Quetiapin "Accord"

Primær information

  • Handelsnavn:
  • Quetiapin "Accord" 300 mg filmovertrukne tabletter
  • Dosering:
  • 300 mg
  • Lægemiddelform:
  • filmovertrukne tabletter
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Quetiapin "Accord" 300 mg filmovertrukne tabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 45447
  • Sidste ændring:
  • 17-07-2018

Indlægsseddel

INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN

Quetiapine Accord 25 mg filmovertrukne tabletter

Quetiapine Accord 100 mg filmovertrukne tabletter

Quetiapine Accord 150 mg filmovertrukne tabletter

Quetiapine Accord 200 mg filmovertrukne tabletter

Quetiapine Accord 300 mg filmovertrukne tabletter

Quetiapin

Læs denne indlægsseddel grundigt inden De begynder at tage medicinen.

Gem indlægssedlen. De kan få brug for at læse den igen.

Spørg lægen eller på apoteket, hvis der er mere, De vil vide.

Lægen har ordineret Quetiapine Accord til Dem personligt. Lad

derfor være med at give det til andre. Det kan være skadeligt for

andre, selvom de har de samme symptomer, som De har.

Tal l med lægen eller apoteket, hvis en bivirkning bliver værre, eller

De får bivirkninger, som ikke er nævnt her.

Oversigt over indlægssedlen:

1. Virkning og anvendelse

2. Det skal De vide, før De begynder at tage Quetiapine Accord

3. Sådan skal De tage Quetiapine Accord

4. Bivirkninger

5. Opbevaring

6. Yderligere oplysninger

1. Virkning og anvendelse

Quetiapine Accord indeholder et stof, der hedder quetiapin. Det tilhører en gruppe

lægemidler, som kaldes antipsykotika. Disse lægemidler bruges mod lidelser, der

forårsager symptomer som f.eks.:

De ser, hører eller føler måske ting, der ikke er der, tror på ting, der ikke er sande,

eller føler Dem usædvanligt mistænksom, angst, forvirret, skyldig, anspændt eller

deprimeret.

De kan føle Dem meget opstemt, opløftet, ophidset, begejstret eller hyperaktiv

eller have

dårlig dømmekraft, som omfatter aggressiv eller destruktiv opførsel.

Påvirkninger

Deres

sindsstemning,

hvor

føler

eller

deprimeret, har skyldfølelse, mangler energi, mister appetitten og/eller har svært

ved at sove.

Deres læge vil måske fortsætte med ordinere Quetiapine Accord til Dem, selv om De

får det bedre, for at forhindre, at symptomerne vender tilbage.

Det kan være en god idé at fortælle en ven eller slægtning, at De lider af disse

symptomer, og bede dem læse denne indlægsseddel. Bed dem sige til, hvis de mener,

symptomerne bliver værre, eller de er bekymret over andre ændringer i Deres adfærd.

2. Det skal De vide, før De begynder at tage Quetiapine Accord

Tag ikke Quetiapine Accord:

hvis

overfølsom

(allergisk)

over

quetiapin

eller

øvrige

indholdsstoffer (se pkt. 6: Yderligere oplysninger).

hvis De tager et af følgende lægemidler:

- proteasehæmmere som f.eks. nelfinavir (mod HIV-infektion)

- lægemidler, der indeholder azoler (mod svampeinfektioner)

- medicin mod infektioner (som f.eks. erythromycin eller clarithromycin)

- nefazodon (mod depression).

Tag ikke Quetiapine Accord, hvis ovenstående gælder for Dem. Hvis De er usikker,

så tal altid med Deres læge eller apoteket, inden De tager Quetiapine Accord.

Vær ekstra forsigtig med at tage Quetiapine Accord:

Quetiapin bør ikke tages af ældre med demens (tab af hjernefunktion). Det

skyldes, at den gruppe lægemidler, som Quetiapin tilhører, øger risikoen for

slagtilfælde og i nogle tilfælde risikoen for død, hos ældre med demens.

Tal med Deres læge, før De tager Deres medicin, hvis:

De eller nogen i Deres familie har eller har haft hjerteproblemer, f.eks. problemer

med hjerterytmen.

De har lavt blodtryk.

De har haft et slagtilfælde, specielt hvis De er ældre.

De har problemer med leveren.

De har haft krampeanfald.

