Fludeoxyglucose "OUH"

Primær information

  • Handelsnavn:
  • Fludeoxyglucose "OUH" 400 MBq-316 GBq/htgl injektionsvæske, opløsning
  • Dosering:
  • 400 MBq-316 GBq/htgl
  • Lægemiddelform:
  • injektionsvæske, opløsning
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

  • for sundhedspersonale:
  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.


    Anmode informationsbrochure for sundhedspersonale.

Lokation

  • Fås i:
  • Fludeoxyglucose "OUH" 400 MBq-316 GBq/htgl injektionsvæske, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 02235
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel

Odense Universitetshospital, PET & Cyklotronenheden. Revisionsdato 11/2015

Indlægsseddel: Information til brugeren

Fludeoxyglucose ”OUH”, 400 MBq – 316 GBq, Injektionsvæske

F]-Fludeoxyglucose, Ph. Eur.

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

vigtige oplysninger.

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

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

Tal med lægen eller sundhedspersonalet, hvis en bivirkning bliver værre, eller du får bivirkninger, som

ikke er nævnt her.

Oversigt over indlægssedlen

Virkning og anvendelse

Det skal du vide, før du begynder at bruge Fludeoxyglucose ”OUH”.

Sådan skal du bruge Fludeoxyglucose ”OUH”

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

1.

Virkning og anvendelse

Fludeoxyglucose

”OUH”

bruges

PET-undersøgelser,

hvor

metabolismen

organer

væv

ønske

undersøgt. Det kan f. eks være i forbindelse med diagnosticering, stadieinddeling og behandlingskontrol ved

kræftsygdom.

Fludeoxyglucose ”OUH” indgives ved intravenøs injektion i henhold til normale injektionsprocedurer for

radioaktive lægemidler. Dit aktivitetsniveau, i perioden lige efter injektion, har beydning for hvordan stoffet

fordels i kroppen. Normalt anbefales det at du skal hvile i 45 – 60 minutter inden skanningen foretages.

Sundhedspersonalet instruerer dig nærmere herom.

2.

Det skal du vide før du begynder at bruge Fludeoxyglucose ”OUH”.

Brug ikke Fludeoxyglucose ”OUH”:

hvis du er allergisk over for det aktive stof eller et af de øvrige indholdsstoffer angivet i punkt 6.

Særlige advarsler og forsigtighedsregler vedrørende brugen

Fludeoxyglucose ”OUH” må kun udleveres til og anvendes af godkendte brugere af radioaktive lægemidler.

Præparatet må først tages i brug når der ligger en skriftlig frigivelse fra producenten.

Som for øvrige

radioaktive

lægemidler bør udbyttet

undersøgelsen vægtes

risikoen

forventede strålingsdosis. Hos patienter med nedsat nyrefunktion og hos børn må der forventes en højere

effektiv dosis per administreret aktivitetsmængde end hos normale voksne. Se senere afsnit om dosimetri.

Fludeoxyglucose ”OUH” må kun gives som intravenøs injektion. Præparatet er stærkt radioaktivt og skal

håndteres under hensyntagen til normale principper for strålebeskyttelse. Da gammastrålingen fra præparatet

er meget gennemtrængende, skal der benyttes blybeholdere med mindst 30 mm vægtykkelse.

Under dosis optræk og indgift bør der tages forholdsregler, der kan nedbringe den lokale strålingsdosis til

eksempelvis hænder.

Odense Universitetshospital, PET & Cyklotronenheden. Revisionsdato 11/2015

Efter

injektionen

udgør

patienten

eventuel

urin

(f.eks

opsamlet

urinpose)

ikke

ubetydelig

strålingskilde og det undersøgende personale bør være instrueret i hvorledes tid, afstand og afskærmning kan

nedbringe den resulterende dosis. Også strålingsdosis til pårørende og medpatienter bør tages i betragtning.

Ved injektionen skal det sikres, at denne finder sted i venen og ikke subkutant eller paravenøst, da dette vil

medføre uhensigtsmæssig stor lokal stråledosis og kompromittere billeddannelsen ved injektionsstedet.

