Olanzapin "Accord"

Primær information

  • Handelsnavn:
  • Olanzapin "Accord" 7,5 mg filmovertrukne tabletter
  • Dosering:
  • 7,5 mg
  • Lægemiddelform:
  • filmovertrukne tabletter
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Olanzapin "Accord" 7,5 mg filmovertrukne tabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 43626
  • Sidste ændring:
  • 17-07-2018

Indlægsseddel

Indlægsseddel: Information til brugeren

Olanzapin Accord 2,5 mg filmovertrukne tabletter

Olanzapin Accord 5 mg filmovertrukne tabletter

Olanzapin Accord 7,5 mg filmovertrukne tabletter

Olanzapin Accord 10 mg filmovertrukne tabletter

Olanzapin Accord 15 mg filmovertrukne tabletter

Olanzapin Accord 20 mg filmovertrukne tabletter

Olanzapin

Læs denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel, da den indeholder vigtige

oplysninger.

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

Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.

Lægen har ordineret dette lægemiddel til dig personligt. Lad derfor være med at give det til andre. Det kan være

skadeligt for andre, selvom de har de samme symptomer, som du har.

Tal med lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt

her.

Oversigt over indlægssedlen:

1. Virkning og anvendelse

2. Det skal du vide, før du begynder at tage Olanzapin Accord

3. Sådan skal du tage Olanzapin Accord

4. Bivirkninger

5. Opbevaring

6. Pakningsstørrelser og yderligere oplysninger

1. Virkning og anvendelse

Olanzapin tilhører en gruppe af lægemidler, der kaldes antipsykotika, og anvendes til behandling af følgende lidelser:

Skizofreni, en sygdom med symptomer såsom at man hører, ser og mærker ting, der ikke eksisterer, føler mistro

eller er usædvanligt mistænksom eller indesluttet. Personer med denne lidelse kan også føle sig deprimerede,

angste eller anspændte.

Moderate til alvorlige maniske episoder, en tilstand med symptomer som ophidselse eller eufori.

Olanzapin har vist sig at forebygge tilbagevenden af disse symptomer hos patienter med bipolar lidelse, når behandling

med olanzapin havde effekt på de maniske episoder.

2. Det skal du vide, før du begynder at tage Olanzapin Accord

Lægen kan have foreskrevet anden anvendelse eller dosering end angivet i denne information. Følg altid lægens

anvisning og oplysningerne på doseringsetiketten.

Tag ikke Olanzapin Accord

Hvis du er allergisk over for olanzapin eller et af de øvrige indholdsstoffer i Olanzapin Accord (angivet i punkt 6).

En overfølsomhedsreaktion kan kendes ved udslæt, kløe, hævelse af ansigt eller læber eller stakåndethed. Hvis du

har oplevet dette, skal du fortælle det til lægen.

Hvis du tidligere er blevet diagnosticeret med øjenproblemer såsom en bestemt slags glaukom (grøn stær, øget tryk i

øjet).

Advarsler og forsigtighedsregler

Kontakt lægen eller apoteket, før du tager Olanzapin Accord.

Brug af Olanzapin Accord til ældre patienter med demens frarådes, da dette kan medføre alvorlige bivirkninger.

Denne type medicin kan forårsage usædvanlige bevægelser af især ansigt eller tunge. Hvis dette forekommer, efter

du har fået olanzapin, skal du fortælle det til lægen.

Denne slags medicin kan meget sjældent forårsage en kombination af feber, hurtigere vejrtrækning, svedtendens,

muskelstivhed og døsighed eller søvnighed. Hvis dette forekommer, skal du straks kontakte din læge.

Hvis du eller andre i din familie har haft blodpropper. Det skyldes, at lægemidler som Olanzapin Accord er sat i

forbindelse med dannelse af blodpropper.

Der er set vægtforøgelse hos patienter, der tog Olanzapin Accord. Du og din læge skal jævnligt kontrollere din vægt.

Der set højt blodsukkerniveau og høje fedtniveauer (triglycerider og kolesterol) hos patienter, der tog Olanzapin

Accord. Din læge skal tage blodprøver for at kontrollere blodsukkeret og niveauet af visse fedtstoffer, inden du

begynder at tage Olanzapin Accord, og jævnligt under behandlingen.

Fortæl det til din læge, hvis du eller andre i din familie har haft blodpropper. Det skyldes, at lægemidler som

Olanzapin Accord er sat i forbindelse med dannelse af blodpropper.

Hvis du lider af en af de følgende sygdomme, skal du fortælle det til din læge snarest muligt:

Slagtilfælde eller "mini"-slagtilfælde (forbigående symptomer på slagtilfælde)

Parkinsons sygdom

Prostata problemer

En tilstoppet tarm (paralytisk ileus)

Lever- eller nyresygdom

Blodsygdomme

Hjertesygdom

Sukkersyge

Epilepsi

Hvis du lider af demens, bør du eller din plejer/pårørende fortælle det til din læge, hvis du nogensinde har haft et

slagtilfælde eller et "mini" slagtilfælde.

