Felimazole

Main information

  • Trade name:
  • Felimazole
  • Pharmaceutical form:
  • Coated tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Felimazole
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Cats

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0198/001
  • Authorization date:
  • 03-07-2012
  • EU code:
  • UK/V/0198/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Felimazole2.5mgCoatedTabletsforCats

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstance:

Thiamazole 2.5mg

Excipients:

TitaniumDioxide(E171) 1.12mg

Erythrosine(E127) 0.01mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Coatedtablet.

Pinksugar-coatedbiconvextablets,5.5mmdiameter.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cats.

4.2 Indicationsforuse,specifyingthetargetspecies

Forthestabilisationofhyperthyroidismincatspriortosurgicalthyroidectomy.

Forthelong-termtreatmentoffelinehyperthyroidism.

4.3 Contraindications

Donotuseincatssufferingfromsystemicdiseasesuchasprimaryliverdiseaseordiabetes

mellitus.

Donotuseincatsshowingsignsofautoimmunedisease.

Donotuseinanimalswithdisordersofwhitebloodcells,suchasneutropeniaand

lymphopenia.

Donotuseinanimalswithplateletdisordersandcoagulopathies(particularly

thrombocytopenia).

Donotuseincatswithhypersensitivitytothiamazoleortheexcipient,polyethyleneglycol.

Donotuseinpregnantorlactatingfemales.

Pleaserefertosection4.7.

4.4 Specialwarnings

Asthiamazolecancausehaemoconcentration,catsshouldalwayshaveaccesstodrinking

water.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Ifmorethan10mgperdayisrequiredanimalsshouldbemonitoredparticularlycarefully.

Useoftheproductincatswithrenaldysfunctionshouldbesubjecttocarefulrisk:benefit

assessmentbytheclinician.Duetotheeffectthiamazolecanhaveonreducingtheglomerular

filtrationrate,theeffectoftherapyonrenalfunctionshouldbemonitoredcloselyas

deteriorationofanunderlyingconditionmayoccur.

Haematologymustbemonitoredduetoriskofleucopeniaorhaemolyticanaemia.

Anyanimalthatsuddenlyappearsunwellduringtherapy,particularlyiftheyarefebrile,

shouldhaveabloodsampletakenforroutinehaematologyandbiochemistry.Neutropenic

animals(neutrophilcounts<2.5x10 9 /l)shouldbetreatedwithprophylacticbactericidal

antibacterialdrugsandsupportivetherapy.

Pleaserefertosection4.9formonitoringinstructions.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Washhandsafteruse.

Inthecaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthepackage

insertorthelabeltothephysician.

Thiamazolemaycausevomiting,epigastricdistress,headache,fever,arthralgia,pruritusand

pancytopaenia.Treatmentissymptomatic.

Washhandswithsoapandwaterafterhandlinglitterusedbytreatedanimals.

Donoteat,drinkorsmokewhilehandlingthetabletorusedlitter.

Donothandlethisproductifyouareallergictoantithyroidproducts.Ifallergicsymptoms

develop,suchasaskinrash,swellingoftheface,lipsoreyesordifficultyinbreathing,you

shouldseekmedicalattentionimmediatelyandshowthepackageleafletorlabeltothedoctor.

Donotbreakorcrushtablets.

Asthiamazoleisasuspectedhumanteratogen,womenofchild-bearingageandpregnant

womenshouldweargloveswhenhandlinglitteroftreatedcats.

Pregnantwomenshouldweargloveswhenhandlingtheproduct.

4.6 Adversereactions(frequencyandseriousness)

Adversereactionshavebeenreportedfollowinglongtermcontrolofhyperthyroidism.In

manycases,signsmaybemildandtransitoryandnotareasonforwithdrawaloftreatment.

Themoreseriouseffectsaremainlyreversiblewhenmedicationisstopped.

Adversereactionsareuncommon.Themostcommonclinicalsideeffectsthatarereported

includevomiting,inappetance/anorexia,lethargy,severepruritusandexcoriationsofthehead

andneck,bleedingdiathesisandicterusassociatedwithhepatopathy,andhaematological

abnormalities(eosinophilia,lymphocytosis,neutropenia,lymphopenia,slightleucopenia,

agranulocytosis,thrombocytopeniaorhaemolyticanaemia).Thesesideeffectsresolvewithin

7-45daysaftercessationofthiamazoletherapy.

Possibleimmunologicalsideeffectsincludeanaemia,withraresideeffectsincluding

thrombocytopeniaandserumanti-nuclearantibodies,and,veryrarely,lymphadenopathycan

occur.Treatmentshouldbestoppedimmediatelyandalternativetherapyconsideredfollowinga

suitableperiodforrecovery.

