Rosuvastatin "Accord"

Primær information

  • Handelsnavn:
  • Rosuvastatin "Accord" 40 mg filmovertrukne tabletter
  • Dosering:
  • 40 mg
  • Lægemiddelform:
  • filmovertrukne tabletter
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Rosuvastatin "Accord" 40 mg filmovertrukne tabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 54422
  • Sidste ændring:
  • 24-02-2018

Indlægsseddel

Indlægsseddel: Information til brugeren

Rosuvastatin Accord 5 mg filmovertrukne tabletter

Rosuvastatin Accord 10 mg filmovertrukne tabletter

Rosuvastatin Accord 20 mg filmovertrukne tabletter

Rosuvastatin Accord 40 mg filmovertrukne tabletter

rosuvastatin

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, apotekspersonalet eller sundhedspersonalet, 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, apotekspersonalet eller sundhedspersonalet, hvis du får bivirkninger, herunder

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

Se den nyeste indlægsseddel på www.indlaegsseddel.dk

Oversigt over indlægssedlen:

1. Virkning og anvendelse

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

3. Sådan skal du tage Rosuvastatin Accord

4. Bivirkninger

5. Opbevaring

6. Pakningsstørrelser og yderligere oplysninger

1.

Virkning og anvendelse

Rosuvastatin Accord tilhører en gruppe lægemidler, som kaldes statiner.

Du har fået ordineret Rosuvastatin Accord, fordi:

Du har forhøjet kolesterol. Det betyder, at du har risiko for at få en blodprop i hjertet eller et

slagtilfælde.

Rosuvastatin Accord anvendes til voksne, unge og børn på 6 år eller derover til behandling af

forhøjet kolesterol.

Du er blevet rådet til at tage et statin, fordi kostændring og mere motion ikke var nok til at ændre dit

kolesterolniveau. Du bør fortsætte med den kolesterolsænkende diæt og motionen, mens du tager

Rosuvastatin Accord.

Eller

du har andre faktorer, der øger din risiko for at få en blodprop i hjertet, et slagtilfælde eller

helbredsproblemer relateret hertil.

blodprop i hjertet, slagtilfælde og helbredsproblemer relateret hertil kan skyldes en sygdom,

der hedder aterosklerose (åreforkalkning). Aterosklerose skyldes aflejring af fedt i årerne.

Hvorfor er det vigtigt at blive ved med at tage Rosuvastatin Accord?

Rosuvastatin Accord bruges til at korrigere niveauerne af fedtstoffer i blodet, som kaldes lipider,

hvoraf det mest almindelige er kolesterol.

Der findes forskellige typer kolesterol i blodet – det ’dårlige’ kolesterol (LDL-C) og det ’gode’

kolesterol (HDL-C).

Rosuvastatin Accord kan mindske mængden af ’dårligt’ kolesterol og øge det ’gode’ kolesterol.

Det virker ved at blokere kroppens egen produktion af det ’dårlige’ kolesterol. Det forbedrer også

kroppens evne til at fjerne det fra blodet.

De fleste mennesker kan ikke mærke, at de har forhøjet kolesterol, fordi det ikke giver nogen

symptomer. Men hvis det ikke bliver behandlet, kan der opbygges fedtaflejringer i blodkarrene, så

de bliver forsnævret.

Det kan ske, at de forsnævrede blodkar bliver blokeret, så blodforsyningen til hjertet eller hjernen

bliver afskåret, og du får dermed en blodprop i hjertet eller et slagtilfælde. Ved at sænke

kolesterolniveauet kan du mindske risikoen for at få en blodprop i hjertet, et slagtilfælde eller

relaterede helbredsproblemer.

Du skal

blive ved med at tage Rosuvastatin Accord

, også selvom du har fået kolesterolet ned på

det rigtige niveau, fordi

det forhindrer, at kolesterolniveauet stiger igen

, så der kan opbygges

fedtaflejringer. Du skal dog holde op, hvis lægen giver dig besked på det, eller hvis du bliver

gravid.

2.

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

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

Følg altid lægens anvisning og oplysningerne på doseringsetiketten.

