Sildenafil "Accord"

Primær information

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

Dokumenter

Lokation

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

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 46042
  • Sidste ændring:
  • 17-07-2018

Indlægsseddel

Indlægsseddel: Information til brugeren

Sildenafil Accord 25 mg filmovertrukne tabletter

Sildenafil Accord 50 mg filmovertrukne tabletter

Sildenafil Accord 100 mg filmovertrukne tabletter

Sildenafil

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 Sildenafil 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, apotekspersonalet eller sundhedspersonalet, hvis en bivirkning bliver værre, eller du får

bivirkninger, som ikke er nævnt her. Se punkt 4.

Oversigt over indlægssedlen:

1. Virkning og anvendelse

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

3. Sådan skal du tage Sildenafil Accord

4. Bivirkninger

5. Opbevaring

6. Pakningsstørrelser og yderligere oplysninger

1. Virkning og anvendelse

Sildenafil

Accord

tilhører

gruppe

medicin,

kaldes

fosfodiesterase

type

(PDE5)

hæmmere.

Sildenafil Accord virker afslappende på blodkarrene i penis og tillade blodet at strømme ind i penis, når du

bliver seksuelt ophidset. Sildenafil Accord vil kun hjælpe dig med at få erektion, hvis du bliver seksuelt

stimuleret.

Sildenafil Accord bruges til behandling af voksne mænd med erektil dysfunktion, nogle gange omtalt som

impotens. Det er manglende evne til at opnå eller opretholde en erektion af penis, der er tilstrækkelig til at

gennemføre tilfredsstillende seksuel aktivitet.

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

Tag ikke Sildenafil Accord

− Hvis du er allergisk over for sildenafil eller et af de øvrige indholdsstoffer i Sildenafil Accord (angivet i

punkt 6).

− Hvis du tager medicin, som kaldes nitrater, da samtidig brug kan medføre et fald i dit blodtryk, som kan

være farligt. Fortæl det til lægen, hvis du tager denne type medicin, som ofte anvendes til at lindre angina

pectoris (eller “brystsmerter”). Spørg lægen eller på apoteket, hvis du er usikker.

− Hvis du tager lægemidler, som kaldes nitrogenoxiddonorer, såsom amylnitrit (“poppers”), da samtidig

brug også kan medføre et fald i dit blodtryk, som kan være farligt.

− Hvis du tager riociguat. Dette lægemiddel anvendes til behandling af pulmonal arteriel hypertension

(dvs. højt blodtryk i lungerne) og kronisk tromboembolisk pulmonal hypertension (dvs. højt blodtryk i

lungerne som følge af blodpropper). PDE5-hæmmere, såsom sildenafil , har vist sig at øge den

blodtrykssænkende virkning af dette lægemiddel. Tal med din læge, hvis du tager riociguat eller

er i tvivl.

− Hvis du har alvorlige hjerte- eller leverproblemer.

− Hvis du for nyligt har haft slagtilfælde eller hjerteanfald, eller hvis du har lavt blodtryk.

− Hvis du lider af visse alvorlige arvelige øjensygdomme (såsom

retinitis pigmentosa

− Hvis du tidligere har haft tab af synet på grund af non-arteritis anterior iskæmisk opticusneuropati

(NAION).

Advarsler og forsigtighedsregler

Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Sildenafil Accord

− hvis du lider af seglcelleanæmi (en abnormitet i de røde blodceller), leukæmi (blodkræft) eller multipelt

myelom (knoglemarvskræft)

− hvis du har en deformitet af penis eller lider af Peyronies sygdom.

− hvis du har hjerteproblemer. I så fald skal din læge omhyggeligt undersøge, om dit hjerte kan tåle den

ekstra anstrengelse, det er at have sex.

− hvis du lider af mavesår eller blødningsforstyrrelser (såsom hæmofili).

− hvis du oplever pludselige nedsættelser eller tab af synet, skal du stoppe med at tage Sildenafil Accord og

straks søge læge.

− du

bør ikke anvende Sildenafil Accord sammen med andre orale eller lokale behandlinger for erektil

dysfunktion.

− du bør ikke anvende Sildenafil Accord sammen med behandlinger af pulmonal arteriel hypertension

(PAH), som indeholder sildenafil eller andre PDE5-hæmmere.

− du bør ikke tage Sildenafil Accord, hvis du ikke lider af erektil dysfunktion.

− du bør ikke tage Sildenafil Accord, hvis du er en kvinde.

