DEXACORTIN

Main information

  • Trade name:
  • DEXACORTIN
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DEXACORTIN
    Portugal
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • dexamethasone
  • Therapeutic area:
  • Cats, Cattle, Dogs, Goats, Horses, Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0207/001
  • Authorization date:
  • 22-12-2009
  • EU code:
  • FR/V/0207/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Estonia,Latvia,Lithuania,Poland,Portugal,Slovenia:

Dexacortin2mg/ mLml solutionforinjectionforcattle,pigs,dogsandcats

France:

Cortadex2mg/ mLml solutionforinjectionforcattle,pigs,dogsandcats

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Each mLml contains:

Activesubstance:

Dexamethasone(assodiumphosphate):2.0mg

Excipient:

Benzylalcohol(E1519),15.6mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Clear,colourless,aqueoussolutionforinjection

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle,pigs,dogsandcats.

4.2 Indicationsforuse,specifyingthetargetspecies

Cattle,pigs,dogsandcats:treatmentofinflammatoryorallergicconditions,andincaseof

emergencytherapy(i.e.endotoxicshockorcirculatorycollapse).

Cattle:treatmentofprimaryketosis(acetonemiaandpregnancytoxemia)andinductionof

parturition.

4.3 Contraindications

Donotuseincaseofdiabetesmellitus,hyperadrenocorticism,renalinsufficiency,cardiac

insufficiency,orgastrointestinalulcer.

Donotuseinanimalswithinfectiousdiseasesunlesssuitableanti-infectivetherapyisgivenatthe

sametime.

4.4 Specialwarnings<foreachtargetspecies>

Whenusedforinductionofparturitioninruminants, theincidenceofplacentalretention

increases . retainedplacentamayoccur .

Seealsosections4.5and4.7.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Administrationinlatepregnancymaycauseearlyparturitionorabortion.

Exceptincasesofacetonemiaandinductionofparturition,corticoidadministrationinducesan

improvementinclinicalsignsratherthanacure.Therefore,itisrecommendedtoidentifyandtreat

theunderlyingdisease.

Whenusedfortreatmentofshock,intravenousfluidsshouldbegiventomaintaincirculatingvolume

andtheacidbasebalanceshouldbecontrolled.

Inpigs,donotexceed3 mLml perinjectionsite.

Seealsosection4.7.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Incaseofaccidentalself-injection,seekmedicaladviceimmediatelyandshowthepackageleaflet

orthelabeltothephysician.

Peoplewithknownhypersensitivitytotheactivesubstanceoranyoftheexcipientsshouldavoid

contactwiththeveterinarymedicinalproduct.

Womenwhoarepregnantshouldnotusetheproduct.

4.6 Adversereactions(frequencyandseriousness)

Longtermuseofcorticosteroidssuchasdexamethasonemayinduceiatrogenic

hyperadrenocorticism,causepolyuria,polydipsia,immuno-depression,polyphagiaandredistribution

ofbodyfat.

Theinductionofparturitionwithcorticosteroidsmaybeassociatedwithreducedviabilityofthe

offspringandanincreasedincidenceofretainedplacenta.

4.7 Useduringpregnancy,lactationorlay

Pregnancy:

Laboratorystudiesinrodentsduringearlypregnancyhaveshownevidenceoffoetotoxiceffects.

Theuseofacorticosteroidduringgestationisnotrecommendedexceptinruminants,toinduce

parturitionduringthelastthirdofthegestation.

Lactation:

Administrationinlactatingruminantscause s atemporaryreductioninmilkyield.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Becausecorticosteroidscanreducetheimmuneresponsetovaccination,theproductshouldnot

beusedincombinationwithvaccines.

Concurrentusewithnon-steroidalanti-inflammatorydrugsmayexacerbategastrointestinaltract

ulceration.

4.9 Amountstobeadministeredandadministrationroute

Forintravenous,intramuscularorsubcutaneousadministration

Species Routeofadministration Dosage(mgdexamethasone/kg)*

Cattleandpigs i.m.,i.v. 0.06mg/kg(3 mLml /100kg)

Dogsandcats i.m.,i.v.,s.c. 0.10mg/kg(0.5 mLml /10kg)

Species Routeofadministration Dosage(mgdexamethasone/kg)*

Cattleandpigs i.m. 0.06mg/kg(3mL/100kg)

i.v. 0.6mg/kg(3mL/100kg)

Dogsandcats i.m.,s.c. 0.10mg/kg(0.5mL/10kg)

i.v. 1.0mg/kg(5mL/100kg)

*Treatmentmayberepeatedonceaftera24to48-hourinterval.