Tag ikke Rosuvastatin Accord

hvis du er allergisk over for rosuvastatin eller et af de øvrige indholdsstoffer i dette lægemiddel

(angivet i punkt 6).

hvis du er gravid eller ammer. Hvis du bliver gravid, mens du tager Rosuvastatin Accord,

skal du

straks holde op med at tage det og fortælle det til lægen

. Kvinder skal undgå at blive gravide,

mens de tager Rosuvastatin Accord, ved at benytte passende prævention.

hvis du har en leversygdom.

hvis du har alvorlige nyreproblemer.

hvis du har gentagen eller uforklarlig muskelømhed eller muskelsmerter.

hvis du tager lægemidlet ciclosporin (f.eks. efter organtransplantation).

Hvis noget af det ovennævnte er tilfældet (eller du er i tvivl), skal du tale med din læge igen.

Desuden må du ikke tage Rosuvastatin Accord 40 mg (den højeste dosis)

hvis du har moderate nyreproblemer (spørg lægen, hvis du er i tvivl)

hvis din skjoldbruskkirtel ikke fungerer optimalt

hvis du har haft gentagen eller uforklarlig muskelømhed eller muskelsmerter, eller du eller nogen

i familien har haft muskelproblemer, eller hvis du har haft muskelproblemer i forbindelse med

andre kolesterolsænkende midler.

hvis du har et stort alkoholforbrug.

hvis du er af asiatisk oprindelse (japansk, kinesisk, filippinsk, vietnamesisk, koreansk og indisk).

hvis du tager anden medicin kaldet fibrater for at sænke kolesterol.

Hvis noget af det ovennævnte er tilfældet (eller du er i tvivl), skal du tale med din læge igen.

Advarsler og forsigtighedsregler

Kontakt lægen eller apotekspersonalet, før du tager Rosuvastatin Accord.

hvis du har problemer med nyrerne.

hvis du har problemer med leveren.

hvis du har haft gentagen eller uforklarlig muskelømhed eller muskelsmerter, eller du eller nogen

i familien har haft muskelproblemer, eller hvis du har haft muskelproblemer i forbindelse med

andre kolesterolsænkende midler. Fortæl det straks til lægen, hvis du har uforklarlig

muskelømhed eller muskelsmerter, især hvis du også er utilpas eller har feber. Fortæl det også til

lægen eller apotekspersonalet, hvis du har en konstant muskelsvaghed..

hvis du har et stort alkoholforbrug.

hvis din skjoldbruskkirtel ikke fungerer optimalt.

hvis du tager anden medicin kaldet fibrater for at sænke kolesterol. Du bedes læse denne

indlægsseddel grundigt, selvom du har taget anden medicin for forhøjet kolesterol før.

hvis du tager lægemidler mod HIV, f.eks. kombinationer af ritonavir med atazanavir, lopinavir,

og/eller tipranavir, bedes du se

Brug af anden medicin sammen med Rosuvastatin Accord

hvis du tager eller i de seneste 7 dage har taget et lægemiddel, der hedder fusidinsyre (et

lægemiddel mod infektion med bakterier), enten gennem munden eller via injektion.

Kombinationen af fusidinsyre og Rosuvastatin Accord kan give alvorlige muskelproblemer

(rhabdomyolyse), se afsnittet

Brug af anden medicin sammen med Rosuvastatin Accord

hvis du er over 70 år (da lægen skal vælge den rette startdosis af Rosuvastatin Accord til dig)

hvis du lider af alvorlige vejrtrækningsproblemer

hvis du er af asiatisk oprindelse (japansk, kinesisk, filippinsk, vietnamesisk, koreansk eller indisk)

da lægen skal vælge den rette startdosis af Rosuvastatin Accord til dig

Hvis noget af det ovennævnte er tilfældet (eller du er i tvivl):

Tag ikke Rosuvastatin Accord 40 mg (den højeste dosis) og kontroller med din læge eller

apotekspersonalet, før du starter med at tage en dosis Rosuvastatin Accord

Statiner kan påvirke leveren hos et lille antal mennesker. Disse mennesker kan identificeres ved en

enkelt blodprøve, der viser lever-enzymernes niveau i blodet. Lægen vil derfor sædvanligvis tage

denne blodprøve før og i løbet af behandlingen med Rosuvastatin Accord.

Så længe du tager dette lægemiddel, vil din læge overvåge dit helbred nøje, hvis du har sukkersyge

(diabetes) eller er i risiko for at udvikle sukkersyge. Du vil muligvis være i risiko for at udvikle

sukkersyge, hvis du har et højt indhold af sukker og fedtstof i blodet, er overvægtig og har forhøjet

blodtryk.

Børn og unge

Hvis patienten er under 6 år: Rosuvastatin Accord må ikke gives til børn under 6 år.

