SODIUM

Main information

  • Trade name:
  • SODIUM SALICYL 80% WSP, powder for oral solution for cattle (calves) and pig
  • Pharmaceutical form:
  • Powder for oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SODIUM SALICYL 80% WSP, powder for oral solution for cattle (calves) and pig
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • sodium salicylate
  • Therapeutic area:
  • Cattle Food, Pigs Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0133/001
  • Authorization date:
  • 27-05-2011
  • EU code:
  • NL/V/0133/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

SODIUMSALICYL80%WSP,powderfororalsolutionforcattle(calves)andpigs(BE,BG,DE,EE,

EL,HU,IT,LT,LV,NL,PT,RO).

SODIUMSALICYL80%,powderfororalsolutionforcattle(calves)andpigs(IE,UK).

SALIMED80%,powderfororalsolutionforcattle(calves)andpigs(PL).

SALIVET80%,powderfororalsolutionforcattle(calves)andpigs(FR).

SINTEM800mg/g,powderfororalsolutionforcattle(calves)andpigs(ES).

SODILIN,800mg/g,powderfororalsolutionforcattle(calves)andpigs(DK).

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Pergram:

Activesubstance:

Sodiumsalicylate:800mg

(equivalentto690mgofsalicylicacidassodiumsalt)

Excipient:

Forafulllistofexcipients,seesection6.1.

3.PHARMACEUTICALFORM

Powderfororalsolution.

Whiteoralmost-whitepowder.

4.CLINICALPARTICULARS

4.1 Targetspecies

Cattle(calves)andpigs.

4.2 Indicationsforuse,specifyingthetargetspecies

Cattle:

Forsupportivetreatmentofpyrexiainacuterespiratorydisease,incombinationwithappropriate

(anti-infective)therapyifnecessary.

Pigs:

Forthetreatmentofinflammation,incombinationwithconcurrentantibiotictherapy.

4.3 Contraindications

Donotadministertoanimalswithsevereliverandkidneyaffections.

Donotadministerincaseofgastrointestinalulcerationsandchronicgastrointestinaldisorders.

Donotadministerincaseofmalfunctionofthehematopoeticsystem,coagulopathies,

haemorrhagicdiathesis.

Donotusesodiumsalicylatesinneonatesorcalveslessthan2weeksofage.

Donotuseinpigletslessthan4weeksofage.

4.4 Specialwarningsforeachtargetspecies

None.

4.5 Specialprecautionsforuse

i.Specialprecautionsforuseinanimals

Giventhatsodiumsalicylatemayinhibitclottingofblood,itisrecommendedthatelective

surgeryshouldnotbeperformedonanimalswithin7daysaftertheendoftreatment.

ii.Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Peoplewithknownhypersensitivitytosodiumsalicylateorcorrelatedpharmaceuticals(e.g.

aspirin)orexcipientsshouldavoidcontactwiththeveterinarymedicinalproduct.

Irritationoftheskin,eye,andrespiratorytractmightoccur.Duringpreparationandmixingofthe

product,directcontactwiththeskinandeyes,anddirectinhalationofthepowdershouldbe

avoided.Itisrecommendedtoweargloves,safetyglasses,andadustmask.Particularattention

shouldbetakenwhenopeningthebucket.

Washaccidentalexposuretoskinimmediatelywithwater.

Intheeventofaccidentaleyecontact,theuserisadvisedtowashtheeyewithplentyofwaterfor

15minutes,andseekmedicaladviceifirritationpersists.

Duringadministrationofthemedicineasreconstitutedproductindrinkingwaterormilk

(replacer)totheanimalsskincontactshouldbepreventedbywearinggloves.Washaccidentally

exposedskinimmediatelywithwater.

4.6 Adversereactions(frequencyandseriousness)

Gastrointestinalirritationmayoccurespeciallyinanimalswithpre-existinggastrointestinal

disease.Suchirritationmayclinicallybemanifestedbyproductionofblackmanureduetoblood

lossinthegastrointestinaltract.

Inhibitionofnormalbloodclottingmayoccurincidentally.Ifthiseffectoccursitwillbe

reversibleandeffectswilldiminishwithinapproximately7days.

4.7Useduringpregnancy,lactationorlay

Laboratorystudiesinratshaveshownevidenceofteratogenicandfoetotoxiceffects.

Salicylicacidcrossestheplacentaandisexcretedwiththemilk.Half-lifeinthenew-bornis

longerandthustoxicitysymptomsmayoccurmuchsooner.Furthermoreplateletaggregationis

inhibitedandbleedingtimeisincreased,asituationwhichisnotfavourableduringharddelivery/

caesareansection.Finallysomestudiesindicatethatdeliveryispostponed.

