Eplerenon "Accord"

Primær information

  • Handelsnavn:
  • Eplerenon "Accord" 25 mg filmovertrukne tabletter
  • Dosering:
  • 25 mg
  • Lægemiddelform:
  • filmovertrukne tabletter
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Eplerenon "Accord" 25 mg filmovertrukne tabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 54572
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel

INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN

Eplerenon Accord 25 mg filmovertrukne tabletter

Eplerenon Accord 50 mg filmovertrukne tabletter

eplerenon

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 medicinen til

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

Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger, herunder 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 du vide, før du begynder at tage Eplerenon Accord

Sådan skal du tage Eplerenon Accord

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

1.

Virkning og anvendelse

Eplerenon Accord tilhører en gruppe lægemidler, som kaldes selektive aldosteronantagonister. De

hæmmer virkningen af aldosteron, som er et stof, der produceres i kroppen og styrer blodtryk og

hjertefunktion. Høje niveauer af aldosteron kan forårsage ændringer i kroppen, som kan føre til

hjertesvigt.

Eplerenon Accord bruges til at behandle hjertesvigt for at forebygge forværring og mindske antallet af

hospitalsindlæggelser, hvis du har:

haft en blodprop i hjertet for nylig, i kombination med andre lægemidler, der bruges til at

behandle dit hjertesvigt, eller

vedvarende, milde symptomer trods den behandling, du har fået hidtil.

2.

Det skal du vide, før du begynder at tage Eplerenon Accord

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

Følg altid lægens anvisning og oplysningerne på doseringsetiketten.

Tag ikke Eplerenon Accord

hvis du er allergisk over for eplerenon eller et af de øvrige indholdsstoffer i Eplerenon Accord

(angivet i punkt 6).

hvis du har høje niveauer af kalium i blodet (hyperkaliæmi)

hvis du tager grupper af lægemidler, som hjælper dig med at udskille overskydende væske fra

kroppen (kaliumbesparende diuretika), eller ”salttabletter” (kaliumtilskud)

hvis du har alvorlig nyresygdom

hvis du har alvorlig leversygdom

hvis du tager lægemidler, der bruges til at behandle svampeinfektioner (ketoconazol eller

itraconazol)

hvis du tager aniviral medicin mod HIV (nelfinavir eller ritonavir)

hvis du tager antibiotika til behandling af bakterieinfektioner (clarithromycin eller

telithromycin)

hvis du tager nefazodon, som bruges til at behandle depression

hvis du tager lægemidler, som bruges til at behandle visse hjertesygdomme eller forhøjet

blodtryk (en såkaldt angiotensinkonverterende enzymhæmmer (ACE-hæmmer) og en

angiotensin II-receptorantagonist (AIIRA) sammen

Advarsler og forsigtighedsregler

Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Eplerenon Accord.

hvis du har nyre- eller leversygdom (se også ”Tag ikke Eplerenon Accord”)

hvis du tager lithium (gives normalt mod maniodepressiv sygdom, også kaldet bipolær

sygdom)

hvis du tager tacrolimus eller ciclosporin (bruges til at behandle hudlidelser som psoriasis eller

eksem og til at forhindre afstødning efter organtransplantation)

Børn og unge

Eplerenons sikkerhed og virkning hos børn og unge er ikke klarlagt.

Brug af anden medicin sammen med Eplerenon Accord

Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for

nylig.

Du må ikke tage Eplerenon Accord sammen med følgende lægemidler (se ”Tag ikke

Eplerenon Accord”):

Itraconazol eller ketoconazol (bruges til at behandle svampeinfektioner), ritonavir, nelfinavir

(antiviral medicin til behandling af HIV), clarithromycin, telithromycin (bruges til behandling

af bakterieinfektioner) eller nefazodon (bruges til at behandle depression), da disse lægemidler

mindsker nedbrydningen af Eplerenon Accord og derved forlænger dets virkning på kroppen.

