ATIPAZOLE

Main information

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

Documents

Localization

  • Available in:
  • ATIPAZOLE
    France
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • atipamezole
  • Therapeutic area:
  • Cats, Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0247/001
  • Authorization date:
  • 26-06-2013
  • EU code:
  • FR/V/0247/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

ATIPAZOLE5mg/mlSolutionforinjectionfordogsandcats [BE,BG,DE,HU,

LT,LV,NL,PL,SI,UK]

ANTIDORM5mg/mlSolutionforinjectionfordogsandcats [ES,FR,IT,PT]

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlofsolutioncontains:

Activesubstance:

Atipamezole......................................................4.27mg

(asatipamezolehydrochloride5.0mg)

Excipients:

Methylparahydroxybenzoate(E218)..............1.0mg

Forafulllistofexcipients,seeSection6.1

3. PHARMACEUTICALFORM

SolutionforInjection.

Clearandcolourlesssolution.

4. CLINICALPARTICULARS

4.1Targetspecies

DogsandCats.

4.2Indicationsforuse,specifyingthetargetspecies

Atipamezolehydrochloride isaselectiveα2-antagonistandindicatedforreversal

ofthesedativeeffectsofmedetomidineanddexmedetomidineindogsandcats.

4.3Contraindications

Donotuseinanimalswithknownhypersensitivitytotheactivesubstanceorany

otherexcipients.

Donotuseinbreedinganimals.

Donotuseinanimalssufferingfromhepaticorrenalorcardiacdiseases.

Seealsosection4.7

4.4Specialwarningsforeachtargetspecies

None.

4.5Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

Afteradministrationoftheproduct,theanimalsshouldbeallowedtorest

inaquietplace.Duringtherecoveryphase,animalsshouldnotbeleft

unattended.Makesuretheanimalhasregainedanormalswallowing

reflexbeforeanyfoodordrinkisoffered.

Duetodifferentdosingrecommendationscautionshouldbetakenusing

theproductofflabelinanimalsotherthanthetargetspecies.

Ifothersedativesdifferentthan(dex)medetomidineareadministered,it

mustbetakenintoaccountthattheeffectsoftheseotheragentsare

likelytopersistafterthereversaloftheeffectsof(dex)medetomidine.

Atipamezoledoesnotreversetheeffectofketamine,whichcancause

seizuresindogsandcausecrampsincatswhenusedalone.Donot

administeratipamezolewithin30-40minutesofprioradministrationof

ketamine.

ii)Specialprecautionsforthepersonadministeringtheveterinarymedicinal

producttoanimals

Duetothepotentpharmacologicalactivityofatipamezole,contactofthe

productwithskin,eyesandmucousmembranesshouldbeavoided.In

caseofaccidentalspillage,washtheaffectedareaimmediatelywith

cleanrunningwater.Seekmedicalattentionifirritationpersists.Remove

contaminatedclothesthatareindirectcontactwithskin.

Careshouldbetakentoavoidaccidentalingestionorself-injection.In

caseofaccidentalself-injectionoringestion,seekmedicaladvice

immediatelyandshowthepackageleafletorthelabeltothephysician.

Donotdrive.Thepatientshouldnotbeleftunattended.

iii)Otherprecautions

None.

4.6Adversereactions(frequencyandseriousness)

Atransienthypotensiveeffecthasbeenobservedduringthefirsttenminutes

post-injectionofatipamezolehydrochloride.Rarecasesofhyperactivity,

tachycardia,salivation,abnormalvocalization,muscletremors,vomiting,

increasedrespiratoryrate,uncontrolledurinationanduncontrolleddefecation

wereobserved.Veryrarecasesofrecurrentsedationmayoccurorthe

recoverytimemaynotbeshortenedaftertheadministrationofatipamezole.

Incats,whenusinglowdosestopartiallyreversetheeffectsofmedetomidine

ordexmedetomidine,thepossibilityofhypothermia(evenwhenarousedfrom

sedation)shouldbeguardedagainst.

4.7Useduringpregnancy,lactationorlay

Thesafetyoftheproducthasnotbeenestablishedduringpregnancyand

lactation.Thereforetheuseisnotrecommendedduringpregnancyand

lactation.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

ConcurrentuseofatipamezolewithotherdrugsaffectingtheCentralnervous

systemsuchasdiazepam,acepromazineoropiatesisnotrecommended.

4.9Amount(s)tobeadministeredandadministrationroute

Forsingleintramuscularuse.

