Tolterodintartrat "Accord"

Primær information

  • Handelsnavn:
  • Tolterodintartrat "Accord" 1 mg filmovertrukne tabletter
  • Dosering:
  • 1 mg
  • Lægemiddelform:
  • filmovertrukne tabletter
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

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Lokation

  • Fås i:
  • Tolterodintartrat "Accord" 1 mg filmovertrukne tabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 43125
  • Sidste ændring:
  • 22-02-2018

Produktresumé

2. september 2015

PRODUKTRESUMÉ

for

Tolterodintartrat "Accord", filmovertrukne tabletter

0.

D.SP.NR.

25944

1.

LÆGEMIDLETS NAVN

Tolterodintartrat "Accord"

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

1 mg

Hver filmovertrukket tablet indeholder 1 mg tolterodintartrat svarende til 0,68 mg

tolterodin.

2 mg

Hver filmovertrukket tablet indeholder 2 mg tolterodintartrat svarende til 1,37 mg

tolterodin.

Alle hjælpestoffer er anført under pkt. 6.1.

3.

LÆGEMIDDELFORM

Filmovertrukne tabletter.

1 mg

Hvid til off-white, rund, ca. 6,35 mm i diameter, bikonveks, filmovertrukket tablet, præget

S16 på den ene side og glat på den anden.

2 mg

Hvid til off-white, rund, ca. 6,35 mm i diameter, bikonveks, filmovertrukket tablet, præget

S042 på den ene side og glat på den anden.

4.

KLINISKE OPLYSNINGER

4.1

Terapeutiske indikationer

Symptomatisk behandling af urgeinkontinens og/eller pludselig og hyppig

vandladningstrang, som kan forekomme hos patienter med overaktiv blære.

43125_spc.doc

Side 1 af 11

4.2

Dosering og indgivelsesmåde

Dosering

Voksne (inklusive ældre)

Den anbefalede dosis er 2 mg to gange daglig undtagen til patienter med nedsat

leverfunktion eller alvorligt nedsat nyrefunktion (GFR<30 ml/min), for hvem den

anbefalede dosis er 1 mg to gange daglig (se pkt. 4.4). I tilfælde af generende bivirkninger

kan dosis reduceres fra 2 mg til 1 mg to gange daglig.

Behandlingens effekt bør revurderes efter 2-3 måneder (se pkt. 5.1).

Pædiatrisk population

Der er ikke vist effekt af Tolterodintartrat "Accord" filmovertrukne tabletter hos børn (se

pkt. 5.1). Derfor anbefales Tolterodintartrat "Accord" filmovertrukne tabletter ikke til børn.

4.3

Kontraindikationer

Tolterodin er kontraindiceret til patienter med:

Urinretention

Ukontrolleret snævervinklet glaukom

Myasthenia gravis

Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne

anført i pkt. 6.1.

Alvorlig colitis ulcerosa

Toksisk megacolon

4.4

Særlige advarsler og forsigtighedsregler vedrørende brugen

Tolterodin skal anvendes med forsigtighed til patienter med:

Signifikant blæreobstruktion med risiko for urinretention

Gastrointestinale obstruktive lidelser, f.eks. pylorusstenose

Nyreinsufficiens (se pkt. 4.2)

Leversygdom (se pkt. 4.2 og 5.2)

Autonom neuropati

Hiatushernie

Risiko for nedsat gastrointestinal motilitet

Gentagen total oral daglig dosis på 4 mg (terapeutisk) og 8 mg (supraterapeutisk)

tolterodintartrat givet i form af konventionel tablet har vist sig at forlænge QTc-intervallet

(se pkt. 5.1).

Den kliniske relevans af dette er uklar og vil afhænge af den enkelte patients risikofaktorer

og påvirkelighed.

Tolterodin bør anvendes med forsigtighed til patienter med risiko for QT-forlængelse,

herunder:

Medfødt eller senere opstået QT-forlængelse

Elektrolytforstyrrelser såsom hypokaliæmi, hypomagnesæmi og hypokalcæmi

Bradykardi

Relevante forudgående hjertesygdomme (dvs. kardiomyopati, myokardieiskæmi,

arytmi, hjertesvigt)

43125_spc.doc

Side 2 af 11

Samtidig administration af lægemidler, der forlænger QT-intervallet, inklusive

antiarytmika af klasse IA (f.eks. quinidin, procainamid) og klasse III (f.eks. amiodaron,

sotalol).