Theproductshouldnotbeusedduringpregnancyandlactation.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrentadministrationofpotentiallynephrotoxicdrugs(e.g.aminoglycosides)shouldbe

avoided.

Salicylicacidishighlyplasma(albumin)boundandcompeteswithavarietyofcompoundsfor

plasmaproteinbindingsites(e.g.ketoprofen).

Plasmaclearanceofsalicylicacidhasbeenreportedtoincreaseincombinationwith

corticosteroids,possiblyduetoinductionofmetabolismofsalicylicacid.

ConcurrentusewithotherNSAIDsisnotrecommended,becauseofincreasedriskofgastro-

intestinalulcers.

Donotuseincombinationwithdrugsknowntohaveanticoagulantproperties.

4.9 Amountstobeadministeredandadministrationroute

Cattle: 40mgsodiumsalicylateperkgofbodyweightoncedaily,

(equivalentto50mgproductperkgBWperday),

for1-3days.

Pigs: 35mgsodiumsalicylateperkgofbodyweightperday,

(equivalentto43.75mgproductperkgBWperday),

for3-5days.

SodiumSalicyl80%WSPcanbeadministeredorallythroughthemilk-replacerand/orthe

drinkingwater.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Calvestoleratedosagesupto80mg/kgfor5daysor40mg/kgfor10dayswithoutanyadverse

effects.

Pigstoleratedosagesupto175mg/kgforupto10dayswithoutanysignificantadverseeffects.

Incaseofanacuteoverdoseintravenousbicarbonateinfusionresultsinahigherclearanceof

salicylicacidbyalkalisationoftheurineandmaybebeneficialincorrecting(secondary

metabolic)acidosis.

4.11Withdrawalperiod(s)

Cattleandpigs:

Meatandoffal:zerodays.

5.PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:NSAID

ATCvet-code:QN02BA04

5.1 Pharmacodynamicproperties

Sodiumsalicylateisanon-steroidalanti-inflammatorydrug(NSAID)andexertsananti-

inflammatory,analgesicandanti-pyreticeffect.Theeffectsarelinkedtotheinhibitionofthe

enzymecyclo-oxygenasebywhichthesynthesisofprostaglandin(mediatorforinflammation)

decreases.

5.2 Pharmacokineticproperties

Orallyingestedsalicylatesareabsorbedrapidlybypassivediffusion,partlyfromthestomachbut

mostlyfromtheuppersmallintestine.

Afterabsorption,salicylateisdistributedthroughoutmostbodytissues.Valuesofvolumeof

distribution(Vd)arehigherinthenewborns.Halflivesarelongerintheveryyoungresultingin

slowereliminationofthesubstance.Thisismostprominentinanimalsupto7-14daysofage.

Themetabolismofsalicylatetakesmainlyplaceinhepaticendoplasmicreticulumand

mitochondria.

ExcretionismainlyviatheurineandisapH-dependentprocess.

6.PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Lactosemonohydrate

6.2 Incompatibilities

Donotmixwithotherveterinarymedicinalproducts.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:36months.

Shelflifeafterfirstopeningtheimmediatepackaging:3months.

Shelflifeafterreconstitutionindrinkingwater:24hours.

Shelflifeafterreconstitutioninmilkreplacer:4hours.

6.4.Specialprecautionsforstorage

Storebelow25ºC.

Donotrefrigerateorfreeze.

Protectfromfrost.

6.5 Natureandcompositionofimmediatepackaging

-Compositecan:containerconsistingofPET/aluminium/adhesive/paper,withaPET/aluminium

tear-offmembraneandaHDPElid.

Thecompositecancontains1kgofproduct.

-Bucket:polypropylenebucketprovidedwithapolypropylenelid.

Thebucketcontains1,2.5or5kgofproduct.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductsorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocal/nationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

DopharmaResearchB.V.

Zalmweg24

4941VXRaamsdonksveerTheNetherlands

research@dopharma.com

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFTHEFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10.DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Supplyonveterinaryprescription.

APPENDIXB:

LABELLINGANDPACKAGELEAFLET

I.LABELLING

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

-Compositecan

-Bucket

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

SODIUMSALICYL80%WSP,powderfororalsolutionforcattle(calves)andpigs

2. STATEMENTOFTHEACTIVEANDOTHERSUBSTANCES

Sodiumsalicylate 800mg/g

(equivalentto690mgofsalicylicacidassodiumsalt)

3. PHARMACEUTICALFORM

Powderfororalsolution.

4. PACKAGESIZE

1,2.5or5kg.

