Pro-Epanutin

Primær information

  • Handelsnavn:
  • Pro-Epanutin 75 mg/ml injektionsvæske/konc. til infusionsvæske, opløsning
  • Dosering:
  • 75 mg/ml
  • Lægemiddelform:
  • injektionsvæske/konc. til infusionsvæske, opløsning
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Pro-Epanutin 75 mg/ml injektionsvæske/konc. til infusionsvæske, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 30073
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel

Indlægsseddel: information til brugeren

Pro-Epanutin 75 mg/ml

koncentrat til infusions-/injektionsvæske, opløsningosphenytoindinatrium

Læs denne indlægsseddel grundigt, inden De begynder at få dette lægemiddel, da den

indeholder vigtige oplysninger.

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

Spørg lægen eller sundhedspersonalet, hvis der er mere, De vil vide.

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

medicinen videre til andre. Det kan være skadeligt for andre, selvom de har de samme

symptomer, som De har.

Kontakt lægen eller sundhedspersonalet, hvis De får bivirkninger, herunder bivirkninger, som

ikke er nævnt her. Se punkt 4.

De vil måske få Pro-Epanutin som en enkeltdosis for kontrol af status epilepticus. I dette

tilfælde, vil De først kunne læse denne indlægsseddel, efter at produktet er blevet givet til Dem.

Deres læge vil have taget hensyn til den vigtige sikkerhedsinformation i denne indlægsseddel,

men Deres akutte behov for behandling kan have været mere vigtigt end de almindelige

forsigtighedsregler. De kan tjekke dem nu, især hvis De skal fortsætte med at have Pro-

Epanutin.

Se den nyeste indlægsseddel på www.indlaegsseddel.dk.

Oversigt over indlægssedlen

Virkning og anvendelse

Det skal De vide om Pro-Epanutin

Sådan bliver De behandlet med Pro-Epanutin

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

1.

Virkning og anvendelse

Pro-Epanutin tilhører den gruppe medicin, der bruges til behandling af epilepsi.

Pro-Epanutin bruges til behandling af svære epileptiske kramper eller krampeanfald (status

epilepticus). Det kan også bruges til kontrol eller forebyggelse af anfald under eller efter en operation i

hjernen og/eller alvorlig hovedlæsion. Pro-Epanutin bruges også til kontrol eller forebyggelse af anfald

i korte perioder, hvis anden medicin mod epilepsi ikke kan tages gennem munden.

Lægen kan have givet Dem Pro-Epanutin for noget andet. Spørg lægen.

2.

Det skal De vide om Pro-Epanutin

De må ikke få Pro-Epanutin

hvis De er allergisk over for fosphenytoinnatrium, phenytoin eller et eller flere af de øvrige

indholdsstoffer (angivet i punkt 6).

hvis De lider af en tilstand, der påvirker hjerterytmen.

hvis De lider af en arvelig sygdom, som påvirker dannelsen af de røde blodlegemer (akut

intermitterende porfyri).

hvis De tager delavirdin, der bruges til behandling af hiv.

Lægen eller sundhedspersonalet vil være ekstra forsigtig med at behandle Dem med Pro-

Epanutin

Lavt blodtryk og alvorlige hjerteproblemer, i nogle tilfælde forbundet med dødsfald, er set efter

behandling med Pro-Epanutin. Disse bivirkninger kan være mere udtalte hos ældre patienter, børn eller

personer, der er meget syge.

En lille andel af de personer, der bliver behandlet med epilepsimedicin, som for eksempel Pro-

Epanutin, har haft selvmordstanker eller tanker om at gøre skade på sig selv. Hvis De på noget

tidspunkt får sådanne tanker, bør De straks kontakte Deres læge.

Der er i sjældne tilfælde set alvorlige hudbivirkninger under behandling med Pro-Epanutin.

Risiko for disse bivirkninger kan være forbundet med en genvariant hos personer af kinesisk

eller thailandsk oprindelse. Tal med lægen før De tager Pro-Epanutin, hvis dette gælder for

Dem, og hvis De tidligere er blevet testet for, om De bærer denne genvariant (HLA-B*1502).

Tal med Deres læge, inden De får Pro-Epanutin, hvis De har eller har haft en af følgende

lidelser:

Leversygdom

Hjertesygdom eller slagtilfælde

Lavt blodtryk eller hjertesvigt

Nyresygdom

Lavt indhold af protein (albumin) i blodet

Diabetes

Speciel diæt med restriktioner i indtag af fosfat.

Der er set doseringsfejl, hvilke har bevirket, at patienter har fået doser, der var højere end anbefalingen.

Dette medførte dødsfald eller alvorlige hjerteproblemer for nogle patienter.

Brug af anden medicin

Anden medicin kan påvirke virkningen af Pro-Epanutin, eller Pro-Epanutin kan påvirke virkningen af

anden medicin, når det tages på samme tid. Sådan medicin omfatter (ikke al medicin er nævnt her. Tal

med lægen eller apotekspersonalet):

Medicin mod problemer med hjertet eller blodomløbet (felbamat, digoxin, amiodarone,

furosemid, quinidin, warfarin, diazoxid, atorvastatin, fluvastatin, simvastatin, disopyramid,

mexiletin og såkaldte calciumblokkere, f.eks. diltiazem, nisoldipin, nifedipin, nicardin,

nimodipin og verapamil).

