Sumatriptan "Accord"

Primær information

  • Handelsnavn:
  • Sumatriptan "Accord" 50 mg filmovertrukne tabletter
  • Dosering:
  • 50 mg
  • Lægemiddelform:
  • filmovertrukne tabletter
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

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Lokation

  • Fås i:
  • Sumatriptan "Accord" 50 mg filmovertrukne tabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 52079
  • Sidste ændring:
  • 22-02-2018

Produktresumé

19. marts 2018

PRODUKTRESUMÉ

for

Sumatriptan ”Accord”, filmovertrukne tabletter

0.

D.SP.NR.

28693

1.

LÆGEMIDLETS NAVN

Sumatriptan ”Accord”

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

Hver 50 mg filmovertrukket tablet indeholder 70 mg sumatriptansuccinat svarende til 50

mg sumatriptan.

Hjælpestof: 72 mg laktosemonohydrat.

Hver 100 mg filmovertrukket tablet indeholder 140 mg sumatriptansuccinat svarende til

100 mg sumatriptan.

Hjælpestof: 143 mg laktosemonohydrat.

Alle hjælpestoffer er anført under pkt. 6.1.

3.

LÆGEMIDDELFORM

Filmovertrukne tabletter.

50 mg: Lyserøde, kapselformede, bikonvekse filmovertrukne tabletter, jævn på begge

sider.

100 mg: Hvide til offwhite, kapselformede, bikonvekse filmovertrukne tabletter, jævn på

begge sider.

4.

KLINISKE OPLYSNINGER

4.1

Terapeutiske indikationer

Akut behandling af migræneanfald med eller uden aura. Sumatriptan må kun anvendes,

hvis der foreligger en sikker migrænediagnose.

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Side 1 af 10

4.2

Dosering og indgivelsesmåde

Dosering

Voksne

Sumatriptan er indiceret til behandling af akut, periodisk tilbagevendende migræne.

Sumatriptan bør ikke anvendes profylaktisk. Den anbefalede dosis sumatriptan bør ikke

overskrides.

Det tilrådes, at sumatriptan gives så tidligt som muligt efter indtræden af migræneanfald,

men det er lige effektivt, uanset hvilket stadie af migræneanfaldet det indtages på.

De følgende anbefalede doser bør ikke overskrides.

Den anbefalede dosis oral sumatriptan er en enkelt 50 mg tablet. Nogle patienter kan have

behov for 100 mg.

Hvis patienten har responderet på den første dosis, men symptomerne recidiverer, kan en

yderligere dosis gives,forudsat, at der minimum er et interval på to timer mellem de to

doser. Der må ikke tages mere end 300 mg inden for 24 timer.

Patienter som ikke responderer på den ordinerede dosis sumatriptan, bør ikke tage endnu

en dosis til samme anfald. I disse tilfælde kan anfaldet behandles med paracetamol,

acetylsalicylsyre eller non-steroid-antiinflammatoriske lægemidler. Sumatriptan kan tages

til efterfølgende anfald.

Sumatriptan anbefales som monoterapi ved akut behandling af migræneanfald og bør ikke

gives samtidig med ergotamin eller ergotaminderivater (herunder methysergid) (se pkt.

4.3).

Sumatriptan ”Accord” fås i styrkerne 50 og 100 mg.

Pædiatrisk population

Virkning og sikkerhed af sumatriptan-tabletter til børn under 10 år er ikke blevet fastslået.

Der foreligger ingen kliniske data vedrørende denne aldersgruppe.

Virkning og sikkerhed af sumatriptan-tabletter til børn i alderen 10 til 17 år er ikke

demonstreret i de kliniske forsøg, der er udført i denne aldersgruppe. Derfor frarådes brug

af sumatriptan-tabletter til børn i alderen 10 til 17 år (se pkt. 5.1).

Ældre (over 65 år)

Erfaringerne med anvendelse af sumatriptan til patienter over 65 år er begrænsede.

