CTC

Main information

  • Trade name:
  • CTC spray
  • Pharmaceutical form:
  • Cutaneous spray, solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CTC spray
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Tetracycline and derivatives
  • Therapeutic area:
  • Cattle Food, Pigs Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0104/001
  • Authorization date:
  • 23-06-2011
  • EU code:
  • NL/V/0104/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CTCSPRAY,2.45%w/wforcattle,sheepandpigs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Percontainerof270ml:

ActiveSubstance:

ChlortetracyclineHCl.

Theactiveingredientcontentis2.45%w/w(equivalentto3.210g)

Excipients:

PatentBlueV(E131) 0.15%w/w(equivalentto0,196g)

Butane100 68.77%w/w(equivalentto89,920g)

Percontainerof520ml:

ActiveSubstance:

ChlortetracyclineHCl.

Theactiveingredientcontentis2.45%w/w(equivalentto6.420g)

Excipients:

PatentBlueV(E131) 0.15%w/w(equivalentto0,392g)

Butane100 68.77%w/w(equivalentto179.840g)

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

CutaneousSpray,Suspension

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle,sheepandpigs.

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofsuperficialtraumaticorsurgicalwoundscontaminatedwithchlortetracycline-sensitive

agents.

Theproductcanbeusedaspartofatreatmentforsuperficialskinandclaw/hoofinfections,in

particularinterdigitaldermatitis(footrotandfoulinthefoot)anddigitaldermatitiscausedbymicro-

organismssensitivetochlortetracycline.

4.3 Contraindications

Donotuseincaseofhypersensitivitytotetracyclinesortootheringredientsoftheproduct.Donotuse

ontheudderoflactatinganimalsifmilkisintendedforhumanconsumption.

4.4 Specialwarningsforeachtargetspecies

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Protecttheeyeswhensprayinginthevicinityofthehead.Cleantheaffectedareathoroughlybefore

spraying.Afteradministrationontheclaw/hooftheanimalshouldbekeptonadrygroundatleastfor

anhourstime.Useoftheproductshouldbebasedonsusceptibilitytestingofthebacteriaisolatedfrom

theanimal.Ifthisisnotpossible,therapyshouldbebasedonlocal(regional,farmlevel)epidemiological

informationaboutsusceptibilityofthetargetbacteria.Useoftheproductdeviatingfromtheinstructions

givenintheSPCmayincreasetheprevalenceofbacteriaresistanttochlortetracyclineandmay

decreasetheeffectivenessoftreatmentwithothertetracyclines,duetothepotentialforcross

resistance.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Becauseoftheriskofsensitisationandcontactdermatitis,skincontactshouldbeavoided.

Wearappropriateimpermeablegloveswhilsthandlingtheproduct.

Becauseofriskofeyeirritation,contactwiththeeyesshouldbeavoided.Protecttheeyesand

face.

Donotsprayonanakedflameoranyincandescentmaterial.

Donotpierceorburn,evenafteruse.

Avoidinhalingvapours.Applytheproductinopenairorinsufficientlyventilatedarea.

Washhandsafteruse.

Donoteatorsmokewhilstadministeringtheproduct.

4.6 Adversereactions(frequencyandseriousness)

Hypersensitivityreactionsmayoccurrarely.

4.7 Useduringpregnancy,lactationorlay

Followingcutaneousadministrationoftheproduct,chlortetracyclineisnotabsorbed,norexcretedwith

themilk.Therefore,theproductissafeforuseduringpregnancyandlactation.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Aftercutaneousadministrationofchlortetracyclinespray,chlortetracyclineisnotabsorbed.Parenteral

ororaladministeredantibioticswillnotpenetratethedermis.Thereforenointeractionsaretobe

expected.

Nodataoninteractionswithotherlocaltreatmentsareavailable.

4.9 Amountstobeadministeredandadministrationroute

Theproductisindicatedforcutaneousadministration.Shakethecontainerthoroughlybeforespraying.

Thecontainershouldbeheldatadistanceofapproximately15-20cmfromtheareatobesprayed;

sprayfor3secondsuntilthetreatment-areaisevenlycoloured.

Incaseofclaw/hoofinfectionsthistreatmentshouldberepeatedafter30seconds.

Fortreatmentofsuperficialtraumaticorsurgicalwoundscontaminatedwithchlortetracycline-

sensitiveagentsasingleadministrationisrecommended.

FortreatmentofDermatitisDigitalisadministrationtwicewitha30secondintervalduringthree

consecutivedaysonceortwicedailyisrecommended.

Fortreatmentofotherclaw/hoofinfections(footrotandfoulinthefoot),administrationtwicewitha30

secondintervalonceortwicedailyisrecommended.Dependentontheseriousnessoftheinjuryand

therateofimprovementtreatmentshouldberepeatedwithin1to3days.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Notapplicable.