Særlige overvejelser i forbindelse med patienter med nyre- eller leverproblemer

Fortæl det til din læge, hvis du har nyre- eller leverproblemer. Lægen kan beslutte, at du skal have

en lavere dosis.

Børn og unge

Sildenafil Accord bør ikke gives til personer under 18 år.

Brug af anden medicin sammen med Sildenafil Accord:

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

Sildenafil Accord kan påvirke virkningen af anden medicin, især medicin mod brystsmerter. I tilfælde af en

alvorlig hændelse skal du fortælle det sundhedspersonale, som behandler dig, at du har taget Sildenafil

Accord, og hvornår du har taget dem. Tag ikke Sildenafil Accord sammen med anden medicin, medmindre

din læge siger, du kan gøre det.

må ikke tage Sildenafil Accord, hvis du tager medicin, som kaldes nitrater, da samtidig brug af disse

lægemidler

medføre

fald

blodtryk,

være

farligt.

Fortæl

altid

lægen,

apotekspersonalet eller sundhedspersonalet, hvis du tager denne type lægemidler, som bruges til lindring af

angina pectoris (eller “brystsmerter”).

Du må ikke tage Sildenafil Accord, hvis du tager lægemidler af typen nitro-genoxiddonorer, såsom

amylnitrit (“poppers”), da samtidig brug også kan medføre et fald i dit blodtryk, som kan være farligt.

Fortæl det til lægen eller apotekspersonalet, hvis du allerede tager riociguat.

Hvis du tager medicin, som kaldes proteasehæmmere, f.eks. til behandling af HIV, kan din læge starte

behandlingen på den laveste dosis Sildenafil Accord (25 mg).

Nogle patienter, som modtager behandling med en alfa-blokker til behandling af højt blodtryk eller

forstørret prostata, kan opleve svimmelhed eller uklarhed, som kan skyldes lavt blodtryk, når man sætter sig

eller rejser sig hurtigt. Visse patienter har haft disse symptomer, når de tager Sildenafil Accord sammen

med alfa-blokkere. Dette vil som regel ske inden for 4 timer efter, at du har indtaget Sildenafil Accord. For

at nedsætte sandsynligheden for, at du får disse symptomer, bør du være på en regelmæssig daglig dosis af

alfa-blokkeren, før du tager Sildenafil Accord. Lægen kan give dig en lavere begyndelsesdosis (25 mg) af

Sildenafil Accord.

Brug af Sildenafil Accord sammen med mad og drikke

Sildenafil Accord kan tages sammen med mad eller uden mad. Du kan måske opleve, at det kan tage lidt

længere tid, før Sildenafil Accord virker, hvis du tager dem i forbindelse med et tungt måltid.

Indtagelse af alkohol kan midlertidig nedsætte din evne til at få rejsning. For at få den fulde virkning af din

medicin, bør du ikke drikke alkohol i store mængder, før du tager Sildenafil Accord.

Graviditet, amning og frugtbarhed

Sildenafil Accord er ikke beregnet til at blive brugt af kvinder.

Trafik- og arbejdssikkerhed

Sildenafil Accord kan forårsage svimmelhed og kan påvirke synet. Du bør være klar over, hvordan du

reagerer på Sildenafil, inden du kører bil eller betjener maskiner.

Vigtig information om nogle af de øvrige indholdsstoffer i Sildenafil Accord

Sildenafil Accord

indeholder laktosemonohydrat. Hvis din læge har fortalt dig, at du ikke kan tåle visse

sukkerarter, skal du kontakte din læge, inden du tager Sildenafil Accord.

3. Sådan skal du tage Sildenafil Accord

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

Den sædvanlige begyndelsesdosis er 50 mg.

Du bør ikke tage Sildenafil Accord mere end én gang dagligt.

bør tage Sildenafil Accord ca. 1 time inden du planlægger at have sex. Synk tabletten hel med et glas

vand.

Hvis du mener, at virkningerne af Sildenafil Accord er for kraftige eller for svage, bør du tale med din læge

om det.

Sildenafil tablets hjælper kun til erektion ved seksuel stimulation. Den tid, der går, inden Sildenafil Accord

begynder at virke, varierer fra person til person, men det tager normalt mellem en halv og en hel time. Det

kan vare længere, inden Sildenafil Accord virker, hvis du tager dem sammen med et tungt måltid.

Hvis Sildenafil Accord ikke hjælper til at give dig erektion, eller hvis erektionen ikke varer længe nok til at

gennemføre samleje, bør du sige det til din læge.