Dette gælder i særlig grad ved brug af potente CYP3A4-hæmmere (se pkt. 5.1). Samtidig

behandling med potente CYP3A4-hæmmere bør undgås (se pkt. 4.5).

Som ved alle behandlinger for symptomer på øget vandladningstrang og urge-inkontinens

bør organiske årsager til den øgede trang og hyppighed overvejes, før behandlingen

påbegyndes.

4.5

Interaktion med andre lægemidler og andre former for interaktion

Samtidig systemisk behandling med potente CYP3A4-hæmmere såsom

makrolidantibiotika (f.eks. erythromycin og claritromycin), svampemidler (f.eks.

ketoconazol og itraconazol) og antiproteaser anbefales ikke på grund af øgede

tolterodinserumkoncentrationer hos langsomme CYP2D6-omsættere med (efterfølgende)

risiko for overdosis (se pkt. 4.4).

Samtidig behandling med andre lægemidler, der har antimuskarine egenskaber, såsom

amantadin, visse antihistaminer, phenthiazin-antipsykotika og tricykliske antidepressiva,

kan resultere i mere udtalt terapeutisk effekt og mere udtalte bivirkninger. Omvendt kan

den terapeutiske effekt af tolterodin reduceres ved samtidig administration af muskarine

kolinerge receptoragonister. Reduktionen i gastrisk motilitet forårsaget af antimuskarine

stoffer kan påvirke absorptionen af andre lægemidler.

Virkningen af prokinetiske midler som metoclopramid, domperidon og cisaprid kan

nedsættes af tolterodin.

Samtidig behandling med fluoxetin (en potent CYP2D6-hæmmer) resulterer ikke i en

klinisk signifikant interaktion, eftersom tolterodin og dets CYP2D6-afhængige metabolit,

5-hydroxymethyltolterodin, er ækvipotente.

Lægemiddelinteraktionsforsøg har ikke vist interaktioner med warfarin eller orale

kontraceptiva af kombinationstypen (ethinylestradiol/levonorgestrel).

Et klinisk forsøg har vist, at tolterodin ikke er en metabolisk hæmmer af CYP2D6, 2C19,

2C9, 3A4 eller 1A2. Derfor forventes der ikke øgede plasmaniveauer af lægemidler, der

metaboliseres af disse isoenzymer, hvis de gives i kombination med tolterodin.

4.6

Graviditet og amning

Graviditet

Erfaringsgrundlaget for anvendelse af tolterodin til gravide er utilstrækkeligt.

Reproduktionstoksicitet er set i dyreforsøg (se pkt. 5.3). Den potentielle risiko for

mennesker kendes ikke. Derfor anbefales Tolterodintartrat "Accord" filmovertrukne

tabletter ikke under graviditet.

Amning

Der foreligger ingen data om udskillelsen af tolterodin i modermælk hos mennesker. Brug

af tolterodin bør undgås under amning.

43125_spc.doc

Side 3 af 11

4.7

Virkninger på evnen til at føre motorkøretøj eller betjene maskiner

Ikke mærkning.

Eftersom dette lægemiddel kan forårsage akkomodationsforstyrrelser og påvirke

reaktionstiden, kan evnen til at køre bil og betjene maskiner påvirkes negativt.

4.8

Bivirkninger

På grund af den farmakologiske effekt kan tolterodin forårsage milde til moderate

antimuskarine påvirkninger, såsom tørhed i munden, dyspepsi og tørre øjne.

Tabellen nedenfor er baseret på data fra kliniske forsøg med tolterodin og fra erfaringer

efter markedsføringen. Den oftest rapporterede bivirkning var tør mund, der optrådte hos

35 % af de patienter, der blev behandlet med tolterodin filmovertrukne tabletter og hos 10

% af de patienter, der blev behandlet med placebo. Hovedpine blev også rapporteret

hyppigt og optrådte hos 10,1 % af de patienter, der blev behandlet med tolterodin

filmovertrukne tabletter og hos 7,4 % af de patienter, der blev behandlet med placebo.

