BUSCOPAN

Main information

  • Trade name:
  • BUSCOPAN 20 MG/ML, solution for injection for horses and calves
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BUSCOPAN 20 MG/ML, solution for injection for horses and calves
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • butylscopolamine
  • Therapeutic area:
  • Cattle Young, Horses Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0107/001
  • Authorization date:
  • 19-02-2012
  • EU code:
  • NL/V/0107/001
  • Last update:
  • 09-08-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

SUMMARYOFPRODUCTCHARACTERISTICS

Page2of17

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Buscopan20mg/mlsolutionforinjectionforhorsesandcalves

Buscopanvet20mg/mlsolutionforinjection(Ireland)

Buscopanvet(Italy)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance

Hyoscinebutylbromide 20mg

(Equivalentto16.32mgbutylhyoscine)

Excipients

Methylparahydroxybenzoate(E218) 1.8mg

Propylparahydroxybenzoate(E216) 0.2mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Colourlesssolutionforinjection

4. CLINICALPARTICULARS

4.1 Targetspecies

Horsesandcalves

4.2 Indicationsforuse,specifyingthetargetspecies

Horse: [Theproduct]isindicatedforantispasmodictreatmentincaseofequinecolic.

Calf: [Theproduct]isindicatedforitsantispasmodiceffect,asanaidtothesymptomatic

treatmentofcalfscour.Oralre-hydrationandotherappropriatetherapymustalsobe

administeredasrequired.

4.3 Contraindications

Donotuseinhorsessufferingfromparalyticileus.

Donotuseinhorseslessthan6weeksofage.

Seealsosection4.11Withdrawalperiodsandsection4.7foruseduringpregnancy.

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

4.4 Specialwarningsforeachtargetspecies

Page3of17

Incaseofnoclinicalresponsethenecessityforsurgicalinterventionshouldbetakenintoconsideration.

Seealsosection4.11Withdrawalperiods.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Horsesshouldbemonitoredcarefullyfollowingtreatment.Iftheresponsetotreatmentwith[the

product]ispoor,carefulre-evaluationofthediagnosisshouldbemadeandthepossibilityofsurgical

interventionshouldbeconsidered,as[theproduct]doesnotmasksymptomsofsurgicalcases.

Incasesofmechanicalobstructionofthegut,concomitanttherapywithpolyionicfluids,laxativesand

analgeticsshouldbeconsidered.

Inanimalswithcardiacdysfunctiontheproductshouldbeadministeredaftermakingarisk/benefit

assessment.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Peoplewithknownhypersensitivitytohyoscinebutylbromideormethyl-,orpropyl

parahydroxybenzoateshouldavoidcontactwiththeproduct.Wearimpermeablegloves.Inthecaseof

accidentalspillageontotheskinoreyes,washoffsplashesfromskinandeyeswithcleanrunning

water.

4.6 Adversereactions(frequencyandseriousness)

Aslighttransientincreaseinheartratemaybeobservedduetotheparasympatholyticactivityof

hyoscinebutylbromide.

4.7 Useduringpregnancy,lactationorlay

Theuseisnotrecommendedduringpregnancy.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Theeffectsofhyoscinebutylbromidemaybepotentiatedbytheconcomitantuseofother

anticholinergicdrugs.Donotuseincombinationwithotherdrugsthatactonthe(para)sympathic

system.Concomitanttherapyshouldtakeinconsiderationthepharmacokineticpropertiesofhyoscine

butylbromide.ConcurrentuseofNon-Steroidal-Anti-InflammatoryDrugs(NSAIDS),orotherproducts

withanalgesicpropertiesmaymasksignsofclinicalconditionsrequiringfurtherdiagnosisand

treatment.

4.9 Amountstobeadministeredandadministrationroute

Horse: [Theproduct]shouldbeadministeredatadosageof0.3mghyoscinebutylbromideperkg

bodyweight,byasingleintravenousinjection.

Thiscorrespondsto1.5mlof[theproduct]/100kgbodyweighti.v.

Calf: [Theproduct]shouldbeadministeredatadosageof0.4mghyoscinebutylbromideperkg

bodyweight,byasingleintramuscularinjection.

Thiscorrespondsto2mlof[theproduct]/100kgbodyweighti.m.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Inatolerancestudyinhorses,usingupto5–foldtherecommendeddosageof0.3mg/kg,theproduct

causednosevereadversereactions.