Farmakokinetikken adskiller sig ikke væsentligt fra en yngre population, men indtil der

foreligger yderligere kliniske data, frarådes brug af sumatriptan til patienter over 65 år.

Nedsat leverfunktion

Til patienter med mildt til moderat nedsat leverfunktion bør lave doser på 25-50 mg

sumatriptan overvejes.

Nedsat nyrefunktion

Sumatriptan skal anvendes med forsigtighed til patienter med nedsat nyrefunktion.

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Side 2 af 10

Administration

Tabletterne skal synkes hele sammen med vand.

4.3

Kontraindikationer

Overfølsomhed over for sumatriptan eller over for et eller flere af hjælpestofferne i

pkt. 6.1.

Sumatriptan bør ikke gives til patienter, der har haft myokardieinfarkt eller har

iskæmisk hjertesygdom, koronar vasospasme (Prinzmetals angina), perifer vaskulær

sygdom eller til patienter, der har symptomer eller tegn på iskæmisk hjertesygdom.

Sumatriptan må ikke administreres til patienter med stroke (CVA) eller transitorisk

iskæmisk anfald (TIA) i anamnesen.

Sumatriptan må ikke administreres til patienter med svært nedsat leverfunktion.

Brug af sumatriptan til patienter med moderat til svær hypertension eller ukontrolleret

mild hypertension er kontraindiceret.

Samtidig administration af ergotamin, ergotaminderivater (inklusive methysergid)

eller andre triptaner/5-hydroxytryptamin

(5-HT

) receptoragonister er kontraindiceret

(se pkt. 4.5).

Samtidig administration af reversible (f.eks. moclobemid) eller irreversible (f.eks.

selegilin) monoaminoxidase-hæmmere (MAOI’er) og sumatriptan er kontraindiceret.

Sumatriptan må ikke bruges inden for 2 uger efter seponering af behandling med

monoaminoxidase-hæmmere.

4.4

Særlige advarsler og forsigtighedsregler vedrørende brugen

Sumatriptan bør kun anvendes, hvis der foreligger en sikker migrænediagnose.

Sumatriptan er ikke indiceret til brug ved hemiplegisk migræne, basilarisk migræne eller

oftalmoplegisk migræne.

Før påbegyndelse af behandling med sumatriptan skal potentielle alvorlige neurologiske

lidelser (f.eks. CVA, TIA) omhyggeligt udelukkes, hvis patienten udviser atypiske

symptomer eller ikke er diagnosticeret til anvendelse af sumatriptan.

Sumatriptan kan være forbundet med forbigående symptomer som brystsmerter og trykken

for brystet, som kan være intense og også omfatte halsen (se pkt. 4.8). Hvis disse

symptomer kan tænkes at skyldes iskæmisk hjertesygdom, må der ikke gives yderligere

doser af sumatriptan, og nærmere undersøgelser skal foretages.

Sumatriptan bør ikke administreres til patienter med risikofaktorer for iskæmisk

hjertesygdom, herunder patienter, der er storrygere eller brugere af nikotin-

substitutionsbehandling, uden forudgående kardiovaskulær evaluering (se pkt. 4.3). Særlig

opmærksomhed kræves ved postmenopausale kvinder og mænd over 40 år med disse

risikofaktorer. Det er dog ikke sikkert, at alle patienter med hjertesygdom kan identificeres

ved sådanne evalueringer, og i meget sjældne tilfælde er der forekommet alvorlige

hjertehændelser hos patienter uden underliggende hjertesygdom.

Sumatriptan bør administreres med forsigtighed hos patienter med mild, kontrolleret

hypertension, eftersom forbigående stigninger i blodtryk og perifer vaskulær modstand er

observeret hos en lille andel af patienterne (se pkt. 4.3).