Followinglong-termtreatmentwiththiamazoleinrodents,anincreasedriskofneoplasiain

thethyroidglandhasbeenshowntooccur,butnoevidenceisavailableincats.

4.7 Useduringpregnancy,lactationorlay

Laboratorystudiesinratsandmicehaveshownevidenceofteratogenicandembryotoxic

effectsofthiamazole.Thesafetyoftheproductwasnotassessedinpregnantorlactatingcats.

Donotuseinpregnantorlactatingfemales.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrenttreatmentwithphenobarbitalmayreducetheclinicalefficacyofthiamazole.

Thiamazoleisknowntoreducethehepaticoxidationofbenzimidazolewormersandmaylead

toincreasesintheirplasmaconcentrationswhengivenconcurrently.

Thiamazoleisimmunomodulatory,thereforethisshouldbetakenintoaccountwhenconsidering

vaccinationprogrammes.

4.9 Amountstobeadministeredandadministrationroute

Fororaladministrationonly.

Forthestabilisationoffelinehyperthyroidismpriortosurgicalthyroidectomyandforthelong

termtreatmentoffelinehyperthyroidism,therecommendedstartingdoseis5mgperday.

Whereverpossible,thetotaldailydoseshouldbedividedintotwoandadministeredmorning

andevening.Tabletsshouldnotbesplit.

If,forreasonsofcompliance,oncedailydosingwitha5mgtabletispreferable,thenthisis

acceptablealthoughthe2.5mgtabletgiventwicedailymaybemoreefficaciousintheshort

term.The5mgtabletisalsosuitableforcatsrequiringhigherdoserates.

Haematology,biochemistryandserumtotalT4shouldbeassessedbeforeinitiatingtreatment

andafter3weeks,6weeks,10weeks,20weeks,andthereafterevery3months.Ateachofthe

recommendedmonitoringintervals,thedoseshouldbetitratedtoeffectaccordingtothetotalT4

andtoclinicalresponsetotreatment.Doseadjustmentsshouldbemadeinincrementsof2.5mg

andtheaimshouldbetoachievethelowestpossibledoserate.

Ifmorethan10mgperdayisrequiredanimalsshouldbemonitoredparticularlycarefully.

Thedoseadministeredshouldnotexceed20mg/day.

Forlongtermtreatmentofhyperthyroidismtheanimalshouldbetreatedforlife.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Intolerancestudiesinyounghealthycats,thefollowingdose-relatedclinicalsignsoccurredat

dosesofupto30mg/animal/day:anorexia,vomiting,lethargy,pruritusandhaematologicaland

biochemicalabnormalitiessuchasneutropenia,lymphopenia,reducedserumpotassiumand

phosphoruslevels,increasedmagnesiumandcreatininelevelsandtheoccurrenceofanti-

nuclearantibodies.Atadoseof30mg/daysomecatsshowedsignsofhaemolyticanaemiaand

severeclinicaldeterioration.Someofthesesignsmayalsooccurinhyperthyroidcatstreatedat

dosesofupto20mgperday.

Excessivedosesinhyperthyroidcatsmayresultinsignsofhypothyroidism.Thisishowever

unlikely,ashypothyroidismisusuallycorrectedbynegativefeedbackmechanisms.Please

refertoSection4.6Adversereactions.

Ifoverdosageoccurs,stoptreatmentandgivesymptomaticandsupportivecare.

4.11 Withdrawalperiods

Notapplicable.

5. PHARMACOLOGICALPARTICULARS

Pharmacotherapeuticgroup:antithyroidpreparations:sulphur-containingimidazolederivatives.

ATCVetCode:QH03BB02.

5.1 Pharmacodynamicproperties

Thiamazoleactsbyblockingthebiosynthesisofthyroidhormoneinvivo.Theprimaryactionis

toinhibitbindingofiodidetotheenzymethyroidperoxidase,therebypreventingthecatalysed

iodinationofthyroglobulinandT

andT

synthesis.

5.2 Pharmacokineticparticulars

Followingoraldosinginhealthycats,thiamazoleisrapidlyandcompletelyabsorbedwitha

bioavailabilityof>75%.However,thereisaconsiderablevariationbetweenanimals.

Eliminationofthedrugfromcatplasmaisrapidwithahalflifeof3.5-4.0hours.Peakplasma

levelsoccurapproximately1-2hoursafterdosing.Cmaxisapproximately0.8µg/ml.