Inductionofparturition:

Cattle: 20mg(10 mLml )

Thestoppershouldnotpuncturedmorethan20times.

Inpigs,donotexceed3 mLml perinjectionsite.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Overdosecaninducedrowsinessandlethargyinhorses.

Seealsosection4.6.

4.11Withdrawalperiod(s)

Tissues Species Withdrawalperiods

Edibletissues Cattle 7days

Edibletissues Pigs 2days

Milk Cattle 3daysmilkings

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:corticosteroidsforsystemicuse,glucocorticoids.

ATCvetcode:QH02AB02

5.1 Pharmacodynamicproperties

Dexamethasoneisahighlypotentsyntheticglucocorticosteroidwhichhasminimal

mineralocorticosteroidactivity.Dexamethasonehastentotwentytimesthepotencyof

prednisolone.Corticosteroidssuppresstheimmunologicresponsebyinhibitionofdilatationof

capillaries,migrationandfunctionofleucocytesandphagocytosis.Glucocorticoidshaveaneffect

onmetabolismbyincreasinggluconeogenesis.Administrationofglucocorticoidsmimicstheeffect

ofcortisolandthereforeprovidesasignalwhichinitiatestheparturitionprocessinruminants(ifthe

foetusisalive).Glucocorticoidshaveanti-shockactivity.

5.2 Pharmacokineticparticulars

Followingintramuscularinjection,thedexamethasonesodiumphosphateesterofisreadilyabsorbed

andhydrolysedintotheparentcompound,dexamethasone(base),resultinginapromptresponse

whichismaintainedforapproximately48hours.Incattle,pigs,dogsandcats,theT

(timeto

reachmaximumconcentrations)isreachedwithin20minutesfollowingintramuscular

administration.Eliminationhalf-life(T

)variesperspeciesbetween5and20hours.Bioavailability

afterintramuscularadministrationisapproximately100%.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Benzylalcohol(E1519),

Sodiumchloride,

Sodiumcitrate,

Sodiumhydroxide1N(forpHadjustment),

Citricacid10%(forpHadjustment),

Waterforinjections

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwith

otherveterinarymedicinalproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:5years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days.

6.4.Specialprecautionsforstorage

DonotstoreaboveThisveterinarymedicinalproductdoesnotrequireanyspecialstorage

conditions+25°C .

6.5 Natureandcompositionofimmediatepackaging

ClearglasstypeIvials,closedwithabromobutylrubberstopperandsealedwithanaluminiumcap.

Onevialof20 mLml ,50 mLml and100 mLml ,inacartonbox.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

IntervetInternationalBV,

WimdeKoorverstraat35,

5831ANBoxmeer,

TheNetherlands

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

<{DD/MM/YYYY}><{DDmonthYYYY}>…

10 DATEOFREVISIONOFTHETEXT

{MM/YYYY}or<monthYYYY>

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

ANNEXII

A. <MANUFACTURER(S)OFTHEBIOLOGICALACTIVE

SUBSTANCE(S)AND>MANUFACTURINGAUTHORISATION

HOLDER(S)RESPONSIBLEFORBATCHRELEASE

B. CONDITIONSORRESTRICTIONSOFTHEMARKETING

AUTHORISATIONREGARDINGSUPPLYORUSE

C. CONDITIONSORRESTRICTIONSOFTHEMARKETING

AUTHORISATIONWITHREGARDTOSAFEANDEFFECTIVEUSE

D. STATEMENTOFTHEMRLs

A. <MANUFACTURER(S)OFTHEBIOLOGICALACTIVESUBSTANCE(S)AND>

MANUFACTURINGAUTHORISATIONHOLDER(S)RESPONSIBLEFOR

BATCHRELEASE

Nameandaddressofthemanufactureroftheactivesubstance

Dexamethasonedisodiumphosphate:

Aventisprincipesactifspharmaceutiques

Chemicalproductionplant

F-63480Vertolaye

France

Namesandaddressesofthemanufacturersresponsibleforbatchrelease

IntervetInternationalGmbH

Feldstrasse1a

POBox1130

D-85701Unterschleissheim

Germany

OR

IntervetInternationalB.V.

WimdeKörverstraat35

5831ANBoxmeer

TheNetherlands

B. CONDITIONSORRESTRICTIONSOFTHEMARKETINGAUTHORISATION

REGARDINGSUPPLYORUSE

Tobesuppliedonlyonveterinaryprescription.