Page4of17

Afive-foldoverdoseoccasionallyproducedsignsofatransient,slightdecreaseindefecation

frequency.Aten-foldoverdosageinhorsesproducedatransitoryabsenceofpupillarylightreflex,a

transitoryincreaseofheartrateandlowerintestinalmotility.Signsofcolicduetoenteroparalysis

appear6-8hoursafteradministration.Adversereactionsafteroverdosageshoulddisappearwithout

anyfurthertreatmentwithin6hours.

Intramuscularinjectionoftheproductincalvesatupto3-foldoftherecommendeddoseof0.4mg/kg

causednosystemicnorlocaladversereactions.

Incaseofoverdoseparasympatholyticsymptomatologymaybepresent.

4.11Withdrawalperiod(s)

Horse: Meatandoffal:1day

Calf: Meatandoffal:2days

Notpermittedforuseinlactatinganimalsproducingmilkforhumanconsumption.

5. PHARMACOLOGICALPROPERTIES

Hyoscinebutylbromideisaquaternaryammoniumderivativeofscopolamine.

Therapeuticsubgroup:Syntheticantispasmodicandanticholinergicagents.

ATCvetcode:QA03BB01butylscopolamine(hyoscinebutylbromide).

5.1 Pharmacodynamicproperties

Likeotherbelladonnaalkaloidderivatives,thiscompoundantagonisestheactionsofacetylcholineatthe

muscarinicreceptorandalsopossessesslightadditionalactivityatnicotinicreceptors.Its

pharmacologicalprofileisqualitativelysimilartotheprincipalmemberofthisclass,atropine.Incontrast

toatropinehyoscinebutylbromidedoesnotcrosstheblood-brainbarrierandexhibitslessimpactonthe

cardiovascularsystemaswellaslessinhibitionofsalivaryandlacrimalsecretion.Incomparisonto

atropinethedurationofeffectisshorteranddisappearswithoutanyantidote.Theantispasmodiceffect

ofhyoscinebutylbromideresultsinrelaxationofsmoothmusculaturelastingforapproximately20-45

minutes.Adosedependentincreaseinheartrateaswellasinhibitionofsalivationandlacrimationcan

beobserved

5.2 Pharmacokineticparticulars

Thequaternaryammoniumstructureoftheactivesubstancepreventspenetrationintothecentral

nervoussystemafterparenteraladministration.Theeliminationhalf-lifefromplasmainthetarget

speciesis1-2hours.Hyoscinebutylbromideisveryrapidlyeliminatedfromtheblood.Twohours

aftertheintravenousadministrationof[theproduct],serumlevelsofhyoscinebutylbromidefallbelow

thelowerlimitofdetectionof100ng/ml.Afterparenteraladministrationinhorses,hyoscine

butylbromideiseliminatedmainlyviaurine,mainlyasunchangedsubstance.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Sodiumchloride

Methylparahydroxybenzoate(E218)

Page5of17

Propylparahydroxybenzoate(E216)

Waterforinjections

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale: 3years

Shelflifeafterfirstopeningtheimmediatepackaging: 28days

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5 Natureandcompositionofimmediatepackaging

Colourlessinjectionglassvials(typeI)withsiliconizedandTeflon-facedstoppersmadeofbromobutyl

rubberandcrimp-onaluminiumcaps.Eachvialcontains50mlandispackedintoacollapsiblecarton.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

tobecompletedbytheOperativeUnit

8. MARKETINGAUTHORISATIONNUMBER(S)

tobecompletedbytheOperativeUnit

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: tobecompletedbytheOperativeUnit

Dateofrenewaloftheauthorisation:tobecompletedbytheOperativeUnitafterRenewal

10 DATEOFREVISIONOFTHETEXT

tobecompletedbytheOperativeUnitafterRenewal

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable

Page6of17

LABELLINGANDPACKAGELEAFLET

Page7of17

A.LABELLING

Page8of17

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Buscopan20mg/mlsolutionforinjectionforhorsesandcalves

Hyoscinebutylbromide

Buscopanvet20mg/mlsolutionforinjection(Ireland)

Buscopanvet

(Italy)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Hyoscinebutylbromide20mg/ml

3. PHARMACEUTICALFORM

Solutionforinjection

4. PACKAGESIZE

50ml

5. TARGETSPECIES

Horsesandcalves

6. INDICATION(S)

Horse: [Theproduct]isindicatedforantispasmodictreatmentincaseofequinecolic.