Som en rutinemæssig forholdsregel kan din læge overvåge dit blodtryk, hvis du er over 65 år.

Børn og teenagere

Olanzapin Accord er ikke til patienter under 18 år.

Brug af anden medicin:

Tag kun anden medicin samtidig med du tager Olanzapin Accord, hvis din læge siger, at du kan. Du kan føle dig døsig,

hvis Olanzapin Accord tages sammen med midler mod depression eller medicin til behandling af angst eller søvnløshed

(afslappende midler).

Fortæl det altid til lægen, hvis du bruger anden medicin eller har brugt det for nylig. Dette gælder også medicin, som

ikke er købt på recept

Det er især vigtigt at fortælle det til lægen, hvis du tager

medicin for Parkinsons sygdom.

carbamazepin (et krampestillende og humør-stabiliserende lægemiddel), fluvoxamin (et middel mod depression)

eller ciprofloxacin (et antibiotikum), da det kan blive nødvendigt at ændre din dosis af Olanzapin Accord.

Brug af Olanzapin Accord sammen med alkohol:

Drik ikke alkohol, hvis du har fået Olanzapin Accord, da Olanzapin Accord og alkohol kan få dig til at føle dig døsig,

hvis de tages samtidig.

Graviditet og amning:

Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din

læge til råds, før du tager dette lægemiddel. Du bør ikke få denne medicin, mens du ammer, da små mængder af

olanzapin kan udskilles i human mælk.

Følgende symptomer kan forekomme hos nyfødte, hvis moderen har anvendt olanzapin 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:

Der er risiko for døsighed, når du får Olanzapin Accord. Hvis dette forekommer, må du ikke føre motorkøretøj eller

arbejde med værktøj eller maskiner. Fortæl det til din læge.

Olanzapin Accord indeholder lactose

Olanzapin Accord indeholder lactose. Hvis din læge har fortalt dig at du ikke kan tåle visse sukkerarter, skal du kontakte

din læge, før du tager denne medicin.

3. Sådan skal du tage Olanzapin Accord

Tag altid dette lægemiddel nøjagtigt efter lægens anvisning. Er du i tvivl, så spørg lægen eller på apoteket.

Din læge vil fortælle dig, hvor mange Olanzapin Accord, du skal tage, og i hvor lang tid, du skal fortsætte med at tage

dem. Den daglige dosis af olanzapin er mellem 5 og 20 mg. Konsulter din læge, hvis dine symptomer vender tilbage,

men stop ikke med at tage Olanzapin Accord, medmindre din læge fortæller dig det.

Du bør tage dine Olanzapin Accord én gang dagligt efter din læges anvisning. Forsøg at tage dine tabletter på samme

tidspunkt hver dag. Det er ligegyldigt, om du tager tabletterne sammen med eller uden et måltid. Olanzapin Accord er til

oral anvendelse. Du bør synke Olanzapin Accord hele med vand.

Hvis du har taget for meget Olanzapin Accord

Kontakt lægen, skadestuen eller apoteket, hvis De/du hartaget mere af Olanzapin Accord, end der står i denne

information, eller mere end lægen har forskrevet (og De/du føler Dem/dig utilpas).

Patienter, som har taget mere Olanzapin Accord end de burde, har oplevet følgende symptomer: hurtigt hjerteslag,

ophidselse/aggression,

problemer

tale,

usædvanlige

bevægelser

(især

ansigt

eller

tunge)

nedsat

bevidsthedsniveau. Andre symptomer kan være: akut forvirring, krampeanfald (epilepsi), koma, en kombination af

feber, hurtigere vejrtrækning, svedtendens, muskelstivhed og døsighed eller søvnighed, langsommere vejrtrækning,

aspiration, højt eller lavt blodtryk, unormal hjerterytme. Kontakt straks din læge eller skadestuen, hvis du får et eller

flere af ovenstående symptomer. Vis lægen tabletpakningen.

Hvis du har glemt at tage Olanzapin Accord

Tag din tabletter lige så snart, som du husker på det. Du må ikke tage to doser på en dag.

Hvis du holder op med at tage Olanzapin Accord

Du må ikke holde op med at tage dine tabletter, blot fordi du får det bedre. Det er vigtigt, at du fortsætter med at tage

Olanzapin Accord, så længe lægen beder dig om det.

Hvis du pludselig holder op med at tage Olanzapin Accord, kan der forekomme symptomer som svedtendens,

søvnløshed, rysten, angst eller kvalme og opkastning. Din læge vil måske forslå dig, at du nedsætter dosen gradvist, før

de stopper behandlingen.