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Side 3 af 10

I rapporter efter markedsføringen er der i sjældne tilfælde beskrevet patienter med

serotonin-syndrom (inklusive ændret psykisk tilstand, autonom ustabilitet og

neuromuskulære abnormaliteter) efter brug af selektive serotonin-reuptake-hæmmere

(SSRI'er) og sumatriptan. Der er rapporteret serotoninsyndrom efter samtidig behandling

med triptaner og serotonin-noradrenalin-reuptake-hæmmere (SNRI'er).

Hvis samtidig behandling med sumatriptan og en SSRI eller SNRI er klinisk indiceret,

tilrådes passende observation af patienten (se pkt. 4.5).

Sumatriptan bør administreres med forsigtighed til patienter med sygdomme, der kan

påvirke absorptionen, metabolismen eller udskillelsen af lægemidlerne, f.eks. nedsat

leverfunktion (Child-Pugh-klasse A eller B, se pkt. 4.2 & 5.2) eller nedsat nyrefunktion.

Sumatriptan bør anvendes med forsigtighed til patienter med krampeanfald eller andre

risikofaktorer, som kan nedsætte deres krampetærskel, i anamnesen, da krampeanfald er

rapporteret i forbindelse med behandling med sumatriptan (se pkt. 4.8).

Patienter med kendt overfølsomhed over for sulfonamider kan få en allergisk reaktion efter

administration af sumatriptan. Reaktionerne kan spænde fra hudreaktioner til anafylaksi.

Sandsynligheden for krydsallergi er begrænset. Dog skal der udvises forsigtighed ved brug

af sumatriptan til disse patienter.

Bivirkninger kan forekomme hyppigere ved samtidig brug af triptaner og naturmedicin

indeholdende prikbladet perikon (Hypericum perforatum).

Længere tids brug af et smertestillende middel mod hovedpine kan gøre hovedpinen værre.

Hvis patienten oplever dette eller har mistanke om det, bør patienten søge læge, og

behandlingen bør seponeres. Diagnosen medicinoverforbrugshovedpine (MOH) bør

overvejes hos patienter, som har hyppig eller daglig hovedpine på trods af (eller på grund

af) regelmæssig brug af midler mod hovedpine.

Patienter med sjældne arvelige problemer med galactose-intolerans, Lapp-lactase-mangel

eller glucose-galactose-malabsorption må ikke tage dette lægemiddel, da det indeholder

lactose.

4.5

Interaktion med andre lægemidler og andre former for interaktion

Studier med raske forsøgspersoner har vist, at sumatriptan ikke interagerer med

propranolol, flunarizin, pizotifen eller alkohol.

Der foreligger begrænsede data om interaktion med præparater, der indeholder ergotamin

eller en anden triptan-/5-HT

-receptoragonist. Øget risiko for koronar vasospasme er en

teoretisk mulighed, og samtidig administration er kontraindiceret (se pkt. 4.3).

Det vides ikke, hvor længe der skal gå mellem brug af sumatriptan og ergotaminholdige

præparater eller en anden triptan-/5-HT

-receptoragonist. Dette vil også afhænge af

dosisstørrelserne og den produkttype, der anvendes. Effekten kan være additiv. Det

anbefales at vente mindst 24 timer efter brugen af ergotaminholdige præparater eller en

anden triptan-/5-HT

-receptoragonist, før der administreres sumatriptan. Omvendt

anbefales det at vente mindst 6 timer efter brug af sumatriptan, før der administreres et

ergotaminholdigt produkt, og mindst 24 timer, før der administreres en anden triptan-/5-

-receptoragonist (se pkt. 4.3).

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Side 4 af 10

Der kan forekomme interaktion mellem sumatriptan og monoaminoxidase-hæmmere

(MAO-hæmmere), og samtidig administration er kontraindiceret (se pkt. 4.3).