Kaliumbesparende diuretika (lægemidler, som hjælper dig med at udskille overskydende

væske fra kroppen) og kaliumtilskud (salttabletter), da disse lægemidler øger risikoen for høje

kaliumniveauer i kroppen.

Angiotensinkonverterende enzymhæmmere (ACE-hæmmere) og

angiotensinreceptorantagonister (AIIRA'er) sammen (bruges til at behandle forhøjet blodtryk,

hjertesygdom eller især nyresygdomme), da disse lægemidler kan øge risikoen for høje

kaliumniveauer i blodet.

Fortæl det til lægen, hvis du tager et eller flere af følgende lægemidler:

Lithium (gives normalt mod maniodepressiv sygdom, også kaldet bipolær sygdom) Det er vist,

at anvendelse af lithium sammen med diuretika og ACE-hæmmere (bruges til at behandle

forhøjet blodtryk og hjertesygdom) bevirker, at lithiumniveauet i blodet bliver for højt, hvilket

kan medføre bivirkninger som tab af appetit, synsforstyrrelser, træthed, muskelsvækkelse,

muskelsammentrækninger.

Ciclosporin eller tacrolimus (bruges til at behandle hudlidelser som psoriasis eller eksem og til

at forhindre afstødning efter organtransplantation). Disse lægemidler kan give nyreproblemer

og øger derfor risikoen for høje kaliumniveauer i blodet.

Non-steroide antiinflammatoriske midler (NSAID'er - visse smertestillende midler som

ibuprofen, der bruges til at lindre smerter, stivhed og betændelsestilstande). Disse lægemidler

kan give nyreproblemer og øger derfor risikoen for høje kaliumniveauer i blodet.

Trimethoprim (bruges til at behandle bakterieinfektioner) kan øge risikoen for høje

kaliumniveauer i blodet.

Alfa-I-antagonister som prazosin eller alfuzosin (bruges til at behandle forhøjet blodtryk og

især prostatasygdomme) kan føre til et fald i blodtrykket og svimmelhed, når du rejser dig op.

Tricykliske antidepressiva som amitryptylin eller amoxapin (til behandling af depressioner),

antipsykotika (også kaldet neuroleptika) som chlorpromazin eller haloperidol (til behandling

af psykiske forstyrrelser), amifostin (bruges under kemoterapi mod kræft) og baclofen (bruges

til at behandle muskelkramper). Disse lægemidler kan føre til et fald i blodtrykket og

svimmelhed, når du rejser dig op.

Glucokortikoider, f.eks. hydrokortison eller prednison (bruges til at behandle

betændelsestilstande og visse hudlidelser) og tetracosactid (bruges hovedsageligt til

diagnosticering og behandling af sygdomme i binyrebarken) kan mindske Eplerenon Accords

blodtrykssænkende virkning.

Digoxin (bruges til at behandle hjertesygdomme). Mængden af digoxin i blodet kan forøges,

når det tages sammen med Eplerenon Accord.

Warfarin (blodfortyndende middel): Der skal udvises forsigtighed, når du tager warfarin, fordi

høje niveauer af warfarin i blodet kan ændre Eplerenon Accords virkning på kroppen.

Erythromycin (bruges til at behandle bakterieinfektioner), saquinavir (antiviral medicin til

behandling af HIV), fluconazol (bruges til at behandle svampeinfektioner), amiodaron,

diltiazem og verapamil (til behandling af hjerteproblemer og forhøjet blodtryk) mindsker

nedbrydningen af Eplerenon Accord og forlænger derved Eplerenon Accords virkning på

kroppen.

Prikbladet perikon (urtemedicin), rifampicin (bruges til at behandle bakterieinfektioner),

carbamazepin, fenytoin og phenobarbital (bruges blandt andet til at behandle epilepsi) kan øge

nedbrydningen af Eplerenon Accord og dermed mindske dets virkning.

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 eller apotekspersonalet til råds, før du tager dette lægemiddel. Eplerenon Accords

virkning er ikke undersøgt under graviditet hos mennesker.

