Acticam 1 mg chewable tablets for Dogs

Main information

  • Trade name:
  • Acticam 1 mg chewable tablets for Dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Acticam 1 mg chewable tablets for Dogs
    Portugal
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0134/001
  • Authorization date:
  • 23-11-2011
  • EU code:
  • NL/V/0134/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

ACTICAM

MELOXICAM1&2.5MG,CHEWABLETABLETS

PART1

PART1B ADMINISTRATIVEDOCUMENTATIONANDSUMMARY

OFTHEDOSSIER

SPC,LABELANDPACKAGEINSERT NTA02dd.August1st,2011

PART1 B1 SUMMARYOFPRODUCTCHARACTERISTICS(SPC)

SPCforActicam1mgChewableTabletsfordogsandActicam2.5mgChewable

Tabletsfordogsarepresentedinsubsequentpages,

ACTICAM

MELOXICAM1&2.5MG,CHEWABLETABLETS

PART1

PART1B ADMINISTRATIVEDOCUMENTATIONANDSUMMARY

OFTHEDOSSIER

SPC,LABELANDPACKAGEINSERT NTA02dd.August1st,2011

SPCforActicam1mgChewableTabletsfordogs

-Enclosed-

ACTICAM

MELOXICAM1&2.5MG,CHEWABLETABLETS

PART1

PART1B ADMINISTRATIVEDOCUMENTATIONANDSUMMARY

OFTHEDOSSIER

SPC,LABELANDPACKAGEINSERT NTA02dd.August1st,2011

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

BE:Acticam1 mgkauwtablettenvoorhonden

CZ:Acticam1 mgžvýkacítabletypro psy

DE:Acticam1 mgKautablettenfürHunde

DK:Meloxitabtyggetabletter1 mg

EE:Acticam1 mgnärimistabletidkoertele

ES:Acticam1 mgcomprimidosmasticablesparaperros

FI:Acticam1 mgpurutabletitkoirille

FR:Acticam1mgComprimésàcroquerpourchien

HU:Acticam1 mgrágótablettákkutyáknak

IE:Acticam1 mgChewableTabletsfordogs

IT:Acticam1 mgcompressemasticabilipercani

LT:Acticam1 mgkramtomosiostabletėsšunims

LU:Acticam1 mgcomprimésàcroquerpourchiens

LV:Acticam1 mgkošļājamāstabletessuņiem

NL:Acticam1 mgkauwtablettenvoorhonden

PL:Acticam1 mgtabletkido żuciadlapsów

PT:Acticam1 mgComprimidosmastigáveisparacães

SE:Acticam1 mgtuggtablettförhund

SK:Acticam1 mgžuvacietabletyprepsy

UK:Acticam1 mgChewableTabletsfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachchewabletabletcontains:

Activesubstance:

Meloxicam 1 mg

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Chewabletablets

Lightlemonyellow,honeyflavoured,round,biconvex,uncoatedtablet,

debossedwith'M1'oneithersideofbreaklineononesideandplainonother

side.

Thetabletscanbedividedintoequalhalves.

ACTICAM

MELOXICAM1&2.5MG,CHEWABLETABLETS

PART1

PART1B ADMINISTRATIVEDOCUMENTATIONANDSUMMARY

OFTHEDOSSIER

SPC,LABELANDPACKAGEINSERT NTA02dd.August1st,2011

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs

4.2 Indicationsforuse, specifyingthetargetspecies

Alleviationofinflammationandpaininbothacuteandchronicmusculo-

skeletaldisorders.

4.3 Contraindications

Donotuseinpregnantorlactatinganimals.

Donotuseinanimalssufferingfromgastrointestinaldisorderssuchas

irritationandhaemorrhage,impairedhepatic,cardiacorrenalfunctionand

haemorrhagicdisorders.

Donotuseindogslessthan6 weeksofageorlessthan4 kgbodyweight.

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyofthe

excipients.

4.4 Specialwarnings

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Ifadversereactionsoccur,treatmentshouldbediscontinuedandtheadviceof

aveterinarianshouldbesought.