Hvis du har taget for mange Sildenafil Accord

Du kan opleve hyppigere og kraftigere bivirkninger. Doser over 100 mg forøger ikke virkningen.

Du må ikke tage flere tabletter, end lægen har foreskrevet.

Kontakt lægen, hvis du har taget flere tabletter, end du skal.

Kontakt lægen eller apoteket, hvis du har yderligere spørgsmål vedrørende brugen af denne medicin.

4. Bivirkninger

Sildenafil Accord

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

De bivirkninger, der er rapporteret i forbindelse med anvendelse af Sildenafil Accord, er normalt milde til

moderate og af kort varighed.

Hvis du oplever en af følgende alvorlige bivirkninger, skal du stoppe med at tage Sildenafil Accord og

straks søge læge:

En allergisk reaktion - dette forekommer

ikke almindeligt

(kan forekomme hos op til en ud af 100

patienter)

Symptomerne omfatter pludselig hvæsen, besvær med at trække vejret eller svimmelhed,

hævelse af øjenlåg, ansigt, læber eller hals.

Smerter i brystet - dette forekommer

ikke almindeligt

Hvis det forekommer under eller efter samleje

- Sæt dig i tilbagelænet stilling og prøv at slappe af.

Tag ikke nitrater

mod dine brystsmerter.

Langvarige og nogle gange smertefulde erektioner - dette forekommer

sjældent

(kan forekomme hos op til

én ud af 1.000). Hvis du får en erektion, som varer længere end 4 timer, bør du straks kontakte lægen.

Pludseligt nedsat syn eller tab af syn - dette forekommer sjældent

Alvorlige hudreaktioner - dette forekommer sjældent

Symptomerne kan omfatte kraftig hudafskalning og hævelser i huden, vabler i munden,

på kønsorganerne og omkring øjnene, feber.

Slagtilfælde eller anfald - dette forekommer sjældent

Meget almindelige bivirkninger

(kan forekomme hos flere end 1 ud af 10)

hovedpine

Almindelige bivirkninger

(kan forekomme hos op til 1 ud af 10)

ansigtsrødmen

hedeture (symptomerne omfatter en pludselig følelse af varme i overkroppen)

kvalme

fordøjelsesbesvær

synsforstyrrelser (herunder farvesyn, lysfølsomhed, sløret syn eller nedsat synsskarphed)

tilstoppet næse

svimmelhed

Ikke almindelige bivirkninger

(kan forekomme hos op til 1 ud af 100)

opkastning

hududslæt

øjenirritationer

blodskudte øjne/røde øjne

øjensmerter

lysglimt

synsindtryk forekommer unormalt klare/lyse

lysfølsomhed

kraftig hjertebanken

hurtig puls

forhøjet blodtryk

lavt blodtryk

muskelsmerter, søvnighed

nedsat følesans

svimmelhed

ringen for ørerne

tør mund

blokerede eller tilstoppede bihuler

betændelse i slimhinderne i næsen (symptomerne omfatter løbende næse, nysen og tilstoppet næse)

smerte i den øverste del af maven

gastroøsofageal reflukssygdom

træthed

blod i urinen

følelse af at være varm

smerter i arme og ben

næseblødning

blod i urinen

øjne, der løber i vand

Sjældne bivirkninger

(kan forekomme hos op til 1 ud af 1.000)

hjerteanfald

uregelmæssig hjerterytme

besvimelse

slagtilfælde

midlertidigt nedsat blodtilførsel til dele af hjernen

følelse af, at halsen snører sig til

følelsesløshed i munden

blødning fra bagsiden af øjet

dobbeltsyn

nedsat synsskarphed

unormal følelse i øjet

hævelse i øje eller øjenlåg

små partikler eller pletter i synsfeltet

farvet ring omkring lyskilder

udvidede pupiller

misfarvning af det hvide i øjet

blødning fra penis

blod i sæden

tørhed i næsen

hævelse i næsen

følelse af at være irritabel

pludselig nedsættelse eller tab af hørelse

Yderligere bivirkninger

, som er rapporteret efter markedsføringen, er bl.a.:

ustabil angina pectoris (en hjertelidelse)

pludselig død

De fleste af de mænd, der fik disse bivirkninger, havde hjerteproblemer, før de tog dette lægemiddel. Det er

ikke muligt at bestemme, om disse bivirkninger var direkte forbundet med Sildenafil Accord.

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 via

Danmark

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 opbevaringsforhold.