5. TARGETSPECIES

Cattle(calves)andpigs.

6. INDICATION(S)

Cattle:

Forsupportivetreatmentofpyrexiainacuterespiratorydisease,incombinationwithappropriate(anti-

infective)therapyifnecessary.

Pigs:

Forthetreatmentofinflammation,incombinationwithconcurrentantibiotictherapy.

7. METHODANDROUTE(S)OFADMINISTRATION

Oraluse,afterdissolutionindrinkingwater/milkreplacer.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Cattleandpigs:

Meatandoffal:zerodays.

9. SPECIALWARNING(S)

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

Exp<<EXPmonth/year>>

Shelflifeafterfirstopeningtheimmediatepackaging:3months.

Shelflifeafterreconstitutionindrinkingwater:24hours.

Shelflifeafterreconstitutioninmilkreplacer:4hours.

Onceopened,useby:

11. SPECIALSTORAGECONDITIONS

Storebelow25ºC.

Donotrefrigerateorfreeze.

Protectfromfrost.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocal/nationalrequirements.

13. THEWORDS"FORANIMALTREATMENTONLY"ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly-tobesuppliedonlyonveterinaryprescription.

14. THEWORDS"KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN"

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

DopharmaResearchB.V.

Zalmweg24

4941VXRaamsdonksveerTheNetherlands

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER'SBATCHNUMBER

Batch<<partijnummer>>

II.PACKAGELEAFLET

PACKAGELEAFLET

SODIUMSALICYL80%WSP,powderfororalsolutionforcattle(calves)andpigs.

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOFTHE

MANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCHRELEASE,

IFDIFFERENT

Marketingauthorisationholder:

DopharmaResearchB.V.

Zalmweg24

4941VXRaamsdonksveerTheNetherlands

Manufacturerresponsibleforthebatchrelease:

DopharmaB.V.

Zalmweg24

4941VXRaamsdonksveerTheNetherlands

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

SODIUMSALICYL80%WSP,powderfororalsolutionforcattle(calves)andpigs.

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Activesubstance:

Sodiumsalicylate 800mg/g

(equivalentto690mgofsalicylicacidassodiumsalt)

Whiteoralmost-whitepowder.

4. INDICATION(S)

Cattle:

Forsupportivetreatmentofpyrexiainacuterespiratorydisease,incombinationwithappropriate(anti-

infective)therapyifnecessary.

Pigs:

Forthetreatmentofinflammation,incombinationwithconcurrentantibiotictherapy.

5. CONTRAINDICATIONS

Donotadministertoanimalswithsevereliverandkidneyaffections.

Donotadministerincaseofgastrointestinalulcerationsandchronicgastrointestinaldisorders.

Donotadministerincaseofmalfunctionofthehematopoeticsystem,coagulopathies,haemorrhagic

diathesis.

Donotusesodiumsalicylatesinneonatesorcalveslessthan2weeksofage.

Donotuseinpigletslessthan4weeksofage.

6. ADVERSEREACTIONS

Gastrointestinalirritationmayoccurespeciallyinanimalswithpre-existinggastrointestinaldisease.Such

irritationmayclinicallybemanifestedbyproductionofblackmanureduetobloodlossinthegastrointestinal

tract.

Inhibitionofnormalbloodclottingmayoccurincidentally.Ifthiseffectoccursitwillbereversibleand

effectswilldiminishwithinapproximately7days.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyourveterinary

surgeon.

7. TARGETSPECIES

Cattle(calves)andpigs

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHOD(S)OFADMINISTRATION

Cattle: 40mgsodiumsalicylateperkgofbodyweightoncedaily,

(equivalentto50mgproductperkgBWperday),

for1-3days.

Pigs: 35mgsodiumsalicylateperkgofbodyweightperday,

(equivalentto43.75mgproductperkgBWperday),

for3-5days.

SodiumSalicyl80%WSPcanbeadministeredorallythroughthemilk-replacerand/orthedrinkingwater.

9. ADVICEONCORRECTADMINISTRATION

None.

10. WITHDRAWALPERIOD

Cattleandpigs:

Meatandoffal:zerodays.

11. SPECIALSTORAGEPRECAUTIONS

Storebelow25ºC.

Donotrefrigerateorfreeze.

Protectfromfrost.

Shelflifeafterfirstopeningtheimmediatepackaging:3months.

Shelflifeafterreconstitutionindrinkingwater:24hours.

Shelflifeafterreconstitutioninmilkreplacer:4hours.

Keepoutofthereachandsightofchildren.