Hvis patienten er under 18 år: Rosuvastatin Accord 40 mg tabletten er ikke egnet til børn og unge

under 18 år.

Brug af anden medicin sammen med Rosuvastatin Accord

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

nylig.

Fortæl lægen hvis du tager følgende: ciclosporin (anvendes for eksempel efter organtransplantation),

warfarin eller clopidogrel (eller andre blodfortyndende midler), fibrater (såsom gemfibrozil eller

fenofibrat) eller anden medicin til at sænke kolesteroltallet (såsom ezetinib), midler mod sure opstød

(syreneutraliserende midler), erythromycin (antibiotikum), fusidinsyre (et antibiotikum – se nedenfor

samt afsnittet Advarsler og forsigtighedsregler) eller svangerskabsforebyggende behandling i form af

tabletter (p-piller), hormonbehandling i forbindelse med overgangsalderen, eller antivirale lægemidler

såsom ritonavir sammen med lopinavir og/eller atazanavir eller simeprevir (anvendes til behandling af

infektioner, herunder hiv- eller hepatitis C-infektion – se afsnittet Advarsler og forsigtighedsregler).

Virkningen af denne type medicin kan ændres af Rosuvastatin Accord eller kan påvirke virkningen af

Rosuvastatin Accord.

Hvis du har behov for at tage fusidinsyre til behandling af en infektion med bakterier, skal du

midlertidigt afbryde anvendelsen af denne medicin. Lægen vil fortælle dig, hvornår det er sikkert at

begynde at bruge Rosuvastatin Accord igen. Hvis Rosuvastatin Accord anvendes samtidig med

fusidinsyre kan det i sjældne tilfælde føre til muskelsvækkelse, ømhed eller smerter (rhabdomyolyse).

Se mere information om rhabdomyolyse i punkt 4.

Graviditet og amning

Tag ikke Rosuvastatin Accord, hvis du er gravid eller ammer. Hvis du bliver gravid, mens du tager

Rosuvastatin Accord, skal du straks holde op med at tage det og fortælle det til lægen.

Kvinder skal

undgå at blive gravide, mens de tager Rosuvastatin Accord, ved at benytte passende prævention.

Spørg din læge eller apoteket til råds, før du tager nogen form for medicin.

Trafik- og arbejdssikkerhed

For de flestes vedkommende påvirker Rosuvastatin Accord ikke evnen til at køre bil eller betjene

maskiner. Nogle kan dog føle sig svimle under behandling med Rosuvastatin Accord. Hvis du føler

dig svimmel, skal du spørge lægen til råds, før du forsøger at køre bil eller betjene maskiner.

Rosuvastatin Accord indeholder lactose, sunset yellow og allura red

Hvis lægen har fortalt dig, at du ikke kan tåle visse former for sukker, skal du kontakte lægen, før du

tager denne medicin.

Rosuvastatin 40 mg filmovertrukne tabletter indeholder også sunset yellow og allura red, som kan

forårsage allergiske reaktioner

En liste med alle indholdsstoffer findes i afsnit 6 - i

Pakningsstørrelser og yderligere oplysninger

3.

Sådan skal du tage Rosuvastatin Accord

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

lægen eller apotekspersonalet.

Sædvanlige doser hos voksne

Hvis du tager Rosuvastatin Accord mod forhøjet kolesterol:

Startdosis

Behandlingen med Rosuvastatin Accord skal starte med 5 mg eller 10 mg, også selvom du har taget

en højere dosis af et andet statin før. Valg af startdosis afhænger af:

Dit kolesterolniveau.

Den risiko, du har for at få blodprop i hjertet eller slagtilfælde.

Om du har en faktor, der gør dig mere følsom over for bivirkninger.

Spørg din læge eller apotekspersonalet, hvilken startdosis af Rosuvastatin Accord som passer til dig.

Din læge kan beslutte at give dig den laveste dosis (5 mg), hvis:

Du er af asiatisk oprindelse (japansk, kinesisk, filippinsk, vietnamesisk, koreansk og indisk).

Du er over 70 år.

Du har moderate nyreproblemer.

Du har risiko for muskelømhed og muskelsmerter (myopati).

