TILDREN

Main information

  • Trade name:
  • TILDREN
  • Pharmaceutical form:
  • Powder and solvent for solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TILDREN
    France
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Tiludronic acid
  • Therapeutic area:
  • Horses

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0134/001
  • Authorization date:
  • 01-06-2012
  • EU code:
  • FR/V/0134/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

11823TILDRENSPCRENEWAL-FinalversionMarch2007

1/5 Dokument1SPCrenewalFinalversion

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

TILDREN5mg/mlpowderandsolventforsolutionforinjection

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Powdervial:

Activesubstance:

Tiludronicacid(asdisodiumsalt).................................................................50mg

Excipientq.s..............................................................................................1vial

Solventvial

Waterforinjections.....................................................................................10ml

Solutionafterreconstitution

Activesubstance:

Tiludronicacid(asdisodiumsalt)............................................................5mg/ml

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Powderandsolventforsolutionforinjection.

Appearance:

Whitepowderandclearcolourlesssolvent.

Afterreconstitution,theproductisaclearcolourlesssolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Horsesover3yearsofage.

4.2 Indicationsforuse,specifyingthetargetspecies

Toaidinthetreatmentoflamenessassociatedwithosteolyticprocessesobservedinbonespavinandin

navicularsyndromeoflessthan6months.

4.3 Contraindications

- Intheabsenceofanydatarelatingtotheadverseeffectsoftiludronicacidontheskeletonof

younganimals,donotadministertohorseslessthan3yearsold.

- Donotuseinhorsesproducingmilkforhumanconsumption.

- Donotadministertohorseswithrenaldysfunction

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4.4 Specialwarningsforeachtargetspecies

Seepoint4.11.Withdrawalperiod.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

TheclinicaleffectofTILDRENdependsonthepresenceofosteolyticprocessescausingpainand

leadingtolameness.TILDRENshouldbeusedonlyafteraproperdiagnosiscombiningacomplete

orthopaedicclinicalexaminationincludinglocalanaesthesiaandappropriateimagingtechniquesinorder

toidentifythecauseofpainandthenatureofbonelesions.

Itisadvisablethatanexperiencedhorsekeepershouldobservethehorseforthefirstfourhours

followingtheinjectionduetothepossibleonsetofsideeffects.

TILDRENshouldbeadministeredwithcautioninhypocalcemichorses.Inthiscase,isadvisedto

slowerthespeedofinjection.Astheriskofappearanceofsideeffectsmightintheseanimalsbe

increased,theseanimalsshouldbethesubjectofparticularsurveillance.

Becauseofitsmildhypocalcemieeffect,TILDRENshouldbeadministeredwithcautioninhorseswith

disordersofheartfunction.Inthiscase,itisadvisedtoslowerthespeedofinjection.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

- Avoidcontactwithskinandeyes.

- Wearsuitablegloveswhenpreparingthesolutionforinjection

- Washhandsafteruse.

- Inthecaseofselfinjection,seekmedicaladviceimmediatelyandshowthepackageinsertorthe

labeltothephysician.

4..6Adversereactions(frequencyandseriousness)

Themainadversereactionsrelatedtotreatmentwithtiludronicacidaresignsofcolic(expressedas

lossofappetite,abdominaldiscomfort,scratchingtheground,restlessnessandpawing),muscletremor

andsweating.Thesesideeffectswereobservedinlessthan5%ofhorsestreatedwiththe

recommendedtherapeuticschemeandcouldberelatedtoamildhypocalcemiceffect.

Thesignsofcolicappearwithinafewhoursfollowingtreatment,aremildandtransientandgenerally

resolvespontaneouslywithoutrequiringanyspecifictreatment.Incasewheresignspersist,

conventionaltreatmentsshouldbeadministered.Interactionswiththesetreatmentshavenotbeen

assessed.

Muscletremorsmaybestoppedbytheadministrationofcalciumgluconateoranyothercalcium

solution.

Phlebitismayoccurinlessthan9%ofhorsesduetolocalreactionattheinjectionsite.Itismostly

seenfromthe5 th

injectiononwards.

Excitation,hypertoniaofthetailandsalivationareotherpossiblesideeffects.

Fatigue,sometimesexpressedbyrecumbency,canbeexperiencedpostinjection.Thissideeffectcould

alsoberelatedtoamildhypocalcemiceffect.Beawarethatthehorseshouldbefreetoliedownina

comfortableunrestrictedarea.

Inrareoccasions(lessthan1outof10,000horses)anaphylacticlikereactionsincludingshockwere

reportedinanimals. Formatiert:Schriftartfarbe:

Automatisch

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4.7 Useduringpregnancy,lactationorlay

Studiesconductedonlaboratoryanimals(mice,rats,rabbits)didnotrevealanyembryotoxic,foetotoxic

orteratogeniceffectsnoreffectsonperi-orpost-nataldevelopment.Particularly,noadverseeffects

havebeenobservedontheskeleton.