Thedosedependsonthepreviouslyadministeredmedetomidineor

dexmedetomidinedose.Atipamezolehydrochlorideisadministered15 –60min

aftermedetomidineordexmedetomidinehydrochloridinjection.

Dogs:Thedoseofatipamezolehydrochloride(inµgperkgofbodyweight)is

fivetimesthatofthepreviousdoseofmedetomidinehydrochlorideortentimes

thatofthedoseofdexmedetomidinehydrochloride.

Duetothe5-foldhigherconcentrationoftheactiveingredient(atipamezole

hydrochloride)inthisproductcomparedtothatofpreparationscontaining1mg

medetomidinehydrochlorideperml,andthe10-foldconcentrationcomparedto

thatpreparationscontaining0.5mgdexmedetomidinehydrochloride,anequal

volumeofeachpreparationisrequired.Duetothe50-foldconcentration

comparedtothatpreparationscontaining0.1mgdexmedetomidine

hydrochloride,avolume5timesloweroftheatipamezolepreparationis

required.

Dosageexampledogs

Medetomidine1.0mg/mlsolution

forinjectiondosage Atipamezolehydrochloride

5.0mg/mlsolutionforinjection

dosage

0.04ml/kgbodyweight(bw),

correspondingwith40μg/kgbw 0.04ml/kgbodyweight(bw),

correspondingwith200μg/kgbw

Dexmedetomidine0.5mg/ml

solutionforinjectiondosage Atipamezolehydrochloride

5.0mg/mlsolutionforinjection

dosage

0.04ml/kgbodyweight(bw),

correspondingwith20μg/kgbw 0.04ml/kgbodyweight(bw),

correspondingwith200μg/kgbw

Dexmedetomidine0.1mg/ml

solutionforinjectiondosage Atipamezolehydrochloride

5.0mg/mlsolutionforinjection

dosage

0.2ml/kgbodyweight(bw),

correspondingwith2 0μg/kgbw 0.04ml/kgbodyweight(bw),

correspondingwith200μg/kgbw

Cats:Thedoseofatipamezolehydrochloride(inµgperkgofbodyweight)is

2.5timesthatofthepreviousdoseofmedetomidinehydrochlorideor5times

thatofthedoseofdexmedetomidinehydrochloride.Duetothe5-fold

concentrationoftheactiveingredient(atipamezolehydrochloride)inthis

productcomparedtothatofpreparationscontaining1mgmedetomidine

hydrochloridepermlandthe10-foldconcentrationcomparedtothatof

preparationscontaining0.5mgdexmedetomidinehydrochloride,halfthe

volumeoftheproducttothatofthepreviouslyadministeredmedetomidineor

dexmedetomidineshouldbegiven.Duetothe50-foldconcentrationcompared

tothatpreparationscontaining0.1mgdexmedetomidinehydrochloride,a

volume10timesloweroftheatipamezolepreparationisrequired.

Dosageexamplecats:

Medetomidine1.0mg/mlsolution

forinjectiondosage Atipamezolehydrochloride

5.0mg/mlsolutionforinjection

dosage

0.08ml/kgbodyweight(bw),

correspondingwith80μg/kgbw 0.04ml/kgbodyweight(bw),

correspondingwith200μg/kgbw

Dexmedetomidine0.5mg/ml

solutionforinjectiondosage Atipamezolehydrochloride

5.0mg/mlsolutionforinjection

dosage

0.08ml/kgbodyweight(bw),

correspondingwith40μg/kgbw 0.04ml/kgbodyweight(bw),

correspondingwith200μg/kgbw

Dexmedetomidine0.1mg/ml

solutionforinjectiondosage Atipamezolehydrochloride

5.0mg/mlsolutionforinjection

dosage

0.4ml/kgbodyweight(bw),

correspondingwith4 0μg/kgbw 0.04ml/kgbodyweight(bw),

correspondingwith200μg/kgbw

Therecoverytimefordogsandcatsisshortenedtoapproximately5minutes.

Theanimalbecomesmobileapproximately10minutesafteradministrationof

theproduct.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Overdoseofatipamezolehydrochloridemayresultintransienttachycardiaand

over-alertness(hyperactivity,muscletremors).Ifnecessary,thesesigns may

bereversedbyamedetomidineordexmedetomidinehydrochloridedosewhich

islowerthanusuallyusedclinically.

Ifatipamezolehydrochlorideisinadvertentlyadministeredtoananimalnot

previouslytreatedwithmedetomidineordexmedetomidinehydrochloride,

hyperactivityandmuscletremorsmayoccur.Theseeffectsmaypersistfor

about15minutes.

