Clopidogrel "Accord"

Primær information

  • Handelsnavn:
  • Clopidogrel "Accord" 75 mg filmovertrukne tabletter
  • Dosering:
  • 75 mg
  • Lægemiddelform:
  • filmovertrukne tabletter
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Clopidogrel "Accord" 75 mg filmovertrukne tabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 45662
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel

Indlægsseddel: Information til brugeren

Clopidogrel Accord 75 mg filmovertrukne tabletter

Clopidogrel

Læs denne indlægsseddel grundigt, inden De begynder at tage dette lægemiddel,

da den indeholder vigtige oplysninger.

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

Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er mere, De

vil vide.

Lægen har ordineret Clopidogrel Accord til Dem personligt. Lad derfor være

med at give medicinen til andre. Det kan være skadeligt for andre, selvom de

har de samme symptomer, som De har.

Kontakt lægen, apotekspersonalet eller sundhedspersonalet, hvis en bivirkning

bliver værre, eller De får bivirkninger, som ikke er nævnt her. Se punkt 4.

Den nyeste indlægsseddel kan findes på www.indlaegsseddel.dk

Oversigt over indlægssedlen:

Virkning og anvendelse

Det skal De vide, før De begynder at tage Clopidogrel Accord

Sådan skal De tage Clopidogrel Accord

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

1.

Virkning og anvendelse

Clopidogrel Accord indeholder clopidogrel og tilhører en gruppe medicin, som kaldes

trombocytfunktionshæmmere, som påvirker blodpladerne. Blodplader er meget små

blodlegemer, mindre end røde og hvide blodceller, som klumper sig sammen og får

blodet til at størkne. Ved at forhindre denne sammenklumpning nedsætter dette

lægemiddel risikoen for, at der dannes blodpropper (en proces, der kaldes trombose).

Clopidogrel Accord tages af voksne for at forhindre, at der opstår blodpropper

(tromber) i forkalkede blodårer, en proces, som kaldes aterotrombose, og som kan

føre til slagtilfælde, hjerteanfald eller dødsfald (aterotrombotiske hændelser).

De har fået ordineret Clopidogrel Accord for at forhindre, at der opstår blodpropper,

og for at nedsætte risikoen for disse alvorlige følger, fordi:

De har forkalkninger i blodårerne (også kaldet aterosklerose), og

De har tidligere haft et hjertetilfælde, et slagtilfælde eller en sygdom, der kaldes

perifer arteriesygdom, eller

De har haft en type alvorlige brystsmerter, som kaldes ‘ustabil angina’ eller

‘myokardieinfarkt’ (hjerteanfald). Til behandling af denne lidelse har De måske

fået anbragt en stent i den blokerede eller indsnævrede blodåre for at genoprette

blødgennemstrømningen. De bør også få acetylsalicylsyre (et stof, som anvendes i

mange lægemidler til at lindre smerter og mod lav feber, samt til at modvirke

blodpropper) af Deres læge.

De har uregelmæssig hjerterytme, en tilstand, der kaldes ‘atrieflimren’, og De kan

ikke tage medicin af typen ‘orale antikoagulanter’ (vitamin K-antagonister), der

forhindrer nye blodpropper i at danne sig og eksisterende blodpropper i at vokse.

Deres læge bør have fortalt Dem, at ‘orale antikoagulanter’ er mere effektive end

acetylsalicylsyre

eller

kombineret

brug

clopidogrel-tabletter

acetylsalicylsyre til behandling af denne tilstand. Deres læge bør have ordineret

clopidogrel-tabletter

plus

acetylsalicylsyre,

hvis

ikke

tage

‘orale

antikoagulanter’, og De ikke har risiko for større blødninger.

2.

Det skal De vide, før De begynder at tage Clopidogrel Accord

Lægen kan have foreskrevet anden anvendelse eller dosering end angivet i denne

information. Følg altid lægens anvisning og oplysningerne på doseringsetiketten.

