BOFLOX

Main information

  • Trade name:
  • BOFLOX 100 mg/ml
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BOFLOX 100 mg/ml
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • marbofloxacin
  • Therapeutic area:
  • Cattle Food, Pigs Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • ES/V/0190/001
  • Authorization date:
  • 23-01-2013
  • EU code:
  • ES/V/0190/001
  • Last update:
  • 09-08-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Page1of12

LABELLINGANDPACKAGELEAFLET

Page2of12

A.LABELLING

Page3of12

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

CARTONBOX

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Boflox,100mg/mlsolutionforinjectionforcattleandpigs

Marbofloxacin

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Activesubstance:

Marbofloxacin100mg/ml

Excipients:

Disodiumedetate

Monothioglycerol

Metacresol

3. PHARMACEUTICALFORM

Solutionforinjection

4. PACKAGESIZE

100ml

250ml

6x100ml

6x250ml

10x100ml

10x250ml

12x100ml

12x250ml

5. TARGETSPECIES

Cattle,pigs(sows)

6. INDICATION(S)

Readthepackageleafletbeforeuse.

7. METHODANDROUTE(S)OFADMINISTRATION

Cattle:IM,SCorIVuse

Pigs(sows):IMuse

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Cattle:

8mg/kgonasingleoccasion(IM)

Page4of12

Meatandoffal:3days

Milk:72hours

2mg/kgfor3to5days(IV/SC/IM)

Meatandoffal:6days

Milk:36hours

Pig(sows):

Meatandoffal:4days

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

EXP

Shelf-lifeafterfirstopeningthecontainer:28days.

Oncebroached,useby…

11. SPECIALSTORAGECONDITIONS

Storeintheoriginalpackageinordertoprotectfromlight.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Disposeofwastematerialinaccordancewithlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,IFAPPLICABLE

Foranimaltreatmentonly.

Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHESIGHTANDREACHOFCHILDREN”

Keepoutofthesightandreachofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

IndustrialVeterinaria,S.A.

Esmeralda,19

E-08950EspluguesdeLlobregat(Barcelona)Spain

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Batch:

Page5of12

PARTICULARSTOAPPEARONIMMEDIATEPACKAGINGUNITS

LABEL100–250ml

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Boflox,100mg/mlsolutionforinjectionforcattleandpigs

Marbofloxacin

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Activesubstance:

Marbofloxacin100mg/ml

Excipients:

Disodiumedetate

Monothioglycerol

Metacresol

3. PHARMACEUTICALFORM

4. PACKAGESIZE

100ml–250ml

5. TARGETSPECIES

Cattle,pigs(sows)

6. INDICATION(S)

Readthepackageleafletbeforeuse

7. METHODANDROUTE(S)OFADMINISTRATION

Cattle:IM,SCorIVuse

Pigs(sows):IMuse

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Cattle:

8mg/kgonasingleoccasion(IM)

Meatandoffal:3days

Milk:72hours

2mg/kgfor3to5days(SC/IM)

Meatandoffal:6days

Milk:36hours

Pig(sows):

Page6of12

Meatandoffal:4days

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

EXP

Shelf-lifeafterfirstopeningthecontainer:28days.

Oncebroached,useby

11. SPECIALSTORAGECONDITIONS

Storeintheoriginalpackageinordertoprotectfromlight.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,IFAPPLICABLE

Foranimaltreatmentonly.

Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHESIGHTANDREACHOFCHILDREN”

Keepoutofthesightandreachofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

IndustrialVeterinaria,S.A.

Esmeralda,19

E-08950EspluguesdeLlobregat(Barcelona)Spain

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Batch:

Page7of12

B.PACKAGELEAFLET

Page8of12

PACKAGELEAFLETFOR:

Boflox100mg/mlsolutionforinjectionforcattleandpigs

Marbofloxacin

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

ANDOFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder:

IndustrialVeterinaria,S.A.

Esmeralda,19

E-08950EspluguesdeLlobregat(Barcelona)Spain

Manufacturerresponsibleforbatchrelease:

KELAN.V.,St.Lenaartseweg48,2320Hoogstraten,Belgium

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Boflox,100mg/mlsolutionforinjectionforcattleandpigs

Marbofloxacin

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER

INGREDIENT(S)

Perml

Activesubstance:

Marbofloxacin 100mg

Excipients:

Disodiumedetate 0.10mg

Monothioglycerol 1mg

Metacresol 2mg

Yellowgreenishtoyellowbrownish,clearsolution

4. INDICATION(S)

Incattle:

-treatmentofrespiratoryinfectionscausedbystrainsofHistophilussomni,Mannheimia

haemolytica,Mycoplasmabovis,Pasteurellamultocidasusceptibletomarbofloxacin.