Meget

almindelig

(≥1/10)

Almindelig

(1/100 og <1/10)

Ikke almindelig

(1/1000 og

<1/100)

Ikke kendt

(kan ikke

estimeres ud fra

forhåndenværende

data)

Infektioner og

parasitære

sygdomme

Bronkitis

Immunsystemet

Hypersensitivitet,

der ikke har

andre årsager

Anafylaktoide

reaktioner

Psykiske

forstyrrelser

Nervøsitet

Konfusion,

hallucinationer,

desorientering

Nervesystemet

Hovedpine

Svimmelhed,

døsighed,

paræstesi

Svækket

hukommelse

Øjne

Tørre øjne,

unormalt syn

inklusive unormal

akkomodation

Øre og labyrint

Vertigo

Hjerte

Palpitationer

Tachykardi,

hjertesvigt,

arytmi

Vaskulære

sygdomme

Hudrødmen

Mave-tarmkanalen

Mundtørhed

Dyspepsi,

konstipation,

abdominalsmerter,

flatulens,

opkastning, diaré

Gastroesofageal

refluks

Hud og subkutane

væv

Tør hud

Angioødem

43125_spc.doc

Side 4 af 11

Nyrer og urinveje

Dysuri,

urinretention

Almene symptomer

og reaktioner på

administrationsstedet

Træthed,

brystsmerter,

perifere ødemer

Undersøgelser

Øget vægt

Der er rapporteret om tilfælde af forværrede symptomer på demens (f.eks. konfusion,

desorientering, vrangforestillinger) efter påbegyndelse af behandling med tolterodin hos

patienter, der fik kolinesterasehæmmere som behandling af demens.

Pædiatrisk population

I to pædiatriske, randomiserede, placebokontrollerede, dobbeltblindede kliniske fase III-

forsøg over 12 uger, hvor i alt 710 pædiatriske patienter blev rekrutteret, var andelen af

patienter med urinvejsinfektioner, diaré og unormal adfærd større i tolterodingruppen end i

placebogruppen (urinvejsinfektion: tolterodin 6,8 %, placebo 3,6 %; diaré: tolterodin 3,3

%, placebo 0,9 %; unormal adfærd: tolterodin 1,6 %, placebo 0,4 %) (se pkt. 5.1).

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:

Sundhedsstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: sst@sst.dk

4.9

Overdosering

Den højeste dosis tolterodin L-tartrat, der er givet til frivillige forsøgspersoner, er 12,8 mg

som enkeltdosis. De alvorligste bivirkninger, der blev observeret, var

akkommodationsforstyrrelser og vandladningsbesvær.

I tilfælde af overdosering med tolterodin, skal der behandles med maveskylning og gives

aktivt kul.

Symptomerne skal behandles som følger:

Alvorlige centrale antikolinerge virkninger (f.eks. hallucinationer og alvorlig

ekscitation): behandles med physostigmin

Kramper eller udtalt ekscitation: behandles med benzodiazepiner

Respirationsinsufficiens: behandles med kunstigt åndedræt

Tachykardi: behandles med betablokkere

Urinretention: behandles med kateterisation

Mydriasis: behandles med pilocarpin øjendråber, og/eller patienten anbringes i et mørkt

En stigning i QT-intervallet blev observeret ved en total daglig dosis på 8 mg tolterodin

givet i form af konventionelle tabletter (det dobbelte af den anbefalede daglige dosis af

formuleringen for konventionelle tabletter, hvilket er tre gange mere end den maksimale

43125_spc.doc

Side 5 af 11

eksponering ved depotkapselformuleringen) givet over 4 dage. I tilfælde af overdosering af

tolterodin bør der gives sædvanlig understøttende behandling af QT-forlængelse.

43125_spc.doc

Side 6 af 11

4.10

Udlevering

5.

FARMAKOLOGISKE EGENSKABER

5.0

Terapeutisk klassifikation

ATC-kode: G 04 BD 07. Midler mod blærespasmer.

5.1

Farmakodynamiske egenskaber

Tolterodin er en kompetitiv, specifik muskarinreceptorantagonist med selektivitet for

urinblæren frem for spytkirtler in vivo. En af tolterodins metabolitter (5-

hydroxymethylderivat) udviser en farmakologisk profil, der ligner modersubstansens. Hos

hurtige omsættere bidrager denne metabolit signifikant til tolterodins terapeutiske effekt

(se pkt. 5.2).

Behandlingseffekt kan forventes inden for 4 uger.