4.11Withdrawalperiod(s)

Meat :zerodays

Milk :zerodays

Seealso4.3contraindications

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:tetracyclineantibiotics.

ATCvetcode:QD06A

5.1 Pharmacodynamicproperties

Invitro,chlortetracyclineisprimarilybacteriostatic.Chlortetracyclineexertsitsactionbyinhibitingthe

proteinsynthesisofthebacterialcell.Especiallycell-divisionandtheformationofthecellwallare

impaired.Chlortetracyclinebindstoreceptorsonthe30S-subunitofthebacterialribosomewherethey

interferewiththebindingoftheaminoacyl-transferRNAtotheacceptorsiteonthemessengerRNA

ribosomecomplex.

5.2 Pharmacokineticparticulars

Followingcutaneousadministrationofchlortetracyclinespray,chlortetracyclineabsorptionisnegligible.

Thereforetheproductwillonlyhavealocaleffect,nosystemiceffectsaretobeanticipated.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Colloidalanhydroussilica

Isopropylalcohol

PatentblueV(E-131)

Sorbitantriolate

Butane100

6.2 Incompatibilities

Notapplicable.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

6.4.Specialprecautionsforstorage

Pressurizedcontainer.Donotexposethecontainertodirectsunlightortotemperatureshigherthan

50°C.Keepawayfromsourcesofignition.

6.5 Natureandcompositionofimmediatepackaging

270mlpressurisedcontainerofcoatedtinplatewithaplasticvalvemechanismandsprayingnozzle.

520mlpressurisedcontainerofcoatedtinplatewithaplasticvalvemechanismandsprayingnozzle.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

EurovetAnimalHealthB.V.

Handelsweg25,POBox179,5530ADBladel

TheNetherlands

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFRENEWALOFTHEAUTHORISATION

20-03-2009

10 DATEOFREVISIONOFTHETEXT

May2011

Methodofretailsaleorsupply

PrescriptionOnlyMedicine

LABELLING

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

Spraywhichcanonlyspraystraightup

Thefulltextwillbeprintedonthecontainer

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

MarketingauthorisationholderandManufacturerforthebatchrelease:

EurovetAnimalHealthB.V.

Handelsweg25,POBox179,5530ADBladel

TheNetherlands

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CTCSPRAY,2.45%w/wforcattle,sheepandpigs

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Percontainerof270ml:

ActiveSubstance:

ChlortetracyclineHCl.

Theactiveingredientcontentis2.45%w/w(equivalentto3.210g)

Excipients:

PatentBlueV(E131) 0.15%w/w(equivalentto0,196g)

Butane100 68.77%w/w(equivalentto89,920g)

Percontainerof520ml:

ActiveSubstance:

ChlortetracyclineHCl.

Theactiveingredientcontentis2.45%w/w(equivalentto6.420g)

Excipients:

PatentBlueV(E131) 0.15%w/w(equivalentto0,392g)

Butane100 68.77%w/w(equivalentto179.840g)

4. INDICATION(S)

Treatmentofsuperficialtraumaticorsurgicalwoundscontaminatedwithchlortetracycline-sensitive

agents.

Theproductcanbeusedaspartofatreatmentforsuperficialskinandclaw/hoofinfections,in

particularinterdigitaldermatitis(footrotandfoulinthefoot)anddigitaldermatitiscausedbymicro-

organismssensitivetochlortetracycline.

5. CONTRAINDICATIONS

Donotuseincaseofhypersensitivitytotetracyclinesortootheringredientsoftheproduct.Donotuse

ontheudderoflactatinganimalsifmilkisintendedforhumanconsumption.

6. ADVERSEREACTIONS

Hypersensitivityreactionsmayoccurrarely.Ifyounoticeanyseriouseffectsorothereffectsnot

mentionedinthisleaflet,pleaseinformyourveterinarysurgeon.

7. TARGETSPECIES

Cattle,sheepandpigs.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Theproductisindicatedforcutaneousadministration.Shakethecontainerthoroughlybeforespraying.

Thecontainershouldbeheldatadistanceofapproximately15-20cmfromtheareatobesprayed;

sprayfor3secondsuntilthetreatment-areaisevenlycoloured.

Incaseofclaw/hoofinfectionsthistreatmentshouldberepeatedafter30seconds.

Fortreatmentofsuperficialtraumaticorsurgicalwoundscontaminatedwithchlortetracycline-

sensitiveagentsasingleadministrationisrecommended.

FortreatmentofDermatitisDigitalisadministrationtwicewitha30secondintervalduringthree

consecutivedaysonceortwicedailyisrecommended.