Patientforberedelsen er meget vigtig for udbyttet og kvaliteten af undersøgelsen. Faktorer der påvirker

blodsukkeret har stor betydning. Patienten skal faste 6 timer op til injektion. FDG bør normalt kun gives til

fastende personer, da FDG konkurrerer med glukose om optagelse i cellerne. Patienten må dog gerne drikke

kaffe/te uden sukker/sødetabletter/mælk. Specielle forholdsregler bør tages før administration til patienter

med diabetes mellitus, hvor det er vigtigt at sikre, at patienter hverken udvikler hypo- eller hyperglycæmi.

Interaktion med andre lægemidler og andre former for interaktion

Mange lægemidler, herunder lægemidler der påvirker blodsukkeret, kan påvirke fordelingen og dermed

undersøgelsesresultatet. PET undersøgelsen og skanningsresultatet må bedømmes under hensyntagen hertil.

Brug af anden medicin sammen med Fludeoxyglucose ”OUH”

Fortæl altid sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nylig. Dette gælder også

medicin, som ikke er købt på recept, f.eks. naturlægemidler og vitaminer og mineraler.

Graviditet og amning

Hvis det er nødvendigt at give radioaktive lægemidler til en kvinde i den fødedygtige alder, skal det altid

oplyses, om patienten er gravid. Ved en udebleven menstruation må kvinden betragtes som værende gravid,

og undersøgelsen må kun gennemføres, hvis en akut foretaget graviditetstest er negativ. Generelt bør PET-

undersøgelser så vidt muligt gennemføres i første halvdel af menstruationscyklus. Stråledosis bør holdes så

lavt

muligt

under

hensyntagen

opnåelse

søgte

kliniske

information.

Andre

undersøgelsesmetoder, der ikke medfører strålebelastning, bør overvejes såsom ultralyd eller MR.

Undersøgelser på gravide foretaget med radioaktive stoffer medfører en strålingsdosis til fosteret. Kun

afgørende vigtige undersøgelser bør udføres under svangerskabet, og kun når hensynet til det forventede

udbytte overstiger risikoen, som undersøgelsen påfører moder og foster. I så tilfælde bør evt. gennemførelse

af undersøgelsen konfereres forinden mellem ansvarlig nuklearmedicinsk læge, ansvarlig fysiker, ansvarlig

henvisende kliniker og Statens Institut for Strålebeskyttelse.

Der er ingen ammepause, men det anbefales (ICRP), at kvinder der ammer, begrænser kontakten til barnet til

så lidt som muligt de første 12 timer efter injektion, for at undgå at udsætte barnet for ekstern stråling fra

moderen. Det anbefales ligeledes at amme umiddelbart inden injektionen, for at gøre tiden fra injektion til

næste amning så lang som muligt.

Trafik- og arbejdssikkerhed

Fludeoxyglucose ”OUH” påvirker ikke evnen til at føre motorkøretøjer.

3.

Sådan skal du bruge Fludeoxyglucose ”OUH”

Brug altid Fludeoxyglucose ”OUH” nøjagtigt efter sundhedspersonalets anvisning. Er du i tvivl, så spørg

sundhedspersonalet.

Dosering Voksne:

Dosering til voksne: 100-600 MBq afhængig af skanner og undersøgelsestype.

Dosering til børn

Dosering

børn:

MBq/kg

legemsvægt

hjerneskanning

MBq/kg

legemsvægt

helkropsskanning.

Odense Universitetshospital, PET & Cyklotronenheden. Revisionsdato 11/2015

Aktiviteten af den aktuelle patientdosis skal kontrolleres i dosiskalibrator inden administration.

Produktet indgives ved intravenøs injektion i henhold til normale injektionsprocedurer for radioaktive

lægemidler.

Hvis du har fået en for stor dosis Fludeoxyglucose ”OUH”

En væsentlig (flerfold) overskridelse af den anbefalede dosisindgift vil både medføre en øget strålingsdosis

til patient og personale, og kompromittere billeddannelsen grundet dødtids- og linearitetsproblemer. Hvis

overdosering har fundet sted, kan dosis til blærevæggen nedsættes gennem øget væskeindtagelse og hyppig

vandladning.

Spørg sundhedspersonalet, hvis der er noget, du er i tvivl om.

4.

Bivirkninger

Dette lægemiddel kan som al anden medicin give bivirkninger, men på nuværende tidspunkt findes der ingen

kendte bivirkninger.