Avoiduseinanydehydrated,hypovolaemicorhypotensiveanimal,asthereis

apotentialriskofrenaltoxicity.

Thisproductfordogsshouldnotbeusedincatsasitisnotsuitableforusein

thisspecies.

Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproductto animals

PeoplewithknownhypersensitivitytoNSAIDsshouldavoidcontactwiththe

veterinarymedicinalproduct.

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthe

packageleafletorthelabeltothephysician.

ACTICAM

MELOXICAM1&2.5MG,CHEWABLETABLETS

PART1

PART1B ADMINISTRATIVEDOCUMENTATIONANDSUMMARY

OFTHEDOSSIER

SPC,LABELANDPACKAGEINSERT NTA02dd.August1st,2011

4.6 Adversereactions(frequencyandseriousness)

TypicaladversedrugreactionsofNSAIDssuchaslossofappetite,vomiting,

diarrhoea,faecaloccultblood,apathyandrenalfailurehaveoccasionallybeen

reported.Thesesideeffectsoccurgenerallywithinthefirsttreatmentweek

andareinmostcasestransientanddisappearfollowingterminationofthe

treatmentbutinveryrarecasesmaybeseriousorfatal.

4.7 Useduringpregnancy,lactationorlay

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduring

pregnancyandlactation(seesection4.3).

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

OtherNSAIDs,diuretics,anticoagulants,aminoglycosideantibioticsand

substanceswithhighproteinbindingmaycompeteforbindingandthusleadto

toxiceffects.Acticamtabletsmustnotbeadministeredinconjunctionwith

otherNSAIDsorglucocorticosteroids.

Pre-treatmentwithanti-inflammatorysubstancesmayresultinadditionalor

increasedadverseeffectsandaccordinglyatreatment-freeperiodwithsuch

drugsshouldbeobservedforatleast24hoursbeforecommencementof

treatment.Thetreatment-freeperiod,however,shouldtakeintoaccountthe

pharmacologicalpropertiesoftheproductsusedpreviously.

4.9 Amountstobeadministeredandadministrationroute

Initialtreatmentisasingledoseof0.2mgmeloxicam/kgbodyweightonthe

firstday.

Treatmentistobecontinuedoncedailybyoraladministration(at24-hour

intervals)atamaintenancedoseof0.1 mgmeloxicam/kgbodyweight.

Eachtabletcontains1mgmeloxicam,whichcorrespondstothedaily

maintenancedosefora10 kgbodyweightdog.

Eachtabletcanbehalvedforaccuratedosingaccordingtotheindividualbody

weightoftheanimal. Acticamtabletscanbeadministeredwithorwithout

food.

ACTICAM

MELOXICAM1&2.5MG,CHEWABLETABLETS

PART1

PART1B ADMINISTRATIVEDOCUMENTATIONANDSUMMARY

OFTHEDOSSIER

SPC,LABELANDPACKAGEINSERT NTA02dd.August1st,2011

Doseschemeforthemaintenancedose:

Bodyweight

(Kg) Numberoftablets

mg/kg

1 mg 2.5 mg

4.0-7.0 ½ - 0.13-0.1

7.1-10.0 1 - 0.14-0.1

10.1-15.0 1½ - 0.15-0.1

15.1-20.0 2 - 0.13-0.1

20.1-25.0 - 1 0.12-0.1

25.1-35.0 - 1½ 0.15-0.1

35.1-50.0 - 2 0.14-0.1

Aclinicalresponseisnormallyseenwithin3-4days.Treatmentshouldbe

discontinuedafter10 daysifnoclinicalimprovementisapparent.

4.10Overdose(symptoms,emergency procedures,antidotes),ifnecessary

Incaseofoverdosagesymptomatictreatmentshouldbeinitiated.