-treatmentofacutemastitiscausedbystrainsofEscherichiacolisusceptibletomarbofloxacin

duringthelactationperiod.

Inpigs:

-treatmentofPostpartumDysgalactiaSyndrome–PDS-(MetritisMastitisAgalactiasyndrome)

causedbybacterialstrainssusceptibletomarbofloxacin.

5. CONTRAINDICATIONS

Donotuseincaseswherethepathogeninvolvedisresistanttootherfluoroquinolones(cross

resistance).

Donotuseinanimalswithknownhypersensitivitytotheactivesubstanceortoanyother

quinoloneortoanyoftheexcipients.

Page9of12

6. ADVERSEREACTIONS

Transitoryinflammatorylesionscanoccurattheinjectionsite,withoutclinicalimpact,when

administeredviatheintramuscularorsubcutaneousroute.

Administrationbytheintramuscularrouteincattlemaycausetransientlocalreactionssuchas

painandswellingattheinjectionsiteandinflammatorylesionswhichmaypersistforatleast12

daysafterinjection.

However,incattle,subcutaneousroutewasshowntobebettertoleratedlocallythan

intramuscularroute.Therefore,thesubcutaneousrouteisrecommendedinheavycattle.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon .

7. TARGETSPECIES

Cattle,pigs(sows)

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Cattle:

Respiratoryinfections:

Therecommendeddosageis8mgmarbofloxacin/kgbodyweight(2mlproduct/25kgbody

weight)inasingleinjectionbyintramuscularroute.Ifthevolumetobeinjectedismorethan20

ml,itshouldbedividedbetweentwoormoreinjectionsites.

IncasesofrespiratoryinfectionscausedbyMycoplasmabovis,therecommendeddoseis2mg

marbofloxacin/kgbodyweight(1mlproduct/50kgbodyweight),inasingledailyinjectionfor

3to5consecutivedays,byintramuscularorsubcutaneousroute.Thefirstinjectionmaybe

givenbytheintravenousroute.

Acutemastitis:

-Intramuscularorsubcutaneoususe:

Therecommendeddosageis2mgmarbofloxacin/kgbodyweight(1mlproduct/50kgbody

weight)inasingledailyinjection,for3consecutivedays.

Thefirstinjectionmayalsobegivenbytheintravenousroute.

Pigs(sows):

-Intramuscularuse:

Therecommendeddosageis2mgmarbofloxacin/kgbodyweight(1mlproduct/50kgbody

weight)inasingledailyinjection,for3consecutivedays.

Toensureadministrationofacorrectdose,bodyweightshouldbedeterminedasaccuratelyas

possible,toavoidunderdosing.

Incattleandpig,thepreferredinjectionsiteistheneckarea.

Thecapmaybesafelypuncturedupto30times.Theusershouldchoosethemostappropriate

vialsizeaccordingtothetargetspeciestotreat.

9. ADVICEONCORRECTADMINISTRATION

10. WITHDRAWALPERIOD

Page10of12

Cattle:

8mg/kgonasingleoccasion(IM)

Meatandoffal:3days

Milk:72hours

2mg/kgfor3to5days(IV/SC/IM)

Meatandoffal:6days

Milk:36hours

Pig(sows):

Meatandoffal:4days

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthesightandreachofchildren.

Storeintheoriginalpackageinordertoprotectfromlight.

Donotusethisveterinarymedicinalproductaftertheexpirydatewhichisstatedonthelabel.

Shelf-lifeafterfirstopeningthecontainer:28days.

12. SPECIALWARNING(S)

Specialprecautionsforuseinanimals:

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhentheproductisused.

Fluoroquinolonesshouldbereservedforthetreatmentofclinicalconditionswhichhave

respondedpoorly,orareexpectedtorespondpoorly,tootherclassesofantimicrobials.

Wheneverpossible,fluoroquinolonesshouldonlybeusedbasedonsusceptibilitytesting.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincreasetheprevalence

ofbacteriaresistanttothefluoroquinolonesandmaydecreasetheeffectivenessoftreatment

withotherquinolonesduetothepotentialforcrossresistance.

Theefficacydatashowedthattheproducthasinsufficientefficacyforthetreatmentofacute

formsofmastitisinducedbygram-positivebacteria.

Userwarnings:

Peoplewithknownhypersensitivityto(fluoro)quinolonesshouldavoidcontactwiththe

veterinarymedicinalproduct.Careshouldbetakentoavoidaccidentalself-injectionasitcan

induceaslightirritation.