Medicin mod epilepsi (carbamazepin, lamotrigin, oxcarbazepin, phenobarbital, natriumvalproat,

topiramat og valproatsyre, succinimider, f.eks. ethosuximid og vigabatrin).

Medicin mod svampeinfektioner (amphotericin B, fluconazol, itraconazol, ketoconazol,

miconazol, posaconazol og voriconazol).

Medicin mod hiv (delavirdin, efavirenz, fosamprenavir, indinavir, lopinavir/ritonavir,

nelfinavir, ritonavir og saquinavir).

Medicin mod tuberkulose og andre infektioner (albendazol, chloramphenicol, isoniazid,

rifampicin, praziquentel, erythromycin, doxycyclin, ciprofloxacin, tetracyclin og sulfonamider

f.eks. sulfafenazol, sulfadiazin, sulfamethizol og sulfamethoxazol-trimetoprim).

Medicin mod mavesår (omeprazol, medicin kendt som H

-agonister, f.eks. cimetidin, ranitidin,

famotidin og visse syreneutraliserende midler).

Medicin mod astma og bronkitis (theophyllin).

Medicin mod smerter og betændelsestilstand (phenylbutazon, salicylater, f.eks. azapropazon,

ticlopidin, acetylsalicylsyre og steroider).

Medicin mod søvnløshed, depression og psykiske lidelser (chlordiazepoxid, clozapin, diazepam,

disulfiram, fluoxetin, fluvoxamin, sertralin, methadon, methylphenidat, paroxetin,

phenothiaziner, quetiapin, trazodon, perikon, tricykliske depressionsmidler og viloxazin).

Medicin mod diabetes (tolbutamid, chlorpropamid, glibenclamid).

Visse hormonerstatninger (østrogener), orale præventionsmidler (p-piller).

Medicin givet i forbindelse med organ- og vævstransplantationer for at forebygge afstødning

(ciclosporin, tacrolimus), binyrebarkhormoner.

Medicin mod kræft (antineoplastiske stoffer f.eks. bleomycin, capecitabin, carboplatin,

cisplatin, doxorubicin, methotrexat og teniposid).

Muskelafslappende medicin i forbindelse med operation (neuromuskulære blokkere f.eks.

cisatracurium, pancuronium, rocuronium og vecuronium) og visse bedøvelsesmidler (halothan).

Visse typer håndkøbsmedicin (folinsyre, theophyllin, D-vitamin).

Deres læge vil under behandlingen tage nogle blodprøver for at bestemme mængden af phenytoin i

blodet, for at afgøre om noget af ovenstående medicin påvirker Deres behandling.

Fortæl det altid til lægen eller sundhedspersonalet, hvis De bruger anden medicin eller har brugt det for

nylig. Dette gælder også medicin, som ikke er købt på recept, medicin købt i udlandet, naturlæge-

midler, stærke vitaminer og mineraler samt kosttilskud.

De må ikke tage naturmedicin, der indeholder perikon (Hyperikon perforatum) på samme tid som Pro-

Epanutin. Tal med lægen, hvis De allerede tager perikum, inden De stopper med at tage perikum.

Oplys altid ved blodprøvekontrol, at De er i behandling med Pro-Epanutin, da Pro-Epanutin kan

påvirke prøveresultaterne.

Brug af Pro-Epanutin sammen med alkohol

Stort indtag af alkohol kan også påvirke koncentrationen af Pro-Epanutin i blodet.

Graviditet og amning

Spørg Deres læge eller apoteket til råds, før De tager nogen form for medicin.

Graviditet

Kontakt straks lægen, hvis De er gravid, hvis De har en formodning om De er gravid, eller planlægger

at blive gravid.

Amning

De må ikke amme, hvis De får Pro-Epanutin. Tal med lægen.

Trafik- og arbejdssikkerhed

Pakningen er forsynet med en rød advarselstrekant. Det betyder, at Pro-Epanutin kan give bivirkninger,

f.eks. svimmelhed og døsighed, især i de første uger, som kan påvirke arbejdssikkerheden og evnen til

at færdes sikkert i trafikken. Kør ikke bil eller motorcykel og lad være med at cykle, hvis De oplever

disse symptomer. Lad være med at arbejde med værktøj eller maskiner.

3.

Sådan bliver De behandlet med Pro-Epanutin

De vil være indlagt, når De får Pro-Epanutin.

De vil få Pro-Epanutin som en intravenøs infusion (indsprøjtning i en blodåre) eller som en

indsprøjtning i en muskel. Når Pro-Epanutin skal gives intravenøst, skal det fortyndes først.

Lægen kan fortælle Dem, hvilken dosis De får og hvor tit, De skal have den. Dosis og

koncentrationen vil altid blive udtrykt ved phenytoinnatriumækvivalenter (PÆ). Dosis vil

være beregnet som mg/dosis, hvis den gives som en injektion, eller som mg/ml opløsning, hvis

den gives som en infusion. Er De i tvivl, så spørg lægen eller sundhedspersonalet. Det er kun

lægen, der kan ændre dosis.

Til intravenøs infusion skal Pro-Epanutin fortyndes i 5% glucose eller 0,9%

natriumchloridopløsning og må ikke indsprøjtes ufortyndet. Koncentrationen skal være 1,5-

25 mg PÆ/ml.

Voksne

Svære epileptiske anfald eller krampeanfald (status epilepticus)

Pro-Epanutin gives sædvanligvis efter behandling med diazepam- eller lorazepamindsprøjtning.