Effekt af behandling med tolterodintartrat 2 mg to gange daglig efter henholdsvis 4 og 12

uger sammenlignet med placebo (sammenlagte data). Absolut ændring og procentvis

ændring i forhold til baseline.

Variabel

4-ugersforsøg

12-ugersforsøg

Tolterodintartrat

2 mg to gange

daglig

Placebo

Statistisk

signifikans

placebo

Tolterodintartrat

2 mg to gange

daglig

Placebo

Statistisk

signifikans

placebo

Antal vandladninger

pr. døgn

-1,6

(-14 %)

n=392

-0,9

(-8 %)

n=189

-2,3

(-20 %)

n=354

-1,4

(-12 %)

n=176

Antal inkontinens-

episoder pr. døgn

-1,3

(-38 %)

n=288

(-26 %)

n=151

i.s.

-1,6

(-47 %)

n=299

-1,1

(-32 %)

n=145

Gennemsnitsvolumen

pr. vandladning (ml)

(+17 %)

n=385

(+8 %)

n=185

(+22 %)

n=354

(+6 %)

n=176

Antal patienter med

ingen eller minimale

blæreproblemer efter

behandling (%)

16 %

n=394

n=190

19 %

n=356

15 %

n=177

i.s.

i.s.=ikke signifikant; *=p<0,05; **= p<0,01; ***= p<0,001

Effekten af tolterodin blev vurderet hos patienter, der blev undersøgt med urodynamisk

måling ved baseline og som – afhængigt af det urodynamiske resultat – blev inddelt i en

urodynamisk positiv gruppe (motorisk trang) eller en urodynamisk negativ gruppe

(sensorisk trang). Inden for hver gruppe blev patienterne randomiseret til enten tolterodin

eller placebo. Forsøget kunne ikke bevise, at tolterodin havde større virkning end placebo

hos patienter med sensorisk trang.

43125_spc.doc

Side 7 af 11

Den kliniske effekt af tolterodin på QT-intervallet er blevet klarlagt ved studier af EKG fra

over 600 behandlede patienter, inklusive ældre og patienter med forudgående

hjertekarsygdom. Ændringerne i QT-intervaller afveg ikke signifikant mellem placebo- og

behandlingsgrupperne.

Tolterodins effekt på QT-forlængelse blev undersøgt yderligere hos 48 raske mandlige og

kvindelige frivillige i alderen 18-55 år. Forsøgspersonerne fik 2 mg tolterodintartrat to

gange daglig og 4 mg to gange daglig i form af konventionelle tabletformuleringer.

Resultaterne (korrigeret for Fridericia) ved maksimal tolterodinkoncentration (1 time) viste

en gennemsnitlig stigning i QTc-interval på 5,0 og 11,8 msek. for tolterodintartratdoser på

henholdsvis 2 mg to gange daglig og 4 mg to gange daglig og 19,3 msek. for moxifloxacin

(400 mg), der blev anvendt som aktiv, intern kontrol. En farmakokinetisk/farmako-

dynamisk model estimerede, at QTc interval-stigningerne hos langsomme omsættere

(manglende CYP2D6) behandlet med 2 mg tolterodintartrat to gange daglig er

sammenlignelige med de stigninger, der er observeret hos hurtigere omsættere, der modtog

4 mg tolterodintartrat to gange daglig. Uanset deres metaboliske profil var der ingen

forsøgspersoner, der ved disse tolterodindoser oversteg 500 msek. for absolut QTcF eller

60 msek. for ændring fra baseline, hvilket anses for at være grænseværdier, der kræver

særlig opmærksomhed. Dosen på 4 mg to gange daglig svarer til en maksimaleksponering

) tre gange større end den, der opnås ved den højeste terapeutiske dosis af

tolterodindepotkapsler.

Pædiatrisk population

Der er ikke blevet påvist effekt i pædiatriske populationer. To pædiatriske, randomiserede,

placebokontrollerede, dobbeltblindede 12-ugers fase III-forsøg er blevet gennemført med

tolterodindepotkapsler. I alt 710 pædiatriske patienter (486 fik tolterodin og 224 placebo) i

alderen 5-10 år med øget vandladningsfrekvens og urgeinkontinens deltog. Der blev ikke

observeret nogen signifikant forskel mellem de to grupper i nogen af studierne med hensyn

til ændring fra baseline i det samlede antal inkontinensepisoder pr. uge (se pkt. 4.8).

