Efex

Main information

  • Trade name:
  • Efex 100mg Chewable Tablets for Dogs
  • Pharmaceutical form:
  • Chewable tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Efex 100mg Chewable Tablets for Dogs
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • marbofloxacin
  • Therapeutic area:
  • Dogs Non Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0441/003
  • Authorization date:
  • 20-02-2013
  • EU code:
  • UK/V/0441/003
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

AN:00347/2013

Revised:August2013

Page 1 of 6

SUMMARYOFTHEPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Efex100mgchewabletabletsfordogs

Efexvet100mgchewabletabletsfordogs(FI,SE)

Axorvet100mgchewabletabletsfordogs(NO)

Axor100mgchewabletabletsfordogs(DK)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Onetabletcontains:

Activesubstance:

Marbofloxacin..................................................100.0mg

Excipient(s):

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Chewabletablet

Clover-shapedscoredbeigetablet.Thetabletcanbedividedintofourequalparts

4. CLINICALPARTICULARS

4.1Targetspecies

Dogs

4.2Indicationsforuse,specifyingthetargetspecies

Indogs

Marbofloxacinisindicatedinthetreatmentof:

-skinandsofttissueinfections(skinfoldpyoderma,impetigo,folliculitis,

furunculosis,cellulitis)causedbysusceptiblestrainsoforganisms.

-urinarytractinfections(UTI)causedbysusceptiblestrainsoforganisms

associatedornotwithprostatitisorepididymitis.

-respiratorytractinfectionscausedbysusceptiblestrainsoforganisms.

4.3Contraindications

AN:00347/2013

Revised:August2013

Page 2 of 6

Donotuseindogsagedlessthan12months,orlessthan18monthsforgiant

breedsofdogswithalongergrowthperiod.

Donotuseincasesofhypersensitivityto(fluoro)quinolones.

4.4Specialwarningsforeachtargetspecies

AlowurinarypHcouldhaveaninhibitoryeffectontheactivityofmarbofloxacin.

4.5Specialprecautionsforuse

(i)Specialprecautionsforuseinanimals

Thechewabletabletsareflavoured.Inordertoavoidanyaccidentalingestion,

storetabletsoutofreachoftheanimals.

Thefluoroquinoloneshavebeenshowntoinduceerosionofarticularcartilagein

juveniledogsandcareshouldbetakentodoseaccuratelyespeciallyinyoung

animals.

Thefluoroquinolonesarealsoknownfortheirpotentialneurologicalsideeffects.

Cautioususeisrecommendedindogsandcatsdiagnosedassufferingfrom

epilepsy.

Fluoroquinolonesshouldbereservedforthetreatmentofclinicalconditionswhich

haverespondedpoorly,orareexpectedtorespondpoorlytootherclassesof

antimicrobials.Wheneverpossible,useoffluoroquinolonesshouldbebasedon

susceptibilitytesting.Useoftheproductdeviatingfromtheinstructionsgivenin

theSPCmayincreasetheprevalenceofbacteriaresistanttothe

fluoroquinolonesandmaydecreaseeffectivenessoftreatmentwithother

quinolonesduetothepotentialforcross-resistance.

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhenthe

productisused.

(ii)Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Peoplewithknownhypersensitivityto(fluoro)quinolonesorothercomponentsof

theformulationshouldavoidusingthisproduct.Incaseofaccidentalingestion

seekmedicalattentionandshowproductlabeland/orpackageleaflettothe

doctor.Washhandsafteruse.

4.6Adversereactions(frequencyandseriousness)

Mildsideeffectsthatdonotnecessitatecessationoftreatmentsuchasvomiting,

softeningoffaeces,modificationofthirstortransientincreaseinactivitymay

occasionallyoccur.Thesesignsceasespontaneouslyaftertreatment.

4.7Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimals(rat,rabbit)showednoembryotoxicity,

teratogenicityandmaternotoxicitywithmarbofloxacinattherapeuticdoses.

Howevernospecificstudieshavebeencarriedoutinpregnantandlactating

dogs.

Inpregnantandlactatinganimals,useonlyaccordingtothebenefit/risk

assessmentbytheresponsibleveterinarian.