Den sædvanlige første dosis (startdosis) af Pro-Epanutin til behandling af svære eller fortsatte

krampeanfald (status epilepticus) er:

15 mg PÆ pr. kilogram legemsvægt indsprøjtet direkte ind i en åre (dette kaldes startdosis).

Herefter følger flere doser Pro-Epanutin direkte indsprøjtet i åren eller ind i musklen, eller De

kan få phenytoindoser gennem munden (dette kaldes vedligeholdelsesdosis).

Hvis Pro-Epanutin ikke stopper Deres krampeanfald, vil de få andre behandlinger.

Operation i hjernen og/eller alvorlig hovedlæsion

Hvis Deres krampeanfald er mindre alvorlig eller Pro-Epanutin bruges til at behandle eller

forebygge, at der opstår krampeanfald under eller efter operation i hjernen eller hovedlæsion, er

den sædvanlige første dosis (startdosis) af Pro-Epanutin:

10-15 mg PÆ pr. kilogram legemsvægt indsprøjtet direkte ind i en åre eller i en muskel.

Herefter følger flere doser Pro-Epanutin direkte indsprøjtet i åren eller ind i musklen, eller De

kan få phenytoindoser gennem munden.

Vedligeholdelsesdosis

Den sædvanlige vedligeholdelsesdosis er 4-5 mg PÆ pr. kilogram legemsvægt pr. dag. Lægen

vil tage en blodprøve for at bestemme den rigtige dosis til Dem.

Hvis Deres læge bestemmer, at De har brug for fortsat behandling, vil De så hurtigt som muligt

få en behandling, der kan tages gennem munden. Dette vil være phenytoin, da Pro-Epanutin

ikke kan tages gennem munden.

Erstatningsbehandling af oral phenytoin

Hvis De får Pro-Epanutin, fordi De ikke kan tage phenytoin gennem munden, har De ikke brug

for en startdosis. Den dosis De vil få, er den samme som Deres phenytoindosis. Da dosis af

Pro-Epanutin gives i PÆ (phenytoinnatriumækvivalenter) vil mængden af mg PÆ af Pro-

Epanutin, som De vil få, være den samme mængde mg af phenytoinnatrium, som De tager

gennem munden.

Brug til børn (over 5 år)

Dosis af Pro-Epanutin pr. kilogram legemsvægt er den samme for børn over 5 år som for

voksne.

Pro-Epanutin gives til børn over 5 år kun ved drop (infusion) i en vene (intravenøst).

Ældre patienter over 65 år, meget dårlige patienter og patienter med nyre- eller

leversygdom

Det kan være nødvendigt at nedsætte dosis eller at give indsprøjtningen i vene med en lavere

hastighed.

Tag altid Pro-Epanutin nøjagtigt efter lægens anvisning. Er De i tvivl, så spørg lægen eller

sundhedspersonalet.

Hvis De har fået for meget Pro-Epanutin

Pro-Epanutin er meget farlig ved en overdosering. Kontakt straks lægen eller sundheds-

personalet, hvis De tror, at De har fået for meget Pro-Epanutin.

Symptomer på overdosering kan være kvalme, opkastning, døsighed, langsom puls, hurtig puls,

hjertestop, lavt blodtryk, besvimelse og død.

Spørg lægen eller sundhedspersonalet, hvis De har yderligere spørgsmål, om hvordan De skal

tage dette produkt.

Hvis en dosis er glemt

Spørg lægen eller sundhedspersonalet, hvis De tror, at De mangler at få en dosis.

Hvis behandlingen bliver stoppet

Kontakt lægen, hvis De ønsker at holde pause eller stoppe behandlingen med Pro-Epanutin.

4.

Bivirkninger

Pro-Epanutin kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.

Kontakt straks læge eller skadestue, hvis De oplever et af følgende symptomer efter De har

fået denne medicin. Skønt disse bivirkninger kan være sjældne, kan disse symptomer blive

alvorlige.

Hvis De udvikler et alvorligt blæreformet hududslæt og betændelse i huden, især på

hænder og fødder samt i og omkring munden ledsaget af feber. Kraftig afskalning og

afstødning af hud. Dette kan være symptomer på en sygdom, der kaldes Stevens-

Johnsons Syndrom eller toksisk epidermal nekrolyse. Deres læge vil i disse tilfælde

stoppe behandlingen.

Hvis De oplever blå mærker, feber, bleghed eller halsbetændelse. Dette kan være de

første tegn på forandringer i blodet, herunder for få røde og hvide blodlegemer og

blodplader. Deres læge vil regelmæssigt tage blodprøver for at undersøge disse

virkninger.

Hududslæt og feber med hævede kirtler, gulfarvning af huden og det hvide i øjnene,

især i de første to måneder af behandlingen kan være tegn på en overfølsomhedsreak-

tion. Hvis disse bliver alvorlige, og De også oplever smerter og betændelse i leddene

kan dette være relateret til en bindevævssygdom, der kaldes systemisk lupus

erythematosus.

Hvis De får misfarvet hud, hævelse eller smerter, der hvor indsprøjtningen blev givet,

der spreder sig til arm samt hænder og fingre. Dette kan være tegn på en tilstand der

kaldes ”purple glove syndrome”. I de fleste tilfælde vil dette forsvinde af sig selv, men i

nogle tilfælde kan det udvikle sig alvorligt og kræve hurtig medicinsk behandling.