De har sukkersyge eller har risiko for at få det. Hvis dette er tilfældet, kan det være,

at Deres læge kontrollerer Deres blodsukkerniveau, mens De tager Quetiapine

Accord.

De ved, at De tidligere har haft et lavt antal hvide blodceller (som måske eller

måske ikke har været forårsaget af andre lægemidler).

De eller nogen i Deres familie har haft blodpropper, da denne type medicin kan

medføre dannelse af blodpropper.

Tal med Deres læge med det samme, hvis De får:

Forhøjet temperatur (feber), muskelstivhed eller føler Dem forvirret.

Ufrivillige bevægelser, specielt i ansigtet eller tungen.

Føler Dem meget træt.

Disse tilstande kan skyldes denne type lægemidler.

Selvmordstanker og forværring af Deres depression

Hvis De er deprimeret, har De måske nogle gange tanker om at skade Dem selv eller

begå selvmord. Disse tanker kan øges, når De begynder på at tage Deres medicin, da

der går noget tid, inden denne type lægemidler virker, normalt omkring to uger, men

nogle gange længere tid. Det kan også være, at De får flere af disse tanker, hvis De

pludselig stopper med at tage deres medicin. Det er sandsynligt, at De vil have lettere

ved at få sådanne tanker, hvis De er en ung, voksen person. Information fra kliniske

forsøg viser, at der er en øget risiko for selvmordstanker og/eller selvmordsadfærd hos

yngre voksne under 25 år med depression.

Hvis De på noget tidspunkt har tanker om at skade Dem selv eller begå selvmord, skal

De straks kontakte din læge eller tage på hospitalet. Det kan være en hjælp at fortælle

en slægtning eller en god ven, at De er deprimeret, og bede dem læse denne

indlægsseddel. Bed dem sige til, hvis de mener, symptomerne bliver værre, eller de er

bekymret over andre ændringer i Deres adfærd.

Brug af anden medicin:

Fortæl det altid til lægen eller på apoteket, hvis De tager anden medicin eller har taget

det for nylig, da det kan påvirke den måde, medicinen virker på. Dette gælder også

medicin, som ikke er købt på recept og naturmedicin.

De må ikke tage Quetiapine Accord, hvis De tager et af følgende lægemidler:

visse lægemidler mod HIV.

lægemidler, der indeholder azoler (mod svampeinfektioner)

medicin mod infektioner (som f.eks. erythromycin eller clarithromycin)

nefazodon (mod depression).

Fortæl det til lægen, hvis De tager et af følgende lægemidler:

lægemidler mod epilepsi (f.eks. phenytoin eller carbamazepin).

lægemidler mod forhøjet blodtryk.

Barbiturater (mod søvnbesvær).

thioridazin (et andet antipsykotika).

Tal med din læge, før De stopper med at tage Deres medicin.

Brug af Quetiapine Accord sammen med mad og drikke:

Quetiapin kan tages med eller uden mad.

Pas på med hvor meget alkohol De indtager. Dette skyldes, at den kombinerede

virkning af

Quetiapine Accord og alkohol kan gøre Dem søvnig.

Drik ikke grapefrugtjuice, når De tager Quetiapine Accord, da det kan påvirke

virkningen af lægemidlet.

Graviditet og amning:

Hvis De er gravid, forsøger at blive gravid eller ammer, bør De tale med din læge, før

De tager

Quetiapine Accord. De bør ikke tage Quetiapine Accord under graviditet, medmindre

De har aftalt det med din læge. De må ikke tage Quetiapine Accord, mens De ammer.

De følgende symptomer kan forekomme hos nyfødte, hvis moderen har anvendt

Quetiapine i det sidste trimester (de sidste tre måneder af graviditeten): rysten,

muskelstivhed og/eller svaghed, søvnighed, ophidselse, vejrtrækningsproblemer og

problemer med fødeindtagelse. Hvis dit barn får disse symptomer, skal du kontakte

din læge.

Trafik- og arbejdssikkerhed:

Quetiapin kan gøre Dem søvnig. De må ikke køre bil eller arbejde med maskiner, før

De ved,

hvordan tabletterne påvirker Dem.

