Diovan Comp 160 mg/12,5 mg

Primær information

  • Handelsnavn:
  • Diovan Comp 160 mg/12,5 mg 160 mg+12,5 mg filmovertrukne tabletter
  • Dosering:
  • 160 mg+12,5 mg
  • Lægemiddelform:
  • filmovertrukne tabletter
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Diovan Comp 160 mg/12,5 mg 160 mg+12,5 mg filmovertrukne tabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Ikke markedsført
  • Autorisationsnummer:
  • 35127
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel: sammensætning, indikationer, bivirkninger, dosering, interaktioner, bivirkninger, graviditet, amning

Indlægsseddel: Information til brugeren

Diovan® Comp 80 mg/12,5 mg filmovertrukne tabletter

Diovan® Comp 160 mg/12,5 mg filmovertrukne tabletter

Diovan® Comp 160 mg/25 mg filmovertrukne tabletter

Diovan® Comp 320 mg/12,5 mg filmovertrukne tabletter

Diovan® Comp 320 mg/25 mg filmovertrukne tabletter

valsartan/hydrochlorthiazid

Læs denne indlægsseddel grundigt inden du begynder at tage medicinen, da den indeholder

vigtige oplysninger.

Gem indlægssedlen. Du kan få brug for at læse den igen.

Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.

Lægen har ordineret dette lægemiddel til dig personligt. Lad derfor være med at give medicinen

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

Kontakt lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller du får bivirkninger,

som ikke er nævnt her. Se afsnit 4.

Vær opmærksom på, at indlægssedler opdateres jævnligt. Du kan altid finde den nyeste

indlægsseddel på www.indlaegsseddel.dk.

Oversigt over indlægssedlen:

Virkning og anvendelse

Det skal du vide, før du begynder at tage Diovan Comp

Sådan skal du tage Diovan Comp

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

1.

Virkning og anvendelse

Diovan Comp filmovertrukne tabletter indeholder to aktive stoffer, der kaldes valsartan og

hydrochlorthiazid. Begge disse stoffer hjælper med at kontrollere forhøjet blodtryk (hypertension).

Valsartan tilhører en gruppe medicin, der kaldes ”angiotensin II-hæmmere”, der hjælper med

at sænke forhøjet blodtryk. Angiotensin II er et stof, som findes i kroppen og får blodkarrene til

at trække sig sammen sådan, at blodtrykket stiger. Valsartan hæmmer virkningen af angiotensin

II. Derved udvides blodkarrene, og blodtrykket falder.

Hydrochlorthiazid tilhører en gruppe medicin, der kaldes thiaziddiuretika (også kendt som

vanddrivende medicin). Hydrochlorthiazid øger urinmængden, som udskilles, hvilket ligeledes

sænker blodtrykket.

Diovan Comp bruges til behandling af forhøjet blodtryk, som ikke kontrolleres tilstrækkeligt af et

enkelt stof alene.

Forhøjet blodtryk øger belastningen af hjertet og blodkarrene. Hvis det ikke behandles, kan det føre

til, at blodkarrene i hjernen, hjertet og nyrerne beskadiges, hvilket kan ende med hjerneblødning,

hjertesvigt eller nyresvigt. Forhøjet blodtryk øger risikoen for hjerteanfald. Ved at sænke blodtrykket

til et normalt niveau nedsættes risikoen for at få disse lidelser.

Følg altid lægens anvisning og oplysningerne på doseringsetiketten. Lægen kan have foreskrevet

anden anvendelse eller dosering end angivet i denne information.

2.

Det skal du vide, før du begynder at tage Diovan Comp

Tag ikke Diovan Comp

hvis du er allergisk over for valsartan, hydrochlorthiazid, sulfonamidderivater (stoffer, der er

kemisk beslægtede med hydrochlorthiazid) eller over for et af de øvrige indholdsstoffer i dette

lægemiddel (se afsnit 6).

hvis du er mere end 3 måneder henne i graviditeten (det er også bedst at undgå Diovan

Comp tidligt i graviditeten – se afsnittet om graviditet).

hvis du har en alvorlig leversygdom, ødelæggelse af de små galdegange i leveren (biliær

cirrose) som fører til ophobning af galde i leveren (kolestase).

hvis du har en alvorlig nyresygdom.

hvis du ikke er i stand til at danne urin (anuri).

hvis du har gennemgået en nyretransplantation (modtaget en ny nyre).

hvis mængden af kalium eller natrium i dit blod er lavere end normalt, eller hvis mængden af

calcium i dit blod er højere end normalt på trods af behandling.

hvis du har urinsyregigt (podagra).

hvis du har sukkersyge eller nedsat nyrefunktion og du tager et blodtrykssænkende lægemiddel,

der indeholder aliskiren

Hvis noget af dette gælder for dig, skal du fortælle det til din læge og ikke tage Diovan Comp.

Advarsler og forsigtighedsregler

Kontakt lægen eller apotekspersonalet, før du tager Diovan Comp

hvis du tager kaliumbesparende medicin, kaliumtilskud, salttilskud, der indeholder kalium, eller

anden medicin, der øger mængden af kalium i dit blod, for eksempel heparin. Din læge kan

være nødt til at måle indholdet af kalium i dit blod regelmæssigt.

hvis mængden af kalium i dit blod er lav.

hvis du har diarré eller voldsom opkastning.

hvis du tager høje doser af vanddrivende medicin (diuretika).

hvis du har en alvorlig hjertesygdom.

hvis du lider af hjertesvigt eller har haft et hjerteanfald. Følg nøje de anvisninger din læge har

givet dig for startdosis. Din læge vil måske også undersøge din nyrefunktion.

hvis du lider af forsnævring i blodårerne til nyrerne.

hvis du for nylig har fået en ny nyre.

hvis du lider af hyperaldosteronisme. Dette er en sygdom, hvor dine binyrer producerer for

meget af hormonet aldosteron. Hvis dette gælder for dig, frarådes det, at du tager Diovan

Comp.

hvis du har en lever- eller nyresygdom.

hvis du tidligere har oplevet hævelse af tunge og ansigt pga. en allergisk reaktion kaldet

angioødem, på grund af anden medicin (inkl. ACE-hæmmere), skal du fortælle det til din læge.

Hvis disse symptomer opstår, når du tager Diovan Comp, skal du øjeblikkeligt stoppe med at

tage Diovan Comp og aldrig tage det igen. Se også afsnit 4 ”Bivirkninger”.

hvis du har feber, udslæt og ledsmerter, hvilket kan være tegn på systemisk lupus

erythematosus (SLE, en såkaldt autoimmun sygdom).

hvis du har sukkersyge, urinsyregigt, for højt indhold af kolesterol eller fedtstoffer

(triglycerider) i blodet.

hvis du har haft allergiske reaktioner ved brug af andre blodtrykssænkende midler af denne type

(angiotensin II-hæmmere), eller hvis du har allergi eller astma.

hvis du oplever synsnedsættelse eller øjensmerter. Dette kan være symptomer på et øget tryk

inde i øjet og kan opstå inden for få timer til flere uger efter, du har taget Diovan Comp. Dette

kan føre til varigt synstab, hvis du ikke behandles for det. Der kan være en højere risiko for, at

du oplever disse symptomer, hvis du tidligere har haft en allergisk reaktion over for penicillin

eller sulfonamid.

hvis du tager noget af følgende medicin, der anvendes til at behandle forhøjet blodtryk:

en ACE-hæmmer (fx enalapril, lisinopril, ramipril), især hvis du har nyreproblemer i

forbindelse med sukkersyge

aliskiren

hvis du bliver behandlet med en ACE-hæmmer sammen med visse andre lægemidler

til at behandle dit hjertesvigt, der er kendt som mineralokortikoid

receptorantagonister (MRA) (fx spironolacton, eplerenon) eller betablokkere (fx

metoprolol)

Din læge vil eventuelt måle din nyrefunktion, dit blodtryk og elektrolytter (fx. kalium) i dit blod med

jævne mellemrum.

Se også information under overskriften ”Tag ikke Diovan Comp”.

Diovan Comp kan forårsage, at hudens følsomhed over for sol øges.

Brug af Diovan Comp til børn og unge (under 18 år) frarådes.

Du skal fortælle det til din læge, hvis du tror, du er (eller planlægger at blive) gravid. Diovan Comp

frarådes i den tidlige periode af graviditeten og må ikke tages, hvis du er mere end 3 måneder henne i

graviditeten, da det kan medføre alvorlige skader på dit barn, hvis det bruges på dette tidspunkt (se

afsnittet om graviditet).

Brug af anden medicin sammen med Diovan Comp

Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin, har gjort det for nylig eller

muligvis kommer til det.

Virkningen af behandlingen kan blive påvirket, hvis du tager Diovan Comp sammen med visse andre

typer medicin. Det kan være nødvendigt at ændre dosis, at tage andre forholdsregler eller i nogle

tilfælde stoppe med at tage den ene medicin. Dette gælder især for følgende medicin:

lithium, medicin, som anvendes til behandling af visse typer psykiske sygdomme

medicin, der kan øge mængden af kalium i blodet, såsom kaliumtilskud, kaliumholdige

salterstatninger kaliumbesparende medicin og heparin

medicin, der kan mindske mængden af kalium i blodet, såsom diuretika (vanddrivende

medicin), kortikosteroider, afføringsmidler, carbenoxolon, amphotericin eller G-penicillin

nogle typer antibiotika (rifamycingruppe), medicin, som anvendes til at beskytte mod

afstødning af et transplantat (ciclosporin) eller antiretroviral medicin, som anvendes til

behandling af HIV/AIDS (ritonavir). Denne medicin kan øge effekten af Diovan Comp

medicin, der kan fremkalde ”torsades de pointes” (uregelmæssig hjerterytme), såsom

antiarytmika (medicin, der bruges til at behandle hjerteproblemer) og nogle antipsykotika

medicin, der kan mindske mængden af natrium i blodet, såsom antidepressiva, antipsykotika,

antiepileptika

medicin til behandling af urinsyregigt (podagra), såsom allopurinol, probenicid, sulfinpyrazon

lægeordineret D-vitamin eller kalktilskud

medicin mod sukkersyge (midler, der synkes såsom metformin, eller insulin)

anden medicin, der sænker blodtrykket, inklusive methyldopa, angiotensin converting enzyme

hæmmer (ACE-hæmmer som fx enalapril, lisinopril, osv.) eller aliskiren

(se også information

under overskrifterne ”Tag ikke Diovan Comp” og ”Advarsler og forsigtighedsregler”)

medicin, der øger blodtrykket, såsom noradrenalin eller adrenalin

digoxin eller andre digitalisglykosider (medicin, der bruges til at behandle hjerteproblemer)

medicin, der kan øge blodsukkeret, såsom diazoxid eller betablokkere

cytotoksisk medicin (mod kræft), såsom methotrexat eller cyclophosphamid

smertestillende midler, såsom non-steroide anti-inflammatoriske midler (NSAID) inklusive

selektive cyklooxygenase-2-hæmmere (Cox-2-hæmmere) og acetylsalicylsyre over 3 gram

muskelafslappende midler, såsom tubocurarin

antikolinerge midler (medicin, der bruges til at behandle forskellige lidelser såsom

mavekramper, urinblærekramper, astma, transportsyge, muskelkramper, Parkinsons sygdom og

som hjælpemiddel til narkose)

amantadin (medicin, der bruges til at behandle Parkinsons sygdom og som også bruges til at

behandle eller forebygge sygdom, som er opstået på grund af en virus)

colestyramin og colestipol (medicin, der hovedsagelig bruges til behandling af forhøjet indhold

af fedt i blodet)

ciclosporin, medicin, der bruges ved organtransplantation for at undgå afstødning

alkohol, sovemedicin og narkosemidler (medicin med søvndyssende eller smertestillende

virkning, der fx bruges under operation)

jod-baserede kontrastmidler (midler, der bruges ved billeddiagnostik)

Diovan Comp sammen med mad, drikke og alkohol

Undgå at indtage alkohol indtil du har talt med din læge. Alkohol kan få dit blodtryk til at falde mere

og/eller øge risikoen for, at du bliver svimmel eller føler, at du er ved at besvime.

Graviditet og amning

Du skal fortælle det til din læge, hvis du tror, du er (eller planlægger at blive) gravid.

Normalt vil din læge råde dig til at stoppe med at tage Diovan Comp, før du bliver gravid, eller så

snart du ved, at du er gravid, og råde dig til at tage anden medicin i stedet for Diovan Comp. Diovan

Comp frarådes i den tidlige periode af graviditeten, og du må ikke tage det, hvis du er mere end

3 måneder henne i graviditeten, da det kan forårsage alvorlig skade på dit barn, hvis det bruges efter

graviditetens tredje måned.

Fortæl det til din læge, hvis du ammer eller skal til at begynde med at amme.

Diovan Comp frarådes til mødre, der ammer, og din læge kan vælge en anden behandling, hvis du

gerne vil amme, især hvis dit barn er nyfødt eller er født for tidligt.

Trafik- og arbejdssikkerhed

Du skal være sikker på, hvordan Diovan Comp påvirker dig, før du kører bil, bruger værktøj eller

betjener maskiner eller udfører andre aktiviteter, der kræver koncentration. Diovan Comp kan, som

megen anden medicin mod forhøjet blodtryk, i sjældne tilfælde give svimmelhed og påvirke evnen til

at koncentrere sig.

3.

Sådan skal du tage Diovan Comp

Tag altid dette lægemiddel nøjagtigt efter lægens anvisning. Det vil hjælpe dig til at opnå den bedste

behandling og mindske risikoen for bivirkninger. Er du i tvivl, så spørg lægen eller på apoteket.

Folk med forhøjet blodtryk har ofte ingen tegn på denne lidelse. Mange føler sig helt raske. Det er

derfor vigtigt, at du overholder dine lægebesøg, selvom du føler dig rask.

Din læge vil fortælle dig helt nøjagtigt, hvor mange Diovan Comp tabletter du skal tage. Afhængig af,

hvordan du reagerer på behandlingen, vil din læge måske foreslå en højere eller lavere dosis.

Den anbefalede dosis Diovan Comp er én tablet daglig.

Du må ikke ændre denne dosis eller holde op med at tage tabletterne uden at tale med din læge.

Medicinen skal tages på samme tidspunkt hver dag, som regel om morgenen.

Du kan tage Diovan Comp med eller uden mad.

Tag tabletten sammen med et glas vand.

Hvis du har taget for meget Diovan Comp

Hvis du oplever kraftig svimmelhed og/eller besvimer, skal du lægge dig ned og omgående kontakte

lægen. Kontakt lægen, skadestuen eller apoteket, hvis du er kommet til at tage for mange tabletter.

Hvis du har glemt at tage Diovan Comp

Hvis du har glemt at tage en dosis, så tag den så snart du kommer i tanker om det. Hvis du snart skal

tage den næste dosis, så spring den glemte dosis over.

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

Hvis du holder op med at tage Diovan Comp

Dit forhøjede blodtryk kan blive værre, hvis du holder op med at tage Diovan Comp. Du må ikke

stoppe med at tage din medicin, medmindre du har talt med din læge om det.

Spørg lægen eller apotekspersonalet, hvis der er noget, du er i tvivl om.

4.

Bivirkninger

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

Nogle bivirkninger kan være alvorlige og kræver omgående lægebehandling:

Du skal omgående kontakte din læge, hvis du får symptomer på angioødem, som fx

hævelse i ansigt, tunge eller svælg

synkebesvær

kløende udslæt og svært ved at trække vejret

Svær hudlidelse, der forårsager udslæt, rød hud, blærer på læber, øjne eller mund, afskallende

hud, feber (toksisk epidermal nekrolyse)

Nedsat syn eller øjensmerter på grund af øget tryk i øjet (mulige symptomer på akut lukket-

vinklet glaukom)

Feber, ondt i halsen, hyppigere forekomst af infektioner (agranulocytose)

Disse bivirkninger forekommer meget sjældent eller med en ikke kendt hyppighed (hyppigheden kan

ikke bestemmes ud fra de tilgængelige data).

Hvis du får nogle af disse symptomer, skal du stoppe med at tage Diovan Comp og omgående

kontakte din læge (se også afsnit 2 ”Advarsler og forsigtighedsregler”).

De øvrige bivirkninger omfatter:

Ikke almindelig (forekommer hos op til 1 ud af 100 patienter):

hoste

lavt blodtryk

svimmelhed

dehydrering (med symptomer som tørst, tør mund og tunge, sjældne vandladninger, mørk urin,

tør hud)

muskelsmerter

træthed

stikken/prikken eller følelsesløshed

sløret syn

lyde (fx hvæsen, summen) i ørerne

Meget sjælden (forekommer hos op til 1 ud af 10.000 patienter):

diarré

ledsmerter

Ikke kendt (hyppigheden kan ikke bestemmes ud fra de tilgængelige data):

vejrtrækningsbesvær

kraftigt nedsat vandladningsmængde

lavt natriumindhold i blodet (som kan medføre træthed, forvirring, muskeltrækning og/eller i

alvorlige tilfælde muskelkramper)

lavt kaliumindhold i blodet (undertiden med muskelsvaghed, muskelkramper, unormal

hjerterytme)

lavt antal hvide blodlegemer i blodet (med symptomer som feber, infektioner i huden, ondt i

halsen eller mundsår pga. infektion, svaghed)

for meget bilirubin i blodet (hvilket i alvorlige tilfælde kan farve hud og det hvide i øjnene gult)

for meget blodureanitrogen og kreatinin i blodet (hvilket kan være tegn på unormal

nyrefunktion)

for meget urinsyre i blodet (hvilket i alvorlige tilfælde kan give podagra)

synkope (følelse af at være ved at besvime)

Følgende bivirkninger er set med lægemidler, der indeholder valsartan eller hydrochlorthiazid

alene:

Valsartan

Ikke almindelig (forekommer hos op til 1 ud af 100 patienter):

snurrende følelse

mavesmerter

Ikke kendt (hyppigheden kan ikke bestemmes ud fra de tilgængelige data):

udslæt med eller uden kløe sammen med nogle af de følgende tegn eller symptomer: feber,

ledsmerter, muskelsmerter, hævede lymfekirtler og/eller influenzalignende symptomer

udslæt, purpurfarvede pletter, feber, kløe (symptomer på betændelse i blodkar)

lavt antal blodplader (undertiden med usædvanlige blødninger eller blå mærker)

for meget kalium i blodet (undertiden med muskelkramper, unormal hjerterytme)

allergiske reaktioner (med symptomer såsom udslæt, kløe, nældefeber, vejrtrækningsbesvær

eller synkebesvær, svimmelhed)

hævelser, især i ansigt og hals, udslæt, kløe

forhøjede levertal

nedsat hæmoglobintal og procentdel røde blodlegemer i blodet (som begge i alvorlige tilfælde

kan give blodmangel)

nyresvigt

lavt natriumindhold i blodet (som kan medføre træthed, forvirring, muskeltrækning og/eller i

alvorlige tilfælde muskelkramper)

Hydrochlorthiazid

Meget almindelig

(forekommer hos mere end 1 ud af 10 patienter):

lavt indhold af kalium i blodet

øget indhold af fedtstoffer (lipider) i blodet

Almindelig (forekommer hos op til 1 ud af 10 patienter):

lavt indhold af natrium i blodet

lavt indhold af magnesium i blodet

højt indhold af urinsyre i blodet

kløende udslæt og andre typer udslæt

nedsat appetit

let kvalme og opkastning

svimmelhed, besvimelse, når man rejser sig op

manglende evne til at få eller bibeholde erektion

Sjælden (forekommer hos op til 1 ud af 1.000 patienter):

hævelser og blæredannelse i huden (pga. øget følsomhed over for sol)

højt indhold af calcium i blodet

højt indhold af sukker i blodet

sukker i urinen

forværring af den metaboliske tilstand ved diabetes

forstoppelse, diarré, mave- og tarmbesvær, leversygdomme som kan forekomme samtidig med

gulfarvning af hud eller af det hvide i øjnene

uregelmæssigt hjerteslag (puls)

hovedpine

søvnforstyrrelser

tristhed (depression)

lavt antal blodplader (undertiden med blødninger eller blå mærker under huden)

svimmelhed

prikkende fornemmelse eller følelsesløshed

synsforstyrrelse

Meget sjælden (forekommer hos op til 1 ud af 10.000 patienter):

betændelse i blodkar med symptomer såsom udslæt, purpurrøde pletter, feber (vasculitis)

eksem, kløen, udslæt, vejrtrækningsbesvær eller synkebesvær, svimmelhed

(overfølsomhedsreaktioner)

udslæt i ansigtet, ledsmerter, muskelsygdomme, feber (lupus erythematosus)

kraftige smerter øverst i maven (betændelse i bugspytkirtlen)

vejrtrækningsbesvær sammen med feber, hoste, hiven efter vejret, åndenød

(vejrtrækningsbesvær inklusive lungebetændelse og pulmonært ødem)

bleg hud, træthed, stakåndethed, mørkfarvet urin (hæmolytisk anæmi)

feber, ondt i halsen eller mundsår pga. infektioner (leukopeni)

forvirring, træthed, muskelspjæt og kramper, hurtigt åndedræt (hypokloræmisk alkalose)

Ikke kendt (hyppigheden kan ikke bestemmes ud fra de tilgængelige data):

svaghed, rødmen og hyppige infektioner (aplastisk anæmi)

meget nedsat vandladning (mulige symptomer på nedsat nyrefunktion eller nyresvigt)

udslæt, rød hud, blæredannelse i læber, øjne eller mund, afskallende hud, feber (mulige

symptomer på erythema multiforme)

muskelkramper

feber (pyreksi)

svaghed (asteni)

Indberetning af bivirkninger

Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket. Dette gælder

også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel. Du eller dine pårørende kan

også indberette bivirkninger direkte til Lægemiddelstyrelsen (se detaljer herunder). Ved at

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

lægemiddel.

Lægemiddelstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: dkma@dkma.dk

5.

Opbevaring

Opbevar dette lægemiddel utilgængeligt for børn.

Brug ikke Diovan Comp efter den udløbsdato, der står på pakningen. Udløbsdatoen (Exp) er

den sidste dag i den nævnte måned.

Opbevar ikke Diovan Comp ved temperaturer over 30 °C. Opbevares i original pakning for at

beskytte mod fugt.

Brug ikke pakninger af dette lægemiddel, der er beskadiget eller viser tegn på at have været

åbnet.

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

smide medicinrester i afløbet, toilettet eller skraldespanden.

6.

Pakningsstørrelser og yderligere oplysninger

Diovan Comp 80 mg/12,5 mg indeholder:

De aktive stoffer er valsartan og hydrochlorthiazid. Hver tablet indeholder 80 mg valsartan og

12,5 mg hydrochlorthiazid.

Øvrige indholdsstoffer: mikrokrystallinsk cellulose, kolloid vandfri silica, crospovidon,

magnesiumstearat.

Filmovertrækket indeholder hypromellose, macrogol 8000, talcum, titandioxid (E 171), rød

jernoxid (E 172) og gul jernoxid (E 172).

Diovan Comp 160 mg/12,5 mg indeholder:

De aktive stoffer er valsartan og hydrochlorthiazid. Hver tablet indeholder 160 mg valsartan og

12,5 mg hydrochlorthiazid.

Øvrige indholdsstoffer: mikrokrystallinsk cellulose, kolloid vandfri silica, crospovidon,

magnesiumstearat.

Filmovertrækket indeholder hypromellose, macrogol 8000, talcum, titandioxid (E 171) og rød

jernoxid (E 172).

Diovan Comp 160 mg/25 mg indeholder:

De aktive stoffer er valsartan og hydrochlorthiazid. Hver tablet indeholder 160 mg valsartan og

25 mg hydrochlorthiazid.

Øvrige indholdsstoffer: mikrokrystallinsk cellulose, kolloid vandfri silica, crospovidon,

magnesiumstearat.

Filmovertrækket indeholder hypromellose, macrogol 4000, talcum, titandioxid (E 171), rød

jernoxid (E 172), gul jernoxid (E 172) og sort jernoxid (E 172).

Diovan Comp 320 mg/12,5 mg indeholder:

De aktive stoffer er valsartan og hydrochlorthiazid. Hver tablet indeholder 320 mg valsartan og

12,5 mg hydrochlorthiazid.

Øvrige indholdsstoffer: mikrokrystallinsk cellulose, kolloid vandfri silica, crospovidon,

magnesiumstearat.

Filmovertrækket indeholder hypromellose, macrogol 4000, talcum, titandioxid (E 171); sort

jernoxid (E 172) og rød jernoxid (E 172).

Diovan Comp 320 mg/25 mg indeholder:

De aktive stoffer er valsartan og hydrochlorthiazid. Hver tablet indeholder 320 mg valsartan og

25 mg hydrochlorthiazid.

Øvrige indholdsstoffer: mikrokrystallinsk cellulose, kolloid vandfri silica, crospovidon,

magnesiumstearat.

Filmovertrækket indeholder hypromellose, macrogol 4000, talcum, titandioxid (E 171), gul

jernoxid (E 172).

Udseende og pakningsstørrelser

Diovan Comp 80 mg/12,5 mg

Lys orange, ovale filmovertrukne tabletter, påtrykt ”HGH” på den ene side og ”CG” på den anden

side.

Diovan Comp 160 mg/12,5 mg

Mørkerøde, ovale filmovertrukne tabletter, påtrykt ”HHH” på den ene side og ”CG” på den anden

side.

Diovan Comp 160 mg/25 mg

Brune, ovale filmovertrukne tabletter, påtrykt ”HXH” på den ene side og ”NVR” på den anden side.

Diovan Comp 320 mg/12,5 mg

Lyserøde, ovale, filmovertrukne tabletter med facetslebne kanter, mærket med ”NVR” på den ene side

og ”HIL” på den anden side.

Diovan Comp 320 mg/25 mg

Gule, ovale, filmovertrukne tabletter, mærket med ”NVR” på den ene side og ”CTI” på den anden

side.

Tabletterne findes i blisterpakninger med 7, 14, 28, 56, 98 eller 280 tabletter.

Perforeret enkeltdosis blisterpakninger med 56x1, 98x1 eller 280x1 tabletter er også tilgængelige.

Ikke alle styrker og pakningsstørrelser er nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen og fremstiller

Novartis Healthcare A/S

Edvard Thomsens Vej 14

2300 København S

E-mail: skriv.til@novartis.com

Dette lægemiddel er godkendt i EU/EØSs medlemslande under følgende navne:

Belgien, Luxembourg

Co-Diovane

Bulgarien, Cypern, Den Tjekkiske republik,

Estland, Grækenland, Holland, Irland,

Kroatien, Letland, Litauen, Malta, Polen,

Rumænien, Slovakiet, Slovenien,

Storbritannien

Co-Diovan

Danmark, Finland, Island, Norge, Sverige

Diovan

Comp

Frankrig, Italien

Cotareg

Portugal, Spanien, Tyskland

Co-Diovan

Co-Diovan

forte

Ungarn

Diovan

Østrig

Co-Diovan

Co-Diovan

forte

Co-Diovan

fortissimum

Denne indlægsseddel blev senest ændret januar/2016

14-2-2019

Modification of the existing maximum residue levels for mandipropamid in various crops

Modification of the existing maximum residue levels for mandipropamid in various crops

Published on: Wed, 13 Feb 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Syngenta Crop Protection B.V. and Agriculture and Horticulture Development Board (AHDB) submitted, respectively, a request to the competent national authorities in the Netherlands and United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance mandipropamid in various crops. The data submitted in support of the request were found to be sufficient to derive MRL propo...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-2-2019

Pesticide active substances that do not require a review of the existing maximum residue levels under Article 12 of Regulation (EC) No 396/2005

Pesticide active substances that do not require a review of the existing maximum residue levels under Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 12 Feb 2019 According to Article 12(1) of Regulation (EC) No 396/2005, EFSA shall provide within 12 months from the date of the inclusion or non‐inclusion of an active substance in Annex I to Directive 91/414/EEC a reasoned opinion on the review of the existing maximum residue levels (MRLs) for that active substance. Among the active substances that need to be reviewed under Article 12(1) of Regulation (EC) No 396/2005, EFSA identified 13 active substances for which a review of MRLs i...

Europe - EFSA - European Food Safety Authority EFSA Journal

11-2-2019

World Waters Issues Voluntary Recall of Select WTRMLN WTR Original 12 Packs Due To The Possible Presence of Soft Plastic Pieces. Company Urges Consumers to Check Packages Prior to Consumption

World Waters Issues Voluntary Recall of Select WTRMLN WTR Original 12 Packs Due To The Possible Presence of Soft Plastic Pieces. Company Urges Consumers to Check Packages Prior to Consumption

World Waters, LLC is initiating a voluntary recall of certain lots of Cold Pressed Juice Watermelon WTRMLN WTR Original 12 packs due to the potential presence of soft plastic that may be loosely floating in some of the finished products

FDA - U.S. Food and Drug Administration

5-2-2019

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

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

Published on: Mon, 04 Feb 2019 The applicant Nihon Nohyaku Co. Ltd. submitted a request to the competent national authority in Finland to evaluate the confirmatory data that were identified for flutolanil in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gaps related to new residue trials for globe artichokes and beans with pods and for storage stability data in products of animal origin were addressed. Further risk mana...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-2-2019

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

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

Published on: Mon, 04 Feb 2019 The applicant Dow AgroSciences Ltd submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified for spinosad in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gaps related to residue trials on globe artichokes, flowering brassica and the nature of residues in processed commodities were satisfactorily addressed. A new feedi...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-2-2019

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that it’s wholly owned subsidiary, Dr Reddy’s Laboratories, Inc is continuing its voluntary nationwide recall of lot ABD807 of Levetiracetram in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in U.S.A.

FDA - U.S. Food and Drug Administration

2-2-2019

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

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

Published on: Fri, 01 Feb 2019 The applicant BASF SE submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified for imazamox 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, the applicant submitted new residue trials on rice. Since the number of trials was not sufficient, the data gap was considered only partially addressed. The remaining dat...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-2-2019

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

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

Published on: Thu, 31 Jan 2019 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 imidacloprid. To assess the occurrence of imidacloprid 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 the import to...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-2-2019

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

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

Published on: Thu, 31 Jan 2019 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 hexythiazox. To assess the occurrence of hexythiazox 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 Commission as well a...

Europe - EFSA - European Food Safety Authority EFSA Journal

30-1-2019

Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee

Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee

February 12, 2019: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee

FDA - U.S. Food and Drug Administration

30-1-2019

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.

FDA - U.S. Food and Drug Administration

26-1-2019

Scientific Opinion on Flavouring Group Evaluation 217 Revision 2 (FGE.217Rev2), consideration of genotoxic potential for α,β‐unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones

Scientific Opinion on Flavouring Group Evaluation 217 Revision 2 (FGE.217Rev2), consideration of genotoxic potential for α,β‐unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones

Published on: Fri, 25 Jan 2019 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 12 flavouring substances from subgroup 4.1 of FGE.19 in the Flavouring Group Evaluation 217 (FGE.217). Based on experimental data, in previous versions of this FGE (FGE.217 and FGE217Rev1), for 6‐methylcoumarin [FL‐no: 13.012] and 5‐ethyl‐3‐hydroxy‐4‐methylfuran‐2(5H)‐one [FL‐no: 10.023] the concern for genotoxicity was ruled out. 6‐Methylc...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-1-2019

Literature review in support of adjuvanticity/immunogenicity assessment of proteins

Literature review in support of adjuvanticity/immunogenicity assessment of proteins

Published on: Fri, 25 Jan 2019 Based on the risk assessment of genetically modified plants, according to Implementing Regulation (EU) No 503/201321 “In cases when known functional aspects of the newly expressed protein or structural similarity to known strong adjuvants may indicate possible adjuvant activity, the applicant shall assess the possible role of these proteins as adjuvants”. To further investigate the topic, an EFSA procurement was launched requesting a comprehensive literature review and cri...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-1-2019

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Published on: Fri, 25 Jan 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) (PHBH), CAS No 147398‐31‐0 and food contact material (FCM) substance No 1059. This biodegradable copolymer is produced by fermentation of palm oil using a genetically modified microorganism (Cupriavidus necator). Overall migration was up to 5.4 mg/kg. Oligomers are hydroxyl‐terminated or with crotyl‐ and hexenyl end‐...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-1-2019

The raw primary commodity (RPC) model: strengthening EFSA's capacity to assess dietary exposure at different levels of the food chain, from raw primary commodities to foods as consumed

The raw primary commodity (RPC) model: strengthening EFSA's capacity to assess dietary exposure at different levels of the food chain, from raw primary commodities to foods as consumed

Published on: Thu, 24 Jan 2019 Dietary exposure is typically calculated by combining food consumption data with occurrence data. EFSA's food consumption data are stored in the Comprehensive European Food Consumption Database (Comprehensive Database). Some of these data, however, cannot be used in exposure assessments when the occurrence data are reported for the raw primary commodities (RPCs). The RPC model aims to bridge this gap by transforming the Comprehensive Database into RPC consumption data. Usi...

Europe - EFSA - European Food Safety Authority EFSA Journal

25-1-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on the FDA’s ongoing investigation into valsartan and ARB class impurities and the agency’s steps to address the root c

Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on the FDA’s ongoing investigation into valsartan and ARB class impurities and the agency’s steps to address the root c

FDA describes the ongoing investigation into the ARB class impurities and agency’s steps to address the root causes of the safety issues

FDA - U.S. Food and Drug Administration

25-1-2019

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

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

Published on: Wed, 23 Jan 2019 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 spiromesifen. To assess the occurrence of spiromesifen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Regulation (EC) No 1107/2009, the MRLs established by the Codex Alimentarius Commission, as well as the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

23-1-2019

FDA Cautions Pet Owners Not to Feed One Lot of Hare Today Gone Tomorrow Due to <i>Salmonella</i> and <i>Listeria monocytogenes</i>

FDA Cautions Pet Owners Not to Feed One Lot of Hare Today Gone Tomorrow Due to <i>Salmonella</i> and <i>Listeria monocytogenes</i>

The FDA is cautioning pet owners not to feed Hare Today Gone Tomorrow Ground Chicken/Bones/Organs, lot 12.04.2018, after the product tested positive for Salmonella and Listeria monocytogenes. If you have this lot of Hare Today Gone Tomorrow Ground Chicken/Bones/Organs, throw it away.

FDA - U.S. Food and Drug Administration

23-1-2019

Safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206)

Safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206)

Published on: Tue, 22 Jan 2019 The food enzyme lysophospholipase (EC 3.1.1.5) is produced with the genetically modified Trichoderma reesei strain RF7206 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The lysophospholipase food enzyme is intended to be used in starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue level for trifloxystrobin in broccoli

Modification of the existing maximum residue level for trifloxystrobin in broccoli

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer Hellas AG submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance trifloxystrobin in broccoli. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for broccoli. Adequate analytical methods for enforcement are available to control the residues of trifloxystrobin o...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Landesanstalt für Landwirtschaft und Gartenbau Sachsen‐Anhalt (LSA) and Dienstleistungszentrum Ländlicher Raum Rheinpfalz (DLR), respectively, submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRL) for the active substance aclonifen in chives, parsley, celery leaves/dill leaves, thyme/savoury and in celeriacs/turnip‐rooted celery. The ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for tetraconazole in kaki/Japanese persimmon, linseeds and poppy seeds

Modification of the existing maximum residue levels for tetraconazole in kaki/Japanese persimmon, linseeds and poppy seeds

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Isagro S.p.A submitted a request to the competent national authority in Italy to modify the existing maximum residue levels (MRLs) for the active substance tetraconazole in various crops and animal commodities. The data submitted in support of the request were found to be sufficient to derive MRL proposals for tetraconazole in kaki/Japanese persimmon, linseeds and poppy seeds. Adequate analytical me...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

SIGMA Animal Disease Data Model: A comprehensive approach for the collection of standardised data on animal diseases

SIGMA Animal Disease Data Model: A comprehensive approach for the collection of standardised data on animal diseases

Published on: Mon, 21 Jan 2019 The European Commission is routinely asking EFSA for scientific and technical support in the epidemiological analysis of animal disease outbreaks (i.e. African swine fever, lumpy skin disease and avian influenza) and to report or assess surveillance data (i.e. Echinococcus multilocularis and avian influenza). For this purpose, EFSA has over the last years carried out several data collections and gathered specific information on outbreaks, surveillance activities and concer...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for aminopyralid in certain cereals

Modification of the existing maximum residue levels for aminopyralid in certain cereals

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences Denmark submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance aminopyralid in cereals. The data submitted in support of the request were found to be sufficient to derive MRL proposals for barley, rye, sorghum, millet and oats. A modification of the existing MRL of aminopyralid in wh...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Safety for the environment of vitamin D3 for salmonids

Safety for the environment of vitamin D3 for salmonids

Published on: Thu, 17 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) of EFSA assessed the safety for the target species and the consumer of the use of a maximum total level of 1.5 mg vitamin D3/kg feed in fish nutrition (2017). The assessment was based on data that had been provided by the Norwegian Food Safety Authority (NFSA). Since the data set provided by the NFSA did not include any new information concerning the safety for the user and the environment...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-1-2019

Publication of scientific data from EU-coordinated monitoring programmes and surveys

Publication of scientific data from EU-coordinated monitoring programmes and surveys