4.11Withdrawalperiod

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antiinflammatoryandantirheumaticproducts,

non-steroids(oxicams)

ATCvetcode:QM01AC06

5.1 Pharmacodynamicproperties

Meloxicamisanon-steroidalanti-inflammatorydrug(NSAID)oftheoxicam

classwhichactsbyinhibitionofprostaglandinsynthesis,therebyexerting

anti-inflammatory,analgesic,anti-exudativeandantipyreticeffects.Itreduces

leukocyteinfiltrationintotheinflamedtissue.Toaminorextentitalsoinhibits

collagen-inducedthrombocyteaggregation.Invitroandinvivostudies

demonstratedthatmeloxicaminhibitscyclooxygenase-2(COX-2)toagreater

extentthancyclooxygenase-1(COX-1).

5.2 Pharmacokineticparticulars

Absorption

Meloxicamiscompletelyabsorbedfollowingoraladministrationandmaximal

plasmaconcentrationsareobtainedafterapproximately4.5hours.Whenthe

productisusedaccordingtotherecommendeddosageregime,steadystate

ACTICAM

MELOXICAM1&2.5MG,CHEWABLETABLETS

PART1

PART1B ADMINISTRATIVEDOCUMENTATIONANDSUMMARY

OFTHEDOSSIER

SPC,LABELANDPACKAGEINSERT NTA02dd.August1st,2011

concentrationsofmeloxicaminplasmaarereachedontheseconddayof

treatment.

Distribution

Thereisalinearrelationshipbetweenthedoseadministeredandplasma

concentrationobservedinthetherapeuticdoserange.Approximately97%of

meloxicamisboundto plasmaproteins.Thevolumeofdistributionis0.3 l/kg.

Metabolism

Meloxicamispredominantlyfoundinplasmaandisalsoamajorbiliary

excretionproductwhereasurinecontainsonlytracesoftheparentcompound.

Meloxicamismetabolisedtoanalcohol,anacidderivativeandtoseveral

polarmetabolites.Allmajormetaboliteshavebeenshowntobe

pharmacologicallyinactive.

Elimination

Meloxicamiseliminatedwithahalf-lifeof24hours.Approximately75%of

theadministereddoseiseliminatedviafaecesandtheremainderviaurine.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

-Sodiumcitrate

-Lactosemonohydrate

-Cellulose,microcrystalline

-Honeyflavour

-PovidoneK30

-Crospovidone

-Colloidalanhydroussilica

-MagnesiumStearate

6.2 Incompatibilities

Notapplicable.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3 years

6.4 Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorage

conditions

ACTICAM

MELOXICAM1&2.5MG,CHEWABLETABLETS

PART1

PART1B ADMINISTRATIVEDOCUMENTATIONANDSUMMARY

OFTHEDOSSIER

SPC,LABELANDPACKAGEINSERT NTA02dd.August1st,2011

6.5 Natureandcompositionofimmediatepackaging

Acticam1mgtabletsaresuppliedin,

PVC/PVDC-Alublisterpack:

PVC/PVDC-AlublisterpackmadeofclearPVC/PVDCandPlainAlufoil.

Eachblisterhas10tablets.Theblistersarepackedinacartonhaving10

tablets(10x1),20tablets(10x2),100tablets(10x10)or500tablets(10x50)

andpacked withpackageinsert.

Notallpack sizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productsorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordance

withnationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

EcupharNV

Legeweg157-i

8020 Oostkamp

Belgium

8. MARKETINGAUTHORISATIONNUMBERS

BE

CZ

DE 401268.00.00

DK 44618

EE

ES 2162ESP

FI

FR FR/V/82320469/2010

HU

IE VPA10491/001/001

IT

LT

LU

LV

NL REGNL104367

PL

PT 312/01/11DFVPT

SE 42074

SK

UK Vm32742/4004

ACTICAM

MELOXICAM1&2.5MG,CHEWABLETABLETS

PART1

PART1B ADMINISTRATIVEDOCUMENTATIONANDSUMMARY

OFTHEDOSSIER

SPC,LABELANDPACKAGEINSERT NTA02dd.August1st,2011

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

BE

CZ

DE 12/10/2010

DK 05/10/2010

EE

ES 23/06/2010

FI

FR 25/06/2010

HU

IE 10/09/2010

IT

LT

LU

LV

NL 08/09/2010

PL

PT 16/02/2011

SE 13/08/2010

SK

UK 08/09/2010

10. DATEOFREVISIONOFTHETEXT

Tobecompleted

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

ACTICAM

MELOXICAM1&2.5MG,CHEWABLETABLETS

PART1

PART1B ADMINISTRATIVEDOCUMENTATIONANDSUMMARY

OFTHEDOSSIER

SPC,LABELANDPACKAGEINSERT NTA02dd.August1st,2011

SPCforActicam2.5 mgChewableTabletsfordogs

-Enclosed-

ACTICAM

MELOXICAM1&2.5MG,CHEWABLETABLETS

PART1

PART1B ADMINISTRATIVEDOCUMENTATIONANDSUMMARY

OFTHEDOSSIER

SPC,LABELANDPACKAGEINSERT NTA02dd.August1st,2011

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

BE:Acticam2.5mgkauwtablettenvoorhonden

CZ:Acticam2.5mgžvýkacítabletypro psy

DE:Acticam2.5mgKautablettenfürHunde

DK:Meloxitabtyggetabletter2.5mg

EE:Acticam2.5mgnärimistabletidkoertele

ES:Acticam2.5mgcomprimidosmasticablesparaperros

FI:Acticam2.5 mgpurutabletitkoirille

FR:Acticam2.5 mgComprimésàcroquerpourchien

HU:Acticam2.5 mgrágótablettákkutyáknak

IE:Acticam2.5mgChewableTabletsfordogs

IT:Acticam2.5mgcompressemasticabilipercani

LT:Acticam2.5mgkramtomosiostabletėsšunims

LU:Acticam2.5mgcomprimésàcroquerpourchiens

LV:Acticam2.5mgkošļājamāstabletessuņiem

NL:Acticam2.5mgkauwtablettenvoorhonden

PL:Acticam2.5mgtabletkido żuciadlapsów

PT:Acticam2.5mgComprimidosmastigáveisparacães

SE:Acticam2.5mgtuggtablettförhund

SK:Acticam2.5mgžuvacietabletyprepsy

UK:Acticam2.5mgChewableTabletsfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachchewabletabletcontains:

Activesubstance:

Meloxicam 2.5 mg

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Chewabletablets

Lightlemonyellow,honeyflavoured,round,biconvex,uncoatedtablet,

debossedwith'M2'oneithersideofbreaklineononesideandplainonother

side.

Thetabletscanbedividedintoequalhalves.

ACTICAM

MELOXICAM1&2.5MG,CHEWABLETABLETS

PART1

PART1B ADMINISTRATIVEDOCUMENTATIONANDSUMMARY

OFTHEDOSSIER

SPC,LABELANDPACKAGEINSERT NTA02dd.August1st,2011

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs

4.2 Indicationsforuse, specifyingthetargetspecies

Alleviationofinflammationandpaininbothacuteandchronicmusculo-

skeletaldisorders.

4.3 Contraindications

Donotuseinpregnantorlactatinganimals.

Donotuseinanimalssufferingfromgastrointestinaldisorderssuchas

irritationandhaemorrhage,impairedhepatic,cardiacorrenalfunctionand

haemorrhagicdisorders.

Donotuseindogslessthan6 weeksofageorlessthan10 kgbodyweight.

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyofthe

excipients.

4.4 Specialwarnings

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Ifadversereactionsoccur,treatmentshouldbediscontinuedandtheadviceof

aveterinarianshouldbesought.

Avoiduseinanydehydrated,hypovolaemicorhypotensiveanimal,asthereis

apotentialriskofrenaltoxicity.

Thisproductfordogsshouldnotbeusedincatsasitisnotsuitableforusein

thisspecies.

Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproductto animals

PeoplewithknownhypersensitivitytoNSAIDsshouldavoidcontactwiththe

veterinarymedicinalproduct.

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthe

packageleafletorthelabeltothephysician.

