TIAMULINE solution

Main information

  • Trade name:
  • TIAMULINE solution
  • Pharmaceutical form:
  • Oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TIAMULINE solution
    France
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • tiamulin
  • Therapeutic area:
  • Chicken, Pigs, Turkeys

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0169/001
  • Authorization date:
  • 17-04-2011
  • EU code:
  • FR/V/0169/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

TIAMVET125 mg/mloralsolution[CZ,HU,PT]

TIAMULINESOLUTIONCEVA [FR]

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Onemlcontains:

Activeingredient:

Tiamulin 101.2mgequivalentto

Tiamulinhydrogenfumarate..................................................................125.0mg

Excipient

Benzylalcohol(E1519).........................................................................15.0mg

Forafulllistofexcipients,seesection6.1

3.PHARMACEUTICALFORM

Oralsolution.

Clearcolourlesstopaleyellowsolution.

4.CLINICALPARTICULARS

4.1Targetspecies

Chickens,turkeysandpigs.

4.2Indicationsforuse,specifyingthetargetspecies

Chickensandturkeys:

Treatmentandpreventionofchronicrespiratorydiseasecausedbytiamulinesusceptiblestrains:

Mycoplasmagallisepticum,Mycoplasmameleagridis.

Pigs:

Treatmentofenzooticpneumoniacausedbytiamulinsusceptiblestrains:Mycoplasmahyopneumoniae,

Mycoplasmahyorhinis.

Treatmentofhaemorragicenteritiscausedbyorcomplicatedbytiamulinsusceptiblestrains:Brachyspira

hyodysenteriae.

4.3Contraindications

Donotadministertheproductwithmonensin,salinomycinandnarasinandothermonovalentionophore-

antibiotics7daysbefore,duringand7daysaftertreatmentofanimals.

Donotuseinanimalswithknownhypersensitivitytotiamulinoranyexcipients.

4.4Specialwarningsforeachtargetspecies

Forpigs:Theuptakeofmedicationbyanimalscanbealteredasaconsequenceofillness.Foranimalswitha

reducedfeedintake,treatparenterallyusinganappropriateinjectableproduct.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Useoftheproductshouldbebasedonsusceptibilitytesting.

Strategictreatmentshouldbelimitedtoanimalswheretiamulinsusceptibleagentshavebeenisolatedinthe

herd.Longtermorrepeateduseshouldbeavoidedbyimprovingmanagementpracticeandthorough

cleansinganddisinfection.

Useoftheproductdeviatingfromtheinstructionsgivenmayincreasetheprevalenceofbacteriaresistantto

tiamuline.

Severegrowthdepressionordeathmayresultifanimalsreceiveproductscontainingmonensin,salinomycin,

narasin,maduramycinorotherionophoresduringorforatleastsevendaysbeforeoraftertreatmentwiththe

product.Seealsosection4.3and4.8.

Donotleavemedicatedwateravailabletootheranimals.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Avoidcontactwiththeskinandeyes.Incaseofcontact,washthoroughlywithwater,andseekmedical

attentionifnecessary.

Personswithknownhypersensitivitytotiamulineshouldavoidcontactwiththisveterinarymedicinal

product.

Washhandsafteruse.

4.6Adversereactions(frequencyandseriousness)

Inrarecases,hypersensitivitytotiamulinefollowingoraladministrationisreportedintermsofacute

dermatitiswithcutaneouserythemaandintensepruritus.Theadversereactionsareoftenmildandtransient

butinveryrarecasesmaybeserious.Ifthesetypicalsideeffectsoccur,stoptreatmentimmediatelyand

cleananimalsandpenswithwater.Normally,theanimalsrecoverfastthereafter.Symptomatictreatment

suchaselectrolytetherapyandananti-inflammatorytherapymaybeuseful.

4.7Useduringpregnancy,lactationorlay

Thesafetyoftheproducthasnotbeenestablishedinpregnantorlactatingsows.Useonlyinaccordancewith

risk/benefitassessmentbytheresponsibleveterinarian.

Laboratorystudiesinrats,rabbitsanddogshaveprovidedanyevidenceofafoetotoxicorteratogeniceffects.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Interactionswithcertainionophore-antibioticsmayoccur.Intoxicationsymptomssuchasgrowth

depression,paralysisanddeatharepossiblefollowingsimultaneousadministration.

Tiamulinmaylessentheantibacterialactivityofβ-lactamantibioticswhoseactionisdependentonbacterial

growth.

