Controloc Control

Primær information

  • Handelsnavn:
  • Controloc Control
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Controloc Control
    Den Europæiske Union
  • Sprog:
  • dansk

Terapeutisk information

  • Terapeutisk gruppe:
  • Lægemidler til syrerelaterede lidelser
  • Terapeutisk område:
  • Gastroøsofageal tilbagesvaling
  • Terapeutiske indikationer:
  • Kortvarig behandling af reflukssymptomer (f.eks. g. halsbrand, syreregurgitation) hos voksne.

Andre oplysninger

Status

  • Kilde:
  • EMA - European Medicines Agency
  • Autorisation status:
  • autoriseret
  • Autorisationsnummer:
  • EMEA/H/C/001097
  • Autorisation dato:
  • 12-06-2009
  • EMEA kode:
  • EMEA/H/C/001097
  • Sidste ændring:
  • 26-02-2018

Offentlige vurderingsrapport

+44 (0)20 7418 8416

© European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.

EMA/237644/2013

EMEA/H/C/001097

EPAR - sammendrag for offentligheden

Controloc Control

pantoprazol

Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for

Controloc Control. Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede

lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til

sine anbefalinger om anvendelsesbetingelserne for Controloc Control.

Hvad er Controloc Control?

Controloc Control er et lægemiddel, der indeholder det aktive stof pantoprazol. Det fås som

enterotabletter (20 mg). "Entero" betyder, at kapslens indhold passerer gennem maven og først bliver

optaget, når det når ned i tarmene. Dette forhindrer det aktive stof i at blive ødelagt af mavesyren.

Controloc Control svarer til et referencelægemiddel ved navn Controloc, som allerede er godkendt i

Den Europæiske Union (EU).

Hvad anvendes Controloc Control til?

Controloc Control anvendes til korttidsbehandling af symptomer på syrerefluks hos voksne. Syrerefluks

er en tilstand, hvor mavesyren trænger op i spiserøret, hvilket medfører halsbrand og

syreregurgitation (hvor syren trænger op i munden).

Lægemidlet udleveres uden recept.

Hvordan anvendes Controloc Control?

Den anbefalede dosis Controloc Control er én tablet én gang dagligt, indtil symptomerne forsvinder.

Det kan være nødvendigt at tage lægemidlet i to til tre på hinanden følgende dage for at opnå en

forbedring af symptomerne. Hvis der ikke er nogen bedring i symptomerne inden for to ugers

kontinuerlig behandling, bør patienten kontakte sin læge. Patienten bør ikke tage lægemidlet i længere

end fire uger uden at konsultere sin læge.

Controloc Control

EMA/237644/2013

Side 2/3

Tabletterne bør sluges hele med væske før et måltid og må ikke tygges eller knuses.

Hvordan virker Controloc Control?

Det aktive stof i Controloc Control, pantoprazol, er en protonpumpehæmmer. Det virker ved at blokere

for "protonpumperne", som er proteiner i specialiserede celler i mavesækkens slimhinde, der pumper

syren ind i maven. Ved at blokere for disse pumper reducerer pantoprazol syreproduktionen, hvorved

symptomerne på syrerefluks mindskes.

Lægemidler indeholdende pantoprazol har kunnet fås i Den Europæiske Union (EU) siden 1994.

Referencelægemidlet Controloc udleveres kun efter recept. Det anvendes til langtidsbehandling og

anvendes desuden til behandling af et større felt af gastrointestinale sygdomme (lidelser i tarmene)

end Controloc Control.

Hvordan blev Controloc Control undersøgt?

Da pantoprazol har været anvendt i mange år, fremlagde ansøgeren data fra faglitteraturen.

Ansøgeren fremlagde desuden data fra to hovedundersøgelser, som vurderede virkningen af

pantoprazol 20 mg hos i alt 563 voksne, som havde symptomer på syrerefluks, herunder mindst ét

tilfælde af halsbrand i løbet af de sidste tre dage op til undersøgelsens start. Den første undersøgelse

sammenlignede pantoprazol med placebo (en uvirksom behandling) hos 219 voksne, og den anden

sammenlignede det med ranitidin (et andet lægemiddel, som anvendes til behandling af symptomer på

syrerefluks) hos 344 voksne. Det primære effektmål var antallet af patienter med symptomer på

halsbrand i løbet af de første to ugers behandling.

Hvilken fordel viser undersøgelserne, at der er ved Controloc Control?

Pantoprazol var mere effektivt end placebo og ranitidin til at forbedre symptomerne på syrerefluks. I

den første undersøgelse havde 74 % af de patienter, der tog pantoprazol (80 ud af 108), og 43 % af

de patienter, der tog placebo (48 ud af 111), ingen tilfælde af halsbrand efter to uger. Pantoprazol var

også mere effektivt end placebo til at reducere symptomerne på syreregurgitation. I den anden

undersøgelse havde 70 % af de patienter, der tog pantoprazol (121 ud af 172), og 59 % af de

patienter, der tog ranitidin (102 ud af 172), ingen tilfælde af halsbrand efter to ugers behandling.

Hvilken risiko er der forbundet med Controloc Control?

De hyppigste bivirkninger ved Controloc Control (som optræder hos omkring 1 ud af 100 patienter) er

diarré og hovedpine. Den fuldstændige liste over de indberettede bivirkninger ved pantoprazol fremgår

af indlægssedlen.

Controloc Control må ikke anvendes af patienter, der er overfølsomme (allergiske) over for

pantoprazol, soja eller andre af indholdsstofferne. Det må ikke anvendes sammen med atazanavir (et

lægemiddel, der anvendes til behandling af humant immundefektvirus (HIV)).

Hvorfor blev Controloc Control godkendt?

CHMP konkluderede, at pantoprazol 20 mg var effektivt til korttidsbehandling af symptomer på refluks,

og at der er lang erfaring med hensyn til sikkerheden ved lægemidlet som receptpligtigt lægemiddel.

CHMP var også af den opfattelse, at adgangen til Controloc Control uden lægelig overvågning, baseret

på erfaringerne med anvendelsen af pantoprazol, er passende. CHMP konkluderede derfor, at fordelene

ved Controloc Control er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for

Controloc Control.

Controloc Control

EMA/237644/2013

Side 3/3

Andre oplysninger om Controloc Control:

Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske

Union for Controloc Control den 12. juni 2009.

Den fuldstændige EPAR for Controloc Control findes på agenturets websted under:

ema.europa.eu/Find

medicine/Human medicines/European public assessment reports. Hvis du ønsker yderligere

oplysninger om behandling med Controloc Control, kan du læse indlægssedlen (også en del af denne

EPAR) eller kontakte din læge eller dit apotek.

Dette sammendrag blev sidst ajourført i 03-2013.

Indlægsseddel

B. INDLÆGSSEDDEL

Indlægsseddel: Information til brugeren

CONTROLOC Control 20 mg enterotabletter

Pantoprazol

Læs denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel, da den

indeholder vigtige oplysninger.

Tag altid dette lægemiddel nøjagtigt som beskrevet i denne indlægsseddel eller efter de anvisninger

lægen eller apotekspersonalet har givet dig.

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

Spørg på apoteket, hvis der er mere, du vil vide.

Kontakt lægen eller apoteketspersonalet, hvis du får bivirkninger, herunder bivirkninger, som

ikke er nævnt her. Se afsnit 4.

Du skal kontakte din læge, hvis du får det værre, eller hvis du ikke har det bedre efter 2 uger.

Du må ikke tage CONTROLOC Control i mere end 4 uger uden at kontakte din læge.

Oversigt over indlægssedlen:

Virkning og anvendelse

Det skal du vide, før du begynder at tage CONTROLOC Control

Sådan skal du tage CONTROLOC Control

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

1.

Virkning og anvendelse

CONTROLOC Control indeholder det aktive stof pantoprazol, som blokerer den ”pumpe”, der

producerer mavesyre. Dermed reduceres mængden af syre i din mave.

CONTROLOC Control bruges til korttidsbehandling af reflukssymptomer (f.eks. halsbrand og sure

opstød) hos voksne.

Refluks er tilbageløb af syre fra maven til spiserøret, som kan blive betændt og smertefuldt. Det kan

give symptomer som smertefuld brændende fornemmelse i brystet, som stiger op i halsen (halsbrand)

og giver en sur smag i munden (sure opstød).

Du kan opleve lindring af dine symptomer på sure opstød og halsbrand efter kun en dags behandling

med CONTROLOC Control , dog er denne medicin ikke beregnet til at give øjeblikkelig lindring. Det

kan være nødvendigt at tage tabletter i 2-3 dage i træk for at lindre symptomerne.

Du skal kontakte din læge, hvis du får det værre, eller hvis du ikke har det bedre efter 2 uger.

2.

Det skal du vide, før du begynder at tage CONTROLOC Control

Tag ikke CONTROLOC Control:

hvis du er allergisk over for pantoprazol eller et af de øvrige indholdsstoffer (angivet i afsnit 6

”CONTROLOC Control indeholder”).

hvis du tager HIV-proteasehæmmere som f.eks. atazanavir, nelfinavir (til behandling af HIV-

infektion). Se brug af andet medicin sammen med CONTROLOC Control .

Advarsler og forsigtighedsregler

Kontakt din læge, før du tager CONTROLOC Control

hvis du er blevet behandlet for halsbrand eller fordøjelsesbesvær uafbrudt i mere end 4 uger

hvis du er over 55 år og daglig tager medicin uden recept mod fordøjelsesbesvær

hvis du er over 55 år og har nye reflukssymptomer eller reflukssymptomer, der for nyligt har

ændret sig.

hvis du tidligere har haft et mavesår eller har fået foretaget en maveoperation

hvis du har leverproblemer eller gulsot (gulfarvning af huden og øjnene)

hvis du regelmæssigt tager til læge på grund af alvorlige sygdomme eller lidelser

hvis du skal have fortaget en endoskopi eller en udåndingstest kaldet C-urea.

Hvis du nogensinde har fået hudreaktioner efter at have taget et lægemiddel af samme slags

som CONTROLOC Control, der nedsætter syreindholdet i maven.

du skal have taget en særlig blodprøve (chromogranin A)

Hvis du tager HIV-proteasehæmmere såsom atazanavir; nelfinavir (til behandling af

HIV-infektion) samtidig med pantoprazole, skal du spørge din læge specifikt om råd.

Tag ikke dette produkt i længere tid end 4 uger uden at tale med din læge. Hvis dine

reflukssymptomer (halsbrand eller opgylpning af syre) varer ved længere end 2 uger, skal du tale med

din læge, som vil træffe beslutning om behovet for langvarig indtagelse af dette lægemiddel.

Hvis du tager Controloc Control i længere perioder, kan det medføre yderligere risici i form af:

Reduceret optagelse af vitamin B12 og vitamin B12-mangel, hvis dine vitamin B12-depoter i

kroppen allerede er lave.

Fraktur af hofte, håndled eller rygsøjle, især hvis du allerede lider af osteoporose, eller hvis du

tager kortikosteroider (som kan øge risikoen for osteoporose).

Faldende magnesiumniveauer i blodet (mulige symptomer: træthed, ufrivillige

muskelsammentrækninger, desorientering, kramper, svimmelhed, øget hjertefrekvens). Lave

magnesiumniveauer kan også medføre en reduktion af kalium- eller calciumniveauerne i blodet.

Du skal tale med din læge om det, hvis du har brugt dette produkt i mere end 4 uger. Din læge

kan beslutte at tage regelmæssige blodprøver for at overvåge dine magnesiumniveauer.

Fortæl det straks til lægen før eller efter du har taget medicinen, hvis du oplever nogle af følgende

symptomer, som kan være et tegn på en anden, mere alvorlig, sygdom:

uventet vægttab (som ikke er relateret til diæt eller et motionsprogram)

opkastning, især ved gentagelse

blodigt opkast, dette kan ses som mørkt kaffegrums i dit opkast

du opdager blodig afføring, som kan være sort eller tjærefarvet

synkebesvær eller smerte i forbindelse med synkning

du ser bleg ud eller føler dig sløj (blodmangel)

brystsmerter

mavesmerter

kraftig og/eller vedvarende diaré, da dette lægemiddel er forbundet med en let øget risiko for

infektiøs diaré

hvis du får udslæt, især på de dele af huden, der er udsat for sol, skal du snarest sige det til

lægen, da du kan være nødt til at holde op med at tage CONTROLOC Control. Husk også at

nævne andre negative virkninger så som ledsmerter.

Din læge kan beslutte at henvise dig til yderligere undersøgelser.

Fortæl lægen, at du tager denne medicin, hvis du skal have taget en blodprøve.

Du kan opleve lindring af dine symptomer på sure opstød og halsbrand efter kun en dags behandling

med CONTROLOC Control , dog er denne medicin ikke beregnet til at give øjeblikkelig lindring.

Du skal ikke tage det som en forebyggende behandling.

Hvis du gennem den seneste tid har lidt af halsbrand- eller fordøjelsesbesværsymptomer, skal du

huske at gå til læge regelmæssigt.

Børn og unge

CONTROLOC Control må ikke bruges af børn og unge under 18 år pga. manglende dokumentation

for sikkerhed i denne aldersgruppe.

Brug af anden medicin sammen med CONTROLOC Control

Fortæl det til lægen eller apoteket, hvis du tager, har taget eller overvejer at tage andet medicin.

CONTROLOC Control kan medføre, at andre lægemidler ikke virker ordentligt. Især lægemidler

som indeholder nogle af følgende aktive stoffer:

HIV-proteasehæmmere som f.eks. atazanavir, nelfinavir (til behandling af HIV-infektion). Du

må ikke tage CONTROLOC Control, hvis du tager HIV-proteasehæmmere. Se ’tag ikke

CONTROLOC Control ’.

ketoconazol (bruges ved svampeinfektion)

warfarin og phenprocoumon (medicin som virker blodfortyndende og forebygger blodpropper).

Du skal muligvis have taget flere blodprøver.

methotrexat (bruges til behandling af reumatoid artrit, psoriasis og cancer) – hvis du tager

methotrexat, kan din læge midlertidigt stoppe din behandling med CONTROLOC Control , da

CONTROLOC Control kan forøge niveauet af methotrexat i blodet.

Tag ikke CONTROLOC Control samtidigt med anden medicin, som begrænser mængden af syre i

din mave, så som andre syrepumpehæmmere (omeprazol, lansoprazol eller rabeprazol) eller en H

antagonist (f.eks. ranitidin, famotidin).

Du må gerne tage CONTROLOC Control samtidig med syreneutraliserende medicin (f.eks.

magaldrat, alginsyre, natriumbicarbonat, aluminiumhydroxid, magnesiumcarbonat eller

kombinationer heraf), hvis det er nødvendigt.

Graviditet og amning

Du skal ikke tage dette lægemiddel hvis du er gravid eller ammer. Hvis du er gravid eller ammer, har

mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller

apotekspersonalet til råds, før du tager dette lægemiddel.

Trafik- og arbejdssikkerhed

Hvis du oplever bivirkninger som svimmelhed og synsforstyrrelser, må du ikke føre motorkøretøj eller

betjene maskiner.

3.

Sådan skal du tage CONTROLOC Control

Tag altid lægemidlet nøjagtigt som beskrevet i denne indlægsseddel eller efter lægens eller

apotekspersonalets anvisning. Er du i tvivl, så spørg lægen eller på apoteket.

Den anbefalede dosis er en tablet daglig. Overskrid ikke den anbefalede daglige dosis på 20 mg

pantoprazol.

Du bør tage denne medicin i mindst 2-3 dage i træk. Stop med at tage CONTROLOC Control , når du

er symptomfri. Du kan opleve lindring af dine symptomer på sure opstød og halsbrand efter kun en

dags behandling med CONTROLOC Control , men denne medicin har ikke til hensigt at give

øjeblikkelig lindring.

Du skal kontakte lægen, hvis du ikke oplever symptomlindring efter 2 hele ugers behandling med

medicinen.

Tag ikke CONTROLOC Control -tabletter i mere end 4 uger uden at kontakte lægen.

Tag tabletten på samme tid hver dag før et måltid. Tabletten skal synkes hel og med væske. Du må

ikke tygge eller knuse tabletten.

Hvis du har taget for meget CONTROLOC Control

Fortæl det til lægen eller apoteket hvis du har taget mere end den anbefalede dosis. Tag om muligt

din medicin og denne indlægsseddel med.

Hvis du har glemt at tage CONTROLOC Control

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

til sædvanlig tid.

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.

Fortæl det straks til lægen eller kontakt skadestuen på det nærmeste hospital, hvis du får nogle af

følgende alvorlige bivirkninger. Hold straks op med at tage medicinen, men tag denne indlægsseddel

og/eller tabletterne med.

Alvorlige allergiske reaktioner (sjældne, kan påvirke mellem 1 og 10 personer patienter):

Overfølsomhedsreaktioner, såkaldte anafylaktiske reaktioner, anafylatisk chok og angioødem.

Typiske symptomer er: Hævelse af ansigt, læber, mund, tunge og/eller hals, hvilket kan give

problemer med at synke eller trække vejret, udslæt (nældefeber), alvorlig svimmelhed med

hurtig hjertebanken og kraftige svedeture.

Alvorlige hudreakioner ( ikke kendt, hyppigheden kan ikke bestemmes ud fra de

tilgængelige data): Udslæt med hævelse, blæredannelse eller afskalning af huden, nedbrydning

af huden og blødning omkring øjne, næse, mund eller kønsdele og hurtig forværring af din

almene helbredstilstand, eller eksem ved udsættelse for sollys.

Andre alvorlige reaktioner ( ikke kendt, hyppigheden kan ikke bestemmes ud fra de

tilgængelige data): Gulfarvning af hud og øjne (på grund af alvorlig leverskade) eller

nyreproblemer så som smertefuld vandladning og smerter i den nedre del af ryggen kombineret

med feber.

Andre bivirkninger omfatter:

Almindelig (kan påvirke op til 1 ud af 10 personer): Godartede polypper i maven.

Ikke almindelige bivirkninger ( kan påvirke mellem 1 og 100 personer):

Hovedpine; svimmelhed; diaré; kvalme, opkastning; oppustethed og luftafgang fra tarmen;

forstoppelse; mundtørhed; smerter og ubehag i maven; hududslæt og eksem; kløe;

svaghedsfornemmelse, udmattet eller generelt utilpas; søvnforstyrrelser; forøgede

leverenzymtal ved blodprøve; fraktur i hofte, håndled eller rygsøjle.

Sjældne bivirkninger (kan påvirke mellem 1 ud af 10.000 personer):

Smagsforstyrrelser eller fuldstændig mangel på smagsans; synsforstyrrelser så som sløret syn;

ledsmerter; muskelsmerter; ændringer i kropsvægt; forhøjet kropstemperatur; hævede hænder

og fødder; allergiske reaktioner; depression; forhøjede værdier af bilirubin og fedt i blodet (kan

ses i blodprøver); forstørrelse af brystkirtlerne hos mænd; høj feber og kraftigt fald i antallet af

hvide blodceller (i blodprøver).

Meget sjældne bivirkninger (kan påvirke færre end 1 ud af 10.000 patienter):

Desorientering; nedsat antal blodplader i blodet, hvilket kan medføre at du lettere bløder eller

får blå mærker; nedsat antal hvide blodlegemer, hvilket kan øge tendensen til betændelse;

unormal reduktion af antallet af hvide og røde blodlegemer samt blodplader (i blodprøver).

Bivirkninger, hvor hyppigheden ikke er kendt:

Hallucinationer, forvirring (specielt hos patienter som i forvejen har haft disse symptomer);

nedsat natrium; magnesium i blodet, udslæt, eventuelt med ledsmerter.

Indberetning af bivirkninger

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

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

indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i

Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information

om sikkerheden af dette lægemiddel.

5.

Opbevaring

Opbevar lægemidlet utilgængeligt for børn.

Brug ikke lægemidlet efter den udløbsdato (EXP), der står på pakningen. Udløbsdatoen er den sidste

dag i den nævnte måned.

Opbevares i den originale pakning for at beskytte mod fugt.

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

medicinrester i afløbet, toilettet eller skraldespanden.

6.

Pakningsstørrelser og yderligere oplysninger

CONTROLOC Control indeholder:

Aktivt stof: Pantoprazol. Hver tablet indeholder 20 mg pantoprazol (som natirumsesquihydrat).

Øvrige indholdsstoffer :

Kerne:

Natriumcarbonat, vandfrit; mannitol (E 421), crospovidon, povidon K90,

calciumstearat.

Overtræk: hypromellose, povidon K25, titandioxid (E 171), gul jernoxid (E 172),

propylenglycol, methacrylsyre-ethylacrylat copolymer (1:1), natriumlaurilsulfat,

polysorbat 80, triethylcitrat.

Blæk til prægning: Shellac; rød, sort og gul jernoxid (E 172); koncentreret

ammoniakopløsning.

Udseende og pakningsstørrelser

Enterotabletterne er gule, ovale, bikonvekse filmovertrukne tabletter præget med ”P20” på den ene

side.

CONTROLOC Control findes i aluminim/aluminium-blister med eller uden kartonforstærkning.

Pakningerne indeholder 7 eller 14 enterotabletter.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen

Takeda GmbH

Byk-Gulden-Straße 2

D-78467 Konstanz

Tyskland

Fremstiller

Takeda GmbH

Production site Oranienburg

Lehnitzstraße 70-98

D-16515 Oranienburg

Tyskland

Novartis Consumer Health GmbH

Zielstattstraße 40

81379 München

Tyskland

Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale

repræsentant for indehaveren af markedsføringstilladelsen:

België/Belgique/Belgien

Takeda Belgium

Tél/Tel: + 32 2 464 06 11

takeda-belgium@takeda.com

Lietuva

Takeda, UAB

Tel: +370 521 09070

lt-info@takeda.com

България

Такеда България

Teл.: + 359 (2) 958 27 36

Luxembourg/Luxemburg

Takeda Belgium

Tél/Tel: + 32 2 464 06 11

takeda-belgium@takeda.com

Česká republika

Takeda Pharmaceuticals Czech Republic s.r.o.

Tel: + 420 234 722 722

Magyarország

Takeda Pharma Kft.

Tel: +361 2707030

Danmark

Takeda Pharma A/S

Tlf: + 45 46 77 11 11

Malta

Takeda Italia S.p.A.

Tel: +39 06 502601

Deutschland

Takeda GmbH

Tel: 0800 825 3324

medinfo@takeda.de

Nederland

Takeda Nederland bv

Tel: +31 23 56 68 777

nl.medical.info@takeda.com

Eesti

Takeda Pharma AS

Tel: +372 617 7669

info@takeda.ee

Norge

Takeda Nycomed AS

Tlf: + 47 6676 3030

infonorge@takeda.com

Ελλάδα

TAKEDA ΕΛΛΑΣ Α.Ε

Τηλ: +30 210 6729570

gr.info@takeda.com

Österreich

Takeda Pharma Ges.m.b.H.

Tel: +43 (0)800-20 80 50

España

Takeda Farmacéutica España S.A.

Tel: + 349 1 714 9900

spain@takeda.com

Polska

Takeda Polska Sp. z o.o.

Tel.: + 48 22 608 13 00

France

Takeda France S.A.S.

Tél: + 33 1 46 25 16 16

Portugal

Takeda - Farmacêuticos Portugal, Lda.

Tel: + 351 21 120 1457

Hrvatska

Takeda Pharmaceuticals

Croatia d.o.o.

Tel: +385 1 377 88 96

România

Takeda Pharmaceuticals SRL

Tel: + 40 21 335 03 91

Ireland

Takeda Products Ireland Limited

Tel: + 353 16 42 00 21

Slovenija

Takeda GmbH, Podružnica

Slovenija

Tel: + 386 (0) 59082480

Ísland

Vistor hf.

tel: +354 535 7000

vistor@vistor.is

Slovenská republika

Takeda Pharmaceuticals Slovakia s.r.o.

Tel: +421 (2) 20602600

Italia

Takeda Italia S.p.A.

Tel: +39 06 502601

Suomi/Finland

Takeda Oy

Puh/Tel: + 358 20 746 5000

Κύπρος

TAKEDA ΕΛΛΑΣ Α.Ε

Τηλ: +30 210 6729570

gr.info@takeda.com

Sverige

Takeda Pharma AB

Tel: + 46 8 731 28 00

infosweden@takeda.com

Latvija

Takeda Latvia SIA

Tel: + 371 67840082

Takeda UK Limited

Tel: +44 (0)1628 537 900

Denne indlægsseddel blev senest ændret { MM/ÅÅÅÅ}

Du kan finde yderligere information om CONTROLOC Control på Det Europæiske

Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/

_________________________________________________________________________________

Følgende anbefalinger omkring livsstil og kostændringer kan også hjælpe med at lindre halsbrand og

syre-relaterede symptomer.

undgå store måltider

spis langsomt

hold op med at ryge

reducer indtaget af alkohol og koffein

vægttab (ved overvægt)

undgå tætsiddende tøj eller bælte

undgå at spise tre timer før sengetid

hæv hovedgærdet (hvis du lider af natlige symptomer)

reducer indtaget af madvarer, som kan medføre halsbrand. Det kan foreksempel være:

Chokolade, pebermynte, spearmint, fed og friturestegt mad, syreholdig mad, krydret mad,

citrusfrugter, frugtjuice og tomater.

17-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Published on: Fri, 16 Nov 2018 The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae by Novozymes A/S. 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 xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was e...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Unauthorized "21st Century DHEA" health product seized from Moose Jaw, SK, store is labelled to contain a controlled substance and may pose serious health risks

Unauthorized "21st Century DHEA" health product seized from Moose Jaw, SK, store is labelled to contain a controlled substance and may pose serious health risks

Health Canada seized “21st Century DHEA” because it is labelled to contain dehydroepiandrosterone (DHEA), a controlled substance that may pose serious health risks. “21st Century DHEA “ is an unauthorized health product promoted to provide “support for the immune system, mental well-being & energy levels.”

Health Canada

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

Published on: Mon, 12 Nov 2018 00:00:00 +0100 This joint ECDC‐EFSA report assesses whether vector count data (abundance) and the way these change throughout the year (seasonality) can provide useful information about vector‐borne diseases epidemiological processes of interest, and therefore, whether resources should be devoted to collecting such data. The document also summarises what measures of abundance and seasonality can be collected for each vector group (mosquitoes, sandflies, midges and ticks), ...

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Popillia japonica(Coleoptera: Scarabaeidae) for the EU. P. japonica is a distinguishable species listed in Annex IAII of Council Directive 2000/29/EC. It is native to Japan but established in the USA in the early 20th century. It spreads from New Jersey to most US states east of the Mississippi, some to the west and north into Canada. P. japonica feeds on over 700 plant species. Adults attack folia...

Europe - EFSA - European Food Safety Authority Publications

8-11-2018

Hazard analysis approaches for certain small retail establishments and food donations: second scientific opinion

Hazard analysis approaches for certain small retail establishments and food donations: second scientific opinion

Published on: Wed, 07 Nov 2018 00:00:00 +0100 In 2017, EFSA published a ‘simplified’ food safety management system (FSMS) for certain small retail establishments (butcher, grocer, baker, fish and ice cream shop) based on the application of prerequisite programme (PRP) criteria. The aim of this opinion was to develop similar FSMSs for other small retail enterprises including retail distribution centres, supermarkets, restaurants (including pubs and other catering activities) and food donation. The latter...

Europe - EFSA - European Food Safety Authority Publications

7-11-2018

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

Kadesh, Inc. of Garden Grove, CA is voluntarily recalling all lots of Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle, UPC 7 36972 1679 0, to the consumer level. During a recent FDA inspection, investigators observed that ophthalmic drugs, which are required to be sterile, are manufactured without necessary production controls and conditions to assure sterility.

FDA - U.S. Food and Drug Administration

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

1-11-2018

Stanley Black & Decker Canada Corp. recalls certain Porter-Cable and Black & Decker hammer drills

Stanley Black & Decker Canada Corp. recalls certain Porter-Cable and Black & Decker hammer drills

The side handle supplied with the drill may slip when the drill is in use and lead to loss of control, posing a risk of injury.

Health Canada

30-10-2018

Pest categorisation of Aleurocanthus spp.

Pest categorisation of Aleurocanthus spp.

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Aleurocanthus spp., a well‐defined insect genus of the whitefly family Aleyrodidae (Arthropoda: Hemiptera). Difficulties within the taxonomy of the genus give doubt about the ability to accurately identify some members to species level. Nevertheless, the genus is thought to currently include about ninety species mainly reported from tropical and subtropical areas. The genus is listed in Council Dir...

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Published on: Thu, 25 Oct 2018 00:00:00 +0200 A multi-country outbreak of 12 listeriosis cases caused by Listeria monocytogenes sequence type (ST) 8 has been identified through whole genome sequencing (WGS) analysis in three EU/EEA countries: Denmark (6 cases), Germany (5) and France (1). Four of these cases have died due to or with the disease. It is likely that the extent of this outbreak has been underestimated since the outbreak was identified through sequencing and only a subset of the EU/EEA count...

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

Zeagle recalls Sport Buoyancy Control Device Inflators

Zeagle recalls Sport Buoyancy Control Device Inflators

There exists a possibility that buttons on the Zeagle Sport BCD inflators may break or fracture leading to a rapid loss of air or auto inflation of the BCD, posing a potential drowning hazard.

Health Canada

18-10-2018

Hydrolevel Company recalls HydroStat 3000

Hydrolevel Company recalls HydroStat 3000

The controller may not shut down the boiler when it reaches the high temperature limit, potentially allowing it to overheat and posing a fire hazard.

Health Canada

17-10-2018

Pest categorisation of Thecaphora solani

Pest categorisation of Thecaphora solani

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of the fungus Thecaphora solani, the causal agent of smut of potato, for the EU. The identity of the pest is well established and reliable methods exist for its detection and identification. T. solaniis present in Bolivia, Chile, Colombia, Ecuador, Mexico, Panama, Peru and Venezuela. The pathogen is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC, meaning its introducti...

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

11-10-2018

Lester Electrical recalls Links Series Chargers

Lester Electrical recalls Links Series Chargers

The control board can fail and overheat, posing fire and burn hazards.

Health Canada

9-10-2018

TerraTrike recalls Rambler x16, Rambler All Terrain and Rambler E.V.O. Adult Tricycles

TerraTrike recalls Rambler x16, Rambler All Terrain and Rambler E.V.O. Adult Tricycles

The right hand wheel hub mount can bend or break and cause the rider to lose control, posing serious crash and injury hazards.

Health Canada

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

5-10-2018

FDA allows marketing of first self-fitting hearing aid controlled by the user

FDA allows marketing of first self-fitting hearing aid controlled by the user

FDA allows marketing of a new device, the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss). This is the first hearing aid authorized for marketing by the FDA that enables the user to fit, program and control the hearing aid on his or her own, without assistance from a health care provider.

FDA - U.S. Food and Drug Administration

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

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

Use of next‐generation sequencing in microbial risk assessment

Use of next‐generation sequencing in microbial risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Despite the ever increase in rigorous control and monitoring measures to assure safe food along the entire farm‐to‐fork chain, the past decade has also witnessed an increase in microbial food alerts. Hence, research on food safety and quality remain of utmost importance. Complementary, and at least as important, is the necessity to be able to assess the potential microbial risks along the food chain. Risk assessment relies on sound scientific data. Unfortuna...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Marvelon 28 birth control pills: Packages do not contain day-of-the-week stickers

Marvelon 28 birth control pills: Packages do not contain day-of-the-week stickers

Health Canada is informing Canadians that packages of certain lots of Marvelon 28 do not include day-of-the-week stickers. The stickers are meant to be applied on the blister pack containing the pills. The stickers indicate the first day of the week when the medication is started, and the weekdays that the pills should be taken. The stickers may be used by women to help them remember if they took their daily pill on a given day. Without these stickers, there may be an increased chance of missing a dose.

Health Canada

11-9-2018

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Novel foods could represent a sustainable alternative to traditional farming and conventional foodstuffs. Starting in 2018, Regulation (EU) 2283/2015 entered into force, laying down provisions for the approval of novel foods in Europe, including insects. This Approved Regulation establishes the requirements that enable Food Business Operators to bring new foods into the EU market, while ensuring high levels of food safety for European consumers. The present ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Antimicrobial resistance (AMR) represents a major challenge for Public Health and the scientific community, and requires immediate and drastic solutions. Acquired resistance to certain antimicrobials is already widespread to such an extent that their efficacy in the treatment of certain life‐threatening infections is already compromised. To date, the emergence and spread of AMR has been attributed to the use, misuse or indiscriminate use of antibiotics as th...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

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

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

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Published on: Tue, 21 Aug 2018 00:00:00 +0200 Abstract In May 2018, EFSA and ECDC co‐facilitated a workshop on preparedness for a multi‐national food safety/public health incident. The workshop, hosted at AGES in Vienna, was conceived to closely align with EFSA's Strategy 2020 commitment to prepare for future risk assessment challenges. EFSA, ECDC, AGES and BfR worked together closely to develop a workshop and associated training materials to be delivered over a 2.5‐day agenda. The workshop was attended...

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

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

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

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

27-8-2018

Several unauthorized products seized from Vitality Health Foods in Drayton Valley, AB, may pose serious health risks

Several unauthorized products seized from Vitality Health Foods in Drayton Valley, AB, may pose serious health risks

Health Canada is advising Canadians that several unauthorized products seized from Vitality Health Foods in Drayton Valley, AB, may pose serious health risks. The 11products include vitamins, dietary supplements, workout supplements and decongestants. Seized products were labelled to contain various ingredients, including prescription drugs and controlled substances.

Health Canada

21-8-2018

Clean Republic recalls Hill Topper Electric Bike Motor Controllers

Clean Republic recalls Hill Topper Electric Bike Motor Controllers

Water can enter the controller and cause it to accelerate unexpectedly posing a crash and injury hazard to the rider.

Health Canada

10-8-2018

FDA approves new vaginal ring for one year of birth control

FDA approves new vaginal ring for one year of birth control

FDA approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring contraceptive that can be used for an entire year.

FDA - U.S. Food and Drug Administration

26-7-2018

Trek Bicycle Corporation recalls Bontrager Line Pro Flat Bicycle Pedals

Trek Bicycle Corporation recalls Bontrager Line Pro Flat Bicycle Pedals

The pedals may have been manufactured with hydrogen embrittlement in the spindle of the pedals, causing one or both of the pedals to fail. When it fails, the pedal body separates from the spindle. If this happens while the bicycle is being operated, the rider could potentially lose control of the bicycle and fall.

Health Canada

18-7-2018

FDA Investigating Multistate Outbreak of Salmonella Sandiego Infections Linked to Hy-Vee Spring Pasta Salad

FDA Investigating Multistate Outbreak of Salmonella Sandiego Infections Linked to Hy-Vee Spring Pasta Salad

The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, is investigating a multi-state outbreak of Salmonella Sandiego illnesses linked to Spring Pasta Salad sold at Hy-Vee locations in Iowa, Illinois, Kansas, Minnesota, Missouri, Nebraska, South Dakota, and Wisconsin.

FDA - U.S. Food and Drug Administration

28-6-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on developments in the romaine outbreak investigation, recent outbreaks and the use of modern tools to advance food safety

Statement from FDA Commissioner Scott Gottlieb, M.D., on developments in the romaine outbreak investigation, recent outbreaks and the use of modern tools to advance food safety

Being able to identify outbreaks is key to being able to take quick action to prevent additional illnesses and find the source of the contamination. In recent years, the FDA and the Centers for Disease Control and Prevention (CDC) have advanced new tools that make it easier and faster to identify outbreaks of human illness and to link them back to the food source that is the culprit responsible for the illnesses. But our improved ability to spot outbreaks has also caused some to question whether we are e...

FDA - U.S. Food and Drug Administration

20-6-2018

June 18, 2018: Vitamin Shop Owner Guilty of Selling Misbranded Drugs and Controlled Substance

June 18, 2018: Vitamin Shop Owner Guilty of Selling Misbranded Drugs and Controlled Substance

June 18, 2018: Vitamin Shop Owner Guilty of Selling Misbranded Drugs and Controlled Substance

FDA - U.S. Food and Drug Administration

16-6-2018

FDA Investigates Multistate Outbreak of Cyclospora illnesses linked to Del Monte Vegetable Trays

FDA Investigates Multistate Outbreak of Cyclospora illnesses linked to Del Monte Vegetable Trays

The U.S. Food and Drug Administration (FDA) along with the Centers for Disease Control and Prevention (CDC) and state and local officials have been investigating a cluster of cyclosporiasis illnesses associated with recalled Del Monte vegetable trays from Kwik Trip/Kwik Star locations in the United States.

FDA - U.S. Food and Drug Administration

15-6-2018

FDA Investigating Multistate Outbreak of Salmonella Mbandaka Infections Likely Linked to Kellogg’s Honey Smacks Cereal

FDA Investigating Multistate Outbreak of Salmonella Mbandaka Infections Likely Linked to Kellogg’s Honey Smacks Cereal

The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, are investigating a multistate outbreak of Salmonella Mbandaka illnesses that may be linked to Kellogg’s Honey Smacks cereal.

FDA - U.S. Food and Drug Administration

14-6-2018

FDA Releases FSMA Draft Guidance on the Supply-Chain Program Preventive Control for Animal Food

FDA Releases FSMA Draft Guidance on the Supply-Chain Program Preventive Control for Animal Food

FDA issued draft guidance to help animal food facilities needing a supply-chain program meet those requirements under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule.

FDA - U.S. Food and Drug Administration

15-10-2018

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4.

 http://fema.gov/hurricane-michael-rumor-co

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4. http://fema.gov/hurricane-michael-rumor-co

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4. http://fema.gov/hurricane-michael-rumor-control … pic.twitter.com/T3h7ZiFUrZ

FDA - U.S. Food and Drug Administration

5-10-2018

Devices flag! The FDA has allowed the marketing a new type of hearing aid, a self-fitted hearing aid controlled by the user. Interested reporters should check out our press release:  https://go.usa.gov/xPkuB 

Devices flag! The FDA has allowed the marketing a new type of hearing aid, a self-fitted hearing aid controlled by the user. Interested reporters should check out our press release: https://go.usa.gov/xPkuB 

Devices flag! The FDA has allowed the marketing a new type of hearing aid, a self-fitted hearing aid controlled by the user. Interested reporters should check out our press release: https://go.usa.gov/xPkuB 

FDA - U.S. Food and Drug Administration

2-10-2018

Nexium Control (Pfizer Healthcare Ireland)

Nexium Control (Pfizer Healthcare Ireland)

Nexium Control (Active substance: esomeprazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6474 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002618/T/0023

Europe -DG Health and Food Safety

26-9-2018

The single-use internal condom (formerly the single-use female condom) is the only female-controlled barrier method intended to provide protection against pregnancy & STI transmission. Check out the FDA's birth control guide:  https://go.usa.gov/xPDQw  #M

The single-use internal condom (formerly the single-use female condom) is the only female-controlled barrier method intended to provide protection against pregnancy & STI transmission. Check out the FDA's birth control guide: https://go.usa.gov/xPDQw  #M

The single-use internal condom (formerly the single-use female condom) is the only female-controlled barrier method intended to provide protection against pregnancy & STI transmission. Check out the FDA's birth control guide: https://go.usa.gov/xPDQw  #MedicalDevices

FDA - U.S. Food and Drug Administration

6-8-2018

Scientific guideline:  Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies, draft: consultation open

Scientific guideline: Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies, draft: consultation open

The guideline aims to address the use of undetectable minimal residual disease (MRD) as an intermediate efficacy endpoint in controlled randomised clinical studies in patients with multiple myeloma (MM), adequately designed to demonstrate efficacy by relevant hard endpoints. MRD as an endpoint in this context would allow earlier approval of new drugs pending final confirmatory data.

Europe - EMA - European Medicines Agency

22-7-2018

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device an

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device an

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device and earlier agency actions

FDA - U.S. Food and Drug Administration

4-7-2018

SOMAC Control (Takeda GmbH)

SOMAC Control (Takeda GmbH)

SOMAC Control (Active substance: pantoprazole) - PSUSA - Modification - Commission Decision (2018) 4345 of Wed, 04 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1098/PSUSA/2285/201708

Europe -DG Health and Food Safety

4-7-2018

PANTOZOL Control (Takeda GmbH)

PANTOZOL Control (Takeda GmbH)

PANTOZOL Control (Active substance: pantoprazole) - PSUSA - Modification - Commission Decision (2018) 4344 of Wed, 04 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1013/PSUSA/2285/201708

Europe -DG Health and Food Safety

4-7-2018

CONTROLOC Control (Takeda GmbH)

CONTROLOC Control (Takeda GmbH)

CONTROLOC Control (Active substance: pantoprazole) - PSUSA - Modification - Commission Decision (2018) 4343 of Wed, 04 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1097/PSUSA/2285/201708

Europe -DG Health and Food Safety

27-6-2018

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Active substance: pantoprazole) - PSUSA - Modification - Commission Decision (2018)4105 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1100/PSUSA/2285/201708

Europe -DG Health and Food Safety

27-6-2018

Nexium Control (Pfizer Consumer Healthcare Limited)

Nexium Control (Pfizer Consumer Healthcare Limited)

Nexium Control (Active substance: esomeprazole) - Centralised - Renewal - Commission Decision (2018) 4111 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2618/R/21

Europe -DG Health and Food Safety

11-6-2018

.@CMSGov is issuing guidance today to make sure patients who use Continuous Glucose Monitors (CGMs) to help control their #diabetes can use apps on their smartphones in conjunction with CGM receivers. Learn more:  http://go.cms.gov/1jc4cdC 

.@CMSGov is issuing guidance today to make sure patients who use Continuous Glucose Monitors (CGMs) to help control their #diabetes can use apps on their smartphones in conjunction with CGM receivers. Learn more: http://go.cms.gov/1jc4cdC 

. @CMSGov is issuing guidance today to make sure patients who use Continuous Glucose Monitors (CGMs) to help control their #diabetes can use apps on their smartphones in conjunction with CGM receivers. Learn more: http://go.cms.gov/1jc4cdC 

FDA - U.S. Food and Drug Administration