Hvis der opstår bivirkninger skal du kontakte din læge. Bivirkninger skal indberettes til indehaveren af

markedsføringstilladelsen (se sidst i denne indlægsseddel) og/eller til Sundhedsstyrelsen.

Du eller dine pårørende kan selv indberette bivirkninger direkte til sundhedsstyrelsen. Du finder skema og

vejledning på Sundhedsstyrelsens netsted: www.meldenbivirkning.dk. Du kan også indberette via mail,

almindeligt brev eller telefonisk ved at rekvirere et indberetningsskema.

5.

Opbevaring

Opbevaring

Præparatet skal indgives inden 10 timer efter fremstillingen (EOS). Udløbstidspunktet er angivet på etiket.

Præparatet må ikke opbevares over 25

C. Præparatet er stærkt radioaktivt og skal opbevaret i det oprindelige

hætteglas i en egnet blybeholder med mindst 30 mm vægtykkelse.

Emballage

Produktet

udleveres

hætteglas

lukket

septum

kapsel.

Hætteglasset

indeholder

angivne

aktivitetsmængde på referencetidspunktet i et volumen på op til 30 ml.

Hætteglasset leveres i særlig blybeholder (35 mm vægtykkelse) placeret i formstøbte skumindlæg i en

transportspand af plastic (Type A forsendelse). Blybeholder, skumindlæg og transportspand skal returneres

til producenten og genanvendes.

Bortskaffelse

Præparatet og hætteglasset bør af hensyn til den intense stråling så vidt muligt håndteres i den oprindelige

blybeholder og bag egnet ekstern blyafskærmning. Bemærk, at alle nødvendige oplysninger om aktivitet,

kalibreringstidspunkt og volumen findes på den ydre etikette. Den enkelte dosis udtages gennem septum,

som desinficeres inden hvert anbrud. Hver patientdosis skal måles i dosiskalibrator inden indgift.

Produktet kan fortyndes med isoton natriumklorid opløsning til injektion (0,9%), der også kan benyttes til

efterskyl af injektionsvejen.

Præparatets aktive indholdsstof forsvinder fuldstændigt ved fysisk henfald inden for en periode af ca. 1 døgn.

Indenfor denne periode skal stoffet behandles i overensstemmelse med reglerne for transport af radioaktive

stoffer og håndtering af åbne radioaktive kilder. Efter det radioaktive henfald udgør det aktive indholdsstof

ingen miljøbelastende risiko og det henfaldne præparat kan bortskaffes i lighed med andre medicinrester.

Blybeholdere returneres og genanvendes.

Odense Universitetshospital, PET & Cyklotronenheden. Revisionsdato 11/2015

6.

Pakningsstørrelser og yderligere oplysninger

Fludeoxyglucose ”OUH”, 400 MBq – 316 GBq, Injektionsvæske indeholder:

Aktivt stof : [

F]-Fludeoxyglucose

Øvrige indholdsstoffer:

Phosphatbuffer

Vand

Ethanol (0.4%)

Indehaver af markedsføringstilladelsen og fremstiller

Odense Universitetshospital

PET & Cyklotronenheden, Nuklearmedicinsk Afdeling

Sdr. Boulevard 29

Tlf. 6541 2980

Fax. 65906192

Email: ouh@rsyd.dk

Kontakt vedr. Markedsføringstilladelsen og produktion

QP: Signe Inglev

Email: Signe.Inglev@rsyd.dk

Indberetning af bivirkninger:

QPPV Henrik Petersen

Email: Henrik.petersen@rsyd.dk

Denne indlægsseddel blev senest ændret 11/2015

-----------------------------------------------------------------------------------------------------------------------------------

Følgende oplysninger er tiltænkt læger og sundhedspersonale:

Følgende organfordeling er beskrevet af Mejia et al i J Nucl Med 1991, 32, 699 – 706:

Organ

% af indgiven dosis

Hjerne

6,9%

Hjerte

3,3%

Nyrer

1,3%

Lever

4,4%

Lunger

0,9%

Ovarier

0,01%

Pancreas

0,3%

Knoglemarv

1,7%

Milt

0,4%

Testes

0,04%

Blæreindhold

6,3%

Resten af kroppen

74,4%

I alt

99,95%

Prækliniske sikkerhedsdata

Ingen bivirkninger ud over stråledosis (se nedenfor).