I rapporter efter markedsføringen er der i sjældne tilfælde beskrevet patienter med

serotonin-syndrom (inklusive ændret psykisk tilstand, autonom ustabilitet og

neuromuskulære abnormaliteter) efter brug af selektive serotonin-reuptake-hæmmere

(SSRI'er) og sumatriptan. Der er også rapporteret serotoninsyndrom efter samtidig

behandling med triptaner og serotonin-noradrenalin-reuptake-hæmmere (SNRI'er) (se pkt.

4.4).

4.6

Graviditet og amning

Graviditet

Efter markedsføringen er der indsamlet data fra over 1.000 kvinder om brug af sumatriptan

i første trimester af graviditeten. Selv om disse data indeholder utilstrækkelige information

til at drage endelige konklusioner, tyder de ikke på en øget risiko for medfødte

misdannelser. Erfaringen med brug af sumatriptan i andet og tredje trimester er begrænset.

Evaluering af dyreforsøg indikerer ikke direkte teratogene eller skadelige påvirkninger af

den peri- og postnatale udvikling. Embryoføtal levedygtighed kan dog være påvirket hos

kaniner (se pkt. 5.3).

Administration af sumatriptan bør kun overvejes, hvis den forventede fordel for moderen

er større end den mulige risiko for fosteret.

Amning

Det er påvist, at sumatriptan udskilles i modermælk efter subkutan administration.

Eksponeringen af spædbarnet kan minimeres ved at undgå amning undgås i 12 timer efter

behandlingen. Modermælk, der malkes ud i disse 12 timer, skal kasseres.

4.7

Virkninger på evnen til at føre motorkøretøj eller betjene maskiner

Ikke mærkning.

Der er ikke udført studier af evnen til at føre motorkøretøj eller betjene maskiner.

Døsighed kan forekomme som følge af migræne eller behandlingen med sumatriptan.

Dette kan påvirke evnen til at køre bil eller betjene maskiner.

4.8

Bivirkninger

Bivirkningerne er opført i henhold til organklasse og hyppighed.

Hyppighederne er defineret som følger: meget almindelig (≥1/10), almindelig (≥1/100,

<1/10), ikke almindelig (≥1/1000, <1/100), sjælden (≥1/10.000, <1/1.000), meget sjælden

(<1/10.000) og ikke kendt (kan ikke estimeres ud fra de forhåndenværende data).

Nogle af de symptomer, som er rapporteret som bivirkninger, kan være migrænerelaterede

symptomer.

Immunsystemet

Ikke kendt:

Overfølsomhedsreaktioner, der kan spænde fra hudreaktioner (såsom

urticaria) til anafylaksi.

Psykiske forstyrrelser

Ikke kendt:

Angst.

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Side 5 af 10

Nerve systemet

Almindelig:

Svimmelhed, døsighed, sensoriske forstyrrelser inklusive paræstesi og

hypoæstesi.

Ikke kendt:

Krampeanfald, selv om nogle af disse er forekommet hos patienter med

krampeanfald i anamnesen eller samtidige lidelser, der disponerer for

krampeanfald. Der er også rapporter om krampeanfald hos patienter

uden åbenlyse disponerende faktorer. Tremor, dystoni, nystagmus,

skotom.

Øjne

Ikke kendt:

Flimren for øjnene, diplopi, nedsat syn. Synstab, herunder permanente

skader. Der kan dog også opstå synsforstyrrelser under selve

migræneanfaldet.

Hjerte

Ikke kendt:

Bradykardi, takykardi, palpitationer, hjertearytmier, forbigående

iskæmiske EKG-forandringer, koronar vasospasme, angina,

myokardieinfarkt (se pkt. 4.3 og 4.4).

Vaskulære sygdomme

Almindelig:

Forbigående stigning i blodtryk kort tid efter behandling. Rødmen.

Ikke kendt:

Hypotension, Raynauds syndrom.

Luftveje, thorax og mediastinum

Almindelig:

Dyspnø.

Mave-tarmkanalen

Almindelig:

Hos nogle patienter forekom kvalme og opkastning, men det er uklart,

om dette skyldtes sumatriptan eller den underliggende sygdom.