4.9Amountstobeadministeredandadministrationroute

Chickens(broiler,replacementpullet,layingandbreedinghens)

20.2mgtiamulin/kgbodyweightdailyadministeredfortheperiodof3to5consecutivedays.Thisis

normallyachievedbyanincorporationrateof20mltiamulinfor100kgindrinkingwater.

Turkeys(youngpoults,breedingturkeys)

32.4mgtiamulin/kgbodyweightdailyadministeredfortheperiodof3to5consecutivedays.Thisis

normallyachievedbyanincorporationrateof32.4mltiamulinfor100kgindrinkingwater.

Theintakeofmedicatedwaterdependsonthephysiologicalandclinicalconditionoftheanimals.Inorderto

obtainthecorrectdosagetheconcentrationoftiamulinhastobeadjustedaccordingly.

PreventivetreatmentwithtiamulinshouldonlybeinitiatedafterconfirmedinfectionwithM.Gallisepticum

orM.Meleagridisandthenasanaidinthepreventionstrategytoreducetheclinicalsignsandmortality

fromrespiratorydiseaseinflocks,whereinfectioninovumislikelybecausethediseaseisknowntoexistin

theparentgeneration.Thepreventionstrategyshouldincludeeffortstoeliminatetheinfectionfromthe

parentgeneration.

Pigs:

6.48–8.1mgoftiamulinbaseperkgbodyweightperday(equivalentto8to10mgtiamulinhydrogen

fumarate/kgbodyweight/day),for5daysbyoralrouteindrinkingwater,equivalentto6.40to8mlof

solutionper100kgofbodyweightperday,for5days.

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossibletoavoidunderdosing.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Notdocumented.

4.11Withdrawalperiods

Pigs,chickensandturkeys:6days

Eggs:zerodays

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:antibacterialsforsystemicuse,pleuromutilins

ATCvetcode:QJ01XQ01.

5.1Pharmacodynamicproperties

Tiamulinisasemi-syntheticderivativeoftheantibioticbelongingtotheclassofpleuromutilin.

Tiamulinisabacteriostaticantibioticandactsbyinhibitingproteinsynthesisbyreversiblybindingtothe

50Sribosomesubunit.

TiamulinisactiveonBrachyspira(Brachyspirahyodysenteriae),Mycoplasmas(Mycoplasma

hyopneumoniae,Mycoplasmahyorhinis,Mycoplasmagallisepticum).

Themechanismofresistanceischromosomal.Appearanceofresistancesisslowandprogressive.Thereisno

crossresistancewithmacrolidesandrelatedsubstances.

5.2Pharmacokineticparticulars

Tiamulinisrapidlyabsorbedafteroraladministration.Thebioavailabilityis,atleast,of90%.Itis

distributed,preferentiallyatintracellularlevel,inthelungsandthecolon.60-65%oftiamulinisexcretedin

thefaeceswithanentero-hepaticcycle,and30-35%intheurine.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzylalcohol(E1519)

Ethanol

Water

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:3months.

Shelf-lifeafterdilutionaccordingtodirections:24hours.

6.4Specialprecautionsforstorage

Nospecialprecautionsforstorage.

6.5Natureandcompositionofimmediatepackaging

Materialoftheprimarycontainer

Polyethylenebottlehighdensity

Polypropylenemeasuringcap.

Packsizes

500mlbottle.

1-litrebottle.

2-litresbottle.

5-litresbottle.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinalproduct

shouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFTHEFIRSTAUTHORISATIONORDATEOFRENEWALOFTHE

AUTHORISATION

10. DATEOFREVISIONOFTHETEXT

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Europe - EFSA - European Food Safety Authority Publications

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FDA - U.S. Food and Drug Administration

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Europe - EFSA - European Food Safety Authority Publications

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Europe - EFSA - European Food Safety Authority Publications

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Europe - EFSA - European Food Safety Authority Publications

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Europe - EFSA - European Food Safety Authority Publications

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Europe - EFSA - European Food Safety Authority Publications

6-11-2018

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Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Published on: Thu, 25 Oct 2018 00:00:00 +0200 A multi-country outbreak of 12 listeriosis cases caused by Listeria monocytogenes sequence type (ST) 8 has been identified through whole genome sequencing (WGS) analysis in three EU/EEA countries: Denmark (6 cases), Germany (5) and France (1). Four of these cases have died due to or with the disease. It is likely that the extent of this outbreak has been underestimated since the outbreak was identified through sequencing and only a subset of the EU/EEA count...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

FDA approves new drug to treat influenza

FDA approves new drug to treat influenza

FDA approved Xofluza (baloxavir marboxil) to treat acute uncomplicated flu in patients 12 years old and older who have been symptomatic for less than 48 hours.