Thesafetyoftheproducthasnotbeenstudiedinpregnantorlactatingmares.Theuseoftheproduct

duringpregnancyorlactationinmaresisnotrecommended.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

DonotadministerconcomitantlybyintravenousroutethereconstitutedsolutionTILDRENwith

solutionsbasedondivalentmetalionssuchasCa 2+

orMg 2+

;asolutionoftiludronicacidmayform

complexeswiththeseions.

Regardingothermedicinalproducts,nodataareavailable.

4.9 Amountstobeadministeredandadministrationroute

0.1mgoftiludronicacidperkgofbodyweightperdayfor10daysbyslowintravenousroute,i.e.1ml

per50kgofbodyweightperdayofareconstitutedsolutioncontaining5mg/mloftiludronicacid.

Thereconstitutedsolutionisobtainedbyaddingunderasepticconditionsthesolventtothepowderand

gentlymixingthem.

-Theproductshouldbeadministeredover20to30secondsfor10ml.

-Thesideofthesiteofinjectionmustbealternatedfromdaytoday.

-Theproductshouldbeusedimmediatelyandnotstoredafterreconstitution

-Donotexceedtherecommendeddosage.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

At3timestherecommendeddosage,anincreaseinfrequencyofthesideeffects,inparticularsignsof

colicandmuscletremor,isobserved.

Thesignsofcolicappearwithinafewhoursfollowingthetreatment,aremildandtransientand

generallyresolvespontaneouslywithoutrequiringanyspecifictreatment.Incasewheresignspersist,

conventionaltreatmentsshouldbeadministered.

Muscletremorsmaybestoppedbytheadministrationofcalciumgluconateoranyothercalcium

solution.

4.11Withdrawalperiods

Meatandoffal:zerodays

Notpermittedforuseinlactatinganimalsproducingmilkforhumanconsumption.

5. PHARMACOLOGICALPROPERTIES

Tiludronicacidisanactiveingredientwhichbelongstothetherapeuticclassofbisphosphonates

(ATCvet:QM05BA)whosemainpharmacologicalpropertyistheinhibitionofboneresorption.

5.1 Pharmacodynamicproperties

ThepharmacodynamiceffectsofTiludronatehavebeenmostlyinvestigatedinvitroandinlaboratory

animals.

Dokument1SPCrenewalFinalversionSPCrenewalV4-trackversion

Tiludronicacidexertsitsinhibitoryeffectonboneresorptionbyblockingsomeoftheosteoclast's

metabolicpathways(productionofnon-hydrolysable,cytotoxic,ATP-analogmetabolites,inhibitionof

theorganisationofthecytoskeletonrequiredfortheactivationoftheosteoclastandinhibitionofthe

osteoclasticprotonpumps).

Asboneresorptionandboneformationaretwocoupledprocessesresponsibleforboneremodelling,

thecontrolofboneresorptionbytiludronateisfollowedbyacontrolinboneformation.Asa

consequence,tiludronatehelpsinregulatingboneremodellingineverysituationswhereexcessivebone

resorption(i.e.increasedosteoclasticactivity)isoccurring.Inlaboratoryanimalsthisregulatoreffectis

notaccompaniedbynegativeeffectsontheformationandmineralisationofboneattherecommended

therapeuticdoses.

Pharmacodynamicdatainhorsesfreeoflamenesshaveshownthat,afterIVadministrationatthedose

1mg/kg,tiludronateproducesimmediateinhibitoryeffectsonboneresorption,asshownbythesharp

decreaseofaserummarkerofboneresorption24hoursafterdosing.Inanotherstudyover4months

posttreatment,tiludronatepreventstheincreaseofboneporosityconsecutivetoareducedphysical

activity.

Osteolysisisapainfulprocess.Inthehorse,bonespavinandnavicularsyndromeare2conditions

whereosteolyticlesionsdevelopinbones,whichprocesscontributestotheclinicalsymptoms.

Tiludronicacidhasalsobeenshowntohaveanti-arthriticpropertiesinapolyarthritismodelintherat.

Invitrostudieshaverevealedthattheproducthasinhibitoryeffectsonthesecretionofenzymes

degradingthecartilaginousmatrixproducedbythechondrocytesandthesynovialcells.

5.2 Pharmacokineticparticulars

Thepharmacokineticprofileoftiludronicacid(asthedisodiumsalt)afterintravenousadministrationsto

thehorseatadoseof0.1mg/kg/dayischaracterisedby:

- Arapiddecreaseinplasmaconcentrationsduringthefirst24hoursaftereachinjection.During

thecourseofa10-daytreatmentwithdailydosesof0.1mg/kgbytheintravenousroute,Cmaxare

about0.9mg/L,plasmat

isshort(about4.5hours)andtotalclearanceisabout0.040to0.050

L/h/kg.Thereisnoplasmaaccumulationoftiludronateduringrepeatedadministrations.