Tag ikke Clopidogrel Accord

Hvis De er allergisk over for clopidogrel eller et af de øvrige indholdsstoffer i

Clopidogrel Accord angivet i punkt 6.

Hvis De lider af en sygdom, som giver blødninger, som f.eks. mavesår eller

blødninger i hjernen.

Hvis De har en alvorlig leversygdom.

I hvis De mener, at De har nogle af disse lidelser, eller hvis De er i tvivl om noget,

skal De kontakte Deres læge, før De begynder at tage Clopidogrel Accord.

Advarsler og forsigtighedsregler

Hvis noget af det følgende gælder for Dem, skal De sige det til Deres læge, før De

tager Clopidogrel Accord:

hvis De har risiko for blødning på grund af

en sygdom, som øger Deres risiko for indre blødninger (fx. mavesår)

en blodsygdom, som giver større risiko for indre blødninger (blødninger i væv,

organer eller led i kroppen).

en nylig alvorlig skade

en nylig operation (herunder tandoperation)

en planlagt operation (herunder tandoperation) inden for de næste syv dage

hvis De har haft en blodprop i en blodåre i hjernen (iskæmisk anfald) inden for de

sidste syv dage

hvis De har en nyre- eller leversygdom

hvis De har haft allergi eller reaktioner på et lægemiddel, som anvendes til at

behandle Deres sygdom.

Mens De tager Clopidogrel Accord:

De skal fortælle det til lægen, hvis De skal gennemgå en operation (også en

tandoperation).

De skal også omgående fortælle lægen det, hvis De får en sygdom, som kaldes

trombotisk trombocytopenisk purpura eller TTP, og som giver feber og mærker

under huden, der kan vise sig som små røde pletter med eller uden uforklarlig

voldsom træthed, forvirring, gulfarvning af huden eller øjnene (gulsot) (se pkt. 4

”Bivirkninger”).

Hvis De kommer til at skære eller skade Dem selv, kan det vare længere end

normalt, før De holder op med at bløde. Det hænger sammen med medicinens

virkning, fordi den forhindrer blodpropper i at opstå. Hvis De får mindre sår, f.eks.

under barbering, er det normalt ikke alvorligt. Men hvis De bliver bekymret over,

hvor meget De bløder, skal De straks kontakte lægen (se pkt. 4 ”Bivirkninger”).

Deres læge kan beslutte, at De skal have taget blodprøver.

Børn og unge

Dette lægemiddel bør ikke tages af børn, da det ikke er virksomt til børn.

Brug af anden medicin sammen med Clopidogrel Accord

Fortæl det altid til lægen eller apotekspersonalet, hvis De bruger anden medicin eller

har gjort det for nylig. Dette gælder også medicin, som ikke er købt på recept.

Nogle

typer medicin kan påvirke brugen af Clopidogrel Accord og omvendt.

De skal fortælle det til lægen, hvis De tager

lægemidler, der øger risikoen for blødning, såsom

orale antikoagulanter (medicin, som nedsætter blodets evne til at størkne).

non-steroid antiinflammatorisk medicin, som normalt anvendes til behandling

af smerter og/eller betændelsestilstande i muskler eller led.

heparin eller anden medicin til indsprøjtning, som nedsætter blodets evne til at

størkne.

ticlopidin, en anden trombocytfunktionshæmmer.

selektive serotoningenoptagelseshæmmere (inklusive, men ikke begrænset til

fluoxetin og fluvoxamin), som normalt anvendes til behandling af depression.

omeprazol eller esomeprazol, lægemidler, der anvendes til behandling af

maveproblemer.

fluconazol eller voriconazol, lægemidler, som anvendes til behandling af

svampeinfektioner.

moclobemid, et lægemiddel til behandling af depression.

efavirenz, et lægemiddel til behandling af HIV-infektion (humant

immundefektvirusinfektion).

carbamazepin, et lægemiddel til behandling af nogle former for epilepsi.

repaglinid, et lægemiddel til behandling af sukkersyge.

paclitaxel, et lægemiddel til behandling af kræft.