C. CONDITIONSORRESTRICTIONSOFTHEMARKETINGAUTHORISATION

WITHREGARDTOTHESAFEANDEFFECTIVEUSEOFTHEPRODUCT

Notapplicable.

D. STATEMENTOFTHEMRLs

DexamethasoneisincludedinAnnexIofCouncilRegulation(EEC)No2377/90inaccordancewith

thefollowingtable:

Pharmacologically

activesubstance(s) Markerresidue Animal

species MRLs Targettissues Otherprovisions

Dexamethasone Dexamethasone Bovine,

Porcine,

Equidae,

Caprine 0.75µg/kg

2.0µg/kg

0.75µg/kg Muscle

Liver

Kidney

Bovine,

Caprine 0.3µg/kg Milk

E. SPECIFICOBLIGATIONSTOBEFULFILLEDBYTHEMARKETING

AUTHORISATIONHOLDER

Notapplicable

ANNEXIII

LABELLINGANDPACKAGELEAFLET

A.LABELLING

<PARTICULARSTOAPPEARONTHEOUTERPACKAGE>

<PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE>

{vialandcartonbox}

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Estonia,Latvia,Lithuania,Poland,Portugal,Slovenia:

Dexacortin2mg/ mLml solutionforinjectionforcattle,pigs,dogsandcats

France:

Cortadex2mg/ mLml solutionforinjectionforcattle,pigs,dogsandcats

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Each mLml contains:

Activesubstance:

Dexamethasone(assodiumphosphate):2.0mg

Excipient:

Benzylalcohol(E1519),15.6mg

3. PHARMACEUTICALFORM

Clear,colourless,aqueoussolutionforinjection

4. PACKAGESIZE

Vialsof20,50and100 mLml

5. TARGETSPECIES

Cattle,pigs,dogsandcats.

6. INDICATION(S)

Cattle,pigs,dogsandcats:treatmentofinflammatoryorallergicconditions,andincaseof

emergencytherapy(i.e.endotoxicshockorcirculatorycollapse).

Cattle:treatmentofprimaryketosis(acetonemiaandpregnancytoxemia)andinductionof

parturition.

7. METHODANDROUTE(S)OFADMINISTRATION

Forintravenous,intramuscular or, subcutaneous orintra-articular administration

Species Routeofadministration Dosage(mgdexamethasone/kg)*

Cattleandpigs i.m.,i.v. 0.06mg/kg(3 mLml /100kg)

Dogsandcats i.m.,i.v.,s.c. 0.10mg/kg(0.5 mLml /10kg)

Species Routeofadministration Dosage(mgdexamethasone/kg)*

Cattleandpigs i.m. 0.06mg/kg(3mL/100kg)

i.v. 0.06mg/kg(30mL/100kg)

Dogsandcats i.m.,s.c. 0.10mg/kg(0.5mL/10kg)

i.v. 0.10mg/kg(5mL/100kg)

*Treatmentmayberepeatedonceaftera24to48-hourinterval.

Inductionofparturition:

Cattle: 20mg(10 mLml )

Thestoppershouldnotpuncturedmorethan20times.

Inpigs,donotexceed3 mLml perinjectionsite.

8. WITHDRAWALPERIOD

Tissues Species Withdrawalperiods

Edibletissues Cattle 7days

Edibletissues Pigs 2days

Milk Cattle milkings3days

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

<EXP{month/year}>

Oncebroached/opened,useby28days

11. SPECIALSTORAGECONDITIONS

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.Donotstore

above+25°C.

Kommentar[F1]:Simplifytable

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

IntervetInternationalB.V.

WimdeKörverstraat35

5831ANBoxmeer

TheNetherlands

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

<Batch><Lot><BN>{number}

B.PACKAGELEAFLET

PACKAGELEAFLET

Dexacortin(orCortadex)2mg/ mLml solutionforinjection

forcattle,pigs,dogsandcats

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

ANDOFTHEMANUFACTURINGAUTHORISATIONHOLDER

RESPONSIBLEFORBATCHRELEASE,IFDIFFERENT

Marketingauthorisationholderandmanufacturer

IntervetInternationalB.V.

WimdeKörverstraat35

5831ANBoxmeer

TheNetherlands

Manufacturersforthebatchrelease:

IntervetInternationalGmbH

Feldstrasse1a

POBox1130

D-85701Unterschleissheim

Germany

OR

IntervetInternationalB.V.