Published on: Thu, 17 Jan 2019 Open government data are about wide and free availability of public information created or collected by public entities. The International Open Data Charter and Findable, Accessible, Interoperable And Reusable Data (FAIR) data principles were selected as the guiding principles for the development of this report. A review of open data maturity reports indicated that most of the EU28+ are making significant progress in open government data, however there are different levels...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Published on: Wed, 16 Jan 2019 The additive cassia gum consists mainly of high-molecular weight polysaccharides composed primarily of a linear chain of 1,4-b-D-mannopyranose units with 1,6-linked a-D-galactopyranose units. In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of cassia gum in cats and dogs. The Panel concluded, based on positive findings observed in a bacterial reverse mutation test with a semi-refined cassia...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Published on: Wed, 16 Jan 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of two compounds belonging to chemical group 20 (aliphatic and aromatic mono‐ and di‐thiols and mono‐, di‐, tri‐, and polysulfides with or without additional oxygenated functional groups). 8‐Mercapto‐p‐menthan‐3‐one [12.038] and p‐menth‐1‐ene‐8‐thiol [12.085] are currently ...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Safety and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Published on: Wed, 16 Jan 2019 The additive under assessment is pure benzoic acid (> 99.8%), manufactured in the form of flakes. It is intended to be used as a technological feed additive (acidity regulator) in feedingstuffs for weaned piglets and pigs for fattening, with maximum contents of 5,000 and 10,000 mg/kg complete feed, respectively. Benzoic acid is safe for weaned piglets at 5,000 mg/kg complete feed, and at 10,000 mg/kg complete feed for pigs for fattening. The use of benzoic acid in feedings...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

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

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

Published on: Tue, 15 Jan 2019 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 dazomet. To assess the occurrence of dazomet 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 (including the supporting re...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Published on: Mon, 14 Jan 2019 Deccox®, containing decoquinate as the active substance, is a feed additive intended to be used for the prevention of coccidiosis in chickens for fattening at a dose range of 20–40 mg/kg complete feed. Decoquinate from Deccox® is safe for chickens for fattening at the highest applied concentration in complete feed of 40 mg/kg. No practically relevant interactions with other additives or veterinary drugs exist except with bentonite. Decoquinate does not have antibacterial a...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

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

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

Published on: Mon, 14 Jan 2019 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 metam. To assess the occurrence of metam residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008C as well as the European authorisations reported by Member States (including the...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Setting of an import tolerance for spiromesifen in coffee beans

Setting of an import tolerance for spiromesifen in coffee beans

Published on: Mon, 14 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted a request to the competent national authority in Greece to set an import tolerance for the active substance spiromesifen in coffee beans. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for coffee beans. Adequate analytical methods for enforcement are available to control the residues of spiromesife...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Assessment of genetically modified soybean A2704‐12 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐009)

Assessment of genetically modified soybean A2704‐12 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐009)

Published on: Mon, 14 Jan 2019 Following the submission of application EFSA‐GMO‐RX‐009 under Regulation (EC) No 1829/2003 from Bayer CropScience N.V., the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified soybean A2704‐12, for food and feed uses, import and processing, excluding cultivation within th...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

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

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

Published on: Mon, 14 Jan 2019 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 fluometuron. To assess the occurrence of fluometuron 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 States (in...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-1-2019

Germany Black Ant 2000mg tablets (Zhansheng Weige Chaoyue Xilishi)

Germany Black Ant 2000mg tablets (Zhansheng Weige Chaoyue Xilishi)

These tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

12-1-2019

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Published on: Fri, 11 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of organic form of selenium produced by Saccharomyces cerevisiae NCYC R397 (Alkosel®) for all animal species. The FEEDAP Panel has delivered two opinions (on 2007 and 2016) on the safety and efficacy of the additive. The additive is characterised as organic selenium mainly selenomethionine (63%); it was ini...

Europe - EFSA - European Food Safety Authority EFSA Journal

10-1-2019

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Trichoderma reesei (strain DP‐Nzb48)

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Trichoderma reesei (strain DP‐Nzb48)

Published on: Wed, 09 Jan 2019 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with a genetically modified strain of Trichoderma reesei by Danisco US Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organic solids (TOS) are removed by distill...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

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

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

Published on: Tue, 08 Jan 2019 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 sedaxane. To assess the occurrence of sedaxane residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

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

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

Published on: Tue, 08 Jan 2019 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 triazoxide. To assess the occurrence of triazoxide 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 States. Bas...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

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

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

Published on: Tue, 08 Jan 2019 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 chromafenozide. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for chromafenozide within the EU. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue limits) for this active subst...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-1-2019

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass.

FDA - U.S. Food and Drug Administration

6-1-2019

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g

Lupin Pharmaceuticals, Inc. is voluntarily recalling 5 lots of Ceftriaxone for Injection, USP, 250mg, 10 lots of Ceftriaxone for Injection, USP, 500mg, 24 lots of Ceftriaxone for Injection, USP, 1g and 3 lots of Ceftriaxone for Injection, USP 2g, to the hospital/physician level. The products have been found to contain visual grey particulate matter in reconstituted vials.

FDA - U.S. Food and Drug Administration

4-1-2019

Modification of the existing maximum residue levels for lambda‐cyhalothrin in celeries, fennel and rice

Modification of the existing maximum residue levels for lambda‐cyhalothrin in celeries, fennel and rice

Published on: Thu, 03 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRLs) for lambda‐cyhalothrin in celeries, fennel and rice. The data submitted in support of the request were found to be sufficient to derive tentative MRL proposals for the concerned crops. They are tentative as formally the general data gap identified in the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-1-2019

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classifi...

FDA - U.S. Food and Drug Administration

22-12-2018

Modification of the existing maximum residue level for captan in cranberries

Modification of the existing maximum residue level for captan in cranberries

Published on: Fri, 21 Dec 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the Belgian Federal Public Service (FPS) for Health, Food chain safety and Environment, submitted an application as the competent national authority in Belgium to modify the existing maximum residue level (MRL) for the active substance captan in cranberries. The data submitted in support of the request were found to be sufficient to derive MRL proposal for cranberries. Adequate analytical methods for enforcement ...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-2-2019


Orphan designation: Recombinant IgG degrading enzyme of Streptococcus pyogenes (imlifidase), Prevention of graft rejection following solid organ transplantation, 12/01/2017, Positive

Orphan designation: Recombinant IgG degrading enzyme of Streptococcus pyogenes (imlifidase), Prevention of graft rejection following solid organ transplantation, 12/01/2017, Positive

Orphan designation: Recombinant IgG degrading enzyme of Streptococcus pyogenes (imlifidase), Prevention of graft rejection following solid organ transplantation, 12/01/2017, Positive

Europe - EMA - European Medicines Agency

13-2-2019


Orphan designation: Agammaglobulinaemia tyrosine kinase, Treatment of pemphigus, 12/12/2017, Positive

Orphan designation: Agammaglobulinaemia tyrosine kinase, Treatment of pemphigus, 12/12/2017, Positive

Orphan designation: Agammaglobulinaemia tyrosine kinase, Treatment of pemphigus, 12/12/2017, Positive

Europe - EMA - European Medicines Agency

13-2-2019


Orphan designation: Humanised single-chain monoclonal antibody against CD37 (otlertuzumab), Treatment chronic lymphocytic leukaemia, 06/12/2012, Positive

Orphan designation: Humanised single-chain monoclonal antibody against CD37 (otlertuzumab), Treatment chronic lymphocytic leukaemia, 06/12/2012, Positive

Orphan designation: Humanised single-chain monoclonal antibody against CD37 (otlertuzumab), Treatment chronic lymphocytic leukaemia, 06/12/2012, Positive

Europe - EMA - European Medicines Agency

12-2-2019

Vaxxitek HVT + IBD (Merial)

Vaxxitek HVT + IBD (Merial)

Vaxxitek HVT + IBD (Active substance: Live vHVT013-69 recombinant virus) - Centralised - Yearly update - Commission Decision (2019)1098 of Tue, 12 Feb 2019

Europe -DG Health and Food Safety

12-2-2019

Halagon (Emdoka bvba)

Halagon (Emdoka bvba)

Halagon (Active substance: halofuginone) - Centralised - Yearly update - Commission Decision (2019)1095 of Tue, 12 Feb 2019

Europe -DG Health and Food Safety

12-2-2019

Helicobacter Test INFAI (INFAI GmbH)

Helicobacter Test INFAI (INFAI GmbH)

Helicobacter Test INFAI (Active substance: 13C - urea) - Centralised - Yearly update - Commission Decision (2019)1109 of Tue, 12 Feb 2019

Europe -DG Health and Food Safety

12-2-2019

Kriptazen (Virbac)

Kriptazen (Virbac)

Kriptazen (Active substance: halofuginone) - Centralised - Authorisation - Commission Decision (2019)1097 of Tue, 12 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/4868

Europe -DG Health and Food Safety

12-2-2019

Vectra Felis (Ceva SantE Animale)

Vectra Felis (Ceva SantE Animale)

Vectra Felis (Active substance: dinotefuran, pyriproxyfen) - Centralised - Renewal - Commission Decision (2019)1096 of Tue, 12 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/2746/R/08

Europe -DG Health and Food Safety

5-2-2019


Human medicines European public assessment report (EPAR): Bevespi Aerosphere, glycopyrronium / formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, Date of authorisation: 18/12/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Bevespi Aerosphere, glycopyrronium / formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, Date of authorisation: 18/12/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Bevespi Aerosphere, glycopyrronium / formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, Date of authorisation: 18/12/2018, Status: Authorised

Europe - EMA - European Medicines Agency

4-2-2019

Memantine Accord (Accord Healthcare S.L.U.)

Memantine Accord (Accord Healthcare S.L.U.)

Memantine Accord (Active substance: memantine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)844 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/T/12

Europe -DG Health and Food Safety

4-2-2019

EU/3/12/1083 (Voisin Consulting S.A.R.L.)

EU/3/12/1083 (Voisin Consulting S.A.R.L.)

EU/3/12/1083 (Active substance: Humanised single chain monoclonal antibody against CD37) - Transfer of orphan designation - Commission Decision (2019)814 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003624

Europe -DG Health and Food Safety

1-2-2019


Human medicines European public assessment report (EPAR): Namuscla, mexiletine hcl, Myotonic Disorders, Date of authorisation: 18/12/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Namuscla, mexiletine hcl, Myotonic Disorders, Date of authorisation: 18/12/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Namuscla, mexiletine hcl, Myotonic Disorders, Date of authorisation: 18/12/2018, Status: Authorised

Europe - EMA - European Medicines Agency

1-2-2019

EU/3/12/1068 (StEphane Gibaud)

EU/3/12/1068 (StEphane Gibaud)

EU/3/12/1068 (Active substance: Melarsoprol) - Transfer of orphan designation - Commission Decision (2019)813 of Fri, 01 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003439

Europe -DG Health and Food Safety

1-2-2019

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names (Active substance: diclofenac/omeprazole) - Community Referrals - Art 29 - Commission Decision (2019)845 of Fri, 01 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-29(4)/1474

Europe -DG Health and Food Safety

1-2-2019


Withdrawn application: Cavoley, pegfilgrastim, Date of withdrawal: 20/12/2018, Initial authorisation

Withdrawn application: Cavoley, pegfilgrastim, Date of withdrawal: 20/12/2018, Initial authorisation

Withdrawn application: Cavoley, pegfilgrastim, Date of withdrawal: 20/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

1-2-2019


Withdrawn application: Efgratin, pegfilgrastim, Date of withdrawal: 20/12/2019, Initial authorisation

Withdrawn application: Efgratin, pegfilgrastim, Date of withdrawal: 20/12/2019, Initial authorisation

Withdrawn application: Efgratin, pegfilgrastim, Date of withdrawal: 20/12/2019, Initial authorisation

Europe - EMA - European Medicines Agency

16-1-2019

EU/3/12/1062 (EUSA Pharma (Netherlands) B.V.)

EU/3/12/1062 (EUSA Pharma (Netherlands) B.V.)

EU/3/12/1062 (Active substance: Chimeric monoclonal antibody against GD2) - Transfer of orphan designation - Commission Decision (2019)238 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003198

Europe -DG Health and Food Safety

11-1-2019

Consultation: Good Clinical Practice Inspections Program

Consultation: Good Clinical Practice Inspections Program

The TGA is seeking comments from interested parties on a pilot Good Clinical Practice (GCP) Inspections Program of 12 months duration that will inform a routine GCP Inspections Program. Closing date: 22 February 2019

Therapeutic Goods Administration - Australia