Over-alertnessinthecatisbesthandledbyminimizingexternalstimuli.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup: α2-receptorantagonist(Antidote)

ATCVetCode:QV03AB90

5.1Pharmacodynamicproperties

Atipamezoleisaselectiveandpotentagentwhichblocksthe 

-2receptors( 

2antagonist)whichinducesthereleaseofaneurotransmitter,noradrenalin,in

centralandperipheralnervoussystemwhichresultsinanactivationofthe

central nervous system through sympathetic activation. Other

pharmacodynamiceffectsthatmaybeobserved,suchasinfluenceonthe

cardiovascularsystem,forexample,arelight.However,atransientdecreasein

bloodpressuremaybeobservedinthefirst10minutesaftertheinjectionof

atipamezolehydrochloride.

As 

-2antagonist,atipamezoleiscapableofeliminating(orinhibiting)the

effects of the 

-2 receptor agonists such as medetomidineor

dexmedetomidine.Likewise,atipamezolereversesthesedativeeffectsof

(dex)medetomidinehydrochlorideindogsandcats,whoseconditionreturnsto

normalandmaycauseatransientincreaseintheheartrate.

5.2Pharmacokineticparticulars

Atipamezolehydrochlorideisquicklyabsorbedafterintramuscularinjection.Itis

alsoquicklyandcompletelymetabolised.Metabolitesareexcretedmainlyin

urineandfaecesinsmallamounts.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Methylparahydroxybenzoate(E218)

SodiumChloride

Waterforinjections

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmust

notbemixedwithotherveterinarymedicinalproductsinthesamesyringe.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:30months.

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days.

6.4Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorage

conditions.

Nospecialstorageconditionsofmedicinalproductarerequiredafterfirst

openingthecontainer.

6.5Natureandcompositionofimmediatepackaging

ColourlessglasstypeIvialcontaining10ml whichisfittedwithabromobutyl

rubberstoppersealedwith aluminiumcapswithplasticflip-off.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts,if

appropriate

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

VETPHARMAANIMALHEALTH,S.L.

C/LesCorts,23

08028Barcelona

Spain

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION

Date:

10.DATEOFREVISIONOFTHETEXT

Date:

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

[ES]

Suppliedonlyonveterinaryprescription

Administeredonlybyaveterinarysurgeon

4-12-2018

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochloroth...

FDA - U.S. Food and Drug Administration

28-11-2018

Enforcement Report for the Week of November 28, 2018

Enforcement Report for the Week of November 28, 2018

Recently Updated Records for the Week of November 28, 2018 Last Modified Date: Tuesday, November 27, 2018

FDA - U.S. Food and Drug Administration

28-11-2018

EFSA Scientific Colloquium 24 – 'omics in risk assessment: state of the art and next steps

EFSA Scientific Colloquium 24 – 'omics in risk assessment: state of the art and next steps

Published on: Tue, 27 Nov 2018 In recent years, the development of innovative tools in genomics, transcriptomics, proteomics and metabolomics (designated collectively as 'omics technologies) has opened up new possibilities for applications in scientific research and led to the availability of vast amounts of analytical data. The interpretation and integration of 'omics data can provide valuable information on the functional status of an organism and on the effect of external factors such as stressors. T...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

Human placenta products for consumption not authorized in Canada, may pose serious health risks

Human placenta products for consumption not authorized in Canada, may pose serious health risks

November 27, 2018 For immediate release

Health Canada

31-10-2018

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft guidance on the scientific requirements for health claims related to muscle function and physical performance, prepared by the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), supported by the Working Group on Claims. The draft guidance was endorsed by the Panel for public consultation ...

Europe - EFSA - European Food Safety Authority Publications

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

9-10-2018

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

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

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

FDA - U.S. Food and Drug Administration

5-10-2018

FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old

FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old

FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old

FDA - U.S. Food and Drug Administration

3-10-2018

Enforcement Report for the Week of October 03, 2018

Enforcement Report for the Week of October 03, 2018

Recently Updated Records for the Week of October 03, 2018 Last Modified Date: Thursday, September 27, 2018

FDA - U.S. Food and Drug Administration

28-9-2018

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Published on: Thu, 27 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, France, for the pesticide active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Enforcement Report for the Week of November 02, 2016

Enforcement Report for the Week of November 02, 2016

Recently Updated Records for the Week of November 02, 2016 Last Modified Date: Thursday, September 27, 2018