Ikke kendt:

Iskæmisk colitis, diarré.

Hud og subkutane væv

Ikke kendt:

Hyperhidrose.

Knogler, led, muskler og bindevæv

Almindelig:

Tyngdefornemmelse (som regel forbigående, men kan være intens og

påvirke alle dele af kroppen, inklusive bryst og hals). Myalgi.

Ikke kendt:

Nakkestivhed, artralgi.

Almene symptomer og reaktioner på administrationsstedet

Almindelig:

Smerte, fornemmelse af varme eller kulde, tryk eller sammensnøring

(disse hændelser er som regel forbigående, men kan være intense og

påvirke alle dele af kroppen, inklusive bryst og hals). Følelse af svaghed,

træthed (begge bivirkninger er som regel lette til moderate i intensitet og

forbigående).

Undersøgelser

Meget sjælden:

Der er i enkelte tilfælde observeret mindre afvigelser i

leverfunktionsprøver.

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Side 6 af 10

Indberetning af mistænkte bivirkninger

Når lægemidlet er godkendt, er indberetning af mistænkte bivirkninger vigtig. Det muliggør

løbende overvågning af benefit/risk-forholdet for lægemidlet. Læger og sundhedspersonale

anmodes om at indberette alle mistænkte bivirkninger via:

Lægemiddelstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: dkma@dkma.dk

4.9

Overdosering

Der er rapporteret tilfælde af overdosering af sumatriptan-tabletter.

Symptomer

Doser over 400 mg oralt og 16 mg subkutant har ikke været forbundet med andre

bivirkninger end de nævnte. Patienter har modtaget op til 12 mg sumatriptan som en enkelt

subkutan injektion uden signifikante bivirkninger.

Håndtering

Hvis der forekommer overdosering, skal patienten monitoreres i mindst 10 timer, og der

skal iværksættes almindelig støttende behandling efter behov. Det er uvist, hvilken effekt

hæmodialyse eller peritonealdialyse har på plasmakoncentrationerne af sumatriptan.

4.10

Udlevering

5.

FARMAKOLOGISKE EGENSKABER

5.0

Terapeutisk klassifikation

ATC-kode: N02CC01. Midler mod migræne, selektive serotonin (5-HT

) agonister.

5.1

Farmakodynamiske egenskaber

Virkningsmekanisme

Det er påvist, at sumatriptan er en specifik og selektiv 5-hydroxytryptamin 1D

(5HT

receptoragonist, der ikke har effekt på andre 5HT-receptor (5HT

-5HT

) undertyper.

Den vaskulære 5HT

-receptor findes hovedsagelig i kranielle blodkar og medierer

vasokonstriktion. Hos dyr forårsager sumatriptan selektive konstriktioner i den

karotisarterielle cirkulation, men ændrer ikke den cerebrale blodforsyning. Den

karotisarterielle cirkulation sørger for blodforsyning til de ekstrakranielle og intrakranielle

væv, såsom meninges, og det menes, at dilatation og/eller ødemdannelse i disse blodkar er

den mekanisme, der ligger til grund for migræneanfald hos mennesker.

Evidens fra dyrestudier tyder desuden på, at sumatriptan hæmmer trigeminusnervens

aktivitet. Begge disse virkninger (kraniel vasokonstriktion og hæmning af trigeminus-

nervens aktivitet) kan bidrage til sumatriptans migrænehæmmende virkning hos

mennesker.

Sumatriptan er effektivt i behandlingen af menstruationsmigræne, dvs. migræne uden aura,

som forekommer mellem 3 dage før og op til 5 dage efter første menstruationsdag.

Sumatriptan bør tages så hurtigt så muligt efter et anfald.

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Side 7 af 10

Klinisk respons ses ca. 30 minutter efter en oral dosis på 100 mg.

