacokineticparticulars

Afteradministrationto pigsbygavageat10 mg/kgunderexperimentalconditions,

absorptionofflorfenicolwasvariablebutpeak serumconcentrationsofapproximately

5µg/mlwerereached approximately3hoursafterdosing. Theterminalhalf-lifewas

between3 and 4 hours. Whenpigsweregivenfreeaccess, for5 days, to feed medicated

withNuflorSwinePremixattherecommendeddoseof10 mg/kgserumflorfenicol

concentrationsexceeds1 µg/mlformorethan16 hourseachdayoftreatment.

Florfenicoliswellabsorbed whenadministered orallyand followingdistributionitisrapidly

eliminated intheurineand faecesinarationof3:1. Afractionisexcreted unchanged and the

restismetabolised into 5 majormetabolites.

Afterparenteraldosingofflorfenicolto pigs, ithasbeenshownthatlungconcentrationsare

similarto serumconcentrations.

6 PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

PropyleneGlycol(E1520)

Ground Limestone

6.2 Incompatibilities

Noneknown

6.3 Shelf-life

Shelflifeoftheveterinarymedicinalproductaspackaged forsale:3 years

Shelflifeafterfirstopeningtheimmediatepackaging:28 days

Shelflifeafterincorporationinto mealorpelleted feed:3 months

6.4 Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5 Natureandcompositionofimmediatepackaging

LDPE/HDPE/papersealed bagcontaining5 kgpremix.

LDPE/paper/paper/papersealed bagcontaining25 kgpremix

Notallpack sizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinary medicinalproductorwaste

materialsderivedfromtheuseofsuchproducts, ifappropriate

Anyunused veterinarymedicinalproductorwastematerialderived fromsuchveterinary

medicinalproductsshould bedisposed ofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

Cf. applicationformforeachMemberState

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION

10. DATEOFREVISIONOFTEXT

LABELLING

A. LABELLING

N.B.:fortheproductthereisnocartonboxandnopackageleaflet.

Allinformationisconveyedtothelabel.

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGING

LDPE/HDPE/paper/HDPEsealed bagcontaining5 kgpremix

LDPE/paper/paper/papersealed bagcontaining 25 kgpremix

N.B.:

Noouterpackagingisprovided (LDPEpaperbagonly).

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Nuflor40mg/gPremixforMedicated FeedingStuffforSwine

Florfenicol

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Compositionpergram:

Activesubstance:

Florfenicol 40 mg

Excipients:

PropyleneGlycol(E1520) 10 mg

Ground Limestone qsto 1g

3. PHARMACEUTICALFORM

Premixformedicated feedingstuff

Whiteto off-white, freeflowingpowder

4. PACKAGESIZE

5 kg

25 kg

5. TARGETSPECIES

Pigs(Fatteningpigs)

6. INDICATION(S)

Forthetreatmentand preventionofswinerespiratorydiseasecaused byPasteurella multocida

susceptibletoflorfenicolininfected herds. Thepresenceofthediseaseshould beestablished inthe

herd beforeinitiatingpreventivetreatment.

7. METHODANDROUTE(S)OFADMINISTRATION

To beadministered orally, inmedicated feedingstuff.

Dosage:

10 mgofflorfenicolperkgbodyweight(bw)(equivalentto 250 mgNuflorswinepremix)perday

administered for5 consecutivedays.

Administration:

Foradailyfeed intakeof50g/kgbodyweight, thisdosagecorrespondsto arateofincorporationof

5 kgofpremixpertonoffeed, i.e. 200 ppmofflorfenicol.

Therateofincorporationofthemedicated premixinthefeed maybeincreased inorderto achieve

therequired dosageonamg/kgbodyweightbasisand to takeinto accounttheactualfeed intake.

Thus, theinclusionlevelmayneed adjustingasfollowsto givethecorrectdose.

250 mgNuflorSwinepremix

perkgbodyweightand day x Averagepigbody

weight(kg) = mgNUFLORSWINE

PREMIXperkgoffeed

Averagedailyfeed intake(kg/animal)

Themaximumrateofincorporationis12.5 kg/ton(500 ppmofflorfenicol), higherratesofinclusion

maylead to poorpalatabilityand decreased food consumption.