AN:00347/2013

Revised:August2013

Page 3 of 6

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Fluoroquinolonesareknowntointeractwithorallyadministeredcations

(Aluminium,Calcium,Magnesium,Iron).Insuchcases,thebioavailabilitymaybe

reduced.

Concomitantadministrationoftheophyllinerequirescarefulmonitoringasserum

levelsoftheophyllinemayincrease.

4.9 Amountstobeadministeredandadministrationroute

Fororaladministration

Therecommendeddoserateis2mg/kg/d(1tabletfor50kgperday)insingle

dailyadministration.

Dogs:

-inskinandsofttissueinfections,treatmentdurationisatleast5days.

Dependingonthecourseofthedisease,itmaybeextendedupto40days.

-inurinarytractinfections,treatmentdurationisatleast10days.Dependingon

thecourseofthedisease,itmaybeextendedupto28days.

-inrespiratoryinfections,treatmentdurationisatleast7daysanddependingon

thecourseofthedisease,itmaybeextendedupto21days.

Bodyweight

(kg) Tablet

10.0-12.5 ¼

12.6 –25.0

½

25.1 –37.5 ¾

37.6 –50.0

1

50.1 –62.5 1¼

62.6 –75.0

75.1 –87.5 1¾

87.6 –100.0

2

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

Thechewabletabletsmaybeacceptedbydogsorcanbeadministereddirectly

intothemouthoftheanimals.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Overdosagemaycauseacutesignsintheformofneurologicaldisorders,which

shouldbetreatedsymptomatically.

4.11Withdrawalperiod(s)

Notapplicable.

AN:00347/2013

Revised:August2013

Page 4 of 6

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,fluoroquinolones

ATCvetcode:QJ01MA93

5.1 Pharmacodynamicproperties

Marbofloxacinisasynthetic,bactericidalantimicrobial,belongingtothe

fluoroquinolonegroupwhichactsbyinhibitionoftopoisomeraseII(DNAgyrase)

andtopoisomeraseIV..Ithasabroad-spectrumactivityinvitroagainstGram-

positivebacteria(inparticularStaphylococci,Streptococci)and,Gram-negative

bacteria(Escherichiacoli,Enterobactercloacae,Proteusspp,Klebsiellaspp,

Shigellaspp,Pasteurellaspp,Pseudomonasspp)aswellasMycoplasmaspp.

AreportonmicrobiologicalsusceptibilityincludingtwoEuropeanfieldsurveys

coveringhundredsofcanineandfelinepathogenssensitivetomarbofloxacinwas

publishedon2009

Micro-organisms MIC(µg/ml)

Staphylococcus

intermedius 0,23-0,25

Escherichiacoli 0,125-0,25

Pasteurellamultocida 0,04

Pseudomonas

aeruginosa 0,94

CasesofresistancehavebeenobservedinStreptococcus.StrainswithMIC≤1

µg/mlaresensitivetomarbofloxacinwhereasstrainswithMIC≥4µg/mlare

resistanttomarbofloxacin.

Marbofloxacinisnotactiveagainstanaerobes,yeastsorfungi.

Theactivityofmarbofloxacinagainstthetargetbacterialspeciesisbactericidal

concentration-dependant.

Resistancetofluoroquinolonesoccursbychromosomalmutationwiththree

mechanisms:decreaseofthebacterialwallpermeability,expressionofefflux

pumpormutationofenzymesresponsibleformoleculebinding.Todate,only

sporadiccaseshavebeenreportedforplasmidmediatedfluoroquinolone

resistanceinanimals.Dependingontheunderlyingresistancemechanismcross-

resistancetoother(fluoro)quinolonesandco-resistancetootherantimicrobial

classescanoccur.

AN:00347/2013

Revised:August2013

Page 5 of 6

5.2Pharmacokineticparticulars

Afteroraladministrationindogsattherecommendeddoseof2mg/kg,

marbofloxacinisreadilyabsorbedandreachesmaximalplasmaconcentrationsof

1.5µg/mlwithin2hours

Itsbioavailabilityiscloseto100%.

Itisweaklyboundtoplasmaproteins(lessthan10%),extensivelydistributedand

inmosttissues(liver,kidney,skin,lung,bladder,digestivetract)itachieveshigher

concentrationsthaninplasma.Marbofloxaciniseliminatedslowly(t½ß=14hin

dogs)predominantlyintheactiveforminurine(2/3)andfaeces(1/3).