Inratsthiamazolehasbeenshowntobepoorlyboundtoplasmaprotein(5%);40%was

boundtoredbloodcells.Themetabolismofthiamazoleincatshasnotbeeninvestigated,

however,inratsthiamazoleisrapidlymetabolisedinthethyroidgland.About64%ofthe

administereddosebeingeliminatedintheurineandonly7.8%excretedinfaeces.Thisisin

contrastwithmanwheretheliverisimportantforthemetabolicdegradationofthe

compound.Thedrugresidencetimeinthethyroidglandisassumedtobelongerthaninthe

plasma.

Frommanandratsitisknownthatthedrugcancrosstheplacentaandconcentratesinthe

foetalthyroidgland.Thereisalsoahighrateoftransferintobreastmilk.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Tabletcore:

Lactosemonohydrate

Povidone

Sodiumstarchglycollate

Magnesiumstearate

Coating:

Sucrose

Povidone

Erythrosine

Macrogol

Purifiedtalc

Whitebeeswax

Carnaubawax

Shellac

Titaniumdioxide(E171)

Sodiummethylparahydroxybenzoate(E219)

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years.

6.4 Specialprecautionsforstorage

Donotstoreabove25ºC.

Keepthecontainertightlyclosedinordertoprotectfrommoisture.

Keepthecontainerintheoutercarton.

6.5 Natureandcontentsofimmediatepackaging

Whitepolypropylenetubwithwhitelowdensitypolyethylenetamperevidentlidcontaining100

tablets.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

DechraLimited

DechraHouse

JamageIndustrialEstate

TalkePits

Stoke-on-Trent

Staffordshire

ST71XW

UK

8. MARKETINGAUTHORISATIONNUMBERS

UK:Vm10434/4050

IE:VPA10799/15/001

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

UK:19/11/2004

IE:20/02/2009

10. DATEOFANYREVISIONOFTHETEXT

27.02.12

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FDA - U.S. Food and Drug Administration

31-8-2018

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA is warning the public about a voluntary recall of one lot of montelukast sodium tablets made by Camber Pharmaceuticals due to incorrect drug in bottles

FDA - U.S. Food and Drug Administration

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

22-8-2018

Germany Niubian tablets

Germany Niubian tablets

Germany Niubian tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

22-8-2018

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industr...

FDA - U.S. Food and Drug Administration

18-8-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probabl...

FDA - U.S. Food and Drug Administration

15-8-2018

G Female Oral Tablets

G Female Oral Tablets

G Female Oral Tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

9-8-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

3-8-2018

Scientific guideline:  Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance, adopted

Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

3-8-2018

Scientific guideline:  Agomelatine tablet 25 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Agomelatine tablet 25 mg product-specific bioequivalence guidance, adopted

Agomelatine tablet 25 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

3-8-2018

Scientific guideline:  Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

25-7-2018

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

Associated Milk Producers Inc. (AMPI) of New Ulm, Minn., is recalling dry whey powder packaged in 50-pound and 25-kg bags that were produced at the cooperative’s Blair, Wis., dry whey plant from May 1-5, 2018; May 24-29, 2018; June 2-5, 2018; and June 7-14, 2018 due to the potential to be contaminated with Salmonella. This is a precautionary recall. All products shipped to the marketplace tested negative for Salmonella.

FDA - U.S. Food and Drug Administration

18-7-2018

FDA Approves NexGard for prevention of infections that cause Lyme disease in dogs

FDA Approves NexGard for prevention of infections that cause Lyme disease in dogs

FDA has approved NexGard (afoxolaner), a chewable tablet administered once monthly to dogs, for the prevention of Borrelia burgdorferi (B. burgdorferi) infections by killing Black-legged ticks (Ixodes scapularis), which carry the bacterium.

FDA - U.S. Food and Drug Administration

17-7-2018

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

FDA - U.S. Food and Drug Administration

17-7-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the U.S. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking wat...

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

28-6-2018

Need for Seal tablets

Need for Seal tablets

Need for Seal tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

28-6-2018

Gold Maka tablets

Gold Maka tablets

Gold Maka tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

28-6-2018

One Night Lover tablets

One Night Lover tablets

One Night Lover tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

19-6-2018

Bulbao Male Enhancer tablets

Bulbao Male Enhancer tablets

Bulbao Male Enhancer tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

19-6-2018

Meltz – Instant Energy For Males tablets

Meltz – Instant Energy For Males tablets

Meltz Instant Energy For Males tablets pose a serious risk to your health and should not be taken.

Therapeutic Goods Administration - Australia

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration

19-9-2018

Targretin (Eisai GmbH)

Targretin (Eisai GmbH)

Targretin (Active substance: bexarotene) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6098 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/326/T/50

Europe -DG Health and Food Safety