WimdeKörverstraat35

5831ANBoxmeer

TheNetherlands

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Dexacortin(orCortadex)2mg/ mLml solutionforinjectionforcattle,pigs,dogsandcats.

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Each mLml contains:

Activesubstance:

Dexamethasone(assodiumphosphate):2.0mg

Excipient:

Benzylalcohol(E1519),15.6mg

4. INDICATION(S)

Cattle,pigs,dogsandcats:treatmentofinflammatoryorallergicconditions,andincaseof

emergencytherapy(i.e.endotoxicshockorcirculatorycollapse).

Cattle:treatmentofprimaryketosis(acetonemiaandpregnancytoxemia)andinductionof

parturition.

5. CONTRAINDICATIONS

Donotuseincaseofdiabetesmellitus,hyperadrenocorticism,renalinsufficiency,cardiac

insufficiency,orgastrointestinalulcer.

Donotuseinanimalswithinfectiousdiseasesunlesssuitableanti-infectivetherapyisgivenatthe

sametime.

6. ADVERSEREACTIONS

Longtermuseofcorticosteroidssuchasdexamethasonemayinduceiatrogenic

hyperadrenocorticism,causepolyuria,polydipsia,immuno-depression,polyphagiaandredistribution

ofbodyfat.

Theinductionofparturitionwithcorticosteroidsmaybeassociatedwithreducedviabilityofthe

offspringandanincreasedincidenceofretainedplacenta.

7. TARGETSPECIES

Cattle,pigs,dogsandcats.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Forintravenous,intramuscularorsubcutaneousadministration.

Species Routeofadministration Dosage(mgdexamethasone/kg)*

Cattleandpigs i.m.,i.v. 0.06mg/kg(3 mLml /100kg)

Dogsandcats i.m.,i.v.,s.c. 0.10mg/kg(0.5 mLml /10kg)

Species Routeofadministration Dosage(mgdexamethasone/kg)*

Cattleandpigs i.m. 0.06mg/kg(3mL/100kg)

i.v. 0.06mg/kg(3mL/100kg)

Dogsandcats i.m.,s.c. 0.10mg/kg(0.5mL/10kg)

i.v. 0.10mg/kg(0.5mL/100kg)

*Treatmentmayberepeatedonceaftera24to48-hourinterval. Kommentar[F2]:Simplifytable

Inductionofparturition:

Cattle: 20mg(10 mLml )

Thestoppershouldnotpuncturedmorethan20times.

Inpigs,donotexceed3 mLml perinjectionsite.

9. ADVICEONCORRECTADMINISTRATION

Administrationinlatepregnancymaycauseearlyparturitionorabortion.

Exceptincasesofacetonemiaandinductionofparturition,corticoidadministrationinducesan

improvementinclinicalsignsratherthanacure.Therefore,itisrecommendedtoidentifyandtreat

theunderlyingdisease.

Whenusedfortreatmentofshock,intravenousfluidsshouldbegiventomaintaincirculatingvolume

andtheacidbasebalanceshouldbecontrolled.

Inpigs,donotexceed3 mLml perinjectionsite.

10. WITHDRAWALPERIOD

Tissues Species Withdrawalperiods

Edibletissues Cattle 7days

Edibletissues Pigs 2days

Milk Cattle 6milking3days

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Donotuseaftertheexpirydatestatedonthebottle.

Shelf-lifeafterfirstuse:28days.

12. SPECIALWARNING(S)

Laboratorystudiesinrodentsduringearlypregnancyhaveshownevidenceoffoetotoxiceffects.

Theuseofacorticosteroidduringgestationisnotrecommendedexceptinruminants,toinduce

parturitionduringthelastthirdofthegestation.

Administrationinlactatingruminantscause s atemporaryreductioninmilkyield.

Duringthefirsttwothirdsofpregnancy,useonlyaccordingtothebenefit/riskassessmentmadeby

theresponsibleveterinarian.

Donotuseduringthelastquarterofpregnancyexceptinruminants,toinduceparturition.

Administrationinlatepregnancymaycauseearlyparturitionorabortion.

Becausecorticosteroidscanreducetheimmuneresponsetovaccination,theproductshouldnot

beusedincombinationwithvaccines.

Concurrentusewithnon-steroidalanti-inflammatorydrugsmayexacerbategastrointestinaltract

ulceration.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Incaseofaccidentalself-injection,seekmedicaladviceimmediatelyandshowthepackageleaflet

orthelabeltothephysician.

Peoplewithknownhypersensitivitytotheactivesubstanceoranyoftheexcipientsshouldavoid

contactwiththeveterinarymedicinalproduct.