Calf: [Theproduct]isindicatedforitsantispasmodiceffect,asanaidtothesymptomatic

treatmentofcalfscour.Oralre-hydrationandotherappropriatetherapymustalsobe

administeredasrequired.

7. METHODANDROUTE(S)OFADMINISTRATION

Horse: [Theproduct]shouldbeadministeredatadosageof0.3mghyoscinebutylbromideperkg

bodyweight,byasingleintravenousinjection.

Thiscorrespondsto1.5mlof[theproduct]/100kgbodyweighti.v.

Calf: [Theproduct]shouldbeadministeredatadosageof0.4mghyoscinebutylbromideperkg

bodyweight,byasingleintramuscularinjection.

Thiscorrespondsto2mlof[theproduct]/100kgbodyweighti.m.

Page9of17

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Horse: Meatandoffal:1day

Calf: Meatandoffal:2days

Notpermittedforuseinlactatinganimalsproducingmilkforhumanconsumption.

9. EXPIRYDATE

<EXP{month/year}>

Shelf-lifeofbroachedvial:28days

10. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Disposeofwastematerialinaccordancewithlocalrequirements.

11. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Tobesuppliedonlyonveterinaryprescription.

12. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

13. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

tobecompletedbytheOperativeUnit

14. MARKETINGAUTHORISATIONNUMBER(S)

tobecompletedbytheOperativeUnit

15. MANUFACTURER’SBATCHNUMBER

Lot{number}

Page10of17

Page11of17

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Buscopan20mg/mlsolutionforinjectionforhorsesandcalves

Hyoscinebutylbromide

Buscopanvet20mg/mlsolutionforinjection(Ireland)

Buscopanvet (Italy)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Hyoscinebutylbromide20mg/ml

3. PACKAGESIZE

50ml

4. TARGETSPECIES

Horsesandcalves

5. METHODANDROUTE(S)OFADMINISTRATION

Horse: Singlei.v.injectionof1.5ml/100kgb.w.

Calf: Singlei.m.injectionof2ml/100kgb.w.

Readthepackageleafletbeforeuse.

6. WITHDRAWALPERIOD

Horse: Meatandoffal:1day

Calf: Meatandoffal:2days

Notpermittedforuseinlactatinganimalsproducingmilkforhumanconsumption.

7. EXPIRYDATE

<EXP{month/year}>

Shelf-lifeofbroachedvial:28days

Page12of17

8. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Tobesuppliedonlyonveterinaryprescription.

9. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

10. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

tobecompletedbytheOperativeUnit

11. MARKETINGAUTHORISATIONNUMBER(S)

tobecompletedbytheOperativeUnit

12. MANUFACTURER’SBATCHNUMBER

Lot{number}

Page13of17

B.PACKAGELEAFLET

Page14of17

PACKAGELEAFLET

Buscopan20mg/mlsolutionforinjectionforhorsesandcalves

Buscopanvet20mg/mlsolutionforinjection(Ireland)

Buscopanvet (Italy)

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder Manufacturerforbatchrelease

tobecompletedbytheOperativeUnit

BoehringerIngelheimVetmedicaGmbH

BingerStrasse173

55218IngelheimamRhein

Germany

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Buscopan20mg/mlsolutionforinjectionforhorsesandcalves

Buscopanvet

(ItalyandIreland)

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Eachmlcontains:

Hyoscinebutylbromide 20mg

Methylparahydroxybenzoate(E218)1.8mg

Propylparahydroxybenzoate(E216)0.2mg

4. INDICATION(S)

Horse: [Theproduct]isindicatedforantispasmodictreatmentincaseofequinecolic.

Calf: [Theproduct]isindicatedforitsantispasmodiceffect,asanaidtothesymptomatic

treatmentofcalfscour.Oralre-hydrationandotherappropriatetherapymustalsobe

administeredasrequired.

5. CONTRAINDICATIONS

Donotuseinhorsessufferingfromparalyticileus.

Donotuseinhorseslessthan6weeksofage.

Seealsosection“Withdrawalperiods”andsection“Specialwarnings”foruseduringpregnancy.