Underno circumstancesshould theincorporationrateofthepremixbebelow5 kg/tonoffeed. Inall

casestherecommended doseof10mgofflorfenicolperkgofbodyweightperday, for5

consecutivedayshasto berespected.

To ensureacorrectdosagebodyweightshould bedetermined asaccuratelyaspossibleto avoid

underdosing. Therequired dosesshould bemeasured bysuitablycalibrated weighingequipment.

Ahorizontalribbonmixershould beused to incorporatetheproductinto thefeedingstuff. Itis

recommended thattheproductisadded to themixercontainingthefeedingstuffingredientsand

mixed thoroughlyto produceahomogeneousmedicated feedingstuff. Medicated feed mayalso

thenbepelleted. Pelletingconditionsincludeapre-conditioningstep withsteamand thenthemixture

ispassed throughapelleterorextruderundernormalconditions.

Shelflifeafterincorporationinto mealorpelleted feed:3 months

8. WITHDRAWALPERIOD

Meatand offal:14 days

9. SPECIALWARNINGS

Thispremixisintended forthemanufacturingofsolid medicated feed and cannotbeused asis;the

incorporationrateofthepremixinfeed cannotbelowerthan5kg/ton.Thispremixcontainsground

limestone, whichcanlead to adecreaseinfood consumptionand to aphosphoruscalciumimbalance

infeed intake.Careshould thereforebetakento considerthecalciumcontentofthefinalmedicated

feed.

Treatmentshould notexceed 5 days.

Do notuseinboarsintended forbreedingpurposes.

Do notadministerincasesofpreviousallergicreactionsto florfenicol.

Animalsshowingadecreased appetiteand/orapoorgeneralconditionshould betreated by

theparenteralroute.

Inafield clinicalstudy, withinaweek aftertheadministrationofthelastdose, theincidenceofpigs

presentingeithermild depressionand/ormild dyspneaand/orpyrexia(40°C)wasapprox. 20 %in

theinitiallyseverelyillanimals.

Skinsensitisationmayoccur. Avoid skincontact.

Do nothandlethisproductincaseofknownsensitisationto activesubstanceoranyofthe

excipients .

Handlethisproductwithcareto avoid exposureduringincorporationofpremixinto feed and

administrationoffeed to animals, takingallrecommended precautions.

Weareitheradisposablehalf-mask respiratorconformingto Europeanstandard EN149 oranon-

disposablerespiratorto EuropeanStandard EN140 withafilterto EN143, chemicallyresistant

gloves, protectivecoverallsand goggleswhileincorporatingthepremixinto feed.

Wearglovesand do notsmoke, eat, ordrink whenhandlingtheproductormedicated feed.

Washhandsthoroughlywithsoap and waterafteruseoftheproductormedicated feedRinse

thoroughlywithwaterincaseofexposure.

Ifyoudevelop symptomsfollowingexposuresuchasskinrash, youshould seek medicaladviceand

takethepackageleafletorthelabelwithyou.

Theproductshould beused inconjunctionwithsusceptibilitytestingand takeinto accountofficial

and localantimicrobialpolicies.

Commonlyobserved adverseeffectsarediarrhoeaperianalinflammationand rectaleversion. These

effectsaretransient, resolvingoncessationoftreatment. Increased serumcalciummayalso be

observed.

Thesafetyoftheproductduringpregnancyand lactationhasnotbeenstudied insows. Useofthe

productduringpregnancyand lactationisthereforenotrecommended.

Do notuseinbreedingboarsbecausetoxicitystudiesinratshaveshownadverseeffectsonthemale

reproductivesystem.

Intheeventofoverdose, areductioninfood and waterconsumption, togetherwithadecrease

inbodyweightmaybeobserved. Theremaybeanincreaseinrefused feed and anincreasein

serumcalcium

Manurefromtreated swinemustbestored foraminimumofonemonthbeforebeingspread and

incorporated infields.

Ifyounoticeanyseriouseffectsorothereffectsnotmentioned inthislabel, pleaseinformyour

veterinarysurgeon.