12. SPECIALWARNING(S)

Specialprecautionsforuseinanimals

Giventhatsodiumsalicylatemayinhibitclottingofblood,itisrecommendedthatelectivesurgeryshould

notbeperformedonanimalswithin7daysaftertheendoftreatment.

Userwarnings

Peoplewithknownhypersensitivitytosodiumsalicylateorcorrelatedpharmaceuticals(e.g.aspirin)or

excipientsshouldavoidcontactwiththeveterinarymedicinalproduct.

Irritationoftheskin,eye,andrespiratorytractmightoccur.Duringpreparationandmixingoftheproduct,

directcontactwiththeskinandeyes,anddirectinhalationofthepowdershouldbeavoided.Itis

recommendedtoweargloves,safetyglasses,andadustmask.Particularattentionshouldbetakenwhen

openingthebucket.

Washaccidentalexposuretoskinimmediatelywithwater.

Intheeventofaccidentaleyecontact,theuserisadvisedtowashtheeyewithplentyofwaterfor15

minutes,andseekmedicaladviceifirritationpersists.

Duringadministrationofthemedicineasreconstitutedproductindrinkingwaterormilk(replacer)tothe

animalsskincontactshouldbepreventedbywearinggloves.Washaccidentallyexposedskinimmediately

withwater.

Useduringpregnancy,lactationorlay

Laboratorystudiesinratshaveshownevidenceofteratogenicandfoetotoxiceffects.

Salicylicacidcrossestheplacentaandisexcretedwiththemilk.Half-lifeinthenew-bornislongerandthus

toxicitysymptomsmayoccurmuchsooner.Furthermoreplateletaggregationisinhibitedandbleedingtime

isincreased,asituationwhichisnotfavourableduringharddelivery/caesareansection.Finallysome

studiesindicatethatdeliveryispostponed.

Theproductshouldnotbeusedduringpregnancyandlactation.

Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrentadministrationofpotentiallynephrotoxicdrugs(e.g.aminoglycosides)shouldbeavoided.

Salicylicacidishighlyplasma(albumin)boundandcompeteswithavarietyofcompoundsforplasma

proteinbindingsites(e.g.ketoprofen).

Plasmaclearanceofsalicylicacidhasbeenreportedtoincreaseincombinationwithcorticosteroids,possibly

duetoinductionofmetabolismofsalicylicacid.

ConcurrentusewithotherNSAIDsisnotrecommended,becauseofincreasedriskofgastro-intestinalulcers.

Donotuseincombinationwithdrugsknowntohaveanticoagulantproperties.

Overdose(symptoms,emergencyprocedures,antidotes)

Calvestoleratedosagesupto80mg/kgfor5daysor40mg/kgfor10dayswithoutanyadverseeffects.

Pigstoleratedosagesupto175mg/kgforupto10dayswithoutanysignificantadverseeffects.

Incaseofanacuteoverdoseintravenousbicarbonateinfusionresultsinahigherclearanceofsalicylicacid

byalkalisationoftheurineandmaybebeneficialincorrecting(secondarymetabolic)acidosis.

Incompatibilities

Donotmixwithotherveterinarymedicinalproducts.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocal/nationalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Listofpacksizes:

-Compositecan:containerconsistingofPET/aluminium/adhesive/paper,withaPET/aluminiumtear-off

membraneandaHDPElid.

Thecompositecancontains1kgofproduct.

-Bucket:polypropylenebucketprovidedwithapolypropylenelid.Thebucketcontains1,2.5or5kgof

product.

Notallpacksizesmaybemarketed.

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Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

21-6-2018

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., is voluntarily recalling all kratom (mitragyna speciosa) powder products, with Lot No.: 0102031800 it manufactured, processed, packed, and/or held, between March 18, 2018 to March 30, 2018 to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordanc...

FDA - U.S. Food and Drug Administration

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

17-4-2018

Gold Viagra 9800mg capsules

Gold Viagra 9800mg capsules

Safety advisory

Therapeutic Goods Administration - Australia

14-3-2018

Sexual enhancement product "Leopard Miracle of Honey" may pose serious health risks

Sexual enhancement product "Leopard Miracle of Honey" may pose serious health risks

Health Canada is advising Canadians that two versions of the sexual enhancement product “Leopard Miracle of Honey” may pose serious health risks. Both versions are labelled as being approved by Health Canada, with NPN 80073650. Health Canada’s testing found that both versions of the product contain the undeclared prescription drug sildenafil. The product was not authorized to contain this prescription drug. Health Canada seized the products from two Ontario convenience stores located in Woodbridge, ON, a...

Health Canada

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

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

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

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/3/18/2043 (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

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