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Page15of17

6. ADVERSEREACTIONS

Aslighttransientincreaseinheartratemaybeobservedduetotheparasympatholyticactivityof

hyoscinebutylbromide.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Horsesandcalves

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Horse: [Theproduct]shouldbeadministeredatadosageof0.3mghyoscinebutylbromideperkg

bodyweight,byasingleintravenousinjection.

Thiscorrespondsto1.5mlof[theproduct]/100kgbodyweighti.v.

Calf: [Theproduct]shouldbeadministeredatadosageof0.4mghyoscinebutylbromideperkg

bodyweight,byasingleintramuscularinjection.

Thiscorrespondsto2mlof[theproduct]/100kgbodyweighti.m.

9. ADVICEONCORRECTADMINISTRATION

Seesection8.

10. WITHDRAWALPERIOD

Horse: Meatandoffal:1day

Calf: Meatandoffal:2days

Notpermittedforuseinlactatinganimalsproducingmilkforhumanconsumption.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Donotuseaftertheexpirydate(EXP)statedonthecartonandvial.

Shelflifeafterfirstopeningthecontainer:28days

12. SPECIALWARNING(S)

Page16of17

Incaseofnoclinicalresponsethenecessityforsurgicalinterventionshouldbetakenintoconsideration.

Seealsosection“Withdrawalperiod.”

Theuseisnotrecommendedduringpregnancy.

Specialprecautionsforuseinanimals

Horsesshouldbemonitoredcarefullyfollowingtreatment.Iftheresponsetotreatmentwith[the

product]ispoor,carefulre-evaluationofthediagnosisshouldbemadeandthepossibilityofsurgical

interventionshouldbeconsidered,as[theproduct]doesnotmasksymptomsofsurgicalcases.

Incasesofmechanicalobstructionofthegut,concomitanttherapywithpolyionicfluids,laxativesand

analgeticsshouldbeconsidered.

Inanimalswithcardiacdysfunctiontheproductshouldbeadministeredaftermakingarisk/benefit

assessment.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Peoplewithknownhypersensitivitytohyoscinebutylbromideormethyl-,orpropyl

parahydroxybenzoateshouldavoidcontactwiththeproduct.Wearimpermeablegloves.Inthecaseof

accidentalspillageontotheskinoreyes,washoffsplashesfromskinandeyeswithcleanrunning

water.

Interactions

Theeffectsofhyoscinebutylbromidemaybepotentiatedbytheconcomitantuseofother

anticholinergicdrugs.Donotuseincombinationwithotherdrugsthatactonthe(para)sympathic

system.Concomitanttherapyshouldtakeinconsiderationthepharmacokineticpropertiesofhyoscine

butylbromide.ConcurrentuseofNon-Steroidal-Anti-InflammatoryDrugs(NSAIDS),orotherproducts

withanalgesicpropertiesmaymasksignsofclinicalconditionsrequiringfurtherdiagnosisand

treatment.

Overdose

Inatolerancestudyinhorses,usingupto5–foldtherecommendeddosageof0.3mg/kg,theproduct

causednosevereadversereactions.

Afive-foldoverdoseoccasionallyproducedsignsofatransient,slightdecreaseindefecation

frequency.Aten-foldoverdosageinhorsesproducedatransitoryabsenceofpupillarylightreflex,a

transitoryincreaseofheartrateandlowerintestinalmotility.Signsofcolicduetoenteroparalysis

appear6-8hoursafteradministration.Adversereactionsafteroverdosageshoulddisappearwithout

anyfurthertreatmentwithin6hours.

Intramuscularinjectionoftheproductincalvesatupto3-foldoftherecommendeddoseof0.4mg/kg

causednosystemicnorlocaladversereactions.

Incaseofoverdoseparasympatholyticsymptomatologymaybepresent.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIAL,IFANY

Disposeofanyunusedproductandemptycontainersinaccordancewithguidancefromyourlocal

wasteregulationauthority.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

tobecompletedbytheOperativeUnitafterrenewal

Page17of17

15. OTHERINFORMATION

50mlinjectionvial.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Food allergies have touched the lives of most of us. Thousands of Americans experience life-threatening, food-related reactions each year, and an estimated 20 people die from them annually. In some cases, such reactions occur despite a careful reading of packaged food labels by conscientious consumers. To me, that’s unacceptable. The FDA is committed to advancing our efforts to help ensure that Americans have access to the information they need about common allergens in packaged foods.