5.2

Farmakokinetiske egenskaber

Farmakokinetiske karakteristika specifikke for denne formulering

Tolterodin absorberes hurtigt. Både tolterodin og 5-hydroxymethylmetabolitten når

maksimale serumkoncentrationer efter 1-3 timer. Halveringstiden for tolterodin givet som

tablet er 2-3 timer hos hurtige omsættere og omkring 10 timer hos langsomme omsættere

(der mangler CYP2D6). Steady state-koncentrationer nås inden for 2 dage efter indtagelse

af tabletterne. Fødeindtagelse påvirker ikke eksponeringen over for ubundet tolterodin og

den aktive 5-hydroxymethylmetabolit hos hurtige omsættere, selv om tolterodin-

niveauerne stiger ved indtagelse sammen med mad. På tilsvarende vis forventes klinisk

relevante ændringer ikke hos langsomme omsættere.

Absorption

Efter oral administration undergår tolterodin CYP2D6-katalyseret first-pass-metabolisme i

leveren, hvilket resulterer i dannelsen af 5-hydroxymethylderivatet, som er en væsentlig

farmakologisk ækvipotent metabolit.

Tolterodins absolutte biotilgængelighed er 17 % hos hurtige omsættere, størstedelen af

patienterne, og 65 % hos langsomme omsættere (som mangler CYP2D6).

Distribution

43125_spc.doc

Side 8 af 11

Tolterodin og 5-hydroxymethylmetabolitten bindes primært til orosomucoid. De ubundne

fraktioner er henholdsvis 3,7 % og 36 %.

Tolterodins distributionsvolumen er 113 l.

Elimination

Efter oral indtagelse metaboliseres tolterodin hovedsagelig i leveren af det polymorfe

enzym CYP2D6, hvilket fører til dannelsen af 5-hydroxymethylmetabolitten. Yderligere

metabolisme fører til dannelse af 5- carboxylsyre og N-dealkyleret 5-carboxylsyre-

metabolitter, der udgør henholdsvis 51 % og 29 % af de metabolitter, der genfindes i

urinen. En undergruppe (cirka 7 %) af befolkningen mangler CYP2D6-aktivitet. Hos denne

befolkningsgruppe (langsomme omsættere) finder metabolismen sted ved dealkylering via

CYP3A4 til N-dealkyleret tolterodin, hvilket ikke bidrager til den kliniske effekt. Resten af

befolkningen betegnes hurtige omsættere. Tolterodins systemiske clearance hos hurtige

omsættere er cirka 30 l/t. Hos langsomme omsættere fører den nedsatte clearance til

signifikant højere tolterodinserumkoncentrationer (ca. 7 gange højere), og ubetydelige

koncentrationer af 5-hydroxymethylmetabolitten ses.

5-hydroxymethylmetabolitten er farmakologisk aktiv og ækvipotent med tolterodin. På

grund af forskellene i tolterodins og 5-hydroxymethylmetabolittens

proteinbindingskarakteristika vil eksponeringen (AUC) fra ubundet tolterodin hos

langsomme omsættere svare til den kombinerede eksponering fra ubundet tolterodin og 5-

hydroxymethylmetabolitten hos patienter med CYP2D6-aktivitet, hvis det samme

dosisregimen følges. Sikkerhed, tolerance og klinisk respons er ens uafhængig af fænotype.

Udskillelsen af radioaktivitet efter administration af [

C]-tolterodin er cirka 77 % i urin og

17 % i fæces. Mindre end 1 % genfindes som uomdannet lægemiddel, og cirka 4 % som 5-

hydroxymethylmetabolitten. Den carboxylerede metabolit og den tilsvarende dealkylerede

metabolit udgør henholdsvis cirka 51 % og 29 % af den mængde, der genfindes i urinen.

Farmakokinetikken er lineær i det terapeutiske dosisområde.

Specifikke patientgrupper

Nedsat leverfunktion: Hos patienter med levercirrhose ses cirka dobbelt så høj eksponering

for ubundet tolterodin og 5-hydroxymethylmetabolitten (se pkt. 4.2 og pkt. 4.4). Nedsat

nyrefunktion: Den gennemsnitlige eksponering for ubundet tolterodin og 5-hydroxy-

methylmetabolitten er fordoblet hos patienter med svær nyreinsufficiens (inulin-clearance

GFR ≤ 30 ml/min). Andre metabolitters plasmaniveauerne er tydeligt forøget (op til 12

gange) hos disse patienter. Den kliniske relevans af den forøgede eksponering over for

disse metabolitter er ukendt. Der foreligger ingen data for patienter med mild til moderat

nyreinsufficiens (se pkt. 4.2 og pkt. 4.4).