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

4. Bivirkninger

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

Fortæl det straks til din læge, hvis du har:

usædvanlige bevægelser, især af ansigt eller tunge (en almindelig bivirkning, der forekommer hos 1 til 10 personer

ud af 100)

blodpropper (en ikke almindelig bivirkning, der forekommer hos 1 til 10 personer ud af 1.000), især i blodårerne i

benene (symptomer kan være hævelse, smerter og rødmen på benene), der kan bevæge sig gennem blodkarrene til

lungerne og give brystsmerter og vejrtrækningsbesvær. Hvis du får disse symptomer, skal du straks søge læge.

en kombination af feber, hurtig vejrtrækning, svedtendens, muskelstivhed og sløvhed eller søvnighed (hyppigheden

af denne bivirkning kan ikke fastslås ud fra de foreliggende data).

Meget almindelige bivirkninger (forekommer hos 1 person ud af 10) omfatter vægtøgning, søvnighed og forhøjede

niveauer af prolaktin i blodet.

Almindelige bivirkninger (forekommer hos 1 til 10 personer ud af 100) omfatter ændringer i niveauer af visse blodceller

og cirkulerende fedtstoffer, forhøjet niveau af sukker i blodet, øget sultfornemmelse, svimmelhed, rastløshed, rysten,

muskelstivhed eller muskelkramper (herunder øjenbevægelser), taleproblemer, forstoppelse, mundtørhed, udslæt, tab af

styrke, ekstrem træthed, væskeophobning, som medfører hævede hænder, ankler eller fødder, nedsat seksualfunktion,

såsom nedsat lyst til sex hos mænd og kvinder og manglende evne til at få rejsning hos mænd.

I begyndelsen af behandlingen kan nogle personer føle sig svimle eller svage (med et langsomt hjerteslag), især når de

rejser sig fra liggende eller siddende stilling. Det vil sædvanligvis gå over af sig selv, men hvis det ikke sker, skal du

fortælle det til din læge.

Ikke almindelige bivirkninger (forekommer hos 1 til 10 personer ud af 1.000) omfatter langsom hjertefrekvens,

følsomhed over for sollys, urininkontinens, manglende evner til at lade vandet, hårtab, udebleven eller uregelmæssig

menstruation, brystændringer hos mænd og kvinder, såsom unormal mælkeproduktion eller unormal vækst.

Andre

mulige

bivirkninger,

hvis

hyppighed

ikke

anslås

forhåndenværende

data

omfatter

overfølsomhedsreaktion (f.eks. hævelser i mund og hals, kløe, udslæt), sukkersyge eller forværring af sukkersyge,

lejlighedsvist

ledsaget

ketoacidose

(ketoner

blod

urin)

eller

koma,

nedsat

normal

legemstemperatur,

krampeanfald,

sædvanligvis

forbindelse

tidligere

krampeanfald

(epilepsi),

kombination

feber,

hurtig

vejrtrækning, svedtendens, muskelstivhed og sløvhed eller søvnighed, muskelspasmer i øjet, som forårsager rullende

øjenbevægelser, unormal hjerterytme, pludselig uforklarlig død, betændelse i bugspytkirtlen, som forårsager svære

mavesmerter, feber og utilpashed, leversygdom, som viser sig ved gulfarvning af huden og af det hvide i øjnene,

muskelsygdom, som viser sig med uforklarlig pine og smerter, forlænget og/eller smertefuld erektion.

Ældre patienter med demens kan under behandling med olanzapin få slagtilfælde, lungebetændelse, urininkontinens,

faldtendens, ekstrem træthed, synsmæssige hallucinationer, en forhøjelse af legemstemperatur, hudrødmen og have

gangbesvær. Der er blevet rapporteret om nogle dødsfald i denne specielle patientgruppe.

Hos patienter med Parkinsons sygdom kan olanzapin forværre symptomerne.

Tal med lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke fremgår af denne

indlægsseddel.

Bivirkningerne kan dermed blive indberettet til Sundhedsstyrelsen, og viden om bivirkninger kan blive bedre.

Patienter eller pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen.

Du finder skema og vejledning under Bivirkninger på Sundhedsstyrelsens netsted.

5. Opbevaring

Opbevar dette lægemiddel utilgængeligt for børn.

Brug ikke dette lægemiddel efter den udløbsdato, der står på blisterkortet og kartonen. Udløbsdatoen (EXP) er den

sidste dag i den nævnte måned.

Må ikke opbevares ved temperaturer over 30 °C.

Spørg på apoteket, hvordan du skal bortskaffe medicinrester. Af hensyn til miljøet må du ikke smide medicinrester i

afløbet, toilettet eller skraldespanden.

6. Pakningsstørrelser og yderligere oplysninger

Olanzapin Accord indeholder:

Aktivt stof: olanzapin.