FDA - U.S. Food and Drug Administration

24-10-2018

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, of Versailles, OH is recalling all products lots manufactured from February 27, 2018 through July 20, 2018, as a precaution because they have the potential to be contaminated with Listeria monocytogenes

FDA - U.S. Food and Drug Administration

4-10-2018

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Samen met de Wereldgezondheidorganisatie (WHO) zal Nederland in april 2019 een wereldwijde ministeriële conferentie organiseren over de strijd tegen antibioticaresistentie. Dat heeft minister Bruno Bruins (Medische Zorg) bekend gemaakt tijdens de G20-bijeenkomst in Argentinië. Bij deze bijeenkomst maakte Bruins afspraken met zijn collega’s uit de grootste 20 economieën van de wereld over een gezamenlijke aanpak van gezondheidsvraagstukken. Mede door jarenlange inzet van Nederland, staat antibioticaresist...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

21-9-2018

Pending EC decision:  Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Pending EC decision: Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Emgality, galcanezumab, Opinion date: 20-Sep-2018

Pending EC decision: Emgality, galcanezumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Pending EC decision: RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Pending EC decision: Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Pending EC decision: Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Gilenya, fingolimod, Opinion date: 20-Sep-2018

Pending EC decision: Gilenya, fingolimod, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Apealea, paclitaxel, Opinion date: 20-Sep-2018

Pending EC decision: Apealea, paclitaxel, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Pending EC decision: Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Pending EC decision: Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Pending EC decision: Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Pending EC decision: Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pifeltro, doravirine, Opinion date: 20-Sep-2018

Pending EC decision: Pifeltro, doravirine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Pending EC decision:  Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Pending EC decision: Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Europe - EMA - European Medicines Agency

29-8-2018

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Published on: Mon, 20 Aug 2018 00:00:00 +0200 Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any...

Europe - EFSA - European Food Safety Authority Publications

9-8-2018

Vita-Mix Corporation recalls Ascent and Venturist Series 8-ounce and 20-ounce Blending Containers

Vita-Mix Corporation recalls Ascent and Venturist Series 8-ounce and 20-ounce Blending Containers

The container can separate from the blade base exposing the blades, posing a laceration hazard to consumers.

Health Canada

5-12-2018

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

The slides from TGA's webinar on Advertising Code Basics have been published

Therapeutic Goods Administration - Australia

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

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

16-11-2018

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Active substance: lurasidone) - Centralised - Renewal - Commission Decision (2018)7674 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2713/R/20

Europe -DG Health and Food Safety

14-11-2018

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7604 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2788/T/20

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

17-9-2018

Agenda:  Agenda - CHMP agenda of the 17-20 September 2018 meeting

Agenda: Agenda - CHMP agenda of the 17-20 September 2018 meeting

Europe - EMA - European Medicines Agency

4-9-2018

Agenda:  Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda: Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda of CHMP written procedure*20-23 August 2018

Europe - EMA - European Medicines Agency

23-8-2018

 Minutes of the CAT meeting 18-20 April 2018

Minutes of the CAT meeting 18-20 April 2018

Europe - EMA - European Medicines Agency

22-8-2018

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye:  http://bit.ly/2h2NcHz .pic.twitter.com/ecJErFeiSH

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye: http://bit.ly/2h2NcHz .pic.twitter.com/ecJErFeiSH

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye: http://bit.ly/2h2NcHz . pic.twitter.com/ecJErFeiSH

FDA - U.S. Food and Drug Administration

22-8-2018

Cholib (Mylan IRE Healthcare Ltd)

Cholib (Mylan IRE Healthcare Ltd)

Cholib (Active substance: fenofibrate / simvastatin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5632 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2559/T/20

Europe -DG Health and Food Safety

15-8-2018

Orbactiv (Rempex London Ltd)

Orbactiv (Rempex London Ltd)

Orbactiv (Active substance: oritavancin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5556 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3785/T/20

Europe -DG Health and Food Safety

6-8-2018

Otezla (Celgene Europe B.V.)

Otezla (Celgene Europe B.V.)

Otezla (Active substance: apremilast) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5391 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3746/T/20

Europe -DG Health and Food Safety