FDA - U.S. Food and Drug Administration

24-10-2018

Vita Health Products Recall (2018-10-24)

Vita Health Products Recall (2018-10-24)

Health Canada

23-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Published on: Mon, 22 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residue trials on strawberries, onions, garlic, tomatoes, peppers, cucumbers, artichokes, leeks and rape seeds were submitted. The data gaps are considere...

Europe - EFSA - European Food Safety Authority Publications

22-10-2018

Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution

Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution

Promise Pharmacy is voluntarily recalling one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3ml vials, to the patient consumer level. The product has been found to have unidentified small particulate floating in the solution.

FDA - U.S. Food and Drug Administration

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for dimethomorph in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted residue data on raspberries were satisfactorily addressing the data gaps on raspberries and blackberries. Considering the new information provided, it is appropri...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

The recalled products may contain phthalate levels that exceed the allowable levels.

Health Canada

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Clackamas Bakery Recalls Fred Meyer Bakery Angel Food Cake Bar Due to Undeclared Allergens

Clackamas Bakery Recalls Fred Meyer Bakery Angel Food Cake Bar Due to Undeclared Allergens

Clackamas Bakery has recalled Fred Meyer Bakery Angel Food Cake Bar (12 oz.) sold in its retail stores because the product may contain milk and soy not listed on the label. Clackamas Bakery initiated the recall when it was discovered that the Fred Meyer Bakery Angel Food Cake Bar label had been incorrectly applied to packages of cornbread.

FDA - U.S. Food and Drug Administration

16-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

10-12-2018

Exondys (AVI BioPharma International Ltd)

Exondys (AVI BioPharma International Ltd)

Exondys (Active substance: eteplirsen) - Centralised - Refusal of marketing authorisation - Commission Decision (2018)8620 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4355

Europe -DG Health and Food Safety

10-12-2018

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (Active substance: ivabradine) - Centralised - Withdrawal - Commission Decision (2018)8623 of Mon, 10 Dec 2018

Europe -DG Health and Food Safety

26-11-2018

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware of those technologies.

FDA - U.S. Food and Drug Administration

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

22-11-2018

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Active substance: emtricitabine / tenofovir disoproxil) - Centralised - 2-Monthly update - Commission Decision (2018)7884 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4215/IB/10G

Europe -DG Health and Food Safety

12-11-2018

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Active substance: efavirenz / emtricitabine / tenofovir disoproxil) - Centralised - Yearly update - Commission Decision (2018)7547 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Ruconest (Pharming Group N.V.)

Ruconest (Pharming Group N.V.)

Ruconest (Active substance: Conestat alfa) - Centralised - Yearly update - Commission Decision (2018)7548 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

Spinraza (Active substance: nusinersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7550 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/T/10

Europe -DG Health and Food Safety

12-11-2018

Irbesartan HCT Zentiva (Zentiva k.s.)

Irbesartan HCT Zentiva (Zentiva k.s.)

Irbesartan HCT Zentiva (Active substance: irbesartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7555 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Xeljanz (Pfizer Europe MA EEIG)

Xeljanz (Pfizer Europe MA EEIG)

Xeljanz (Active substance: Tofacitinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7554 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004214/T/0015

Europe -DG Health and Food Safety

12-11-2018

Tracleer (Janssen-Cilag International NV)

Tracleer (Janssen-Cilag International NV)

Tracleer (Active substance: bosentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7556 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000401/T/0088

Europe -DG Health and Food Safety

12-11-2018

Neupro (UCB Pharma S.A.)

Neupro (UCB Pharma S.A.)

Neupro (Active substance: Rotigotine) - Centralised - Yearly update - Commission Decision (2018)7551 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Active substance: Sildenafil citrate) - Transfer of orphan designation - Commission Decision (2018)6993 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/068/10/T/01

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

Recocam (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6954 of Fri, 19 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2247/T/10

Europe -DG Health and Food Safety

12-10-2018

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Active substance: Irbesartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6772 of Fri, 12 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/785T/79

Europe -DG Health and Food Safety