Forhøjelse af dosis og maksimal daglig dosis:

Din læge kan beslutte at sætte din dosis op. Det sker, for at du kan tage den mængde Rosuvastatin

Accord, som passer til dig. Hvis du startede med 5 mg, kan din læge beslutte at fordoble den til 10

mg, derefter til 20 mg og derefter til 40 mg, hvis det er nødvendigt. Hvis du startede med 10 mg, kan

din læge beslutte at fordoble den til 20 mg og derefter til 40 mg, hvis det er nødvendigt. Der skal gå

fire uger mellem hver dosisjustering.

Den maksimale daglige dosis af Rosuvastatin Accord er 40 mg. Den er kun til patienter med højt

kolesterolniveau og høj risiko for blodprop i hjertet eller slagtilfælde, hvis deres kolesterolniveau ikke

sænkes tilstrækkeligt med 20 mg.

Hvis du tager Rosuvastatin Accord for at mindske risikoen for at få blodprop i hjertet,

slagtilfælde eller relaterede helbredsproblemer:

Den anbefalede dosis er 20 mg dagligt. Din læge kan beslutte at nedsætte dosis, hvis du har nogle af

ovennævnte faktorer.

Børn og unge i alderen 6-17 år

Dosisintervallet til børn og unge i alderen 6 til 17 år er 5 til 20 mg én gang dagligt. Den normale

startdosis er 5 mg pr.dag og din læge kan gradvist øge din dosis for at finde den mængde

Rosuvastatin Accord, der passer til dig. Den maksimale daglige dosis af Rosuvastatin Accord er 10

mg eller 20 mg til børn på 6 til 17 årafhængig af den underliggende sygdom, der behandles. Tag

dosen en gang dagligt. Rosuvastatin Accord

40 mg tabletten må ikke anvendes til børn.

Sådan tages tabletterne

Tabletterne synkes hele med et glas vand.

Tag Rosuvastatin Accord en gang dagligt.

Du kan tage det på et hvilket som helst tidspunkt i løbet

af dagen med eller uden mad.

Prøv at tage din tablet på samme tidspunkt hver dag, så du husker det.

Regelmæssig kontrol af kolesterol

Det er vigtigt, at du jævnligt får kontrolleret dit kolesterol hos lægen, så du sikrer dig, at det har nået

det rigtige niveau og bliver der.

Din læge kan beslutte at sætte din dosis op, så du tager den mængde Rosuvastatin Accord, som passer

til dig.

Hvis du har taget for meget Rosuvastatin Accord

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

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

Hvis du tager på skadestuen eller får behandling for en anden sygdom, skal du oplyse personalet om,

at du tager Rosuvastatin Accord.

Hvis du har glemt at tage Rosuvastatin Accord

Der er ingen grund til bekymring. Du skal bare tage den næste dosis på det planlagte tidspunkt. Du må

ikke tage en dobbeltdosis som erstatning for den glemte tablet.

Hvis du holder op med at tage Rosuvastatin Accord

Fortæl det til lægen, hvis du holder op med at tage Rosuvastatin Accord. Dit kolesteroltal kan stige

igen, hvis du holder op med at tage Rosuvastatin Accord.

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.

Det er vigtigt, at du er klar over, hvilke bivirkninger der kan være. De er normalt milde og forsvinder

efter kort tid.

Hold op med at tage Rosuvastatin Accord, og søg straks læge, hvis du får en af følgende

allergiske reaktioner:

Vejrtrækningsbesvær med eller uden hævelse i ansigt, læber, tunge og/eller svælg.

Sjældne (kan

forekomme hos op til 1 ud af 1.000 patienter)

Hævelse i ansigt, læber, tunge og/eller svælg, som kan give synkebesvær. Sjældne (kan

forekomme hos op til 1 ud af 1.000 patienter)

Kraftig kløe i huden (med hævelser). Sjældne (kan forekomme hos op til 1 ud af 1.000 patienter)

Hold også op med at tage Rosuvastatin Accord, og tal straks med din læge, hvis du har

usædvanlig ømhed eller smerter

i musklerne, som vedvarer længere end forventet. Sjældne (kan

forekomme hos op til 1 ud af 1.000 patienter)

Muskelsymptomer er mere almindelige hos børn og unge end hos voksne. Som ved andre statiner

har et meget lille antal mennesker oplevet ubehagelige muskelvirkninger, og disse er i sjældne

tilfælde blevet til en potentielt livstruende muskelskade, som kaldes

rhabdomyolyse

Rosuvastatin Accord kan forårsage følgende bivirkninger:

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

Hovedpine

Mavesmerter

Forstoppelse

Kvalme

Muskelsmerter

Svaghed

Svimmelhed

En stigning i mængden af protein i urinen - den vender normalt tilbage til det normale af sig selv,

uden at du behøver at holde op med at tage Rosuvastatin Accord (gælder kun Rosuvastatin

Accord 40 mg).