Det vides ikke, om eplerenon udskilles i modermælk hos mennesker. Du skal i samråd med din læge

beslutte, om du skal stoppe amningen eller stoppe behandlingen med lægemidlet.

Trafik- og arbejdssikkerhed

Du kan føle dig svimmel, når du har taget Eplerenon Accord. Hvis det sker, må du ikke køre bil eller

betjene maskiner.

Eplerenon Accord indeholder lactosemonohydrat

Eplerenon Accord indeholder lactosemonohydrat (en form for sukker). Hvis lægen har fortalt dig, at

du ikke kan tåle visse former for sukker, skal du kontakte lægen, før du tager denne medicin.

3.

Sådan skal du tage Eplerenon Accord

Tag altid lægemidlet nøjagtigt efter lægens eller apotekspersonalets anvisning. Er du i tvivl, så spørg

lægen eller apotekspersonalet.

Eplerenon Accord-tabletter kan tages sammen med mad eller på tom mave. Tabletterne skal synkes

hele med rigeligt vand.

Eplerenon Accord gives normalt sammen med anden medicin mod hjertesvigt, f.eks. betablokkere.

Den sædvanlige startdosis er en 25 mg tablet en gang dagligt stigende til 50 mg en gang dagligt efter 4

uger (enten som en 50 mg tablet eller to 25 mg tabletter). Den maksimale dosis er 50 mg dagligt.

Kalium i blodet skal måles, før behandlingen med Eplerenon Accord påbegyndes, inden for den første

uge og 1 måned efter behandlingens start eller efter dosisændring. Din læge kan justere dosis, alt efter

hvor meget kalium du har i blodet.

Hvis du har mild nyresygdom, skal du starte på en 25 mg tablet hver dag. Hvis du har moderat

nyresygdom, skal du starte på en 25 mg tablet hver anden dag. Doserne kan reguleres, hvis din læge

anbefaler det, og det afhænger af mængden af kalium i blodet.

Eplerenon Accord anbefales ikke til patienter med alvorlig nyresygdom.

Det er ikke nødvendigt at justere dosis til patienter med mild til moderat leversygdom. Hvis du har

nyre- eller leverproblemer, kan det være nødvendigt at undersøge kaliumniveauet i blodet oftere (se

også ”Tag ikke Eplerenon Accord”).

Ældre: Det er ikke nødvendigt at justere startdosis.

Børn og unge: Eplerenon Accord anbefales ikke.

Hvis du har taget for meget Eplerenon Accord

Kontakt lægen, skadestuen eller apoteket, hvis du har taget mere af

Eplerenon Accord

, end der står i

denne information, eller mere end lægen har foreskrevet (og du føler dig utilpas).

Hvis du har taget for meget af din medicin, vil du sandsynligvis få symptomer som for lavt blodtryk

(viser sig ved, at du føler dig let i hovedet, svimmelhed, sløret syn, svækkelse, akut tab af bevidsthed)

eller hyperkaliæmi, høje niveauer af kalium i blodet (viser sig ved muskelkramper, diarré, kvalme,

svimmelhed eller hovedpine).

Hvis du har glemt at tage Eplerenon Accord

Hvis det næsten er tid til den næste tablet, springer du den glemte tablet over og tager den næste tablet

på det sædvanlige tidspunkt.

Ellers kan du tage tabletten, når du kommer i tanke om det, hvis der er mindst 12 timer, til du skal tage

den næste tablet. Tag derefter medicinen, som du plejer.

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

Hvis du holder op med at tage Eplerenon Accord

Du skal ikke holde op med at tage Eplerenon Accord, medmindre din læge har bedt dig om det.

Spørg lægen eller apotekspersonalet, 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.

Hvis du oplever et eller flere af følgende:

Skal du straks søge læge

hævelse i ansigt, tunge eller svælg

synkebesvær

nældefeber og vejrtrækningsbesvær

Dette er symptomer på angioneurotisk ødem, som er en ikke almindelig bivirkning (kan forekomme

hos op til 1 ud af 100 patienter).