Odense Universitetshospital, PET & Cyklotronenheden. Revisionsdato 11/2015

Dosimetri

Nedenstående tabel

ICRP publikation 80

viser den beregnede absorberde

dosis per administreret

aktivitetsmængde (mSv/MBq) for Fludeoxyglukose (18 F):

T½=

109,77

Absorbed

dose

unit

activity

administered

(mGy/MBq)

Organ

Adult

15 years

10 yesrs

5 years

1 year

Adrenal glands

0.012

0.015

0.024

0.038

0.072

Bladder wall

0.16

0.21

0.28

0.32

0.59

Bone surfaces

0.011

0.014

0.022

0.035

0.066

Brain

0.028

0.028

0.030

0.034

0.048

Breasts

0.0086

0.011

0.018

0.029

0.056

Bile duct

0.012

0.015

0.023

0.035

0.066

Inte4stinal wall

0.011

0.014

0.022

0.036

0.068

Small intestine

0.013

0.017

0.027

0.041

0.077

Colon

0.013

0.017

0.027

0.040

0.074

ULI wall

0.012

0.016

0.025

0.039

0.072

LLI wall

0.015

0.019

0.029

0.042

0.076

Heart

0.062

0.081

0.12

0.20

0.35

Kidney

0.021

0.025

0.036

0.054

0.096

Lier

0.011

0.014

0.022

0.037

0.070

Lungs

0.010

0.014

0.021

0.034

0.065

Muscles

0.011

0.014

0.021

0.034

0.065

Oesophagus

0.011

0.015

0.022

0.035

0.068

Ovaries

0.015

0.020

0.030

0.044

0.082

Pancreas

0.012

0.016

0.025

0.040

0.076

Bone marrow

0.011

0.014

0.022

0.032

0.061

Skin

0.0080

0.010

0.016

0.027

0.052

Spleen

.0.011

0.014

0.022

0.036

0.069

Testes

0.012

0.016

0.026

0.038

0.073

Thymus

0.011

0.015

0.022

0.035

0.068

Thyroid

0.010

0.013

0.021

0.035

0.068

Uterus

0.021

0.026

0.039

0.055

0.10

Other organs

0.011

0.014

0.022

0.034

0.063

Effective dose

(mSV/MBq)

0.019

0.025

0.036

0.050

0.095

Annals of the ICRP, ICRP Publication 80

Radiation Dose to Patients from Radiopharmaceuticals, Addendum 2 to ICRP Publication 53, Also includes

Addendum 1 to ICRP Publication 72, Editor J. Valentin. Den effektive dosis fra indgift af 400 MBq til en

typisk normal voksen er cirka 7,6 mSv. Ved denne aktivitetsmængde er absorberet dosis til de kritiske

organer blære, hjerte og hjerne henholdsvis 64 mGy, 25 mGy og 11 mGy.

Farmakologiske Oplysninger

Terapeutisk klassifikation

Præparatet er et diagnostisk radiofarmakon. ATC-kode V09IX04.

Odense Universitetshospital, PET & Cyklotronenheden. Revisionsdato 11/2015

Farmakodynamiske egenskaber

fremstilles

dispenseres

under

stort

carrierfri

betingelser,

maksimale

mængde

administreret FDG (aktiv og inaktiv) er meget lille (under 10 mg) sammenlignet med den samlede mængde

glukose der metaboliseres på et givet tidspunkt. Præparatet har derfor ingen primære eller sekundære

farmakodynamiske egenskaber. Gentagen administration bør kun ske efter overvejelse af den samlede

strålingsdosis

Farmakokinetiske egenskaber

Fludeoxyglukose (18F) er en glukose analog, som ophobes i alle celler der udnytter glukose som energikilde.