Fortreatmentofotherclaw/hoofinfections(footrotandfoulinthefoot),administrationtwicewitha30

secondintervalonceortwicedailyisrecommended.Dependentontheseriousnessoftheinjuryand

therateofimprovementtreatmentshouldberepeatedwithin1to3days.

9. ADVICEONCORRECTADMINISTRATION

--

10. WITHDRAWALPERIOD

Meat :zerodays

Milk :zerodays

Seealsocontraindications.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Pressurizedcontainer.Donotexposethecontainertodirectsunlightortotemperatureshigherthan

50°C.Keepawayfromsourcesofignition.

12. SPECIALWARNING(S)

Specialprecautionforuseinanimals

Protecttheeyeswhensprayinginthevicinityofthehead.Cleantheaffectedareathoroughlybefore

spraying.Afteradministrationontheclaw/hooftheanimalshouldbekeptonadrygroundatleastfor

anhourstime.Useoftheproductshouldbebasedonsusceptibilitytestingofthebacteriaisolatedfrom

theanimal.Ifthisisnotpossible,therapyshouldbebasedonlocal(regional,farmlevel)epidemiological

informationaboutsusceptibilityofthetargetbacteria.Useoftheproductdeviatingfromtheinstructions

givenintheSPCmayincreasetheprevalenceofbacteriaresistanttochlortetracyclineandmay

decreasetheeffectivenessoftreatmentwithothertetracyclines,duetothepotentialforcross

resistance.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Becauseoftheriskofsensitisationandcontactdermatitis,skincontactshouldbeavoided.

Wearappropriateimpermeablegloveswhilsthandlingtheproduct.

Becauseofriskofeyeirritation,contactwiththeeyesshouldbeavoided.Protecttheeyesandface.

Donotsprayonanakedflameoranyincandescentmaterial.

Donotpierceorburn,evenafteruse.

Avoidinhalingvapours.Applytheproductinopenairorinsufficientlyventilatedarea.

Washhandsafteruse.

Donoteatorsmokewhilstadministeringtheproduct.

Hypersensitivityreactionsmayoccurrarely.

Useduringpregnancyorlactation

Followingcutaneousadministrationoftheproduct,chlortetracyclineisnotabsorbed,norexcretedwith

themilk.Therefore,theproductissafeforuseduringpregnancyandlactation.

Interactionwithothermedicinalproducts

Aftercutaneousadministrationofchlortetracyclinespray,chlortetracyclineisnotabsorbed.Parenteral

ororaladministeredantibioticswillnotpenetratethedermis.Thereforenointeractionsaretobe

expected.

Nodataoninteractionswithotherlocaltreatmentsareavailable.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

May2011

15. OTHERINFORMATION

Methodofretailsaleorsupply

PrescriptionOnlyMedicine

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

Spraywhichcanspraystraightupandinverted

Thefulltextwillbeprintedonthecontainer

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

MarketingauthorisationholderandManufacturerforthebatchrelease:

EurovetAnimalHealthB.V.

Handelsweg25,POBox179,5530ADBladel

TheNetherlands

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CTCSPRAY,2.45%w/wforcattle,sheepandpigs

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Percontainerof270ml:

ActiveSubstance:

ChlortetracyclineHCl.

Theactiveingredientcontentis2.45%w/w(equivalentto3.210g)

Excipients:

PatentBlueV(E131) 0.15%w/w(equivalentto0,196g)

Butane100 68.77%w/w(equivalentto89,920g)

Percontainerof520ml:

ActiveSubstance:

ChlortetracyclineHCl.

Theactiveingredientcontentis2.45%w/w(equivalentto6.420g)

Excipients:

PatentBlueV(E131) 0.15%w/w(equivalentto0,392g)

Butane100 68.77%w/w(equivalentto179.840g)

4. INDICATION(S)

Treatmentofsuperficialtraumaticorsurgicalwoundscontaminatedwithchlortetracycline-sensitive

agents.

Theproductcanbeusedaspartofatreatmentforsuperficialskinandclaw/hoofinfections,in

particularinterdigitaldermatitis(footrotandfoulinthefoot)anddigitaldermatitiscausedbymicro-

organismssensitivetochlortetracycline.

5. CONTRAINDICATIONS

Donotuseincaseofhypersensitivitytotetracyclinesortootheringredientsoftheproduct.Donotuse

ontheudderoflactatinganimalsifmilkisintendedforhumanconsumption.

6. ADVERSEREACTIONS

Hypersensitivityreactionsmayoccurrarely.Ifyounoticeanyseriouseffectsorothereffectsnot

mentionedinthisleaflet,pleaseinformyourveterinarysurgeon.

7. TARGETSPECIES

Cattle,sheepandpigs.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Theproductisindicatedforcutaneousadministration.Shakethecontainerthoroughlybeforespraying.