FDA - U.S. Food and Drug Administration

27-9-2018

Health Canada reminds Canadians not to mix caffeinated drinks with alcohol

Health Canada reminds Canadians not to mix caffeinated drinks with alcohol

September 27, 2018 Ottawa Health Canada

Health Canada

24-9-2018

Bezoek Staatssecretaris Blokhuis aan VN in teken van strijd tegen roken

Bezoek Staatssecretaris Blokhuis aan VN in teken van strijd tegen roken

Staatssecretaris Paul Blokhuis is van dinsdag 25 t/m donderdag 27 september in New York voor een bezoek aan de Algemene Vergadering van de Verenigde Naties. Voor Blokhuis staat tijdens zijn bezoek het tabaksontmoedigingsbeleid centraal.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

22-9-2018

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for...

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The goal of this research is to better address the problems related to the widespread presence of pesticides in the environment. Despite the unquestionable utility of the pesticides against various pests in the agricultural field, most pesticides and the corresponding pesticide residues are toxic to the environment and hazardous to human health. The recent literature on organophosphate compounds emphasises a clear correlation between their use and the occurr...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

Use of next‐generation sequencing in microbial risk assessment

Use of next‐generation sequencing in microbial risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Despite the ever increase in rigorous control and monitoring measures to assure safe food along the entire farm‐to‐fork chain, the past decade has also witnessed an increase in microbial food alerts. Hence, research on food safety and quality remain of utmost importance. Complementary, and at least as important, is the necessity to be able to assess the potential microbial risks along the food chain. Risk assessment relies on sound scientific data. Unfortuna...

Europe - EFSA - European Food Safety Authority Publications

12-9-2018

Application of data science in risk assessment and early warning

Application of data science in risk assessment and early warning

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The currently applied approaches, procedures and tools used for the identification of emerging risks vary greatly among Member States of the EU. EFSA established a structured approach for emerging risk identification that mainly consists of systematically searching, collecting, collating and analysing information and data. In addition, EFSA concluded that new methodologies and tools are needed to facilitate efficient and transparent sharing of data, knowledg...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk ranking of chemical and microbiological hazards in food

Risk ranking of chemical and microbiological hazards in food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Risk ranking is a versatile tool used to prioritise activities performed by public health regulatory bodies. It also allows efficient communication between all stakeholders in the process of risk analysis. However, risk ranking methods are still not optimal. Because of the different approaches employed in the risk assessment of microbiological agents and chemicals, it is difficult to rank them together using the same metrics. In our work, we first discuss di...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Antimicrobial resistance (AMR) represents a major challenge for Public Health and the scientific community, and requires immediate and drastic solutions. Acquired resistance to certain antimicrobials is already widespread to such an extent that their efficacy in the treatment of certain life‐threatening infections is already compromised. To date, the emergence and spread of AMR has been attributed to the use, misuse or indiscriminate use of antibiotics as th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Published on: Mon, 27 Aug 2018 00:00:00 +0200 EFSA regards the household as a stage in the food chain that is important for the final number of food‐borne infections. The fate of a pathogen in the private kitchen largely depends on consumer hygiene during preparation of food and on its proper cooking, especially in the case of meat. Unfortunately, detailed information on the microbiological survival in meat products after heating in the consumer kitchen is lacking. The aim of the study was to improve th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Plant protection products (PPPs) are pesticides containing at least one active substance that drives specific actions against pests (diseases). PPPs are regulated in the EU and cannot be placed on the market or used without prior authorisation. EFSA assesses the possible risks of the use of active substances to humans and environment. Member States decide whether or not to approve their use at EU level. Furthermore, Member States decide at national level on ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Heat processing of food gives rise to a plethora of chemical compounds whose toxicological effects are largely unknown. Due to a general lack of experimental toxicological data, assessing the risks associated with the consumption of these substances remains a challenge. Computer models that allow for an in silico prediction of physicochemical and toxicological characteristics, may be able to fill current data gaps and facilitate the risk assessment of toxico...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Livestock Health and Food Chain Risk Assessment

Livestock Health and Food Chain Risk Assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EUFORA fellowship programme ‘Livestock Health and Food Chain Risk Assessment’ was proposed by the Animal and Plant Health Agency (APHA), a British governmental institution responsible for safeguarding animal and plant health in the UK. The working programme, which was organised into four different modules, covered a wide range of aspects related to risk assessment including identification of emerging risks, risk prioritisation methods, scanning surveilla...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Preparation of Dutch food consumption data for risk assessment