Selv om den anbefalede orale dosis af sumatriptan er 50 mg, kan migræneanfald variere i

sværhedsgraden både hos den enkelte patient og mellem patienter. I kliniske studier har

doser på 25-100 mg vist sig at have større effekt end placebo, men 25 mg er statistisk set

signifikant mindre effektivt end både 50 og 100 mg.

Pædiatrisk population

Der er udført en række placebokontrollerede kliniske forsøg, der vurderede sikkerheden og

effekten af orale sumatriptanstandardtabletter hos ca. 650 børn og unge i alderen 10-17 år

med migræne. I disse forsøg kunne der ikke påvises nogen statistisk signifikant forskel

med hensyn til hovedpinelindring efter to timer mellem placebo og sumatriptan, uanset

dosis. Oral sumatriptans bivirkningsprofil hos børn og unge i alderen 10-17 år var

sammenlignelig med den bivirkningsprofil, som er set i forsøg med voksne patienter.

5.2

Farmakokinetiske egenskaber

Det ser ikke ud til, at oral sumatriptans farmakokinetik påvirkes i signifikant grad af

migræneanfald.

Absorption

Efter oral administration absorberes sumatriptan hurtigt, og 70 % af den maksimale

koncentration indtræffer efter 45 minutter. Efter en dosis på 100 mg er den maksimale

koncentration i plasma 54 ng/ml, og den nås inden for to timer. Den gennemsnitlige

absolutte orale biotilgængelighed er 14 %, hvilket dels skyldes præsystemisk metabolisme

og dels skyldes ufuldstændig absorption.

Distribution

Plasmaproteinbindingen er lav (14-21 %), og den gennemsnitlige fordelingsvolumen er

170 liter.

Biotransformation

Hovedmetabolitten, indoleddikesyreanalogen af sumatriptan, udskilles primært i urinen,

hvor den forekommer som en fri syre og glukuronidkonjugatet. Metabolitten har ingen

kendt 5HT

- eller 5HT

-aktivitet. Der er ikke identificeret mindre betydende metabolitter.

Elimination

Eliminationshalveringstiden er ca. to timer. Den gennemsnitlige totale plasmaclearance er

ca. 1160 ml/min, og den gennemsnitlige renale clearance er ca. 260 ml/min. Non-renal

clearance udgør ca. 80 % af den totale clearance, hvilket tyder på, at sumatriptan primært

elimineres gennem oxidativ metabolisme medieret af monoaminoxidase A.

Ældre

I et pilotstudie blev der ikke fundet signifikante forskelle med hensyn til de

farmakokinetiske parametre mellem ældre og yngre raske frivillige forsøgspersoner.

Særlige patientpopulationer

Nedsat leverfunktion

Sumatriptans farmakokinetik efter administration af en oral dosis (50 mg) og en subkutan

dosis (6 mg) blev undersøgt hos 8 patienter med mild til moderat nedsat leverfunktion,

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Side 8 af 10

parret efter køn, alder og vægt med 8 raske forsøgspersoner. Efter en oral dosis blev

eksponeringen af sumatriptan i plasma (AUC og Cmax) næsten fordoblet (forøget med ca.

80 %) hos patienter med mild til moderat nedsat leverfunktion sammenlignet med

kontrolgruppen med normal leverfunktion. Der var ingen forskel mellem patienter med

nedsat leverfunktion og kontrolgruppen efter den subkutane dosis. Dette indikerer, at mild

til moderat nedsat leverfunktion nedsætter den præsystemiske clearance og øger

biotilgængeligheden og eksponeringen for sumatriptan sammenlignet med raske

forsøgspersoner.

Efter oral administration er den præsystemiske clearance reduceret hos patienter med mild

til moderat nedsat leverfunktion, og den systemiske eksponering er næsten fordoblet.

Farmakokinetikken hos patienter med svært nedsat leverfunktion er ikke blevet undersøgt

(se pkt. 4.3, ”Kontraindikationer”, og pkt. 4.4, ”Særlige advarsler og forsigtighedsregler

vedrørende brugen”).