Womenwhoarepregnantshouldnotusetheproduct.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

Askyourveterinarysurgeonhowtodisposeofmedicinesnolongerrequired.Thesemeasuresshould

helptoprotecttheenvironment.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Notallpacksizesmaybemarketed.

Foranyinformationaboutthisveterinarymedicinalproduct,pleasecontactthelocalrepresentative

ofthemarketingauthorisationholder.

Nameandaddressofthelocalrepresentative:

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Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

25-5-2018

Orphan designation:  Treprostinil sodium,  for the: Treatment of chronic thromboembolic pulmonary hypertension

Orphan designation: Treprostinil sodium, for the: Treatment of chronic thromboembolic pulmonary hypertension

On 8 February 2013, orphan designation (EU/3/13/1103) was granted by the European Commission to SciPharm S.a.r.L, Luxembourg, for treprostinil sodium for the treatment of chronic thromboembolic pulmonary hypertension.

Europe - EMA - European Medicines Agency

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

22-11-2018

Ozurdex (Allergan Pharmaceuticals Ireland)

Ozurdex (Allergan Pharmaceuticals Ireland)

Ozurdex (Active substance: dexamethasone) - PSUSA - Modification - Commission Decision (2018)7886 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1140/PSUSA/985/201801

Europe -DG Health and Food Safety

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

24-9-2018

Inhixa (Techdow Europe AB)

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

Europe -DG Health and Food Safety

24-9-2018

Neofordex (Laboratoires CTRS)

Neofordex (Laboratoires CTRS)

Neofordex (Active substance: dexamethasone) - Centralised - Yearly update - Commission Decision (2018)6239 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

10-8-2018

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Active substance: tedizolid phosphate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5522 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2846/T/28

Europe -DG Health and Food Safety

3-8-2018

Sodium oxybate

Sodium oxybate

Sodium oxybate (Active substance: Sodium oxybate) - Centralised - Art 28 - (PSUR - Commission Decision (2018)5381 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10612/201710

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2047 (Glycomine SARL)

EU/3/18/2047 (Glycomine SARL)

EU/3/18/2047 (Active substance: Liposomal mannose-1-phosphate) - Orphan designation - Commission Decision (2018)5279 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/055/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Active substance: Combination of carboplatin and sodium valproate) - Orphan designation - Commission Decision (2018)5275 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/036/18

Europe -DG Health and Food Safety

11-7-2018

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Active substance: Alendronate Sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4518 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/619/T/42

Europe -DG Health and Food Safety

10-7-2018

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Active substance: Alendronate sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4477 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/759/T/39

Europe -DG Health and Food Safety

10-7-2018

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Active substance: Sodium phenylbutyrate) - Centralised - Yearly update - Commission Decision (2018)4483 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Withdrawn application:  Prohippur, sodium benzoate, Initial authorisation

Withdrawn application: Prohippur, sodium benzoate, Initial authorisation

Europe - EMA - European Medicines Agency

27-6-2018

EU/3/02/124 (BioMarin International Limited)

EU/3/02/124 (BioMarin International Limited)

EU/3/02/124 (Active substance: 3,4-diaminopyridine phosphate) - Transfer of orphan designation - Commission Decision (2018)4095 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/050/02/T/03

Europe -DG Health and Food Safety

19-6-2018

Xyrem (UCB Pharma S.A.)

Xyrem (UCB Pharma S.A.)

Xyrem (Active substance: Sodium oxybate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3912 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/593/T/74

Europe -DG Health and Food Safety

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

28-3-2018

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (Active substance: Sodium (1R,3R,4R,5S)-3-({2-N-acetylamino-2-deoxy-3-O-[(1S)-1-carboxylato-2-cyclohexylethyl]-beta-D-galactopyranosyl}oxy)-4-({6-deoxy-alpha-L-galactopyranosyl}oxy)-5-ethyl-cyclohexan-1-yl-(38-oxo-2,5,8,11,14,17,20,23,26,29,32,35-dodecaoxa-39-azahentetracontan-41-yl)carboxamide) - Transfer of orphan designation - Commission Decision (2018)2011 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/17/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1711 (Akcea Therapeutics UK Ltd)

EU/3/16/1711 (Akcea Therapeutics UK Ltd)

EU/3/16/1711 (Active substance: Volanesorsen sodium) - Transfer of orphan designation - Commission Decision (2018)1822 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/082/16/T/01

Europe -DG Health and Food Safety