4.6 Adversereactions(frequencyandseriousness)

TypicaladversedrugreactionsofNSAIDssuchaslossofappetite,vomiting,

diarrhoea,faecaloccultblood,apathyandrenalfailurehaveoccasionallybeen

reported.Thesesideeffectsoccurgenerallywithinthefirsttreatmentweek

ACTICAM

MELOXICAM1&2.5MG,CHEWABLETABLETS

PART1

PART1B ADMINISTRATIVEDOCUMENTATIONANDSUMMARY

OFTHEDOSSIER

SPC,LABELANDPACKAGEINSERT NTA02dd.August1st,2011

andareinmostcasestransientanddisappearfollowingterminationofthe

treatmentbutinveryrarecasesmaybeseriousorfatal.

4.7 Useduringpregnancy,lactationorlay

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduring

pregnancyandlactation(seesection4.3).

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

OtherNSAIDs,diuretics,anticoagulants,aminoglycosideantibioticsand

substanceswithhighproteinbindingmaycompeteforbindingandthusleadto

toxiceffects.Acticamtabletsmustnotbeadministeredinconjunctionwith

otherNSAIDsorglucocorticosteroids.

Pre-treatmentwithanti-inflammatorysubstancesmayresultinadditionalor

increasedadverseeffectsandaccordinglyatreatment-freeperiodwithsuch

drugsshouldbeobservedforatleast24hoursbeforecommencementof

treatment.Thetreatment-freeperiod,however,shouldtakeintoaccountthe

pharmacologicalpropertiesoftheproductsusedpreviously.

4.9 Amountstobeadministeredandadministrationroute

Initialtreatmentisasingledoseof0.2mgmeloxicam/kgbodyweightonthe

firstday.

Treatmentistobecontinuedoncedailybyoraladministration(at24-hour

intervals)atamaintenancedoseof0.1 mgmeloxicam/kgbodyweight.

Eachtabletcontains2.5mgmeloxicam,whichcorrespondstothedaily

maintenancedosefora25 kgbodyweightdog.

Eachtabletcanbehalvedforaccuratedosingaccordingtotheindividualbody

weightoftheanimal. Acticamtabletscanbeadministeredwithorwithout

food.

Doseschemeforthemaintenancedose:

Bodyweight

(Kg) Numberoftablets

mg/kg

1 mg 2.5 mg

4.0-7.0 ½ - 0.13-0.1

7.1-10.0 1 - 0.14-0.1

10.1-15.0 1½ - 0.15-0.1

15.1-20.0 2 - 0.13-0.1

20.1-25.0 - 1 0.12-0.1

25.1-35.0 - 1½ 0.15-0.1

35.1-50.0 - 2 0.14-0.1

ACTICAM

MELOXICAM1&2.5MG,CHEWABLETABLETS

PART1

PART1B ADMINISTRATIVEDOCUMENTATIONANDSUMMARY

OFTHEDOSSIER

SPC,LABELANDPACKAGEINSERT NTA02dd.August1st,2011

Aclinicalresponseisnormallyseenwithin3-4days.Treatmentshouldbe

discontinuedafter10 daysifnoclinicalimprovementisapparent.

4.10Overdose(symptoms,emergency procedures,antidotes),ifnecessary

Incaseofoverdosagesymptomatictreatmentshouldbeinitiated.

4.11Withdrawalperiod

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antiinflammatoryandantirheumaticproducts,

non-steroids(oxicams)

ATCvetcode:QM01AC06

5.1 Pharmacodynamicproperties

Meloxicamisanon-steroidalanti-inflammatorydrug(NSAID)oftheoxicam

classwhichactsbyinhibitionofprostaglandinsynthesis,therebyexerting

anti-inflammatory,analgesic,anti-exudativeandantipyreticeffects.Itreduces

leukocyteinfiltrationintotheinflamedtissue.Toaminorextentitalsoinhibits

collagen-inducedthrombocyteaggregation.Invitroandinvivostudies

demonstratedthatmeloxicaminhibitscyclooxygenase-2(COX-2)toagreater

extentthancyclooxygenase-1(COX-1).

5.2 Pharmacokineticparticulars

Absorption

Meloxicamiscompletelyabsorbedfollowingoraladministrationandmaximal

plasmaconcentrationsareobtainedafterapproximately4.5hours.Whenthe

productisusedaccordingtotherecommendeddosageregime,steadystate

concentrationsofmeloxicaminplasmaarereachedontheseconddayof

treatment.