- Adegreeofbindingtoplasmaproteinsofabout80%-85%,

- Afastandwidespreaddistributioninthebone,thestoragecompartmentwheretiludronicacid

preferentiallybindstotheactiveremodellingsites,bybindingtohydroxyapatitecrystals.Aftera

treatmentwithsingledailyinjectionsfor10days,theboundquantitycorrespondsto30to50%of

thetotaladministereddose.Thedistributionofthetiludronateintheboneisnotuniform;bindingis

greaterincancellousbonethanincorticalbone,

- Alowdistributioninallotherbodytissues,

- Nobiotransformation,

- Aneliminationmainlyviatheurine,inunchangedform.Afterasingleinjection,thedoseexcreted

viatheurineoveraperiodof96hourscorrespondsto25to50%oftheinjecteddose.Thedose

excretedviathefaecescorrespondstolessthan1%oftheinjecteddose.

5.3 Environmentalproperties

Notrelevant.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Dokument1SPCrenewalFinalversionSPCrenewalV4-trackversion

Sodiumchloride.

Mannitol.

Waterforinjections.

6.2 MajorIncompatibilities

DonotmixthereconstitutedsolutionwithsolutionsbasedondivalentmetalionssuchasCa 2+ orMg 2+ ;

asolutionoftiludronicacidmayformcomplexeswiththeseions.

6.3 Shelflife

3years.

Tobeusedimmediatelyafterreconstitution,anyremainingproductshouldbediscarded.

6.4.Specialprecautionsforstorage

Keepthecontainerintheoutercarton.

6.5 Natureandcompositionofimmediatepackaging

Materialoftheprimarycontainer

- Glass,type-IIvialincardboardbox,

- Chlorobutylstopper,

- Aluminiumcap.

Packsizes

- Boxcontaining1vialof50mgofTiludronicacidand1vialof10mlsolvent

- Boxcontaining5vialsof50mgofTiludronicacidand5vialsof10mlsolvent

- Boxcontaining10vialsof50mgofTiludronicacidand10vialsof10mlsolvent

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

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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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Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

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Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

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Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Published on: Thu, 25 Oct 2018 00:00:00 +0200 The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the gen...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

15-10-2018

Toy Land Company recalls Boom Boom ChemsSlime andPutty

Toy Land Company recalls Boom Boom ChemsSlime andPutty

Health Canada has determined that the slime and putty products do not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

15-10-2018

Dollar Novelty (Karapelle Inc) recalls Barrel-O-Slime Toy

Dollar Novelty (Karapelle Inc) recalls Barrel-O-Slime Toy

Health Canada's sampling and evaluation program has determined the Barrel-O-Slime toy does not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

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

22-9-2018

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) soybean BPS‐CV127‐9. This soybean was found to be as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 16 February 2018, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soy...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

Kangaroo Manufacturing Inc. recalls Kangaroo's Super Cool Slime

Kangaroo Manufacturing Inc. recalls Kangaroo's Super Cool Slime

Health Canada's sampling and evaluation program has determined the Super Cool Slime products donot meet the Canadian toy safety requirements related to boric acid content.

Health Canada

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

14-8-2018

Genius Premium Craft Boxes recalls Do-It-Yourself Slime Kits

Genius Premium Craft Boxes recalls Do-It-Yourself Slime Kits

Health Canada’s sampling and evaluation program has determined the Do-It-Yourself Slime Kits do not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

10-8-2018

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves new drug for treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR). This is the first FDA-approved treatment for this rare, debilitating and often fatal genetic disease and the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

FDA - U.S. Food and Drug Administration

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

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

21-11-2018

EU/3/18/2081 (Pharma Gateway AB)

EU/3/18/2081 (Pharma Gateway AB)

EU/3/18/2081 (Active substance: 3-(3-(3,5-dimethyl-1H-pyrazol-4-yl)propoxy)-4-fluorobenzoic acid) - Orphan designation - Commission Decision (2018)7790 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/096/18

Europe -DG Health and Food Safety

5-11-2018

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Active substance: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid) - Orphan designation - Commission Decision (2018)7271 of Mon, 05 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/114/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

29-10-2018

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7249 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1144/WS1433/0051

Europe -DG Health and Food Safety

29-10-2018

DuoPlavin (Sanofi Clir SNC)

DuoPlavin (Sanofi Clir SNC)

DuoPlavin (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7255 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1143/WS/1433/0050

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6488 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)6427 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/183/16/T/02

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6486 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6466 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

24-9-2018

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Active substance: zoledronic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6243 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2365/T/33

Europe -DG Health and Food Safety

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

28-8-2018

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Active substance: (S)-(-)-3-(4-aminophenyl)-2-methoxypropanoic acid) - Orphan designation - Commission Decision (2018)5728 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/075/18

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

1-8-2018

Ucedane (Lucane Pharma)

Ucedane (Lucane Pharma)

Ucedane (Active substance: carglumic acid) - Centralised - Yearly update - Commission Decision (2018)5230 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

27-7-2018

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Active substance: Synthetic cyclic 8 amino acid analogue of human unacylated ghrelin) - Transfer of orphan designation - Commission Decision (2018)5049 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/066/17/T/01

Europe -DG Health and Food Safety