Hududslæt, feber, hævede kirtler, forhøjet antal hvide blodlegemer og betændelse i

indre organer (lever, lunger, hjerte, nyrer og tarmene), da det kan være tegn på en

overfølsomhedsreaktion.

Hvis De oplever tilstand af forvirring eller alvorlig psykisk sygdom kan dette være tegn

på, at De har for meget phenytoin i blodet. Hvis mængden af fosphenytoin i blodet

forbliver højt, kan der i sjældne tilfælde forekomme en permanent hjerneskade. Deres

læge kan undersøge blodet for at se, hvor meget phenytoin De har i blodet, og kan

ændre deres dosis.

Pludselig hvæsende vejrtrækning, vejrtrækningsbesvær, hævelse af øjenlåg, ansigt eller

læber, udslæt eller kløe (spredt over hele kroppen), da det kan være tegn på en

overfølsomhedsreaktion.

Andre bivirkninger er:

Virkning på nervesystemet: Rykvise, ufrivillige øjenbevægelser, usikker gang, usikre

bevægelser, rysten, unormal koordination af bevægelser, sløret tale, forvirring, tab af

følesans i tungen, prikkende, snurrende fornemmelser eller følelseshed i huden,

døsighed, svimmelhed, snurrende eller gyngende fornemmelse (vertigo), søvnløshed,

nervøsitet, muskelsitren, hovedpine, kramper, unormale tanker, humørsvingninger.

Virkning på huden: hududslæt, herunder mæslingelignende reaktioner, som er milde.

Virkning på mave-tarmkanalen: kvalme, opkast og forstoppelse, appetitændringer,

mundtørhed.

Virkning på blod-og lymfesystem: hævede kirtler.

Virkning på lever og nyrer: betændelse i nyrer og lever, leverskader (ses som

gulfarvning af hud og det hvide i øjnene).

Virkning på hænder, ansigt og krop: ændringer i hænder, så det bliver svært at rette

fingrene ud, ændringer i ansigtstræk, forstørrelse af læber og tandkød, øget eller

unormalt hårvækst på kroppen eller i ansigtet, tab af energi eller styrke, kulderystelser,

muskelsmerter eller muskelsvaghed.

Virkning på øjne eller øre: ringen for ørerne, høretab, dobbeltsyn, sløret syn.

Virkning på laboratorieresultater: øget sukker i blodet (glucose) eller fald i indhold

af kalk, folinsyre og D-vitamin i blodet. Hvis De ikke får nok D-vitamin fra Deres kost

eller sollys, kan De måske lide af knoglesmerter eller brud.

Virkning på åndedrætssystemet: vejrtrækningsbesvær, lungehindebetændelse.

Virkning på immunsystemet: problemer med kroppens forsvar mod infektioner,

betændelse i blodårevæggen.

Virkning på hjertet og blodomløbet: lavt blodtryk, hævelser i blodkarrene,

langsommere hjerteslag. Deres blodtryk kan måske falde, når De får Pro-Epanutin

indsprøjtet for hurtigt i en blodåre, eller hvis De får en for høj dosis.

Virkning på knoglerne: Der har været rapporteret om knoglelidelser, herunder

afkalkning af knoglerne, knogleskørhed og knoglebrud. Tal med Deres læge eller

apotekspersonalet hvis De er i langtidsbehandling med epilepsimedicin, har

knogleskørhed eller tager medicin med binyrebarkhormon.

Virkning på injektionsstedet: Smerter eller reaktioner på injektionsstedet, midlertidig

kløe, brænden, varme eller prikken i lysken kan af og til forekomme under eller kort tid

efter indsprøjtning af Pro-Epanutin i blodåren. Deres læge kan nedsætte hastigheden af

indsprøjtningen af Pro-Epanutin eller midlertidigt stoppe indsprøjtningen af Pro-

Epanutin, hvis De føler disse fornemmelser.

Tal med lægen eller sundhedspersonalet, hvis en bivirkning er generende eller bliver værre,

eller hvis De får bivirkninger, som ikke er nævnt her.

Indberetning af bivirkninger

Hvis De oplever bivirkninger, bør De tale med Deres læge eller sundhedspersonalet. Dette

gælder også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel. De eller Deres

pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via de oplysninger,

der fremgår herunder.

Lægemiddelstyrelsen

Axel Heides Gade 1

2300 København S

Websted: www.meldenbivirkning.dk

E-mail: dkma@dkma.dk

Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om

sikkerheden af dette lægemiddel.

5.

Opbevaring

Opbevaring af Pro-Epanutin vil ikke være Deres ansvar.

Opbevares utilgængeligt for børn.

Opbevares i køleskab ved 2

C. Det ufortyndede produkt kan opbevares ved stuetemperatur

C-25

C) i op til 24 timer. Efter åbning skal ubrugt opløsning kasseres.

Opløsninger med synlig misfarvning eller partikler må ikke anvendes.

Brug ikke Pro-Epanutin efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er

den sidste dag i den nævnte måned.

Aflever altid medicinrester på apoteket. Af hensyn til miljøet må De ikke smide medicinrester i

afløbet, toilettet eller skraldespanden.

6.

Pakningsstørrelser og yderligere oplysninger

Pro-Epanutin indeholder:

1 ml Pro-Epanutin indeholder 75 mg fosphenytoindinatrium, hvilket svarer til 50 mg phenytoinnatrium

(50 mg PÆ).

Øvrige indholdsstoffer: Vand til injektionsvæsker, trometamol (som buffer), saltsyre (til justering af pH

til 8,6-9,0).

Udseende og pakningsstørrelser

Udseende

Pro-Epanutin er en klar, farveløs til lys gul steril opløsning.

Pakningsstørrelser

Pro-Epanutin koncentrat til infusion/injektionsvæske, opløsning findes i små glasflasker (hætteglas) på

2 ml eller 10 ml.

Hvert hætteglas på 10 ml indeholder 750 mg fosphenytoindinatrium svarende til 500 mg

PÆ.

Hvert hætteglas på 2 ml indeholder 150 mg fosphenytoindinatrium svarende til 100 mg

PÆ.

Findes i kartoner med:

5 hætteglas på 2 ml injektionsvæske, opløsning

10 hætteglas på 2 ml injektionsvæske, opløsning

25 hætteglas på 2 ml injektionsvæske, opløsning

10 kartoner med 5 hætteglas (= 50 hætteglas) på 2 ml injektionsvæske, opløsning

5 hætteglas på 10 ml injektionsvæske, opløsning

10 hætteglas på 10 ml injektionsvæske, opløsning

5 kartoner med 5 hætteglas (= 25 hætteglas) på 10 ml injektionsvæske, opløsning

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen og fremstiller

Indehaver af markedsføringstilladelsen

Pfizer ApS, Lautrupvang 8, 2750 Ballerup

Fremstiller

Pfizer Service Company BVBA, Hoge Wei 10, 1930 Zaventem, Belgien.

Denne indlægsseddel blev sidst opdateret i marts 2018.

20-11-2018

Pest categorisation of non‐EU Monochamus spp.

Pest categorisation of non‐EU Monochamus spp.

Published on: Mon, 19 Nov 2018 The Panel on Plant Health performed a pest categorisation of non‐EU Monochamus spp., a well‐defined insect genus in the family Cerambycidae (Insecta: Coleoptera). Species can be identified using taxonomic keys at national and regional level, and DNA barcoding. Two online world catalogues exist for the genus. The genus includes about one hundred species and many subspecies colonising conifers and non‐conifer trees in many areas in the world. The non‐EU species are listed in...

Europe - EFSA - European Food Safety Authority Publications

19-11-2018

Jay Robb Enterprises Issues Allergy Alert on Undeclared Milk Allergen in Unflavored Egg White Protein

Jay Robb Enterprises Issues Allergy Alert on Undeclared Milk Allergen in Unflavored Egg White Protein

Jay Robb Enterprises is recalling Jay Robb Unflavored Egg White Protein Product, manufactured by Agropur MSI, LLC of La Crosse, Wisconsin, because it may contain undeclared milk allergen. 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.

FDA - U.S. Food and Drug Administration

19-11-2018

Dollarama recalls MONTOY Doll and Toy Furniture Set

Dollarama recalls MONTOY Doll and Toy Furniture Set

The plastic doll and furniture toy set contains levels of phthalates that exceed the allowable limit and may pose a chemical hazard. Studies suggest that certain phthalates, including DEHP, may cause reproductive and developmental abnormalities in young children when soft vinyl products containing phthalates are sucked or chewed for extended periods.

Health Canada

17-11-2018

The Quaker Oats Company Issues Voluntary Recall of a Small Quantity of Cap’n Crunch’s Peanut Butter Crunch Cereal Distributed to Five Target Stores Due to Possible Health Risk

The Quaker Oats Company Issues Voluntary Recall of a Small Quantity of Cap’n Crunch’s Peanut Butter Crunch Cereal Distributed to Five Target Stores Due to Possible Health Risk

The Quaker Oats Company, a subsidiary of PepsiCo, Inc., today announced a voluntary recall of a small quantity of Cap’n Crunch’s Peanut Butter Crunch cereal due to the potential presence of Salmonella. While the potentially affected product only reached five specific Target stores and is limited to 21 boxes of one variety with two Best Before Dates, Quaker is initiating the voluntary recall to protect public health.

FDA - U.S. Food and Drug Administration

17-11-2018

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

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

Published on: Fri, 16 Nov 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member St...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

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

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

Published on: Fri, 16 Nov 2018 The applicant BASF Agro B.V. submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for picolinafen in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new validated analytical method for enforcement of the residue in dry/high starch‐, high water content‐, high acid content‐ and high oil content commodities ...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Chukar Cherries Issues Allergy Alert on Undeclared Milk in 7.5 Oz Amaretto Rainier Chocolate Cherries Pouches

Chukar Cherries Issues Allergy Alert on Undeclared Milk in 7.5 Oz Amaretto Rainier Chocolate Cherries Pouches

Chukar Cherries of Prosser, WA is recalling 7.5oz Amaretto Rainier Chocolate Cherries because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

16-11-2018

Statement from USDA Secretary Perdue and FDA Commissioner Gottlieb on the regulation of cell-cultured food products from cell lines of livestock and poultry

Statement from USDA Secretary Perdue and FDA Commissioner Gottlieb on the regulation of cell-cultured food products from cell lines of livestock and poultry

The U.S. Department of Agriculture and U.S. Food and Drug Administration are announcing that USDA and FDA should jointly oversee the production of cell-cultured food products derived from livestock and poultry.

FDA - U.S. Food and Drug Administration

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

Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed new steps to protect youth by preventing access to flavored tobacco products and banning menthol in cigarettes

Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed new steps to protect youth by preventing access to flavored tobacco products and banning menthol in cigarettes

Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed new steps to protect youth by preventing access to flavored tobacco products and banning menthol in cigarettes

FDA - U.S. Food and Drug Administration

15-11-2018

Vanpak Limited recalls various Cosmetic products in pressurised containers.

Vanpak Limited recalls various Cosmetic products in pressurised containers.

The recalled products do not have mandatory hazard labelling as required by the Cosmetics Regulations under the Food and Drugs Act. Improper labelling could result in misuse of the product and lead to serious injury.

Health Canada

15-11-2018

MPS Canada Corporation recalls various Cosmetic products in pressurised containers.

MPS Canada Corporation recalls various Cosmetic products in pressurised containers.

The recalled products do not have mandatory hazard labelling as required by the Cosmetics Regulations under the Food and Drugs Act. Improper labelling could result in misuse of the product and lead to serious injury.

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

15-11-2018

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Published on: Wed, 14 Nov 2018 The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM‐JB 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 acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organi...

Europe - EFSA - European Food Safety Authority Publications

14-11-2018

Nor Cal Food Solutions, LLC ISSUES ALLERGY ALERT ON UNDECLARED Tree Nut – Walnut in The Purveyors Kitchen - Pumpkin Pesto Tapenade

Nor Cal Food Solutions, LLC ISSUES ALLERGY ALERT ON UNDECLARED Tree Nut – Walnut in The Purveyors Kitchen - Pumpkin Pesto Tapenade

Nor Cal Food Solutions, LLC of Auburn, CA is announcing a recall of 567 cases of Pumpkin Pesto Tapenade, manufactured by Purveyors Kitchen, because it contains an undeclared tree nut (walnut). People who have an allergy or severe sensitivity to tree nuts (walnuts) run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

14-11-2018

Several children's strawberry-flavoured acetaminophen syrups recalled because of defective child-resistant safety caps on the bottles

Several children's strawberry-flavoured acetaminophen syrups recalled because of defective child-resistant safety caps on the bottles

Laboratoire RivaInc. and Laboratoires Trianon Inc. are voluntarily recalling several over-the-counter children’s strawberry-flavoured acetaminophen syrups labeled as Biomedic, Option, or Laboratoires Trianon Inc. The products, which are used for pain and fever relief, are being recalled because the child-resistant safety cap may be defective.

Health Canada

14-11-2018

“Vita-X Revitalizing Capsules” for men may pose serious health risks

“Vita-X Revitalizing Capsules” for men may pose serious health risks

Health Canada is advising Canadians that two versions of “Vita-X Revitalizing Capsules” by Lanlay Healthmetic Inc., promoted for “long lasting vital energy for men,” may pose serious health risks. One version contains seven capsules and has “NPN 80053009,” a Natural Product Number (NPN) indicating Health Canada authorization, on the label. The second version contains one capsule, has no NPN on the label and is not authorized by Health Canada.

Health Canada

13-11-2018

Oscor Inc. Issues Recall Product Expansion of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

Oscor Inc. Issues Recall Product Expansion of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

On September 26, 2018 Oscor notified customers of a recall for certain lots (Recall No. 1035166- 09/07/2018-01-R) of TB Unshrouded Bipolar Pacing Leads. As part of the recall correction activities, Oscor is retrieving any remaining inventory out in the field. The recall scope is being expanded to include expired inventory for devices distributed between December 21, 2011 to May 17, 2018. The recall expansion is to ensure proper disposition of expired units. The FDA has been notified and is aware Oscor In...

FDA - U.S. Food and Drug Administration

13-11-2018

FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk

FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk

FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk

FDA - U.S. Food and Drug Administration

10-11-2018

Recall of Bittersweet & Feve Chocolate Bars Due to High Levels of Milk Allergens

Recall of Bittersweet & Feve Chocolate Bars Due to High Levels of Milk Allergens

Today, Recchiuti Confections (San Francisco, CA) discovered two batches of their Bittersweet Chocolate Bar and two batches of their Feve Chocolate Bar contain high levels of milk protein after FDA sampling. No illnesses have been reported to date. 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 chocolate bars can be enjoyed if you do not have milk allergies or sensitivities. Recchiuti Confections is...

FDA - U.S. Food and Drug Administration

9-11-2018

FDA seizes food and medical products held under insanitary conditions at an Arkansas grocery warehouse

FDA seizes food and medical products held under insanitary conditions at an Arkansas grocery warehouse

U.S. Marshals Service has conducted a mass seizure of FDA-regulated products that were being held in an Arkansas grocery warehouse under insanitary conditions

FDA - U.S. Food and Drug Administration

9-11-2018

In Association With Sunshine Mills, Lidl Voluntarily Recalls Orlando Brand Grain Free Chicken & Chickpea Superfood Recipe Dog Food Due to Elevated Levels of Vitamin D.

In Association With Sunshine Mills, Lidl Voluntarily Recalls Orlando Brand Grain Free Chicken & Chickpea Superfood Recipe Dog Food Due to Elevated Levels of Vitamin D.

In association with Sunshine Mills, Lidl is voluntarily recalling specific lots of Orlando brand Grain Free Chicken & Chickpea Superfood Recipe Dog Food because the products may contain elevated levels of Vitamin D.

FDA - U.S. Food and Drug Administration

9-11-2018

Natural Life Pet Products Expands Recall of Dry Food Due to Elevated Levels of Vitamin D

Natural Life Pet Products Expands Recall of Dry Food Due to Elevated Levels of Vitamin D

We regret to inform you that Natural Life® Chicken & Potato dry dog food has been confirmed to contain elevated levels of Vitamin D.

FDA - U.S. Food and Drug Administration

9-11-2018

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in ...

FDA - U.S. Food and Drug Administration

9-11-2018

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

9-11-2018

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Baked Potatoes with Cheddar Cheese and Bacon (2 Count) Mis-Labeled as Herb Roasted Potatoes

Baked Potatoes with Cheddar Cheese and Bacon (2 Count) Mis-Labeled as Herb Roasted Potatoes

Ukrop’s Homestyle Foods is voluntarily recalling Baked Potatoes with Cheddar Cheese and Bacon (2 count), as the product is mislabeled Herb Roasted Potatoes (see photo attached).

FDA - U.S. Food and Drug Administration

8-11-2018

Public Notification: Best Leopard Miracle of Honey contains hidden drug ingredients

Public Notification: Best Leopard Miracle of Honey contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Best Leopard Miracle of Honey, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

8-11-2018

Public Notification: Gold Max Blue contains hidden drug ingredient

Public Notification: Gold Max Blue contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Gold Max Blue, a product promoted and sold for sexual enhancement on various websites, including www.goldmaxblue.com, and possibly in some retail stores.

FDA - U.S. Food and Drug Administration

8-11-2018

Public Notification: Leopard Secret Miracle Honey contains hidden drug ingredient

Public Notification: Leopard Secret Miracle Honey contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Leopard Secret Miracle Honey, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

8-11-2018

Wegmans Food Markets, Inc. Issues Allergy Alert on Undeclared Milk in Wegmans Pumpkin Loaf, 11 oz., and Wegmans Placek Coffee Cake, 11 oz. and 22 oz.

Wegmans Food Markets, Inc. Issues Allergy Alert on Undeclared Milk in Wegmans Pumpkin Loaf, 11 oz., and Wegmans Placek Coffee Cake, 11 oz. and 22 oz.

Wegmans has initiated a voluntary recall of the following products because they may contain milk not declared 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 this product.

FDA - U.S. Food and Drug Administration

7-11-2018

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Vita Health Products is voluntarily recalling several store-brand (Care, Exact, Life, and Pharmasave) over-the-counter drugs used for pain or sinus relief because of a labelling issue. Consumers may be unable to peel open the wrap-around label on the bottle to access the warning statements, or the label may not peel off completely, which may make it difficult to read some of the important safety information.

Health Canada

7-11-2018

Nature's Ultimate recalls NuWrench and NuStainless Products

Nature's Ultimate recalls NuWrench and NuStainless Products

The recalled products are not provided with the required child-resistant containers required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

7-11-2018

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

6-11-2018

FDA Approves Experior for Reduction of Ammonia Gas Released from Beef Cattle Waste

FDA Approves Experior for Reduction of Ammonia Gas Released from Beef Cattle Waste

FDA announced today the approval of Experior (lubabegron Type A medicated article), a beta-adrenergic agonist/antagonist drug that, when fed to beef cattle under specific conditions, results in less ammonia gas released as a by-product of their waste.

FDA - U.S. Food and Drug Administration

6-11-2018

Duncan Hines Classic White, Classic Butter Golden, Signature Confetti and Classic Yellow Cake Mixes Recalled Due to Potential Presence of Salmonella

Duncan Hines Classic White, Classic Butter Golden, Signature Confetti and Classic Yellow Cake Mixes Recalled Due to Potential Presence of Salmonella

Conagra Brands is collaborating with health officials in connection with a positive finding of Salmonella in a retail sample of Duncan Hines Classic White cake mix that may be linked to a Salmonella outbreak that is currently being investigated by CDC and FDA. While it has not been definitively concluded that this product is linked to the outbreak and the investigation is still ongoing, Conagra has decided to voluntarily recall the specific Duncan Hines variety identified (Classic White) and three other ...

FDA - U.S. Food and Drug Administration

5-11-2018

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Plant protection products containing metam-sodium are used in market gardening and horticulture to disinfect the soil. Following the substance's approval at European level, ANSES reassessed the dossiers and notified the industrial companies concerned of its intention to withdraw all marketing authorisations for metam-sodium products. ANSES is also taking this opportunity to reiterate the importance of phytopharmacovigilance and the requirement for professionals to report any adverse effects on humans or ...

France - Agence Nationale du Médicament Vétérinaire

5-11-2018

Vanpak Limited recalls David Ross Extra purified Butane gas

Vanpak Limited recalls David Ross Extra purified Butane gas

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

3-11-2018

Natural Life Pet Products Issues Recall of Dry Food Due to Elevated Levels of Vitamin D

Natural Life Pet Products Issues Recall of Dry Food Due to Elevated Levels of Vitamin D

Natural Life Pet Products of Saint Louis, Missouri is voluntarily recalling our Chicken & Potato dry dog food (described below) due to it containing elevated levels of Vitamin D.

FDA - U.S. Food and Drug Administration

2-11-2018

FDA and DoD formalize collaboration to advance medical products in support of American military personnel

FDA and DoD formalize collaboration to advance medical products in support of American military personnel

FDA and DoD formalize collaboration to advance medical products in support of American military personnel. New Memorandum of Understanding aligns agency efforts to foster the development and use of safe and effective medical products for members of the U.S. military.