Hvis De har haft alvorlige brystsmerter (ustabil angina eller hjerteanfald), kan Deres

læge have ordineret Clopidogrel Accord sammen med acetylsalicylsyre, et stof, der

anvendes i mange lægemidler til at lindre smerter og mod lav feber. Lejlighedsvis

brug af acesylsalicylsyre (ikke mere end 1000 mg inden for et døgn bør generelt ikke

give problemer), men langvarig brug under andre betingelser bør drøftes med lægen.

Brug af Clopidogrel Accord sammen med mad og drikke

Clopidogrel Accord kan tages med eller uden mad.

Graviditet og amning

Det er bedst ikke at tage dette lægemiddel, hvis De er gravid.

Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at

blive gravid, skal De spørge Deres læge eller apotekspersonalet til råds, før De tager

dette lægemiddel.

Hvis De bliver gravid, mens De tager Clopidogrel Accord, skal De straks kontakte

lægen, da det ikke anbefales at tage clopidogrel mens man er gravid.

De må ikke amme, mens De får dette lægemiddel.

Hvis De ammer eller planlægger at amme, skal De tale med Deres læge, inden De

tager dette lægemiddel.

Spørg Deres læge eller apoteket til råds, før De tager nogen form for medicin.

Trafik- og arbejdssikkerhed

Det er usandsynligt, at Clopidogrel Accord vil påvirke Deres evne til at køre bil eller

betjene maskiner.

Clopidogrel Accord indeholder lactose:

Hvis Deres læge har oplyst Dem om, at De ikke kan tåle visse sukkerarter (f.eks.

lactose), bør De kontakte lægen, før De tager dette lægemiddel.

Clopidogrel Accord indeholder hydrogeneret ricinusolie

Clopidogrel

Accord

indeholder

hydrogeneret

ricinusolie,

forårsage

maveproblemer og diarré.

3.

Sådan skal De tage Clopidogrel Accord

altid

Clopidogrel

Accord

nøjagtigt

efter

lægens

eller

apotekspersonalets

anvisning. Er De i tvivl, så spørg lægen eller på apoteket.

Den anbefalede dosis, herunder også til patienter med ”atrieflimmer” (uregelmæssig

hjerterytme), er 1 Clopidogrel Accord-tablet på 75 mg dagligt på samme tidspunkt

hver dag. Tabletten indtages gennem munden med eller uden mad.

Hvis De har haft alvorlige brystsmerter (hjertekrampe (ustabil angina pectoris) eller

hjertetilfælde), vil Deres læge måske indlede behandlingen med at give Dem 300 mg

clopidogrel (4 tabletter à 75 mg). Derefter er den anbefalede dosis 1 clopidogrel-tablet

på 75 mg dagligt, som beskrevet ovenfor.

De skal fortsætte med at tage Clopidogrel Accord, så længe Deres læge udskriver det

til Dem.

Hvis De har taget for mange Clopidogrel Accord:

Kontakt lægen eller den nærmeste skadestue på grund af den øgede risiko for

blødning.

Hvis De har glemt at tage Clopidogrel Accord:

Hvis De glemmer at tage en dosis Clopidogrel Accord, men kommer i tanke om det

inden for 12 timer efter det tidspunkt, hvor De normalt tager den, skal De tage

tabletten

samme

derefter

tage

næste

tablet

sædvanlige

tidspunkt.

Hvis der er gået mere end 12 timer, skal De bare tage den næste dosis på det normale

tidspunkt. De må ikke tage en dobbeltdosis som erstatning for den glemte tablet.

Hvis De holder op med at tage Clopidogrel Accord:

Stop ikke behandlingen, medmindre Deres læge siger, De skal gøre det. Kontakt

lægen eller apoteket, før De stopper behandlingen.

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

4.

Bivirkninger

Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får

bivirkninger.