Vigtig information om nogle af de øvrige indholdsstoffer i Quetiapine Accord:

Quetiapine Accord indeholder lactose, der er en sukkerart. Hvis Deres læge har fortalt

Dem, at De ikke kan tåle visse sukkerarter, skal De kontakte lægen, før De tager dette

lægemiddel.

3. Sådan skal De tage Quetiapine Accord

Tag altid Quetiapine Accord nøjagtigt efter lægens anvisning. Er De i tvivl, så spørg

lægen eller på apoteket. Deres læge vil bestemme, hvilken dosis De skal starte med,

og vil måske øge Deres dosis gradvist. Herefter vil Deres dosis normalt være mellem

150 mg og 800 mg, men Dette vil afhænge af Deres sygdom og Deres behov.

Deres læge vil måske give Dem en lavere dosis i begyndelsen og øge Deres dosis

langsomt, hvis:

- De er ældre, eller

- De har leverproblemer.

De skal tage tabletten én gang dagligt ved sengetid eller to gange dagligt afhængig

af Deres sygdom.

Synk tabletterne hele med et glas vand.

De kan tage tabletterne med eller uden mad.

Drik ikke grapefrugtjuice, når De tager

Quetiapine Accord. Det kan påvirke

lægemidlets effekt.

Stop ikke med at tage tabletterne, selvom De føler, at De har det bedre, medmindre

Deres læge siger, De skal stoppe.

Børn og unge under 18 år

Quetiapine Accord må ikke tages af børn og unge under 18 år.

Hvis De har taget for mange Quetiapine Accord

Hvis De tager flere Quetiapine Accord, end Deres læge har ordineret, kan De blive

søvnig, svimmel og få uregelmæssig hjertebanken. Kontakt straks din læge eller

nærmeste hospital. Tag Quetiapine Accordne med Dem.

Hvis De har glemt at tage Quetiapine Accord

Hvis De glemmer at tage en dosis, så tag den, så snart De kommer i tanke om det.

Hvis det er tæt på at være tid til den næste dosis, så vent bare indtil da. De må ikke

tage en dobbeltdosis som erstatning for den glemte tablet.

Hvis De holder op med at tage Quetiapine Accord

I Hvis De pludselig stopper med at tage Quetapin tabletter, kan det være, at De får

svært ved at sove, får kvalme eller hovedpine, diarré, opkastning, bliver svimmel eller

irritabel. Deres læge kan derfor foreslå at mindske Deres dosis gradvist, før De

stopper behandlingen.

Spørg lægen eller på apoteket, hvis der er noget, De er i tvivl om.

4. Bivirkninger

Quetiapine Accord kan som al anden medicin give bivirkninger, men ikke alle får

bivirkninger. Tal med lægen eller apoteket, hvis en bivirkning er generende eller

bliver værre, eller De får bivirkninger, som ikke er nævnt her.

Meget almindelig (forekommer hos flere end 1 ud af 10 patienter):

svimmelhed (kan medføre fald), hovedpine, tør mund.

søvnighed (forsvinder oftest med tiden, når De fortsætter med at tage

Quetiapine Accord).

seponeringssymptomer (symptomer som forekommer, når De stopper med at

tage quetiapin),

kan omfatte søvnløshed, kvalme, hovedpine, diarré, opkastning, svimmelhed og

irritabilitet. De forsvinder som regel inden for 1 uge efter sidste dosis.

vægtøgning.

Almindelig (forekommer hos færre end 1 ud af 10 patienter):

Hurtig hjertebanken

Tilstoppet næse

Forstoppelse, irriteret mave (fordøjelsesbesvær)

Følelse af at være svag, besvimelse (kan medføre fald)

Hævelser i armen eller ben

Fald i blodtryk når De rejser Dem op. De kan føle Dem svimmel eller besvime

(kan medføre fald)

Øget blodsukker

Sløret syn

Unormale muskelbevægelser. Der kan være problemer med at få gang i

musklerne, rysten, rastløshed eller muskelstivhed uden smerte

Abnorme drømme og mareridt

Øget sultfornemmelse

Irritabilitet

Tale- og sprogforstyrrelser

Ikke almindelig (forekommer hos 1 til 10 ud af 1000 patienter):

Krampeanfald

Overfølsomhedsreaktioner, der kan omfatte knopper, hævelse i huden og

hævelser omkring munden

Ubehagelig følelse i benene (uro i benene).