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Copovidone

Silica,colloidalanhydrous

Croscarmellosesodium

Hydrogenatedcasteroil

Pigliverpowder

Maltedyeast

Cellulosemicrocrystalline

6.2Incompatibilities

Notapplicable

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:

Blister:PVC-TE-PVDC –aluminiumheatsealed:24months

Blister:PA-AL-PVC –aluminiumheatsealed:36months

Shelf-lifeafterfirstopeningtheimmediatepackaging:72hours:

6.4.Specialprecautionsforstorage

Blister:PVC-TE-PVDC –aluminiumheatsealed: Donotstoreabove30°C

Blister:PA-AL-PVC –aluminiumheatsealed:Thisveterinarymedicinalproduct

doesnotrequireanyspecialtemperaturestorageconditions.

Tabletportionsshouldbestoredintheblisterpack

Anytabletportionsremainingafter72hoursshouldbediscarded

Keeptheblisterintheoutercarton.

AN:00347/2013

Revised:August2013

Page 6 of 6

6.5Natureandcompositionofimmediatepackaging

(Polyvinylchloride-Thermo-elast-Polyvinylidenechloride –aluminiumheat

sealed)containing6tabletsperblister

(Polyamide-Aluminium-Polyvinylchloride –aluminiumheatsealed)

containing6tabletsperblister

Cardboardboxof6tabletscontaining1blisterof6tablets

Cardboardboxof12tabletscontaining2blistersof6tablets

Cardboardboxof120tabletscontaining20blistersof6tablets

Cardboardboxof240tabletscontaining40blistersof6tablets

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

SOGEVAL

200avenuedeMayenne

ZoneIndustrielledesTouches

53000LAVAL

FRANCE

Tel:33243495151

Fax:33243539700

E-mail: sogeval@sogeval.fr

8. MARKETINGAUTHORISATIONNUMBER

20749/4032

9. DATEOFFIRSTAUTHORISATION

August2013

10 DATEOFREVISIONOFTHETEXT

August2013

Approved:01/08/2013

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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

15-8-2018

Salt & Straw Voluntarily Recalls Certain Lots of Chocolate Gooey Brownie Ice Cream Pints Due to Possible Undeclared Peanuts

Salt & Straw Voluntarily Recalls Certain Lots of Chocolate Gooey Brownie Ice Cream Pints Due to Possible Undeclared Peanuts

Salt & Straw Ice Cream is voluntarily recalling a limited number of its Chocolate Gooey Brownie pints because it may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of a serious or life threatening allergic reaction if they consume this product. The product is safe to consume unless you have a peanut allergy or sensitivity. No illnesses have been reported to date in connection with this problem.

FDA - U.S. Food and Drug Administration

14-8-2018

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix LLC, is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the U.S. Food and Drug Administration (“FDA”) and found to be contaminated with High Microbial Loads. Additionally, this serves as a update to a previous press release posted on June 30th 2018, concerning Blissful...

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

22-6-2018

Metronidazole intravenous infusion 500 mg/100 mL bag

Metronidazole intravenous infusion 500 mg/100 mL bag

Shortage and althernative supply of Metronidazole intravenous infusion 500 mg/100 mL bag

Therapeutic Goods Administration - Australia

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

12-6-2018

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Teer, nicotine en koolmonoxide gehalten in sigaretten die gemeten worden volgens de Canadian Intense (CI) methode zijn minimaal twee keer zo hoog als de gehalten gemeten met de wettelijke voorgeschreven ISO methode waarmee de EU en dus ook Nederland werkt. In sommige gevallen liggen de gehaltes zelfs tot meer dan 20 keer hoger. Dat blijkt uit onderzoek van het RIVM, dat 100 sigaretten onder de loep nam. Staatssecretaris Paul Blokhuis (VWS) heeft als opdrachtgever het onderzoek vandaag in ontvangst genome...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

4-5-2018

Maya Distribution, LLC Recalls Dragon Label Kratom Because Of Possible Salmonella Contamination

Maya Distribution, LLC Recalls Dragon Label Kratom Because Of Possible Salmonella Contamination

Maya Distribution, LLC of South Salt Lake City, Utah is voluntarily recalling Dragon Kratom labeled bottles and sealed packages of encapsulated and raw powder product because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. 