5.3

Prækliniske sikkerhedsdata

Sumatriptan udviste ingen genotoksiske eller carcinogene virkninger i in vitro-systemer

eller dyrestudier.

I et fertilitetsstudie med rotter sås nedsat succes af insemination ved koncentrationer langt

over den maksimale koncentration hos mennesker.

Hos kaniner blev der set fosterdød uden udprægede teratogene effekter. Det vides ikke, om

disse fund har relevans for mennesker.

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Tabletkerne:

Lactosemonohydrat

Hypromellose

Mikrokrystallinsk cellulose

Croscarmellosenatrium

Magnesiumstearat

Filmovertræk

Hypromellose

Titandioxid (E 171)

Rød jernoxid (E 172) (50 mg tablet)

Triacetin (50 mg tablet)

6.2

Uforligeligheder

Ikke relevant.

6.3

Opbevaringstid

2 år.

6.4

Særlige opbevaringsforhold

Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.

52079_spc.docx

Side 9 af 10

6.5

Emballagetyper og pakningsstørrelser

De enkelte tabletter er pakket i blistere (Al/al).

For 50 mg: 4, 6, 12 og 18 tabletter.

For 100 mg: 4, 6, 12 og 18 tabletter.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

6.6

Regler for destruktion og anden håndtering

Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale

retningslinjer.

Ingen særlige forholdsregler.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow, Middlesex, HA1 4HF

Storbritannien

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

50 mg:

52079

100 mg:

52080

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

22. oktober 2013

10.

DATO FOR ÆNDRING AF TEKSTEN

19. marts 2018

52079_spc.docx

Side 10 af 10

  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.

    Anmode informationsbrochure for offentligheden.



  • Dokumenter på andre sprog er tilgængelige her

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

3-7-2014

More clinical trials to Denmark

More clinical trials to Denmark

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

Danish Medicines Agency

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

Pelgraz (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6288 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/003961/0000

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Active substance: lenalidomide) - Centralised - Authorisation - Commission Decision (2018)6237 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4857

Europe -DG Health and Food Safety

7-8-2018

Accofil (Accord Healthcare Limited)

Accofil (Accord Healthcare Limited)

Accofil (Active substance: Filgrastim) - Centralised - Yearly update - Commission Decision (2018)5428 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Active substance: memantine) - Centralised - Renewal - Commission Decision (2018)5421 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/R/10

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

18-7-2018

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011.  Read more about preventing surgical fires here:  https://go.usa.gov/xU5zs  #FDA #MedicalDevice

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011. Read more about preventing surgical fires here: https://go.usa.gov/xU5zs  #FDA #MedicalDevice

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011. Read more about preventing surgical fires here: https://go.usa.gov/xU5zs  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

4-7-2018

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Active substance: Docetaxel) - Centralised - Yearly update - Commission Decision (2018)4341 of Wed, 04 Jul 2018

Europe -DG Health and Food Safety

3-7-2018

Temozolomide Accord (Accord Healthcare Limited)

Temozolomide Accord (Accord Healthcare Limited)

Temozolomide Accord (Active substance: temozolomide) - Centralised - Yearly update - Commission Decision (2018) 4240 of Tue, 03 Jul 2018

Europe -DG Health and Food Safety

11-6-2018

Pemetrexed Accord (Accord Healthcare Limited)

Pemetrexed Accord (Accord Healthcare Limited)

Pemetrexed Accord (Active substance: pemetrexed) - Centralised - Yearly update - Commission Decision (2018)3761 of Mon, 11 Jun 2018

Europe -DG Health and Food Safety

30-5-2018

Bortezomib Accord (Accord Healthcare Limited)

Bortezomib Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

23-5-2018

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

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

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

Europe - EMA - European Medicines Agency

15-5-2018

Pramipexole Accord (Accord Healthcare Limited)

Pramipexole Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety