Fluanxol Mite

Primær information

  • Handelsnavn:
  • Fluanxol Mite 1 mg filmovertrukne tabletter
  • Dosering:
  • 1 mg
  • Lægemiddelform:
  • filmovertrukne tabletter
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Fluanxol Mite 1 mg filmovertrukne tabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 47697
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel

Indlægsseddel: Information til brugeren

Flaunxol® Mite 0,5 mg og 1 mg filmovertrukne tabletter

Flupentixol (som dihydrochlorid)

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

indeholder vigtige oplysninger.

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

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

Lægen har ordineret Fluanxol Mite 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 punkt 4.

Bemærk:

Der kan være kommet opdateringer til teksten i indlægssedlen, efter indlægssedlen er blevet

trykt og lagt i pakningen til din medicin. På www.indlaegsseddel.dk kan du finde den nyeste version af

indlægssedlen. Du skal rette dig efter den nyeste version – se dateringen nederst på indlægssedlerne.

Hvis du er i tvivl, skal du kontakte din læge.

Oversigt over indlægssedlen

Virkning og anvendelse

Det skal du vide, før du begynder at tage Fluanxol Mite

Sådan skal du tage Fluanxol Mite

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

1.

Virkning og anvendelse

Fluanxol Mite er et middel mod sindslidelser.

Fluanxol Mite virker på særlige områder af hjernen og er med til at rette den ubalance i hjernen, som

er årsagen til dine symptomer.

Du kan få Fluanxol Mite mod depression.

Du kan også få Fluanxol Mite mod angst og uro.

Fluanxol Mite dæmper depression samt angst og uro. Fluanxol i højere doser anvendes kun til

behandling af andre sindslidelser.

Lægen kan have givet dig Fluanxol Mite for noget andet. Følg altid lægens anvisning.

2.

Det skal du vide, før du begynder at tage Fluanxol Mite

Tag ikke Fluanxol Mite:

Hvis du er overfølsom (allergisk) over for flupentixol eller et af de øvrige indholdsstoffer

(angivet i punkt 6).

Hvis du er påvirket af alkohol, stærk smertestillende medicin (morfin) eller medicin mod

epilepsi (phenobarbital).

Hvis du har et voldsomt fald i blodtrykket eller hjertesvigt.

Bemærk: Bevidstløse patienter må ikke få Fluanxol Mite.

Advarsler og forsigtighedsregler

Kontakt lægen eller apotekspersonalet før du tager Fluanxol Mite, hvis:

Du har en leversygdom.

Du lider af eller tidligere har lidt af kramper eller krampeanfald.

Du har diabetes. Det kan være nødvendigt at justere din dosis af insulin og/eller andre midler

mod diabetes.

Du har hjerneskade som følge af alkoholforgiftning eller brug af organiske opløsningsmidler.

Du har et stort forbrug af alkohol eller stærk, smertestillende medicin (morfin og

morfinlignende medicin).

Du har eller tidligere har haft sygdom i hjertet.

Nogen i din familie har sygdom i hjertet med for langsomt hjerteslag og ændringer i

hjertekurven (QT-forlængelse).

Du tager anden medicin for din sindslidelse (f.eks. lithium, haloperidol, perphenazin).

Du føler dig mere opstemt, end du plejer, eller er overdrevent aktiv.

Du er psykisk udviklingshæmmet.

Du eller en anden i din familie har haft blodpropper, idet lægemidler som dette har været

forbundet med dannelse af blodpropper.

Selvmordstanker og forværring af din depression eller angst

Hvis du er deprimeret og/eller lider af angst, kan du sommetider have selvmordstanker eller tanker om

at gøre skade på dig selv. Disse tanker kan forstærkes, når du starter med at tage antidepressiv

medicin, fordi medicinen er et stykke tid om at virke, ofte omkring 14 dage, men nogle gange længere

tid.

Du kan have øget risiko for sådanne tanker:

Hvis du tidligere har haft selvmordstanker eller tanker om at gøre skade på dig selv.

Hvis du er ung. Information fra kliniske studier har vist, at der var en øget risiko for

selvmordsadfærd hos voksne under 25 år med psykiatriske lidelser, der blev behandlet med

antidepressiv medicin.

Hvis du på noget tidspunkt får tanker om selvmord eller tanker om at gøre skade på dig selv

, bør du

straks kontakte din læge eller hospitalet.

Det kan måske være en hjælp at tale med en ven eller pårørende

om, at du er deprimeret eller

angst, og bede dem om at læse denne indlægsseddel. Du kan eventuelt bede dem om at fortælle dig,

hvis de synes, at din depression eller angst bliver værre, eller hvis de bliver bekymrede over ændringer

i din opførsel.

Vær desuden opmærksom på

Nogle patienter (f.eks. ældre og demente) har større risiko for at få slagtilfælde. Tal med lægen.

Kontakt straks lægen, hvis du får høj feber med stivhed i muskler og bevægelser, stærk svedtendens og

sløret bevidsthed (malignt neuroleptisk syndrom). Det kan være livsfarligt og kræver øjeblikkelig

lægehjælp.

Oplys altid ved blodprøvekontrol og urinprøvekontrol, at du er i behandling med Fluanxol Mite. Det

kan have betydning for prøveresultaterne.

Brug af anden medicin sammen med Fluanxol Mite

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

det for nylig.

Tal med din læge, hvis du tager medicin mod:

Forstyrrelser i hjerterytmen (f.eks. amiodaron, sotalol)

Sindslidelser (f.eks. lithium, haloperidol, perphenazin)

Depression (tricykliske antidepressiva, f.eks. amitriptylin, imipramin)

Angst, uro, søvnløshed (f.eks. diazepam, flunitrazepam)

Epilepsi (barbiturater, f.eks. phenobarbital)

Parkinsons sygdom (f.eks. biperidin, levodopa)

For højt blodtryk (f.eks. guanethidin)

Infektioner (f.eks. erythromycin, moxifloxacin)

Mave- og tarmsygdomme (f.eks. metoclopramid)

Adrenerge midler, såsom astmamidler (f.eks. salbutamol, terbutalin)

Allergi (visse antihistaminer) - tal med lægen

Samt hvis du tager vanddrivende medicin (f.eks. bendroflumethiazid).

Anden medicin kan påvirke virkningen af Fluanxol Mite, og Fluanxol Mite kan påvirke behandlingen

med anden medicin. Dette er normalt uden praktisk betydning. Spørg lægen eller på apoteket, hvis du

ønsker flere oplysninger herom.

Brug af Fluanxol Mite sammen med mad, drikke og alkohol

Du kan tage Fluanxol Mite i forbindelse med et måltid, men det er ikke nødvendigt. Du må ikke tygge

tabletterne. Synk dem med et glas vand.

Fluanxol Mite kan øge den sløvende virkning af alkohol og gøre dig mere døsig. Du bør derfor ikke

drikke alkohol, mens du er i behandling med Fluanxol Mite.

Graviditet, amning og fertilitet

Hvis du er gravid eller ammer, har mistanke om at du er gravid, eller planlægger at blive gravid, skal

du spørge din læge til råds, før du tager dette lægemiddel.

Graviditet

Hvis du er gravid, må du kun tage Fluanxol Mite efter aftale med lægen.

De følgende symptomer kan forekomme hos nyfødte, hvis mødre har taget Fluanxol Mite i sidste

trimester (de sidste tre måneder af graviditeten): Rystelser, muskelstivhed og/eller -svaghed,

søvnighed, ophidselse, vejrtrækningsbesvær og besvær med at spise. Hvis din baby får nogen af disse

symptomer, skal du kontakte din læge.

Amning

Hvis du ammer, må du kun tage Fluanxol Mite efter aftale med lægen.

Fertilitet

Studier på dyr har vist at Fluanxol Mite påvirker fertiliteten. Spørg din læge til råds.

Trafik- og arbejdssikkerhed

Fluanxol Mite kan virke sløvende i større eller mindre grad. Det skal du tage hensyn til, hvis du skal

færdes i trafikken og arbejde med maskiner. Du skal derfor være opmærksom på, hvordan medicinen

påvirker dig.

Fluanxol Mite indeholder lactose

Kontakt lægen, inden du begynder at tage Fluanxol Mite, hvis lægen har fortalt dig, at du ikke tåler

visse sukkerarter.

3.

Sådan skal du tage Fluanxol Mite

Tag altid Fluanxol Mite nøjagtigt efter lægens anvisning. Er du i tvivl, så spørg lægen eller

apotekspersonalet.

Dosis er afhængig af din sygdom.

Det er lægen, der afgør, i hvor lang tid du skal behandles. Bliv derfor ved med at tage Fluanxol Mite i

den periode, lægen har anbefalet - også selvom du får det bedre. Din sygdom kan vare længe, og hvis

du stopper behandlingen for tidligt, kan dine symptomer vende tilbage.

Du må ikke tygge tabletterne. Synk dem med et glas vand.

Den anbefalede dosis er:

Voksne

Angst, depression, alvorlig træthed:

Du skal begynde med at tage 1 tablet på 1 mg om morgenen eller 1 tablet på 0,5 mg 2 gange (1 mg)

dagligt.

Efter en uge kan lægen vælge at sætte din dosis op til 1 tablet på 1 mg 2 gange (2 mg) dagligt. Du skal

normalt ikke have højere dosis end 3 mg dagligt fordelt på to doser.

Ældre patienter (over 65 år)

Du skal normalt begynde med at tage 1 tablet på 0,5 mg om morgenen. Efter en uge kan lægen vælge

at sætte din dosis op til 1 tablet på 0,5 mg 2 gange dagligt. Normalt vil højeste dosis være 1,5 mg

dagligt fordelt på to doser.

Brug til børn

Børn må normalt ikke få Fluanxol Mite tabletter.

Nedsat nyrefunktion

Det er normalt ikke nødvendigt at ændre dosis. Følg lægens anvisninger.

Nedsat leverfunktion

Det kan være nødvendigt at ændre dosis. Følg lægens anvisninger.

Hvis du har taget for mange Fluanxol Mite tabletter

Kontakt lægen, skadestuen eller apoteket, hvis du har taget flere Fluanxol Mite, end der står her, eller

flere, end lægen har foreskrevet. Tag pakningen med.

Symptomer på overdosering kan være:

Døsighed, bevidstløshed stigende til koma

Kramper, ufrivillige bevægelser

For lavt blodtryk, svag puls, hurtig hjertebanken, bleghed, rastløshed

Forhøjet eller nedsat legemstemperatur

Ændringer i hjerterytmen f.eks. uregelmæssig hjerterytme eller langsom hjerterytme

Hvis du har glemt at tage Fluanxol Mite

Du må ikke tage en dobbelt dosis, som erstatning for den glemte dosis. Fortsæt blot med den

sædvanlige dosis.

Hvis du holder op med at tage Fluanxol Mite

Du må kun holde pause eller stoppe behandlingen efter aftale med lægen. Hvis du stopper

behandlingen pludseligt, kan du få kvalme, opkastning, diaré, madlede, løbende næse, svedtendens,

muskelsmerter, prikken/snurren i huden, søvnløshed, rastløshed, angst, uro og svimmelhed.

Kontakt straks lægen, hvis du igen føler dig syg, efter behandlingen med Fluanxol Mite er stoppet.

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.

Alvorlige bivirkninger

Almindelige bivirkninger (kan påvirke mellem 1 og 10 ud af 100 patienter):

Hurtig puls. Kontakt læge eller skadestue. Ring evt. 112.

Ikke almindelige bivirkninger (kan påvirke mellem 1 og 10 ud af 1.000 patienter):

Kramper. Kontakt straks læge eller skadestue. Ring evt. 112.

Sjældne bivirkninger (kan påvirke mellem 1 og 10 ud af 10.000 patienter):

Alvorlig påvirkning af hjertet med hurtig, evt. meget uregelmæssig, puls, som kan føre til

hjertestop. Kontakt straks læge eller skadestue. Ring evt. 112.

Pludselige overfølsomhedsreaktioner, f.eks. hududslæt, åndedrætsbesvær og besvimelse

(anafylaktisk reaktion). Ring 112. Det kan være livsfarligt.

Blødning fra hud og slimhinder og blå mærker på grund af forandringer i blodet (for få

blodplader). Kontakt straks læge.

Almen sløjhed, tendens til betændelse (infektioner), især halsbetændelse, og feber på grund af

forandringer i blodet (alvorlig mangel på hvide blodlegemer). Kontakt straks læge.

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

Høj feber, usædvanlig muskelstivhed og påvirkning af bevidstheden, øget svedtendens og

hurtig hjertebanken (malignt neuroleptisk syndrom). Ring 112. Det kan være livsfarligt.

Ændrede levertal, gulsot. Kontakt læge eller skadestue.

Nogle patienter har indberettet (hyppighed ikke kendt):

Tilfælde af selvmordstanker og selvmordsadfærd er rapporteret under behandling med

Fluanxol Mite eller kort efter behandlingsophør. Kontakt læge eller skadestue.

Ikke alvorlige bivirkninger

Meget almindelige bivirkninger (kan påvirke flere end 1 ud af 10 patienter):

Ufrivillige, langsomme eller hurtige bevægelser eller muskelstivhed eller besvær med at sidde

eller stå stille.

Mundtørhed, som kan øge risikoen for huller i tænderne.

Døsighed.

Almindelige bivirkninger (kan påvirke mellem 1 og 10 ud af 100 patienter):

Depression. Det kan hos nogle udvikle sig til en alvorlig bivirkning. Tal med lægen.

Besvær med at lade vandet, evt. vandladningsstop. Det kan hos nogle udvikle sig til en

alvorlig bivirkning. Tal med lægen.

Hjertebanken, rysten, svimmelhed, hovedpine.

Åndenød, uskarpt syn, synsforstyrrelser.

Spytflåd, forstoppelse, opkastning, ubehag i maven, diaré.

Stærkt forøget svedtendens, hudkløe.

Muskelsmerter.

Øget appetit, vægtøgning.

Kraftesløshed, træthed.

Søvnløshed, nervøsitet, rastløs uro, nedsat seksuallyst.

Ikke almindelige bivirkninger (kan påvirke mellem 1 og 10 ud af 1.000 patienter):

Bevægelsesforstyrrelser og langsomme, ufrivillige bevægelser.

Rysten af hænder og hoved, stive bevægelser og stivnet ansigtsudtryk.

Taleforstyrrelser.

Kredsende bevægelser af øjnene.

Mavesmerter, kvalme, øget luft i tarmen.

Udslæt, øget følsomhed af huden for lys, eksem eller irritation af huden.

Muskelstivhed.

Nedsat appetit.

Lavt blodtryk.

Hedeture.

Mænd kan få problemer i forbindelse med rejsning og sædafgang.

Forvirring.

Sjældne bivirkninger (kan påvirke mellem 1 og 10 ud af 10.000 patienter):

Hurtig, langsom og/eller uregelmæssig puls. Det kan være alvorligt. Kontakt lægen.

Almen sløjhed, tendens til betændelse (infektioner), især halsbetændelse, og feber pga.

forandringer i blodet (for få hvide blodlegemer). Det kan blive alvorligt. Hvis du får feber,

skal du straks kontakte lægen.

Hyppig vandladning, tørst, træthed på grund af højt blodsukker (blodglukose). Det kan hos

nogle udvikle sig til en alvorlig bivirkning. Tal med lægen.

Overfølsomhed.

Udvikling af bryster hos mænd.

Mælkeflåd, ophør af menstruationerne.

Der er set blodpropper i venerne i benene (med symptomer som hævelse, smerte og rødmen på

benene), som kan løsrives og føres med blodet til lungerne, hvor de kan forårsage brystsmerter og

åndedrætsbesvær. Hvis du oplever nogle af disse symptomer, skal du søge læge omgående.

Hos ældre med demens er der rapporteret et lidt forøget antal dødsfald blandt patienter, der er i

behandling med antipsykotika sammenlignet med dem, der ikke er i behandling med antipsykotika.

Indberetning af bivirkninger til Lægemiddelstyrelsen

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

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

også indberette bivirkninger direkte til Lægemiddelstyrelsen via:

Lægemiddelstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: dkma@dkma.dk

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

af dette lægemiddel.

5.

Opbevaring

Opbevar lægemidlet utilgængeligt for børn.

Brug ikke lægemidlet efter den udløbsdato, der står på pakningen. Udløbsdatoen er den sidste dag i

den nævnte måned.

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

Fluanxol Mite 0,5 mg og 1 mg filmovertrukne tabletter indeholder:

Aktivt stof: Flupentixol (som dihydrochlorid)

Øvrige indholdsstoffer: Betadex, lactosemonohydrat, majsstivelse, hydroxypropylcellulose,

mikrokrystallinsk cellulose, croscarmellosenatrium, talcum, hydrogeneret vegetabilsk olie og

magnesiumstearat

Tabletovertræk og farvestoffer: Delvist hydrolyseret polyvinylalkohol, titandioxid (E171),

macrogol/PEG 3350, talcum, gul jernoxid (E172), macrogol/PEG 6000.

Udseende og pakningsstørrelser

Du kan få Fluanxol Mite filmovertrukne tabletter i styrkerne 0,5 mg og 1 mg.

Udseende

0,5 mg tabletterne er runde, lidt hvælvede, gule og præget med FD.

1 mg tabletterne er ovale, lidt hvælvede, gule og præget med FF.

Pakningsstørrelser

0,5 mg tabletter:

100 tabletter i HDPE tabletbeholder.

1 mg tabletter:

100 tabletter i HDPE tabletbeholder.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen og fremstiller

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Repræsentant for Danmark

Lundbeck Pharma A/S

Ottiliavej 9

2500 Valby

Denne indlægsseddel blev senest revideret oktober 2016.

Du kan finde yderligere oplysninger om Fluanxol Mite på Lægemiddelstyrelsens hjemmeside

www.laegemiddelstyrelsen.dk.

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of white willow (Salix alba) in food

Risk assessment of white willow (Salix alba) in food

Published on: Tue, 28 Aug 2018 00:00:00 +0200 This Technical Report contains a description of the activities within the work programme of the EU‐FORA Fellowship on the risk assessment of white willow in food. The bark of different varieties of willow has had a long history of medical use as a means to reduce fever and as a painkiller. Willow bark is also used in weight loss and sports performance food supplements. The labelling of these products usually does not mention any restrictions to the length of...

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

29-8-2018

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industr...

FDA - U.S. Food and Drug Administration

18-8-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probabl...

FDA - U.S. Food and Drug Administration

15-8-2018

Salt & Straw Voluntarily Recalls Certain Lots of Chocolate Gooey Brownie Ice Cream Pints Due to Possible Undeclared Peanuts

Salt & Straw Voluntarily Recalls Certain Lots of Chocolate Gooey Brownie Ice Cream Pints Due to Possible Undeclared Peanuts

Salt & Straw Ice Cream is voluntarily recalling a limited number of its Chocolate Gooey Brownie pints because it may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of a serious or life threatening allergic reaction if they consume this product. The product is safe to consume unless you have a peanut allergy or sensitivity. No illnesses have been reported to date in connection with this problem.

FDA - U.S. Food and Drug Administration

9-8-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

3-8-2018

HP Hood LLC Recalls Select Units of Half-Gallon Refrigerated Vanilla Almond Breeze Almond Milk due to Possible Milk Allergen

HP Hood LLC Recalls Select Units of Half-Gallon Refrigerated Vanilla Almond Breeze Almond Milk due to Possible Milk Allergen

HP Hood LLC is voluntarily recalling a limited number of half-gallon (1.89 L) cartons of refrigerated Vanilla Almond Breeze almond milk because the product may contain milk, an allergen not listed on the label. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. The product is safe to consume unless you have a milk allergy or sensitivity. To date, there has been one report of an allergic reaction. Medical ...

FDA - U.S. Food and Drug Administration

2-8-2018

Orphan designation:  Lenalidomide,  for the: Treatment of diffuse large B-cell lymphoma

Orphan designation: Lenalidomide, for the: Treatment of diffuse large B-cell lymphoma

On 13 May 2011, orphan designation (EU/3/11/868) was granted by the European Commission to Celgene Europe Limited, United Kingdom, for lenalidomide for the treatment of diffuse large B-cell lymphoma.

Europe - EMA - European Medicines Agency

2-8-2018

Sweet Earth Foods Issues Allergy Alert for Undeclared Egg and Milk in Aloha BBQ Quesadillas Due to Mismatched Packaging

Sweet Earth Foods Issues Allergy Alert for Undeclared Egg and Milk in Aloha BBQ Quesadillas Due to Mismatched Packaging

Sweet Earth Foods is initiating a voluntary recall of a limited amount of 8-ounce packages of Sweet Earth Aloha BBQ Quesadilla due to mismatched packaging, resulting in undeclared egg and milk allergens. People who are allergic to eggs or milk could have a serious or life- threatening reaction if they consume this item. A UPC code of 016741000551 appears on the back of the package. The “best by” date of 6/28/19 and lot number of 8149 appears on the side of the package.

FDA - U.S. Food and Drug Administration

2-10-2018

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Active substance: adalimumab) - Centralised - 2-Monthly update - Commission Decision (2018)6458 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/IB/14

Europe -DG Health and Food Safety

2-10-2018

Intuniv (Shire Pharmaceuticals Ireland Limited)

Intuniv (Shire Pharmaceuticals Ireland Limited)

Intuniv (Active substance: guanfacine) - Centralised - Yearly update - Commission Decision (2018)6473 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

25-9-2018

Slenyto (RAD Neurim Pharmaceuticals EEC Limited)

Slenyto (RAD Neurim Pharmaceuticals EEC Limited)

Slenyto (Active substance: melatonin) - Centralised - Authorisation - Commission Decision (2018)6223 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4425

Europe -DG Health and Food Safety

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

24-9-2018

Nitisinone MDK (MendeliKABS Europe Limited)

Nitisinone MDK (MendeliKABS Europe Limited)

Nitisinone MDK (Active substance: nitisinone) - Centralised - Yearly update - Commission Decision (2018)6241 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Xerava (Tetraphase Pharmaceuticals Ireland Limited)

Xerava (Tetraphase Pharmaceuticals Ireland Limited)

Xerava (Active substance: Eravacycline) - Centralised - Authorisation - Commission Decision (2018)6231 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4237

Europe -DG Health and Food Safety

24-9-2018

Cosentyx (Novartis Europharm Limited)

Cosentyx (Novartis Europharm Limited)

Cosentyx (Active substance: secukinumab) - PSUSA - Modification - Commission Decision (2018)6213 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00010341/201712

Europe -DG Health and Food Safety

10-9-2018

Alkindi (Diurnal Limited)

Alkindi (Diurnal Limited)

Alkindi (Active substance: hydrocortisone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5945 of Mon, 10 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4416/T/03

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

Retacrit (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5946 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

4-9-2018

Spinraza (Biogen Idec Limited)

Spinraza (Biogen Idec Limited)

Spinraza (Active substance: nusinersen) - Centralised - 2-Monthly update - Commission Decision (2018)5862 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/II/4

Europe -DG Health and Food Safety

29-8-2018

Mekinist (Novartis Europharm Limited)

Mekinist (Novartis Europharm Limited)

Mekinist (Active substance: trametinib) - Centralised - 2-Monthly update - Commission Decision (2018)5778 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2643/WS/1274

Europe -DG Health and Food Safety

29-8-2018

Nucala (GlaxoSmithKline Trading Services Limited)

Nucala (GlaxoSmithKline Trading Services Limited)

Nucala (Active substance: mepolizumab) - Centralised - 2-Monthly update - Commission Decision (2018)5770 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3860/II/13/G

Europe -DG Health and Food Safety

29-8-2018

Varuby (TESARO U.K. Limited)

Varuby (TESARO U.K. Limited)

Varuby (Active substance: rolapitant) - Centralised - Yearly update - Commission Decision (2018)5765 of Wed, 29 Aug 2018

Europe -DG Health and Food Safety

28-8-2018

Kalydeco (Vertex Pharmaceuticals (Europe) Limited)

Kalydeco (Vertex Pharmaceuticals (Europe) Limited)

Kalydeco (Active substance: ivacaftor) - PASS - Modification - Commission Decision (2018)5693 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2494/RSR/S/14

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2062 (IQVIA RDS Ireland Limited)

EU/3/18/2062 (IQVIA RDS Ireland Limited)

EU/3/18/2062 (Active substance: Bertilimumab) - Orphan designation - Commission Decision (2018)5740 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/098/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2060 (Biogen Idec Limited)

EU/3/18/2060 (Biogen Idec Limited)

EU/3/18/2060 (Active substance: Adeno-associated viral vector serotype hu68 containing the human SMN1 gene) - Orphan designation - Commission Decision (2018)5732 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/065/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2058 (IQVIA RDS Ireland Limited)

EU/3/18/2058 (IQVIA RDS Ireland Limited)

EU/3/18/2058 (Active substance: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-cystinyl)-L-lysinamide, disulfide, acetate) - Orphan designation - Commission Decision (2018)5730 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/099/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2063 (IQVIA RDS Ireland Limited)

EU/3/18/2063 (IQVIA RDS Ireland Limited)

EU/3/18/2063 (Active substance: CD34+ haematopoietic stem and progenitor cells with CD3+ T-cells) - Orphan designation - Commission Decision (2018)5733 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/088/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Active substance: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt) - Orphan designation - Commission Decision (2018)5729 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Active substance: (S)-(-)-3-(4-aminophenyl)-2-methoxypropanoic acid) - Orphan designation - Commission Decision (2018)5728 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/075/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2055 (IQVIA RDS Ireland Limited)

EU/3/18/2055 (IQVIA RDS Ireland Limited)

EU/3/18/2055 (Active substance: (3R,3aS,9R,9aS,9bS)-3-((dimethylamino)methyl)-9-hydroxy-6,9-dimethyl-3,3a,4,5,7,8,9,9a-octahydroazuleno[4,5-b]furan-2(9bH)-one fumarate) - Orphan designation - Commission Decision (2018)5727 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/060/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2067 (Omeros London Limited)

EU/3/18/2067 (Omeros London Limited)

EU/3/18/2067 (Active substance: Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2) - Orphan designation - Commission Decision (2018)5737 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/044/18

Europe -DG Health and Food Safety

28-8-2018

Orkambi (Vertex Pharmaceuticals (Europe) Limited)

Orkambi (Vertex Pharmaceuticals (Europe) Limited)

Orkambi (Active substance: Lumacaftor/Ivacaftor) - PSUSA - Modification - Commission Decision (2018)5710 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10455/201711

Europe -DG Health and Food Safety

27-8-2018

Firazyr (Shire Pharmaceuticals Ireland Limited)

Firazyr (Shire Pharmaceuticals Ireland Limited)

Firazyr (Active substance: icatibant) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5697 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/899T/41

Europe -DG Health and Food Safety

27-8-2018

Kymriah (Novartis Europharm Limited)

Kymriah (Novartis Europharm Limited)

Kymriah (Active substance: tisagenlecleucel) - Centralised - Authorisation - Commission Decision (2018)5717 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4090

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

25-8-2018

Xagrid (Shire Pharmaceuticals Ireland Limited)

Xagrid (Shire Pharmaceuticals Ireland Limited)

Xagrid (Active substance: anagrelide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5682 of Sat, 25 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/480/T/82

Europe -DG Health and Food Safety

22-8-2018

Lenvima (Eisai Europe Limited)

Lenvima (Eisai Europe Limited)

Lenvima (Active substance: lenvatinib) - Centralised - 2-Monthly update - Commission Decision (2018)5627 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3727/II/11/G

Europe -DG Health and Food Safety

15-8-2018

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)5555 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/172/17/T/01

Europe -DG Health and Food Safety

7-8-2018

Inovelon (Eisai Limited)

Inovelon (Eisai Limited)

Inovelon (Active substance: Rufinamide) - Centralised - 2-Monthly update - Commission Decision (2018)5424 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/660/II/45

Europe -DG Health and Food Safety

7-8-2018

Accofil (Accord Healthcare Limited)

Accofil (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

7-8-2018

EU/3/16/1694 (GlaxoSmithKline Trading Services Limited)

EU/3/16/1694 (GlaxoSmithKline Trading Services Limited)

EU/3/16/1694 (Active substance: Autologous CD4+ and CD8+ T-cells transduced with lentiviral vector containing an affinity-enhanced T-cell receptor targeting the New York esophageal antigen-1) - Transfer of orphan designation - Commission Decision (2018)5405 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/064/16/T/01

Europe -DG Health and Food Safety

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

7-8-2018

Duloxetine Mylan (Generics [UK] Limited)

Duloxetine Mylan (Generics [UK] Limited)

Duloxetine Mylan (Active substance: Duloxetine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5417 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3981/T/14

Europe -DG Health and Food Safety

7-8-2018

Numient (Impax Laboratories Ireland Limited)

Numient (Impax Laboratories Ireland Limited)

Numient (Active substance: levodopa / carbidopa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5418 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2611/T/5

Europe -DG Health and Food Safety

6-8-2018

Rapamune (Pfizer Limited)

Rapamune (Pfizer Limited)

Rapamune (Active substance: sirolimus) - Centralised - 2-Monthly update - Commission Decision (2018)5384 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/273/II/164

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

3-8-2018

EU/3/18/2042 (MeiraGTx UK II Limited)

EU/3/18/2042 (MeiraGTx UK II Limited)

EU/3/18/2042 (Active substance: Adenovirus associated viral vector serotype 2/8 containing the human CNGA3 gene) - Orphan designation - Commission Decision (2018)5274 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2051 (Wave life Sciences Ireland Limited)

EU/3/18/2051 (Wave life Sciences Ireland Limited)

EU/3/18/2051 (Active substance: Synthetic antisense oligonucleotide directed against human dystrophin pre-mRNA) - Orphan designation - Commission Decision (2018)5283 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/032/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2054 (Mallinckrodt Specialty Pharmaceuticals Ireland Limited)

EU/3/18/2054 (Mallinckrodt Specialty Pharmaceuticals Ireland Limited)

EU/3/18/2054 (Active substance: Tetracosactide) - Orphan designation - Commission Decision (2018)5286 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/043/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2041 (Ionis USA Limited)

EU/3/18/2041 (Ionis USA Limited)

EU/3/18/2041 (Active substance: 2'-O-(2-methoxyethyl) antisense oligonucleotide targeting microtubule-associated protein tau pre-mRNA) - Orphan designation - Commission Decision (2018)5273 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/050/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2052 (Dicerna EU Limited)

EU/3/18/2052 (Dicerna EU Limited)

EU/3/18/2052 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues) - Orphan designation - Commission Decision (2018)5284 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/052/18

Europe -DG Health and Food Safety