Synkebesvær

Ufrivillige bevægelser, særligt i ansigt og tunge

Sjælden (forekommer hos 1 til 10 ud af 10.000 patienter):

Forhøjet temperatur (feber), ondt i halsen over længere tid eller mundsår, hurtigt

åndedræt, svedeture, muskelstivhed, følelse af stærk døsighed eller besvimelse.

Gulfarvning af hud og øjne (gulsot).

En langvarig og smertefuld erektion (priapismus).

Øget brystudvikling og uventet produktion af brystmælk (galaktoré).

Blodpropper i venerne, særligt i benene (symptomerne omfatter hævelse, smerte

og rødmen af

benet), som gennem blodårerne kan transporteres til lungerne og forårsage

smerter i brystet og problemer med at trække vejret.

Meget sjælden (forekommer hos færre end 1 ud af 10.000 patienter):

Forhøjet blodsukker eller forværring af eksisterende sukkersyge.

Leverbetændelse (hepatitis).

Alvorligt udslæt, blærer eller røde pletter på huden.

En alvorlig allergisk reaktion (anafylakse), som kan medføre åndedrætsbesvær

og shock.

Hurtig hævelse af huden, som regel omkring øjnene, læber og hals (angioødem).

Den gruppe af lægemidler, som Quetiapin tilhører, kan forårsage problemer med

hjerterytmen, som kan være alvorlige og i værste fald medføre døden.

Nogle bivirkninger kan kun ses, når der tages en blodprøve. Det kan være ændringer i

mængden af visse fedttyper (triglycerider og totalkolesterol) eller sukker i blodet, fald

i mængden af

visse typer blodlegemer og stigninger i mængden af hormonet prolaktin i blodet.

Stigninger i hormonet prolaktin kan i sjældne tilfælde medføre følgende:

Mænd og kvinder kan få øget brystudvikling og uventet produktion af

brystmælk (galaktoré).

Kvinder kan få manglende eller uregelmæssig menstruation.

Det kan være, at din læge tager blodprøver ind imellem.

Børn og unge:

De bivirkninger, der kan forekomme hos voksne, kan også forekomme hos børn og

unge.

De følgende bivirkninger er kun observeret hos børn og unge voksne:

Meget almindelig (forekommer hos flere end 1 ud af 10 patienter):

Øget blodtryk.

De følgende bivirkninger er kun observeret hyppigere hos børn og unge voksne:

Meget almindelig (forekommer hos flere end 1 ud af 10 patienter):

Stigninger i mængden af et hormon, der kaldes prolaktin, der i sjældne tilfælde

kan medføre følgende:

Drenge og piger kan få øget brystudvikling og uventet produktion af

brystmælk.

Piger kan få manglende eller uregelmæssig menstruationen.

Øget appetit.

Ufrivillige muskelbevægelser. Der kan være problemer med at få gang i

musklerne, rysten, rastløshed eller muskelstivhed uden smerte.

5. Opbevaring

Opbevares utilgængeligt for børn.

Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.

Brug ikke Quetiapine Accord efter den udløbsdato, der står på kartonen eller

blisterpakningen. Udløbsdatoen (EXP) er den sidste dag i den nævnte måned.

Spørg på apoteket, hvordan De skal aflevere medicinrester. Af hensyn til miljøet

må De ikke smide

medicinrester i afløbet, toilettet eller skraldespanden.

6. Yderligere oplysninger

Quetiapine Accord indeholder:

Det aktive stof er quetiapin.

Hver filmovertrukket tablet indeholder 25 mg /100 mg/150 mg/200 mg/300 mg

quetiapin (som quetiapin hemifumarat).

Øvrige indholdsstoffer:

Tabletkerne:

Lactosemonohydrat,

mikrokrystallinsk

cellulose,

povidon

magnesiumstearat,

natriumstivelsesglycolat

(type

calciumhydrogenphosphatdihydrat.

Filmovertræk:

25 mg: Opadry pink (03B84929)

Hypromellose 6cP

Titandioxid

Macrogol 400

Gul jernoxid

Rød jernoxid

100 mg: Opadry gul (03B52117)

Hypromellose 6cP

Titandioxid

Macrogol 400

Gul jernoxid

150 mg: Opadry gul (03B82929)

Hypromellose 6cP

Titandioxid

Macrogol 400

Gul jerndioxid

200 mg:

Hypromellose E-5

Macrogol 400

Titandioxid

300 mg:

Hypromellose E-5

Macrogol 400

Titanoxid

Udseende og pakningsstørrelse

25 mg tabletter er pink, runde, bikonvekse, filmovertrukne tabletter, jævne på begge

sider.