Incaseofaccidentalselfinjection,seekmedicaladviceimmediatelyandshowthepackage

leafletorthelabeltothephysician.

Incaseofcontactwithskinoreyes,rinsewithplentyofwater.

Washhandsafteruse.

Pregnancyandlactation:

Laboratorystudiesinratsandrabbitshavenotproducedanyevidenceofteratogenic,foetotoxic

ormaternotoxiceffects.

Safetyoftheproductat2mg/kgbodyweighthasbeenestablishedinpregnantcowsand

suckingcalvesandpigletswhenusedincowsandsows.Canbeusedduringpregnancyand

lactation.Safetyoftheproductat8mg/kgbodyweighthasnotbeenestablishedinpregnant

cowsorinsuckingcalveswhenusedincows.Therefore,thisdoseregimenshouldbeusedonly

accordinglytothebenefit/riskassessmentbytheresponsibleveterinarian.

Page11of12

Incaseofuseinlactatingcow,seesection“Withdrawalperiod”.

Interactionwithothermedicinalproductsandotherformsofinteraction:

Noneknown.

Overdose(symptoms,emergencyprocedures,antidotes):

Nosignsofoverdosagehavebeenobservedafteradministrationof3timestherecommended

dose.

Signsasacuteneurologicaldisordersmayoccurwhenthedoseisexceeded.Thissignsshould

betreatedsymptomatically.Donotexceedtherecommendeddose.

Incompatibilities:

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixed

withotherveterinarymedicinalproducts.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithlocalrequirements.

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.

Askyourveterinarysurgeonorpharmacisthowtodisposeofmedicinesnolongerrequired.

Thesemeasuresshouldhelptoprotecttheenvironment.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

DDmonthYYYY

15. OTHERINFORMATION

Vialsof100mland250ml.

Vialsareindividuallypackedinacartonbox.

Six,tenortwelvevialsaregroupedasaclinicalpack.

Notallpacksizesmaybemarketed.

Pharmacodynamicsproperties

Marbofloxacinisasynthetic,bactericidalantimicrobial,belongingtothefluoroquinolonegroup

whichactsbyinhibitionofDNAgyrase.Ithasabroad-spectrumactivityinvitroagainstGram-

negativebacteria(E.coli,Histophilussomni,MannheimiahaemolyticaandPasteurella

multocida)andagainstMycoplasma(Mycoplasmabovis).ResistancetoStreptococcusmay

occur.

StrainswithMIC≤1µg/mlaresensitivetomarbofloxacinwhereasstrainswithMIC≥4µg/ml

areresistanttomarbofloxacin.

Page12of12

Resistancetofluoroquinolonesoccursbychromosomalmutationwiththreemechanisms:

decreaseofthebacterialwallpermeability,expressionofeffluxpumpormutationofenzymes

responsibleformoleculebinding.

Pharmacokineticparticulars

Aftersubcutaneousorintramuscularadministrationincattleandintramuscularadministrationin

pigsattherecommendeddoseof2mg/kgbodyweight,marbofloxacinisreadilyabsorbedand

reachesmaximalplasmaconcentrationsof1.5µg/mlwithinlessthan1hour.Itsbioavailability

iscloseto100%.

Itisweaklyboundtoplasmaproteins(lessthan10%inpigs,and30%incattle),extensively

distributedandinmosttissues(liver,kidney,skin,lung,bladder,uterus,digestivetract)it

achievesahigherconcentrationthaninplasma.

Incattle,marbofloxaciniseliminatedslowlyinpre-ruminatingcalves(t½β=5-9h)butfasterin

ruminantcattle(t½β=4-7h)predominantlyintheactiveforminurine(3/4inpre-ruminating

calves,½inruminants)andfaeces(1/4inpre-ruminatingcalves,½inruminants).

Afterasingleintramuscularadministrationincattleattherecommendeddoseof8mg/kgbody

weight,themaximumplasmaconcentrationofmarbofloxacin(Cmax)is7.3µg/mlreachedin

0.78hours(Tmax).Marbofloxaciniseliminatedslowly(T1/2terminal=15.60hours).

Afterintramuscularadministrationinlactatingcows,amaximumconcentrationinthemilkof

marbofloxacinof1.02µg/mlisreached(Cmaxafterthefirstadministration)after2.5hours

(Tmaxafterthefirstadministration).

Inpigs,marbofloxaciniseliminatedslowly(t½β=8-10h)predominantlyintheactiveformin

urine(2/3)andfaeces(1/3).

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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

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

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

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

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

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