Preparation of Dutch food consumption data for risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The availability of detailed and high‐quality food consumption data collected at an individual level is essential for assessing the exposure to potential risks in the food chain. During the years 2012–2016, the Dutch National Food Consumption Survey was conducted in the Netherlands as part of the EU Menu survey, following the EFSA 2009 guidance on ‘General principles for the collection of national food consumption data in the view of a pan‐European dietary s...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EFSA Panel on Plant Protection Products and their Residues reviewed the guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessment. The inclusion of aged sorption is a higher tier in the groundwater leaching assessment. The Panel based its review on a test with three substances taken from a data set provided by the European Crop Protection Association. Particular points of attention were the quali...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 27 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance prochloraz. To assess the occurrence of prochloraz residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Published on: Mon, 27 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRL) for the active substance prohexadione in linseeds, poppy seeds, sunflower seeds, rape seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all oilseeds under consid...

Europe - EFSA - European Food Safety Authority Publications

1-8-2018

Enforcement Report for the Week of August 01, 2018

Enforcement Report for the Week of August 01, 2018

Recently Updated Records for the Week of August 01, 2018 Last Modified Date: Friday, July 27, 2018

FDA - U.S. Food and Drug Administration

27-11-2018

Pifeltro (Merck Sharp and Dohme B.V.)

Pifeltro (Merck Sharp and Dohme B.V.)

Pifeltro (Active substance: doravirine) - Centralised - Authorisation - Commission Decision (2018)7983 of Tue, 27 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4747

Europe -DG Health and Food Safety

27-11-2018

Soliris (Alexion Europe SAS)

Soliris (Alexion Europe SAS)

Soliris (Active substance: Eculizumab) - Centralised - Yearly update - Commission Decision (2018)7968 of Tue, 27 Nov 2018

Europe -DG Health and Food Safety

24-9-2018

News and press releases:  EMA to launch new corporate website on 27 September 2018

News and press releases: EMA to launch new corporate website on 27 September 2018

Fresh design and improved features to provide better user experience

Europe - EMA - European Medicines Agency

28-8-2018

 Minutes - PDCO minutes of the 24-27 July 2018 meeting

Minutes - PDCO minutes of the 24-27 July 2018 meeting

Paediatric Committee (PDCO) minutes of the meeting on 24-27 July 2018

Europe - EMA - European Medicines Agency

27-8-2018

Nivestim (Pfizer Europe MA EEIG)

Nivestim (Pfizer Europe MA EEIG)

Nivestim (Active substance: Filgrastim) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5683 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1142/T/51

Europe -DG Health and Food Safety

27-8-2018

Biktarvy (Gilead Sciences Ireland UC)

Biktarvy (Gilead Sciences Ireland UC)

Biktarvy (Active substance: bictegravir / emtricitabine / tenofovir alafenamide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5680 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004449/T/0001

Europe -DG Health and Food Safety

27-8-2018

Somavert (Pfizer Europe MA EEIG)

Somavert (Pfizer Europe MA EEIG)

Somavert (Active substance: Pegvisomant ) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5684 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000409/T/0087

Europe -DG Health and Food Safety

27-8-2018

Opsumit (Actelion Registration Ltd)

Opsumit (Actelion Registration Ltd)

Opsumit (Active substance: macitentan) - Centralised - Renewal - Commission Decision (2018)5713 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2697/R/27

Europe -DG Health and Food Safety

27-8-2018

Mepsevii (Ultragenyx Germany GmbH)

Mepsevii (Ultragenyx Germany GmbH)

Mepsevii (Active substance: vestronidase alfa) - Centralised - Authorisation - Commission Decision (2018)5714 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4438

Europe -DG Health and Food Safety

27-8-2018

Beromun (BELPHARMA s.a.)

Beromun (BELPHARMA s.a.)

Beromun (Active substance: Tasonermin (Tumor Necrosis Factor alfa-1a)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5699 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/206/T/40

Europe -DG Health and Food Safety

27-8-2018

Strimvelis (Orchard Therapeutics (Netherlands) B.V.)

Strimvelis (Orchard Therapeutics (Netherlands) B.V.)

Strimvelis (Active substance: autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5703 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3854/T/14

Europe -DG Health and Food Safety

27-8-2018

Steglujan (Merck Sharp and Dohme B.V.)

Steglujan (Merck Sharp and Dohme B.V.)