100 mg tabletter er gule, runde, bikonvekse, filmovertrukne tabletter, jævne på begge

sider.

150 mg tabletter er lysegule, runde, bikonvekse, filmovertrukne tabletter, jævne på

begge sider.

200 mg tabletter er hvide til offwhite, runde, bikonvekse, filmovertrukne tabletter,

jævne på begge sider.

300 mg tabletter er hvide til offwhite, kapselformede, bikonvekse, filmovertrukne

tabletter, mærket med ‘300’ på den ene side, jævne på den anden.

PVC/aluminiumfolieblistere i pakker med 6, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90,

98 og 100 tabletter per karton.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen:

Accord

Healthcare

Limited,

Sage

House,

319,

Pinner

Road,

North

Harrow,

Middlesex, HA1 4HF, Storbritannien

Fremstiller:

Accord

Healthcare

Limited,

Sage

House,

319,

Pinner

Road,

North

Harrow,

Middlesex, HA1 4HF, Storbritannien

Cemelog BRS, H2040 Budaörs, Vasút u. 13, Ungarn

Denne indlægsseddel blev senest godkendt 12/2010.

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Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Modification of the existing maximum residue level for flonicamid in various crops

Modification of the existing maximum residue level for flonicamid in various crops

Published on: Tue, 25 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Ne...

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

The recalled products have not been properly classified according to the Consumer Chemicals and Containers Regulations, 2001, in order to ensure appropriate hazard labelling. These regulations are empowered by the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

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

19-9-2018

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LTZ Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in raspberries, blackberries, currants, blueberries, gooseberries and elderberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under c...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

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

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

Published on: Wed, 12 Sep 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 fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

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

4-9-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Published on: Mon, 03 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 evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Health Canada is advising consumers and pet owners not to use homeopathic and veterinary products made by King Bio Inc. and labeled as "Dr. King's," "Dr King's Natural Pet" or "Natural Pet." These products may pose a health risk to people and pets, especially children, pregnant women and those with compromised immune systems, because of potential microbial contamination. According to the United States Food and Drug Administration, high levels of microbial contamination were identified at the manufacturin...

Health Canada

1-9-2018

Acknowledgement:EFSA  wishes  to  thank  the  rapporteur  Member  State  Denmark  for  thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Acknowledgement:EFSA wishes to thank the rapporteur Member State Denmark for thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Published on: Fri, 31 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 napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

Published on: Fri, 31 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 fenbuconazole. To assess the occurrence of fenbuconazole 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...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

National summary reports on pesticide residue analysis performed in 2016

National summary reports on pesticide residue analysis performed in 2016

Published on: Tue, 07 Aug 2018 00:00:00 +0200 In accordance with Article 31 of Regulation (EC) No 396/2005, European Union (EU) Member States have to communicate to the European Food Safety Authority (EFSA) the results of their official controls on pesticide residues in food. In the framework of this communication, the EU Member States, Iceland and Norway provided a short summary report outlining the main findings of the control activities during the reference year. This technical report is the compilat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Tue, 28 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 sintofen. To assess the occurrence of sintofen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member ...

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

29-8-2018

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

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

Published on: Fri, 24 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 napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

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

29-8-2018

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Published on: Thu, 16 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Sumitomo Chemical Agro Europe SAS submitted a request to the competent national authority in Austria to set an import tolerance for the active substance mandestrobin in strawberries, table grapes and wine grapes. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for the crops under consideration. Adequate analytica...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Published on: Mon, 13 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Arysta LifeSciences SAS submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance fluoxastrobin in certain oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the oilseeds for which a modification was requested. Adequate analytical...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 13 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 myclobutanil. To assess the occurrence of myclobutanil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Com...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

2-7-2018

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies., is voluntarily recalling only Lot No.: 112710 with expiration 03/2019 found embedded on the top of package of kratom ( mitragyn a speciosa) powder products, it manufactured, processed, packed, and/or held, between “March 1, 2018” to “April 30, 2018” to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing to have salmonella contamination. Blissful Remedies has not received reports of adverse events related to this recall. ...