Brug ikke Sildenafil Accord

efter den udløbsdato, som står på pakningen. Udløbsdatoen er den sidste dag i

den nævnte måned.

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

medicinrester i afløbet, toilettet eller skraldespanden.

6. Pakningsstørrelser og yderligere oplysninger

Sildenafil Accord indeholder

aktive

stof

Sildenafil.

Hver

tablet

indeholder

eller

sildenafil

sildenafilcitrat.

Øvrige indholdsstoffer:

-Tabletkerne: mikrokrystallinsk cellulose, vandfri calciumhydrogenfosfat, natriumcroscarmellose,

hypromellose 5cp (E464), magnesiumstearat

-Filmovertræk hypromellose 15cp (E464), titaniumdioxid (E171),

laktosemonohydrat, triacetin, indigo carminaluminium-lake (E132) (

se

også pkt. 2: Vigtig information om nogle af de øvrige indholdsstoffer i

Sildenafil Accord)

Sildenafil Accord udseende og pakningsstørrelser

Sildenafil Accord 25 mg er blå, mandelfarvede, bikonvekse, filmovertrukne tabletter indpræget ‘25’ på den

ene side, jævne på den anden side.

Sildenafil Accord 50 mg er blå, mandelformede, bikonvekse, filmovertrukne tabletter indpræget ‘50’ på den

ene side, jævne på den anden side.

Sildenafil Accord 100 mg er blå, mandelformede, bikonvekse, filmovertrukne tabletter indpræget ‘100’ på

den ene side, jævne på den anden side.

Sildenafil Accord fås i blisterpakninger med 2, 4, 8 eller 12 tabletter.

(Ikke alle pakningsstørrelser er nødvendigvis markedsført).

Indehaver af markedsføringstilladelsen

Accord Healthcare Limited,

Sage House, 319, Pinner Road,

North Harrow, Middlesex,

HA1 4HF,

Storbritannien

Fremstiller

Accord Healthcare Limited,

Sage House, 319, Pinner Road,

North Harrow, Middlesex,

HA1 4HF,

Storbritannien

Denne indlægsseddel blev senest ændret 12/2016.

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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

11-7-2018

MyNicNaxs, LLC Issues Voluntary Nationwide Recall of Various Dietary Supplements Due to Undeclared Active Pharmaceutical Ingredient (API)

MyNicNaxs, LLC Issues Voluntary Nationwide Recall of Various Dietary Supplements Due to Undeclared Active Pharmaceutical Ingredient (API)

MyNicNaxs, LLC, Deltona, FL is voluntarily recalling all lots of dietary supplements distributed nationwide to the consumer level. The products have been found to contain undeclared active pharmaceutical ingredients (API). The presence of Sildenafil, Sibutramine, Diclofenac and/or Phenolphthalein in the dietary supplements renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. These products were distributed from January 2013, to December ...

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

18-5-2018

7K and Poseidon 4500 by Shoreside Enterprises: Voluntary Recall - Due to Presence of Undeclared Sildenafil and/or Tadalafil

7K and Poseidon 4500 by Shoreside Enterprises: Voluntary Recall - Due to Presence of Undeclared Sildenafil and/or Tadalafil

Use of products with the undeclared active ingredients, sildenafil and tadalafil, may pose a threat to consumers because the active ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are the most at risk from these products. These products are considered ta...

FDA - U.S. Food and Drug Administration

17-5-2018

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil

Shoreside Enterprises, Inc. is voluntarily recalling 7K (Lot specific: Lot #RO) and Poseidon 4500 (Extreme 1000 mg) (Lot specific: Lot #20117BL) to the consumer level. FDA analysis found the samples of these products to contain undeclared Sildenafil and/or Tadalafil. Sildenafil and Tadalafil are active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED).

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

1-8-2018

Viagra (Pfizer Europe MA EEIG)

Viagra (Pfizer Europe MA EEIG)

Viagra (Active substance: sildenafil) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5203 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/202/T/98

Europe -DG Health and Food Safety

1-8-2018

Revatio (Pfizer Europe MA EEIG)

Revatio (Pfizer Europe MA EEIG)

Revatio (Active substance: sildenafil) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5221 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/638/T/82

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

15-5-2018

Effentora (Teva B.V.)

Effentora (Teva B.V.)

Effentora (Active substance: fentanyl citrate) - PSUSA - Modification - Commission Decision (2018)3013 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/1369/201704

Europe -DG Health and Food Safety