Thecontainershouldbeheldatadistanceofapproximately15-20cmfromtheareatobesprayed;

sprayfor3secondsuntilthetreatment-areaisevenlycoloured.

Incaseofclaw/hoofinfectionsthistreatmentshouldberepeatedafter30seconds.

Fortreatmentofsuperficialtraumaticorsurgicalwoundscontaminatedwithchlortetracycline-

sensitiveagentsasingleadministrationisrecommended.

FortreatmentofDermatitisDigitalisadministrationtwicewitha30secondintervalduringthree

consecutivedaysonceortwicedailyisrecommended.

Fortreatmentofotherclaw/hoofinfections(footrotandfoulinthefoot),administrationtwicewitha30

secondintervalonceortwicedailyisrecommended.Dependentontheseriousnessoftheinjuryand

therateofimprovementtreatmentshouldberepeatedwithin1to3days.

9. ADVICEONCORRECTADMINISTRATION

--

10. WITHDRAWALPERIOD

Meat :zerodays

Milk :zerodays

Seealsocontraindications.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Pressurizedcontainer.Donotexposethecontainertodirectsunlightortotemperatureshigherthan

50°C.Keepawayfromsourcesofignition.

12. SPECIALWARNING(S)

Specialprecautionforuseinanimals

Protecttheeyeswhensprayinginthevicinityofthehead.Cleantheaffectedareathoroughlybefore

spraying.Afteradministrationontheclaw/hooftheanimalshouldbekeptonadrygroundatleastfor

anhourstime.Useoftheproductshouldbebasedonsusceptibilitytestingofthebacteriaisolatedfrom

theanimal.Ifthisisnotpossible,therapyshouldbebasedonlocal(regional,farmlevel)epidemiological

informationaboutsusceptibilityofthetargetbacteria.Useoftheproductdeviatingfromtheinstructions

givenintheSPCmayincreasetheprevalenceofbacteriaresistanttochlortetracyclineandmay

decreasetheeffectivenessoftreatmentwithothertetracyclines,duetothepotentialforcross

resistance.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Becauseoftheriskofsensitisationandcontactdermatitis,skincontactshouldbeavoided.

Wearappropriateimpermeablegloveswhilsthandlingtheproduct.

Becauseofriskofeyeirritation,contactwiththeeyesshouldbeavoided.Protecttheeyesandface.

Donotsprayonanakedflameoranyincandescentmaterial.

Donotpierceorburn,evenafteruse.

Avoidinhalingvapours.Applytheproductinopenairorinsufficientlyventilatedarea.

Washhandsafteruse.

Donoteatorsmokewhilstadministeringtheproduct.

Hypersensitivityreactionsmayoccurrarely.

Useduringpregnancyorlactation

Followingcutaneousadministrationoftheproduct,chlortetracyclineisnotabsorbed,norexcretedwith

themilk.Therefore,theproductissafeforuseduringpregnancyandlactation.

Interactionwithothermedicinalproducts

Aftercutaneousadministrationofchlortetracyclinespray,chlortetracyclineisnotabsorbed.Parenteral

ororaladministeredantibioticswillnotpenetratethedermis.Thereforenointeractionsaretobe

expected.

Nodataoninteractionswithotherlocaltreatmentsareavailable.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

May2011

15. OTHERINFORMATION

Methodofretailsaleorsupply

PrescriptionOnlyMedicine

Symbolswillbeplacedonthelabeltextpresentedonthecan

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1-11-2018

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La FDA aprueba el uso ampliado de Gardasil 9 para incluir a personas de 27 a 45 años de edad

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Nederland organiseert volgende wereldwijde WHO conferentie tegen tabak

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26-6-2018

ANSES Newsletter in English - N°45 - April 2018

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12-7-2018

Econor (Elanco Europe Ltd)

Econor (Elanco Europe Ltd)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4580 of Thu, 12 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Active substance: duloxetine hydrochloride) - Centralised - Withdrawal - Commission Decision (2018)4515 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency

3-7-2018

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4254 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/896/T/90

Europe -DG Health and Food Safety

3-7-2018

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4249 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1235/T/77

Europe -DG Health and Food Safety

3-7-2018

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4252 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/862/T/93

Europe -DG Health and Food Safety

3-7-2018

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4251 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/861/T/90

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (Active substance: (R)-1-(3-(aminomethyl) phenyl)-N-(5-((3-cyanophenyl)(cyclopropylmethylamino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide dihydrochloride) - Orphan designation - Commission Decision (2018)4173 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/003/18

Europe -DG Health and Food Safety

14-6-2018

Kuvan (BioMarin International Limited)

Kuvan (BioMarin International Limited)

Kuvan (Active substance: sapropterin dihydrochloride) - Centralised - Yearly update - Commission Decision (2018)3859 of Thu, 14 Jun 2018

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

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