Distribution

Thereisalinearrelationshipbetweenthedoseadministeredandplasma

concentrationobservedinthetherapeuticdoserange.Approximately97%of

meloxicamisboundto plasmaproteins.Thevolumeofdistributionis0.3 l/kg.

Metabolism

Meloxicamispredominantlyfoundinplasmaandisalsoamajorbiliary

excretionproductwhereasurinecontainsonlytracesoftheparentcompound.

Meloxicamismetabolisedtoanalcohol,anacidderivativeandtoseveral

polarmetabolites.Allmajormetaboliteshavebeenshowntobe

pharmacologicallyinactive.

Elimination

ACTICAM

MELOXICAM1&2.5MG,CHEWABLETABLETS

PART1

PART1B ADMINISTRATIVEDOCUMENTATIONANDSUMMARY

OFTHEDOSSIER

SPC,LABELANDPACKAGEINSERT NTA02dd.August1st,2011

Meloxicamiseliminatedwithahalf-lifeof24hours.Approximately75%of

theadministereddoseiseliminatedviafaecesandtheremainderviaurine.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

-Sodiumcitrate

-Lactosemonohydrate

-Cellulose,microcrystalline

-Honeyflavour

-PovidoneK30

-Crospovidone

-Colloidalanhydroussilica

-MagnesiumStearate

6.2 Incompatibilities

Notapplicable.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

6.4 Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorage

conditions

6.5 Natureandcompositionofimmediatepackaging

Acticam2.5mgtabletsaresuppliedin,

PVC/PVDC-Alublisterpack:

PVC/PVDC-AlublisterpackmadeofClearPVC/PVDCandPlainAlufoil.

Eachblisterhas10tablets.Theblistersarepackedinacartonhaving10

tablets(10x1),20tablets(10x2),100tablets(10x10)or500tablets(10x50)

andpacked withpackageinsert.

Notallpack sizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productsorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordance

withnationalrequirements.

ACTICAM

MELOXICAM1&2.5MG,CHEWABLETABLETS

PART1

PART1B ADMINISTRATIVEDOCUMENTATIONANDSUMMARY

OFTHEDOSSIER

SPC,LABELANDPACKAGEINSERT NTA02dd.August1st,2011

7. MARKETINGAUTHORISATIONHOLDER

EcupharNV

Legeweg157-i

8020 Oostkamp

Belgium

8. MARKETINGAUTHORISATIONNUMBERS

BE

CZ

DE 401268.01.00

DK 44619

EE

ES 2163ESP

FI

FR FR/V/27040856/2010

HU

IE VPA10491/001/002

IT

LT

LU

LV

NL REGNL104368

PL

PT 312/02/11DFVPT

SE 42075

SK

UK Vm32742/4003

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

BE

CZ

DE 12/10/2010

DK 05/10/2010

EE

ES 23/06/2010

FI

FR 25/06/2010

HU

IE 10/09/2010

IT

LT

LU

LV

ACTICAM

MELOXICAM1&2.5MG,CHEWABLETABLETS

PART1

PART1B ADMINISTRATIVEDOCUMENTATIONANDSUMMARY

OFTHEDOSSIER

SPC,LABELANDPACKAGEINSERT NTA02dd.August1st,2011

NL 08/09/2010

PL

PT 16/02/2011

SE 13/08/2010

SK

UK 08/09/2010

10. DATEOFREVISIONOFTHETEXT

Tobecompletednationally

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

4-12-2018

FDA Approves Pexion for Treating Noise Aversion in Dogs

FDA Approves Pexion for Treating Noise Aversion in Dogs

The U.S. Food and Drug Administration announced today that its Center for Veterinary Medicine has approved Pexion (imepitoin tablets) to treat noise aversion in dogs. Dogs with noise aversion are sensitive to loud noises such as fireworks, street/traffic noises, and gun shots.

FDA - U.S. Food and Drug Administration

18-7-2018

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

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

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

FDA - U.S. Food and Drug Administration

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