FDA - U.S. Food and Drug Administration

2-11-2018

Brin de Folie recalls Wind-up Racoon Toys

Brin de Folie recalls Wind-up Racoon Toys

Health Canada's sampling and evaluation program has determined that the affected products do not meet the Canadian safety requirements for toys. The tail can detach from the toy, posing a choking hazard to young children.

Health Canada

1-11-2018

Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031

Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031

Published on: Wed, 31 Oct 2018 00:00:00 +0100 Article 42 of the new Plant Health Law (Regulation (EU) 2016/2031 on protective measures against pests of plants), introduce a concept of “high risk plants, plant products and other objects” in relation to the presence of a pest risk of an unacceptable level for the Union territory, identified on the basis of a preliminary assessment to be followed by a risk assessment. Upon request of the European Commission (EC), the European Food Safety Authority (EFSA) d...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

19-11-2018

By providing more clarity around how these prescription-drug-use-related software products will be regulated, #FDA hopes to promote development of these innovations. We believe these innovative products can help significantly improve patients’ health

By providing more clarity around how these prescription-drug-use-related software products will be regulated, #FDA hopes to promote development of these innovations. We believe these innovative products can help significantly improve patients’ health

By providing more clarity around how these prescription-drug-use-related software products will be regulated, #FDA hopes to promote development of these innovations. We believe these innovative products can help significantly improve patients’ health

FDA - U.S. Food and Drug Administration

16-11-2018

Daptomycin Hospira (Hospira UK Limited)

Daptomycin Hospira (Hospira UK Limited)

Daptomycin Hospira (Active substance: daptomycin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7678 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004310/T/0008

Europe -DG Health and Food Safety

16-11-2018

Benlysta (GlaxoSmithKline (Ireland) Limited)

Benlysta (GlaxoSmithKline (Ireland) Limited)

Benlysta (Active substance: belimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7679 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2015/T/60

Europe -DG Health and Food Safety

15-11-2018

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Active substance: infliximab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7549 of Thu, 15 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4020/T/30

Europe -DG Health and Food Safety

14-11-2018

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7604 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2788/T/20

Europe -DG Health and Food Safety

14-11-2018

Ebymect (AstraZeneca AB)

Ebymect (AstraZeneca AB)

Ebymect (Active substance: dapagliflozin / metformin) - Centralised - 2-Monthly update - Commission Decision (2018)7605 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4162/WS/1380

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Active substance: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains) - Transfer of orphan designation - Commission Decision (2018)7574 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/270/16/02

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1964 (Incyte Biosciences Distribution B.V.)

EU/3/17/1964 (Incyte Biosciences Distribution B.V.)

EU/3/17/1964 (Active substance: Itacitinib) - Transfer of orphan designation - Commission Decision (2018)7573 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/169/17/T/01

Europe -DG Health and Food Safety

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

Spinraza (Active substance: nusinersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7550 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/T/10

Europe -DG Health and Food Safety

6-11-2018

Symkevi (Vertex Pharmaceuticals (Europe) Limited)

Symkevi (Vertex Pharmaceuticals (Europe) Limited)

Symkevi (Active substance: tezacaftor/ivacaftor) - Centralised - Authorisation - Commission Decision (2018)7415 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4682

Europe -DG Health and Food Safety

6-11-2018

Trelegy Ellipta (GlaxoSmithKline Trading Services Limited)

Trelegy Ellipta (GlaxoSmithKline Trading Services Limited)

Trelegy Ellipta (Active substance: fluticasone furoate/umeclidinium/vilanterol) - Centralised - 2-Monthly update - Commission Decision (2018)7416 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4363/WS/1369

Europe -DG Health and Food Safety

6-11-2018

Elebrato Ellipta (GlaxoSmithKline Trading Services Limited)

Elebrato Ellipta (GlaxoSmithKline Trading Services Limited)

Elebrato Ellipta (Active substance: fluticasone furoate/umeclidinium/vilanterol) - Centralised - 2-Monthly update - Commission Decision (2018)7417 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4781/WS/1369

Europe -DG Health and Food Safety

6-11-2018

Samsca (Otsuka Pharmaceutical Netherlands B.V.)

Samsca (Otsuka Pharmaceutical Netherlands B.V.)

Samsca (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7419 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/980/T/36

Europe -DG Health and Food Safety

5-11-2018

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Active substance: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid) - Orphan designation - Commission Decision (2018)7271 of Mon, 05 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/114/18

Europe -DG Health and Food Safety

1-11-2018

Zolvix (Elanco GmbH)

Zolvix (Elanco GmbH)

Zolvix (Active substance: monepantel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7383 of Thu, 01 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/000154/T/0024

Europe -DG Health and Food Safety

31-10-2018

Integrilin (GlaxoSmithKline (Ireland) Limited)

Integrilin (GlaxoSmithKline (Ireland) Limited)

Integrilin (Active substance: Eptifibatide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7340 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/230/T/79

Europe -DG Health and Food Safety

31-10-2018

Volibris (GlaxoSmithKline (Ireland) Limited)

Volibris (GlaxoSmithKline (Ireland) Limited)

Volibris (Active substance: Ambrisentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7339 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/839/T/56

Europe -DG Health and Food Safety

31-10-2018

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Active substance: adalimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7344 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/T/15

Europe -DG Health and Food Safety