Kontakt straks lægen, hvis De får:

Feber, tegn på infektion eller bliver ekstremt træt. Det kan skylde en sjælden

sygdom i visse blodceller.

Tegn på leverproblemer såsom gulfarvning af huden og/eller øjnene (gulsot), som

kan være eller ikke være forbundet med blødninger, der viser sig under huden som

bittesmå

røde

pletter

og/eller

forvirring

pkt.

“Advarsler

forsigtighedsregler’).

Hævelser i munden eller hudproblemer såsom udslæt og kløe, blærer på huden. Det

kan være tegn på en allergisk reaktion.

Den mest almindelige bivirkning

som er rapporteret med Clopidogrel Accord,

er blødning.

Blødning kan forekomme fra maven eller tarmene, som blå mærker og

blødning under huden (hæmatom), næseblod og blod i urinen. I et lille antal tilfælde

er der også rapporteret blødninger i øjne, i hovedet, lungerne eller led.

Hvis De oplever længerevarende blødning, mens De tager Clopidogrel Accord:

Hvis De kommer til at skære eller skade Dem selv, kan det vare længere end normalt,

før De holder op med at bløde. Det hænger sammen med medicinens virkning, fordi

den forhindrer blodpropper i at opstå. Hvis De får mindre sår, f.eks. under barbering,

er det normalt ikke alvorligt. Men hvis De bliver bekymret over, hvor meget De

bløder, skal De straks kontakte lægen (se pkt. 2 ‘Advarsler og forsigtighedsregler’).

Andre bivirkninger omfatter:

Almindelige bivirkninger (kan påvirke op til 1 ud af 10 patienter): Diarré, diarré,

mavesmerter, fordøjelsesbesvær eller halsbrand.

Ikke almindelige bivirkninger (kan påvirke op til 1 ud af 100 patienter): Hovedpine,

mavesår, opkastning, kvalme, forstoppelse, for meget luft i maven eller tarmene,

udslæt, kløen, svimmelhed, følelsesløshed og prikken i huden.

Sjældne bivirkninger (kan påvirke op til 1 ud af 1.000 patienter): Stærk svimmelhed

(vertigo), forstørrede bryster hos mænd.

Meget sjældne bivirkninger (kan påvirke op til 1 patient ud af 10.000): gulsot;

voldsomme mavesmerter med eller uden rygsmerter; feber, åndedrætsbesvær, i nogle

tilfælde med hoste; forskellige allergiske reaktioner (f.eks. varmefølelse over hele

kroppen

pludselig

generel

utilpashed

eventuelt

besvimelse);

hævelser

munden;

blærer

huden;

hudallergi;

ømhed

munden

(stomatitis);

faldende

blodtryk; forvirring; hallucinationer; ledsmerter; muskelsmerter; akut

generaliseret

eksantematøs pustulose

(AGEP); ændret smagssans.

Ikke kendt (hyppigheden kan ikke vurderes ud fra eksisterende oplysninger):

Overfølsomhedsreaktioner med bryst- eller mavesmerter.

Desuden kan lægen finde ændringer i blod- og urinprøver.

Indberetning af bivirkninger

Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.

Dette gælder også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel.

Du eller dine pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen

Sundhedsstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: dkma@dkma.dk

5.

Opbevaring

Opbevar lægemidlet utilgængeligt for børn.

Brug

ikke

lægemidlet

efter

udløbsdato,

står

pakningen

efter

Exp.

Udløbsdatoen er den sidste dag i den nævnte måned.

Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.

Brug ikke lægemidlet, hvis De bemærker synlige tegn på fordærvelse.

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

De ikke smide medicinrester i afløbet, toilettet eller skraldespanden.

6.

Pakningsstørrelser og yderligere oplysninger

Clopidogrel Accord indeholder

Det aktive stof er clopidogrel. Hver tablet indeholder 75

mg clopidogrel (som

hydrogensulfat).