Hver filmovertrukken tablet indeholder enten 2,5 mg, 5 mg, 7,5 mg, 10 mg, 15 mg eller 20 mg olanzapin,

Tabletten

indeholder

også:

Lactosemonohydrat,

mikrokrystallinsk

cellulose,

crospovidon,

hydroxypropylcellulose,

magnesiumstearat

Filmovertrækningen

indeholder:

Hypromellose (E464), titandioxid (E171),

macrogol

400,

polysorbat 80 (E433).

Ydermere indeholder filmovertrækningen af de 15 mg tabletter også indigokarmin aluminiumslak (E132) og 20 mg

tabletter indeholder rød jernoxid ( E172 )

Udseende og pakningsstørrelser:

Olanzapin Accord 2,5 mg: Hvide til off-white, runde, bikonvekse, filmovertrukne tabletter, glatte på begge sider.

Olanzapin Accord 5 mg: Hvide til off-white, runde, bikonvekse, filmovertrukne tabletter, præget med ‘O1’ på den ene

side og glatte på den anden side.

Olanzapin Accord 7,5 mg: Hvide til off-white, runde, bikonvekse, filmovertrukne tabletter, præget med ‘O2’ på den ene

side og glatte på den anden side.

Olanzapin Accord 10 mg: Hvide til off-white, runde, bikonvekse, filmovertrukne tabletter, præget med ‘O3’ på den ene

side og glatte på den anden side.

Olanzapin Accord 15 mg tabletter: Lyseblå, runde, bikonvekse, filmovertrukne tabletter, glatte på begge sider.

Olanzapin Accord 20 mg tabletter: Lyserøde, runde, bikonvekse, filmovertrukne tabletter, glatte på begge sider.

Tabletterne fås i pakningsstørrelser på 28, 30, 35, 56 eller 70 tabletter pr. 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:

CEMELOG- BRS Limited, 2040 Budaors, Vasut u.13., Ungarn

eller

Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, Storbritannien

Denne indlægsseddel blev senest revideret 22/10/2012.

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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

6-4-2018

"Organic Traditions Shatavari Powder" sold at Choices Markets Yaletown in Vancouver, B.C., contaminated with Salmonella

"Organic Traditions Shatavari Powder" sold at Choices Markets Yaletown in Vancouver, B.C., contaminated with Salmonella

Health Canada is advising Canadians that one lot of “Organic Traditions Shatavari Powder” is being voluntarily recalled by Advantage Health Matters Inc. Company testing found Salmonella bacteria contamination, which may pose serious health risks. According to Advantage Health Matters Inc., 13 units from the affected lot were distributed. Of the 13 units, only 2 packages, sold at Choices Markets Yaletown (1202 Richards Street) in Vancouver, B.C., have not been recovered.

Health Canada

23-1-2018

Overview of changes requiring an inspection in the GMP area

Overview of changes requiring an inspection in the GMP area

Companies that manufacture medicines must be authorised to perform manufacturing activities by the Danish Medicines Agency according to section 39 of the Danish Medicines Act. They must comply with the rules on good manufacturing practice (GMP) and will be inspected regularly by our GMP inspectors.

Danish Medicines Agency

22-1-2018

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

Ocean Township, NJ. In accordance with a Consent Decree of Permanent Injunction ordered in the United States District Court for the District of New Jersey, Flawless Beauty, LLC is voluntarily recalling all lots of nineteen different products sold individually or as part of multi-unit kits alleged by the U.S. Food and Drug Administration ("FDA") to be misbranded or unapproved new drugs pursuant to the Federal Food, Drug, and Cosmetic Act. The FDA believes that these drugs present serious public health risks.

FDA - U.S. Food and Drug Administration

11-2-2015

MIA format updated according to EMA's community procedures

MIA format updated according to EMA's community procedures

We have updated our IT systems and are now able to transfer Manufacturing and Importation Authorisations (MIA) to EudraGMDP via EMA's latest XML form. This implies some changes to how we will issue MIAs in future.

Danish Medicines Agency

5-1-2015

Fees for medical devices in 2015

Fees for medical devices in 2015

The fees for medical devices have been adjusted in accordance with Danish Government regulations, including the fees for registration of manufacturers and devices, importers and distributors, assessment of applications for the authorisation for clinical investigation of medical devices, and amendments to investigations, as well as supervision and control of notified bodies in Denmark.

Danish Medicines Agency

3-7-2014

More clinical trials to Denmark

More clinical trials to Denmark

The number of clinical trial applications increased by 35 trials (14%) from 2012 to 2013, which is the highest level in seven years. The increase covers both companies and researchers according to the Danish Health and Medicines Authority's annual report 2013 on clinical trials of medicines in humans.

Danish Medicines Agency

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

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

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