Sukkersyge Det er mere sandsynligt, hvis du har et højt niveau af sukker og fedtstoffer i blodet, er

overvægtig og har forhøjet blodtryk. Din læge vil overvåge dig nøje, mens du tager dette

lægemiddel.

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

Udslæt, kløe eller andre hudreaktioner.

En stigning i mængden af protein i urinen – den vender normalt tilbage til det normale af sig selv,

uden at du behøver at holde op med at tage Rosuvastatin Accord (gælder kun Rosuvastatin

Accord 5 mg, 10 mg og 20 mg).

Sjældne (kan forekomme hos op til 1 ud af 1.000 patienter)

Kraftige mavesmerter (betændelse i bugspytkirtlen).

Forhøjede leverenzymer i blodet.

lavt antal blodplader (trombocytopeni)

Meget sjældne (kan forekomme hos op til 1 ud af 10.000 patienter)

Gulsot (gulfarvning af hud og øjne).

Hepatitis (leverbetændelse).

Spor af blod i urinen.

Skader på nerverne i arme og ben (f.eks. følelsesløshed).

Ledsmerter.

Hukommelsestab.

Forstørrede bryster hos mænd (gynækomasti).

Ikke kendt (hyppighed kan ikke estimeres ud fra forhåndenværende data)

Diarré (løs afføring).

Stevens-Johnsons syndrom (kraftig blæredannelse på huden, i munden, i øjnene og på

kønsdelene).

Hoste.

Kortåndethed.

Ødem (hævelse).

Søvnforstyrrelser, inkl. søvnløshed og mareridt.

Seksuelle problemer.

Depression.

Vejrtrækningsproblemer, herunder vedvarende hoste og/eller kortåndethed eller feber.

Seneskader.

Konstant muskelsvaghed.

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 de oplysninger, der fremgår

herunder.

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

Der er ingen særlige krav vedrørende opbevaringstemperaturer for dette lægemiddel. Opbevar i

originalemballagen for at beskytte mod lys.

Pakningen med HDPE-glasset skal anvendes senest 3 måneder efter åbning.

Opbevar lægemidlet utilgængeligt for børn.

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

sidste dag i den nævnte måned.

Brug ikke dette lægemiddel, hvis der er tegn på, at pakningen er beskadiget eller har været forsøgt

åbnet.

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

Rosuvastatin Accord indeholder:

Aktivt stof: rosuvastatin (som rosuvastatincalcium)

Hver filmovertrukket tablet indeholder 5 mg rosuvastatin (som rosuvastatin calcium).

Hver filmovertrukket tablet indeholder 10 mg rosuvastatin (som rosuvastatin calcium).

Hver filmovertrukket tablet indeholder 20 mg rosuvastatin (som rosuvastatin calcium).

Hver filmovertrukket tablet indeholder 40 mg rosuvastatin (som rosuvastatin calcium).

Øvrige indholdsstoffer:

Kernetablet

Lactose, vandfri

Cellulose, mikrokrystallinsk (E460)

Magnesiumoxid, let

Magnesiumstearat (E470b)

Crospovidon, typ A (E1202)

Filmovertræk

5 mg -

Hypromellose (E464), triacetin (E1518), titandioxid (E171), lactosemonohydrat, jernoxid, gult

(E172).

10 mg og 20 mg -

Opadry II 39K540032-lyserød, som indeholder: Hypromellose (E464), triacetin (E1518), titandioxid

(E171), lactosemonohydrat, jernoxid, rødt (E172), quinolingult aluminum lake (E104), brilliant blue

FCF aluminum lake (E133).

40 mg -

Opadry II 39K540012-lyserød, som indeholder: Hypromellose (E464), triacetin (E1518), titandioxid

(E171), lactosemonohydrat, sunset yellow FCF aluminium lake (E110), allura red AC aluminium lake

(E129) og brilliant blue FCF aluminum lake (E133).

Udseende og pakningsstørrelser

Dette lægemiddel findes som 5 mg, 10 mg, 20 mg og 40 mg filmovertrukne tabletter.

5 mg: Gul, rund, ca. 7,0 mm i diameter, bikonveks, filmovertrukket tablet med ”5” præget på den ene

side og ”R” præget på den anden side.