Pædiatrisk population

Eksponeringen over for det aktive stof er den samme hos voksne og unge. Den

gennemsnitlige eksponering for det aktive stof pr. dosis i mg er cirka dobbelt så høj hos

børn mellem 5 og 10 år som hos voksne (se pkt. 4.2 og 5.1).

5.3

Prækliniske sikkerhedsdata

I toksicitets-, genotoksicitets-, karcinogenicitets- og sikkerhedsfarmakologiske forsøg er

der ikke observeret klinisk relevante påvirkninger, bortset fra dem, der har relation til

lægemidlets farmakologiske virkning.

43125_spc.doc

Side 9 af 11

Der er udført reproduktionsforsøg med mus og kaniner.

Der var ingen effekt på fertilitet eller reproduktionsevne hos mus. Tolterodin forårsagede

fosterdød og misdannelser ved plasmaeksponeringer (C

eller AUC) 20 eller 7 gange

højere end dem hos behandlede mennesker.

Der sås ikke misdannelser hos kaniner, men forsøgene blev udført ved 20 eller 3 gange

højere plasmaeksponeringer (C

eller AUC) end dem hos behandlede mennesker.

Tolterodin og dets aktive humane metabolitter forlænger aktionspotentialets varighed (90

% repolarisation) i Purkinjes tråde fra hunde (14-75 gange det terapeutiske niveau) og

blokerer K+-strømmen i klonede humane ‘ether-a-go-go-related gene’-kanaler (hERG-

kanaler) (0,5- 26,1 gange det terapeutiske niveau). Hos hunde er der set forlængelse af QT-

interval efter brug af tolterodin og dets humane metabolitter (3,1-61,0 gange det

terapeutiske niveau). Den kliniske relevans af dette kendes ikke.

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Kerne

Mikrokrystallinsk cellulose pH 102

Natriumstivelseglycolat (type A)

Magnesiumstearat

Kolloid vandfri silica

Filmovertræk

Hypromellose (E464)

Titaniumdioxid (E171)

Macrogol 8000

Talkum (E553b)

6.2

Uforligeligheder

Ikke relevant.

6.3

Opbevaringstid

2 år.

6.4

Særlige opbevaringsforhold

Dette lægemiddel kræver ikke særlige forholdsregler vedrørende opbevaringen.

6.5

Emballagetyper og pakningsstørrelser

PVC/PVDC–aluminiumblister.

Pakningsstørrelser

14 tabletter (1 blisterkort med 14 tabletter)

28 tabletter (2 blisterkort med 14 tabletter)

56 tabletter (4 blisterkort med 14 tabletter)

20 tabletter (2 blisterkort med 10 tabletter)

50 filmovertrukne tabletter (5 blisterkort med 10)

43125_spc.doc

Side 10 af 11

100 filmovertrukne tabletter (10 blisterkort med 10)

30 tabletter (3 blisterkort med 10 tabletter eller 2 blisterkort med 15 tabletter)

60 tabletter (6 blisterkort med 10 tabletter eller 4 blisterkort med 15 tabletter)

90 tabletter (9 blisterkort med 10 tabletter eller 6 blisterkort med 15 tabletter)

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

6.6

Regler for destruktion og anden håndtering

Ingen særlige forholdsregler.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

Accord Healthcare Limited

Sage house, 319, Pinner Road

North Harrow, Middlesex HA1 4HF

Storbritannien

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

1 mg: 43125

2 mg: 43126

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

18. september 2009

10.

DATO FOR ÆNDRING AF TEKSTEN

2. september 2015

43125_spc.doc

Side 11 af 11

  • 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

10-11-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Published on: Fri, 09 Nov 2018 00:00:00 +0100 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 propolis extract are presented. The context of the evaluation ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Published on: Mon, 22 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residue trials on strawberries, onions, garlic, tomatoes, peppers, cucumbers, artichokes, leeks and rape seeds were submitted. The data gaps are considere...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

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

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