FDA - U.S. Food and Drug Administration

3-5-2018

CVM eSubmitter Webinar 1 Agenda

CVM eSubmitter Webinar 1 Agenda

CVM will host the first of a three-part webinar series to provide information on the use of CVM’s electronic submission tool, eSubmitter, in the new animal drug application approval process. These webinars will support the use of eSubmitter as we move to 100% electronic submission.

FDA - U.S. Food and Drug Administration

28-2-2018

Help 100% & Pure Natural & Body Slim capsules

Help 100% & Pure Natural & Body Slim capsules

Help 100% & Pure Natural & Body Slim Capsules pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

8-9-2017

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector. The Agency is looking for a candidate who is willing and able to work on demanding and interesting tasks, including travels in Iceland and abroad on behalf of the Agency. The vacancy is a full post (100%).

IMA - Icelandic Medicines Agency

3-7-2017

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Agency advertises two vacancies for experts in its Quality Assessment Team. The Agency is looking for strong candidates who are willing to work on challenging and interesting tasks. Each vacancy is a full position (100%). Application deadline is up to and including 16 July 2017.

IMA - Icelandic Medicines Agency

12-12-2018

Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

TGO 100 has been registered on the Federal Register of Legislation. It commences on 8 December 2018, repealing and replacing TGO 98

Therapeutic Goods Administration - Australia

21-11-2018

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Active substance: Propagermanium) - Orphan designation - Commission Decision (2018)7810 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/103/18

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

2-10-2018

NexoBrid (MediWound Germany GmbH)

NexoBrid (MediWound Germany GmbH)

NexoBrid (Active substance: Concentrate of proteolytic enzymes enriched in bromelain) - PSUSA - Modification - Commission Decision (2018)6460 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10028/201712

Europe -DG Health and Food Safety

19-9-2018

Kadcyla (Roche Registration GmbH)

Kadcyla (Roche Registration GmbH)

Kadcyla (Active substance: Trastuzumab emtansine) - Centralised - Renewal - Commission Decision (2018)6100 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2389/R/39

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Active substance: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt) - Orphan designation - Commission Decision (2018)5729 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/18

Europe -DG Health and Food Safety

23-8-2018

 Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Europe - EMA - European Medicines Agency

27-7-2018

EU/3/12/1003 (bluebird bio (Germany) GmbH)

EU/3/12/1003 (bluebird bio (Germany) GmbH)

EU/3/12/1003 (Active substance: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA) - Transfer of orphan designation - Commission Decision (2018)5033 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/009/12/T/01

Europe -DG Health and Food Safety

27-6-2018

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Active substance: pantoprazole) - PSUSA - Modification - Commission Decision (2018)4105 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1100/PSUSA/2285/201708

Europe -DG Health and Food Safety

12-6-2018

EU/3/17/1834 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/17/1834 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/17/1834 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate salt) - Transfer of orphan designation - Commission Decision (2018)3797 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/244/16/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl] acetate salt) - Transfer of orphan designation - Commission Decision (2018)3798 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/166/12/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3802 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/152/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3801 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/11/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3799 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/11/T/03

Europe -DG Health and Food Safety

6-6-2018

Agenda:  Agenda for the 100th meeting of the Management Board

Agenda: Agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

5-6-2018

Agenda:  Draft agenda for the 100th meeting of the Management Board

Agenda: Draft agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety

24-5-2018

Tybost (Gilead Sciences International Limited)

Tybost (Gilead Sciences International Limited)

Tybost (Active substance: cobicistat) - PSUSA - Modification - Commission Decision (2018)3255 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10081/201708

Europe -DG Health and Food Safety

24-5-2018

Stribild (Gilead Sciences International Limited)

Stribild (Gilead Sciences International Limited)

Stribild (Active substance: elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (as fumarate)) - PSUSA - Modification - Commission Decision (2018)3277 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2574/PSUSA/10082/201708

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Active substance: 4-{[(2R,3S,4R,5S)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid) - Transfer of orphan designation - Commission Decision (2018)3149 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/14/T/01

Europe -DG Health and Food Safety