10 mg: Lyserød, rund, ca. 7,0 mm i diameter, bikonveks, filmovertrukket tablet med ”10” præget på

den ene side og ”R” præget på den anden side.

20 mg: Lyserød, rund, ca. 9,0 mm i diameter, bikonveks, filmovertrukket tablet med ”20” præget på

den ene side og ”R” præget på den anden side.

40 mg: Lyserød, oval, ca. 11,5 mm lang og 6,9 mm bred, bikonveks, filmovertrukket tablet med ”40”

præget på den ene side og ”R” præget på den anden side.

Tabletterne er pakket i Alu-Alu-blister & HDPE-glas (hvidt uigennemsigtigt HDPE-glas med hvid

uigennemsigtig PP-lukning og hvid uigennemsigtig tørremiddelbeholder med blåt tryk).

Pakningsstørrelser:

5 mg:

Blisterpakning: 7, 28, 30, 60, 84, 90 eller 98 tabletter i blister.

HDPE-glas: 30 eller 500 tabletter

10 mg: Blisterpakning: 7, 28, 30, 60, 84, 90, 98 eller 100 tabletter i blister.

HDPE-glas: 30 eller 500 tabletter

20 mg: Blisterpakning: 7, 28, 30, 60, 84, 90, 98 eller 100 tabletter i blister.

HDPE-glas: 30 eller 500 tabletter

40 mg: Blisterpakning: 7, 28, 30, 60, 90, 98 eller 100 tabletter i blister.

HDPE-glas: 500 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

Fremstillere

Accord Healthcare Limited

Sage house, 319, Pinner Road

North Harrow

Middlesex, HA1 4HF

Storbritannien

Wessling Hungary Kft.

Fóti út 56., Budapest 1047,

Ungarn

Pharmacare Premium Ltd.

HHF003, Hal Far Industrial Estate

BBG3000 Birzebbugia

Malta

Denne indlægsseddel blev senest ændret 01/2018.

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

Europe - EFSA - European Food Safety Authority Publications

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

Published on: Fri, 05 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriculture & Horticulture Development Board submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance epoxiconazole in beetroots. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for beetroots. Adequate analytical methods for enforcement are...

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

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

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

Published on: Mon, 01 Oct 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 cyflufenamid. To assess the occurrence of cyflufenamid 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 (in...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

Published on: Wed, 26 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

Published on: Wed, 26 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Me...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

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

Health Canada

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

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

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

Published on: Wed, 12 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Published on: Mon, 27 Aug 2018 00:00:00 +0200 EFSA regards the household as a stage in the food chain that is important for the final number of food‐borne infections. The fate of a pathogen in the private kitchen largely depends on consumer hygiene during preparation of food and on its proper cooking, especially in the case of meat. Unfortunately, detailed information on the microbiological survival in meat products after heating in the consumer kitchen is lacking. The aim of the study was to improve th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Plant protection products (PPPs) are pesticides containing at least one active substance that drives specific actions against pests (diseases). PPPs are regulated in the EU and cannot be placed on the market or used without prior authorisation. EFSA assesses the possible risks of the use of active substances to humans and environment. Member States decide whether or not to approve their use at EU level. Furthermore, Member States decide at national level on ...

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

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

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

Published on: Mon, 03 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

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

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

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

Health Canada

1-9-2018

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

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

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fenbuconazole. To assess the occurrence of fenbuconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

National summary reports on pesticide residue analysis performed in 2016

National summary reports on pesticide residue analysis performed in 2016

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Tue, 28 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sintofen. To assess the occurrence of sintofen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 27 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance prochloraz. To assess the occurrence of prochloraz residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Published on: Mon, 27 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRL) for the active substance prohexadione in linseeds, poppy seeds, sunflower seeds, rape seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all oilseeds under consid...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Fri, 24 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Published on: Mon, 20 Aug 2018 00:00:00 +0200 Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 13 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance myclobutanil. To assess the occurrence of myclobutanil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Com...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

2-7-2018

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

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

FDA - U.S. Food and Drug Administration

22-6-2018

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

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

The products have been found by the FDA via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines

FDA - U.S. Food and Drug Administration

21-6-2018

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., is voluntarily recalling all kratom (mitragyna speciosa) powder products, with Lot No.: 0102031800 it manufactured, processed, packed, and/or held, between March 18, 2018 to March 30, 2018 to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordanc...

FDA - U.S. Food and Drug Administration

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

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