De øvrige indholdsstoffer er (se punkt 2 ”Clopidogrel Accord indeholder lactose” og

”Clopidogrel Accord indeholder hydrogeneret ricinusolie”):

Tabletkerne:

Vandfri lactose, hydroxypropylcellulose, mikrokrystallinsk cellulose, hydrogeneret

ricinusolie, vandfri kolloid silica.

Filmovertræk:

Triacetin (E1518), rød jernoxid (E172), hypromellose (E464), titandioxid (E171),

lactosemonohydrat

Udseende og pakningsstørrelser

Clopidogrel 75 mg filmovertrukne tabletter er pink, runde, bikonvekse tabletter,

jævne på begge sider.

Clopidogrel 75 mg tabletter er pakket i aluminium-aluminium-blistere og desuden

pakket i en karton.

Pakningsstørrelser: 7, 10, 14, 28, 30, 50, 84, 90 og 100 tabletter.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen og fremstiller:

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

Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne:

Medlemslandets

navn

Lægemidlets navn

Bulgarien

Clopidogrel Accord 75 mg Film-coated Tablets

Tjekkiet

Clopidogrel Accord 75mg potahované tablety

Danmark

Clopidogrel Accord 75 mg filmovertrukne tabletter,

Estland

Clopidogrel Accord

Finland

Clopidogrel

Accord

tabletti,

kalvopäällysteinen

filmdragerade tabletter

Letland

Clopidogrel Accord 75 mg apvalkotās tabletes

Litauen

Clopidogrel Accord 75 mg plėvele dengtos tabletės

Slovakiet

Clopidogrel Accord 75mg filmom obalené tablety

Storbritannien

Clopidogrel 75 mg Film-coated Tablets

Østrig

Clopidogrel Accord 75 mg Filmtabletten

Cypern

Clopidogrel Accord 75 mg film-coated tablets

Frankrig

Clopidogrel Accord 75 mg comprimé pelliculé sécable

Irland

Clopidogrel 75 mg Film-coated Tablets

Malta

Clopidogrel 75 mg Film-coated Tablets

Holland

Clopidogrel Accord 75 mg Filmomhulde Tabletten

Norge

Clopidogrel Accord

Sverige

Clopidogrel Accord 75 mg filmdragerade tabletter

Denne indlægsseddel blev senest ændret 01/2018.

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

Published on: Wed, 26 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 tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 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 the first 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 Me...

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

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

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

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

19-6-2018

Iscover (Sanofi-Aventis groupe)

Iscover (Sanofi-Aventis groupe)

Iscover (Active substance: Clopidogrel) - Centralised - Yearly update - Commission Decision (2018)3888 of Tue, 19 Jun 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

30-5-2018

Plavix (Sanofi Clir SNC)

Plavix (Sanofi Clir SNC)

Plavix (Active substance: Clopidogrel) - Centralised - Yearly update - Commission Decision (2018)3470 of Wed, 30 May 2018

Europe -DG Health and Food Safety

30-5-2018

Bortezomib Accord (Accord Healthcare Limited)

Bortezomib Accord (Accord Healthcare Limited)

Bortezomib Accord (Active substance: bortezomib) - Centralised - Variation - Commission Decision (2018)3460 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3984/X/8

Europe -DG Health and Food Safety

23-5-2018

Scientific guideline:  Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice, draft: consul

Scientific guideline: Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice, draft: consul

The guideline lays down the principles for the two-step release and shipping of the investigational medicinal products by the qualified person and the sponsor. The guideline also describes the areas of interface between the manufacturer and the sponsor and the required contractual agreements.

Europe - EMA - European Medicines Agency

15-5-2018

Pramipexole Accord (Accord Healthcare Limited)

Pramipexole Accord (Accord Healthcare Limited)

Pramipexole Accord (Active substance: pramipexole) - Centralised - Yearly update - Commission Decision (2018)2995 of Tue, 15 May 2018

Europe -DG Health and Food Safety