Andre indberettede bivirkninger:

Almindelige bivirkninger

(kan forekomme hos op til 1 ud af 10 patienter):

forhøjet kalium i blodet (symptomer kan være muskelkramper, diarré, kvalme, svimmelhed

eller hovedpine)

svimmelhed

besvimelse

forhøjet mængde kolesterol i blodet

søvnløshed

hovedpine

hjerteproblemer, f.eks. uregelmæssig hjerterytme og hjertesvigt

hoste

forstoppelse

lavt blodtryk

diarré

kvalme

opkastning

unormal nyrefunktion

udslæt

kløe

rygsmerter

svaghed

muskelkramper

forøgelse af carbamid i blodet

forhøjet kreatininniveau, som kan tyde på nyreproblemer

Ikke almindelige bivirkninger

(kan forekomme hos op til 1 ud af 100 patienter):

infektion

eosinofili (forøgelse af visse hvide blodlegemer)

dehydrering

forhøjet mængde triglycerider (fedtstoffer) i blodet

lavt niveau af natrium i blodet

hurtig hjerterytme

betændelse i galdeblæren

lavt blodtryk, som kan give svimmelhed, når du rejser dig op

trombose (blodprop) i benet

ondt i halsen

oppustethed

underaktiv skjoldbruskkirtel

forhøjet blodsukker

nedsat følesans

øget svedtendens

muskuloskeletale smerter

generel følelse af utilpashed

nyrebetændelse

forstørrede bryster hos mænd

ændringer i nogle blodprøveresultater

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 Lægemiddelstyrelsen:

Lægemiddelstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: dkma@dkma.dk

Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden

af dette lægemiddel.

5.

Opbevaring

Opbevar lægemidlet utilgængeligt for børn.

Dette lægemiddel kræver ingen særlige forholderegler vedrørende opbevaringen.

Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den

sidste dag i den nævnte måned.

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

medicinrester i afløbet eller skraldespanden.

6.

Pakningsstørrelser og yderligere oplysninger

Eplerenon Accord indeholder:

Aktivt stof: eplerenon. Hver tablet indeholder 25 mg eller 50 mg eplerenon.

Øvrige indholdsstoffer: Lactosemonohydrat, mikrokrystallinsk cellulose, hypromellose,

croscarmellosenatrium, talcum, magnesiumstearat.

Opadry 13B52001-gult filmovertræk på Eplerenon Accord indeholder:Hypromellose, titandioxid

(E171), Macrogol 400, polysorbat 80, gult jernoxid (E172) og rødt jernoxid (E172)

Udseende og pakningsstørrelser

Eplerenon Accord 25 mg er en gul, rombeformet, bikonveks filmovertrukket tablet med “E1” præget

på den ene side og uden prægning på den anden side. Den filmovertrukne tablets længde, bredde og

tykkelse er henholdsvis 7,20 ±0,3 mm, 6,40 ±0,3 mm og 3,15 ±0,3 mm

Eplerenon Accord 50 mg er en gul, rombeformet, bikonveks filmovertrukket tablet med “E2” præget

på den ene side og uden prægning på den anden side. Den filmovertrukne tablets længde, bredde og

tykkelse er henholdsvis 9,00 ±0,3 mm, 8,10 ±0,3 mm og 4,25 ±0,3 mm.

Eplerenon filmovertrukne tabletter 25 mg og 50 mg fås i blistere med 10, 20, 28, 30, 50, 90 eller 100

tabletter eller i perforerede enhedsdosisblistere med 10 x 1, 20 x 1, 28 x 1, 30 x 1, 50 x 1, 90 x 1 eller

100 x 1 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

Wessling Hungary Kft

Fòti ùt 56., Budapest 1047,

Ungarn

Denne indlægsseddel blev senest ændret 11/2016.

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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