Steglujan (Active substance: ertugliflozin / sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5698 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4313T/04

Europe -DG Health and Food Safety

27-8-2018

Firazyr (Shire Pharmaceuticals Ireland Limited)

Firazyr (Shire Pharmaceuticals Ireland Limited)

Firazyr (Active substance: icatibant) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5697 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/899T/41

Europe -DG Health and Food Safety

27-8-2018

Duzallo (GrUnenthal GmbH)

Duzallo (GrUnenthal GmbH)

Duzallo (Active substance: allopurinol / lesinurad) - Centralised - Authorisation - Commission Decision (2018)5696 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4412

Europe -DG Health and Food Safety

27-8-2018

Vyxeos (Jazz Pharmaceuticals Ireland Ltd)

Vyxeos (Jazz Pharmaceuticals Ireland Ltd)

Vyxeos (Active substance: daunorubicin / cytarabine) - Centralised - Authorisation - Commission Decision (2018)5695 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4282

Europe -DG Health and Food Safety

27-8-2018

Evicel (Omrix Biopharmaceuticals N.V.)

Evicel (Omrix Biopharmaceuticals N.V.)

Evicel (Active substance: human fibrinogen / human thrombin) - Centralised - Renewal - Commission Decision (2018)5689 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/898/R/54

Europe -DG Health and Food Safety

27-8-2018

Aranesp (Amgen Europe B.V.)

Aranesp (Amgen Europe B.V.)

Aranesp (Active substance: darbepoetin alfa) - Centralised - Yearly update - Commission Decision (2018)5707 of Mon, 27 Aug 2018

Europe -DG Health and Food Safety

27-8-2018

Yescarta (Kite Pharma EU B.V.)

Yescarta (Kite Pharma EU B.V.)

Yescarta (Active substance: axicabtagene ciloleucel) - Centralised - Authorisation - Commission Decision (2018)5718 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4480

Europe -DG Health and Food Safety

27-8-2018

Kymriah (Novartis Europharm Limited)

Kymriah (Novartis Europharm Limited)

Kymriah (Active substance: tisagenlecleucel) - Centralised - Authorisation - Commission Decision (2018)5717 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4090

Europe -DG Health and Food Safety

27-8-2018

Entyvio (Takeda Pharma A/S)

Entyvio (Takeda Pharma A/S)

Entyvio (Active substance: vedolizumab) - PSUSA - Modification - Commission Decision (2018)5712 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10186/201711

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

27-8-2018

RoActemra (Roche Registration GmbH)

RoActemra (Roche Registration GmbH)

RoActemra (Active substance: tocilizumab) - Centralised - 2-Monthly update - Commission Decision (2018)5687 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/955/II/78

Europe -DG Health and Food Safety

27-7-2018

EU/3/11/890 (Kowa Pharmaceutical Europe GmbH)

EU/3/11/890 (Kowa Pharmaceutical Europe GmbH)

EU/3/11/890 (Active substance: Peretinoin) - Transfer of orphan designation - Commission Decision (2018)5056 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/003/11/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/14/1410 (Chiesi Farmaceutici S.p.A.)

EU/3/14/1410 (Chiesi Farmaceutici S.p.A.)

EU/3/14/1410 (Active substance: Recombinant human aspartylglucosaminidase) - Transfer of orphan designation - Commission Decision (2018)5051 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/172/14/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/11/911 (Chiesi Farmaceutici S.p.A.)

EU/3/11/911 (Chiesi Farmaceutici S.p.A.)

EU/3/11/911 (Active substance: Recombinant human galactocerebrosidase) - Transfer of orphan designation - Commission Decision (2018)5050 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/042/11/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/18/2019 (Reata UK Limited)

EU/3/18/2019 (Reata UK Limited)

EU/3/18/2019 (Active substance: Bardoxolone methyl) - Transfer of orphan designation - Commission Decision (2018)5055 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/011/18/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/06/363 (Telix Pharmaceuticals Holdings Germany GmbH)

EU/3/06/363 (Telix Pharmaceuticals Holdings Germany GmbH)

EU/3/06/363 (Active substance: 4-[131I]iodo-L-phenylalanine) - Transfer of orphan designation - Commission Decision (2018)5036 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/05/T/02

Europe -DG Health and Food Safety

27-7-2018

EU/3/15/1473 (Celgene Europe B.V.)

EU/3/15/1473 (Celgene Europe B.V.)

EU/3/15/1473 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5042 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/284/14/T/01

Europe -DG Health and Food Safety