Acticam

Main information

  • Trade name:
  • Acticam 2.5 mg chewable tablets for Dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Acticam 2.5 mg chewable tablets for Dogs
    Ireland
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0134/002
  • Authorization date:
  • 23-11-2011
  • EU code:
  • NL/V/0134/002
  • 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.

14-9-2018

Pending EC decision:  Inflacam, meloxicam, Opinion date: 13-Sep-2018

Pending EC decision: Inflacam, meloxicam, Opinion date: 13-Sep-2018

Europe - EMA - European Medicines Agency

14-9-2018

Pending EC decision:  Rheumocam, meloxicam, Opinion date: 13-Sep-2018

Pending EC decision: Rheumocam, meloxicam, Opinion date: 13-Sep-2018

Europe - EMA - European Medicines Agency

29-11-2018

Inflacam (Chanelle Pharmaceuticals Manufacturing Limited)

Inflacam (Chanelle Pharmaceuticals Manufacturing Limited)

Inflacam (Active substance: Meloxicam) - Centralised - Variation - Commission Decision (2018)8036 of Thu, 29 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2497/X/15

Europe -DG Health and Food Safety

21-11-2018

Rheumocam (Chanelle Pharmaceuticals Manufacturing Limited)

Rheumocam (Chanelle Pharmaceuticals Manufacturing Limited)

Rheumocam (Active substance: Meloxicam) - Centralised - Variation - Commission Decision (2018)7841 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/121/X/22

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

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

Europe -DG Health and Food Safety

7-8-2018

Novem (Boehringer Ingelheim Vetmedica GmbH)

Novem (Boehringer Ingelheim Vetmedica GmbH)

Novem (Active substance: Meloxicam) - Centralised - Yearly update - Commission Decision (2018)5413 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

29-5-2018

Meloxivet (Eli Lilly and Company Limited)

Meloxivet (Eli Lilly and Company Limited)

Meloxivet (Active substance: Meloxicam) - Centralised - Withdrawal - Commission Decision (2018)3408 of Tue, 29 May 2018

Europe -DG Health and Food Safety

16-2-2018

Pending EC decision:  Metacam, meloxicam, Opinion date: 15-Feb-2018

Pending EC decision: Metacam, meloxicam, Opinion date: 15-Feb-2018

Europe - EMA - European Medicines Agency