10.EXPIRYDATE

EXP{month/year

Oncebroached/opened, usewithin.28 days.

Shelflifeafterincorporationinto mealorpelleted feed:3 months

11.SPECIALSTORAGECONDITIONS

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS, IFANY

Anyunusedveterinarymedicinalproductorwastematerialderived fromsuchveterinarymedicinal

productsshould bedisposed ofinaccordancewithlocalrequirements.

13.THEWORDS“FORANIMALTREATMENTONLY” ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly-to besupplied onlyonveterinaryprescription.

14.THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keep outofthereachand sightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

Marketingauthorisationholder:

IntervetInternationalBV

WimdeKörverstraat35

5831 ANBoxmeer

TheNetherlands

Manufacturerforthebatchrelease:

EurovetAnimalHealthBV

Handelsweg25

5531 AEBladel

TheNetherlands

16.MARKETINGAUTHORISATIONNUMBER(S)

[To becompleted nationally.]

17.MANUFACTURER’SBATCHNUMBER

<Batch> <Lot> <BN> {number}

Otherinformation

LDPE/HDPE/paper/HDPEsealed bagcontaining5 kgpremix.

LDPE/paper/paper/papersealed bagcontaining25kgpremix

Notallpack sizesmaybemarketed.

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FDA - U.S. Food and Drug Administration

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

11-7-2018

African swine fever: EFSA assesses measures to prevent spread

African swine fever: EFSA assesses measures to prevent spread

African swine fever: EFSA assesses measures to prevent spread

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

12-6-2018

Ashley Furniture Industries , Inc. recalls Signature Design by Ashley Amnon Floor Lamp

Ashley Furniture Industries , Inc. recalls Signature Design by Ashley Amnon Floor Lamp

The lamp has incorrect lightbulb wattage information printed on a label on the sockets of the lamp. The incorrect labels indicate that each socket can support 40 W bulbs, however the product is only rated for each socket supporting a 25 W bulb. The use of lightbulbs with the incorrect wattage could potentially melt the power-switch, posing a burn hazard.

Health Canada

29-5-2018

Résultats ILPT Classical Swine Fever SEROLOGY 2018

Résultats ILPT Classical Swine Fever SEROLOGY 2018

France - Agence Nationale du Médicament Vétérinaire

21-11-2018

Osurnia (Elanco GmbH)

Osurnia (Elanco GmbH)

Osurnia (Active substance: terbinafine / florfenicol / betamethasone acetate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7842 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/003753/T/0010

Europe -DG Health and Food Safety

27-8-2018

Beromun (BELPHARMA s.a.)

Beromun (BELPHARMA s.a.)

Beromun (Active substance: Tasonermin (Tumor Necrosis Factor alfa-1a)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5699 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/206/T/40

Europe -DG Health and Food Safety

7-8-2018

ACMD meeting statement, Meeting 40, 12 April 2018

ACMD meeting statement, Meeting 40, 12 April 2018

Advisory Committee on Medical Devices meeting statement

Therapeutic Goods Administration - Australia

25-7-2018

Respiporc Flu3 (IDT Biologika GmbH)

Respiporc Flu3 (IDT Biologika GmbH)

Respiporc Flu3 (Active substance: Inactivated vaccine against swine influenza in pigs) - Centralised - Yearly update - Commission Decision (2018)4991 of Wed, 25 Jul 2018

Europe -DG Health and Food Safety

11-6-2018

Zydelig (Gilead Sciences Ireland UC)

Zydelig (Gilead Sciences Ireland UC)

Zydelig (Active substance: idelalisib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3765 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3843/T/40

Europe -DG Health and Food Safety

29-5-2018

Osurnia (Elanco Europe Ltd)

Osurnia (Elanco Europe Ltd)

Osurnia (Active substance: terbinafine / florfenicol / betamethasone acetate) - Centralised - Yearly update - Commission Decision (2018)3406 of Tue, 29 May 2018

Europe -DG Health and Food Safety

16-5-2018

Elonva (Merck Sharp and Dohme B.V.)

Elonva (Merck Sharp and Dohme B.V.)

Elonva (Active substance: corifollitropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3049 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1106/T/40

Europe -DG Health and Food Safety