FDA - U.S. Food and Drug Administration

22-6-2018

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

The products have been found by the 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 accordance to FDA guidelines

FDA - U.S. Food and Drug Administration

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

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

Pelgraz (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6288 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/003961/0000

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Active substance: lenalidomide) - Centralised - Authorisation - Commission Decision (2018)6237 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4857

Europe -DG Health and Food Safety

29-8-2018

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Active substance: aliskiren hemifumarate / hydrochlorothiazide) - Centralised - Renewal - Commission Decision (2018)5769 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/964/R/87

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Active substance: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt) - Orphan designation - Commission Decision (2018)5729 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2055 (IQVIA RDS Ireland Limited)

EU/3/18/2055 (IQVIA RDS Ireland Limited)

EU/3/18/2055 (Active substance: (3R,3aS,9R,9aS,9bS)-3-((dimethylamino)methyl)-9-hydroxy-6,9-dimethyl-3,3a,4,5,7,8,9,9a-octahydroazuleno[4,5-b]furan-2(9bH)-one fumarate) - Orphan designation - Commission Decision (2018)5727 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/060/18

Europe -DG Health and Food Safety

7-8-2018

Accofil (Accord Healthcare Limited)

Accofil (Accord Healthcare Limited)

Accofil (Active substance: Filgrastim) - Centralised - Yearly update - Commission Decision (2018)5428 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Active substance: memantine) - Centralised - Renewal - Commission Decision (2018)5421 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/R/10

Europe -DG Health and Food Safety

7-8-2018

Duaklir Genuair (AstraZeneca AB)

Duaklir Genuair (AstraZeneca AB)

Duaklir Genuair (Active substance: aclidinium bromide / formoterol fumarate dihydrate) - Centralised - Yearly update - Commission Decision (2018)5419 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

7-8-2018

Brimica Genuair (AstraZeneca AB)

Brimica Genuair (AstraZeneca AB)

Brimica Genuair (Active substance: aclidinium bromide / formoterol fumarate dihydrate) - Centralised - Yearly update - Commission Decision (2018)5420 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

25-7-2018

Viread (Gilead Sciences Ireland UC)

Viread (Gilead Sciences Ireland UC)

Viread (Active substance: tenofovir disoproxil fumarate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4980 of Wed, 25 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/419/T/187

Europe -DG Health and Food Safety

18-7-2018

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011.  Read more about preventing surgical fires here:  https://go.usa.gov/xU5zs  #FDA #MedicalDevice

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011. Read more about preventing surgical fires here: https://go.usa.gov/xU5zs  #FDA #MedicalDevice

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011. Read more about preventing surgical fires here: https://go.usa.gov/xU5zs  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

4-7-2018

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Active substance: Docetaxel) - Centralised - Yearly update - Commission Decision (2018)4341 of Wed, 04 Jul 2018

Europe -DG Health and Food Safety

3-7-2018

Temozolomide Accord (Accord Healthcare Limited)

Temozolomide Accord (Accord Healthcare Limited)

Temozolomide Accord (Active substance: temozolomide) - Centralised - Yearly update - Commission Decision (2018) 4240 of Tue, 03 Jul 2018

Europe -DG Health and Food Safety

11-6-2018

Pemetrexed Accord (Accord Healthcare Limited)

Pemetrexed Accord (Accord Healthcare Limited)

Pemetrexed Accord (Active substance: pemetrexed) - Centralised - Yearly update - Commission Decision (2018)3761 of Mon, 11 Jun 2018

Europe -DG Health and Food Safety

6-6-2018

Truvada (Gilead Sciences Ireland UC)

Truvada (Gilead Sciences Ireland UC)

Truvada (Active substance: emtricitabine / tenofovir disoproxil fumarate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3690 of Wed, 06 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/594/T/148

Europe -DG Health and Food Safety

6-6-2018

Stribild (Gilead Sciences Ireland UC)

Stribild (Gilead Sciences Ireland UC)

Stribild (Active substance: elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (as fumarate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3691 of Wed, 06 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2574/T/93

Europe -DG Health and Food Safety

30-5-2018

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Active substance: emtricitabine / rilpivirine (as hydrochloride) / tenofovir disoproxil (as fumarate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3453 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2312/T/91

Europe -DG Health and Food Safety