Stoffet ophobes i tumorer med højt glukose forbrug. Aktivitetskoncentrationen i det vaskulære system efter

intravenøs

injektion

følger

biexponentiel

kurve

fordelingstid

cirka

minut

eliminationstid på 12 minutter. Vævenes optag af Fludeoxyglukose (18 F) beror på en række vævsspecifikke

transportsystemer, hvoraf nogle er insulin-afhængige. Vævsoptagelsen kan derfor påvirkes af fødeindtag,

ernæringstilstand

eventuel

sukkersyge.

patienter

diabetes

mellitus

nedsat

optag

Fludeoxyglukose (18 F), der skyldes ændret vævsfordeling og ændret glukosestofskifte. Fludeoxyglukose

(18 F) transporteres over cellemembranen som glukose, men gennemgår kun det første trin i glykolysen, som

resulterer i dannelsen af Fludeoxyglukose (18 F)-6-fosfat, som forbliver fanget intracellulært i flere timer,

fordi defosforyleringen forårsaget af intracellulære fosfataser er langsom. Hos normale raske personer

fordeles Fludeoxyglukose (18 F) i hele kroppen, og optages særligt i hjernen og hjertet, og i mindre grad

også i lunger og lever. Udskillelsen sker primært gennem nyrene, idet ca 20% af aktiviteten kan forventes i

urinen indenfor 2 timer fra injektionen. Bindingen til selve nyreparenkymet er svag, men de samlede urinveje

indeholder megen aktivitet p.g.a. urinudskillelsen. Fludeoxyglukose (18 F) passerer blod-hjerne barrieren.

Cirka 7 % af den injicerede aktivitet akkumuleres i hjernen indenfor en periode af 80-100 minutter fra

indgift. Epileptiske foci udviser nedsat optag i perioderne uden kramper. Cirka 3% af aktiviteten optages af

myokardiet indenfor de første 40 minutter. Fordelingen i det normale hjerte er nogenlunde homogen, idet der

dog er beskrevet op til 15% regional forskel for septum. Under og efter reversibel myokardieiskæmi ses en

øget optagelse af Fludeoxyglukose (18 F) i de berørte områder. Ca. 0.3 % af aktiviteten går til pancreas, og

0.9 - 2.4 % akkumuleres i lungerne. Fludeoxyglukose (18 F) bindes også til øjets muskler, til pharynx og til

tarmen. Binding til muskelvæv kan ses efter nylig fysisk anstrengelse umiddelbart inden undersøgelsen eller

følge

muskelaktivitet

fordelings-

undersøgelsesforløbet.

Depoter

brunt

fedt

optager

Fludeoxyglukose (18 F).

10-10-2018

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

5-10-2018

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

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

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

FDA - U.S. Food and Drug Administration

3-10-2018

Sportminister Bruno Bruins brengt verrassingsbezoek aan Talent TeamNL in Buenos Aires

Sportminister Bruno Bruins brengt verrassingsbezoek aan Talent TeamNL in Buenos Aires

Van 6 tot 18 oktober wordt in Buenos Aires, Argentinië, de derde editie van de Jeugd Olympische Spelen gehouden. Toptalenten uit 206 landen tussen de 15 en 18 jaar oud doen hieraan mee. Talent TeamNL bestaat uit 41 sporters die uitkomen in  19 disciplines. Minister voor Sport Bruno Bruins bracht vandaag een verrassingsbezoek aan de Nederlandse ploeg. Hij bezocht het Olympisch Dorp waar de talenten onder leiding van Chef de Mission Mark Huizinga zich voorbereiden op de Spelen die zaterdag beginnen. 

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

19-9-2018

September 18, 2018: "The Drug Llama" Faces Federal Indictment and Mandatory Minimum Sentence for Distributing Fentanyl on Dark Web

September 18, 2018: "The Drug Llama" Faces Federal Indictment and Mandatory Minimum Sentence for Distributing Fentanyl on Dark Web

September 18, 2018: "The Drug Llama" Faces Federal Indictment and Mandatory Minimum Sentence for Distributing Fentanyl on Dark Web

FDA - U.S. Food and Drug Administration

19-9-2018

Enforcement Report for the Week of September 19, 2018

Enforcement Report for the Week of September 19, 2018

Recently Updated Records for the Week of September 19, 2018 Last Modified Date: Tuesday, September 18, 2018

FDA - U.S. Food and Drug Administration

19-9-2018

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LTZ Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in raspberries, blackberries, currants, blueberries, gooseberries and elderberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under c...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Published on: Mon, 20 Aug 2018 00:00:00 +0200 Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Update of the tolerable upper intake level for vitamin D for infants

Update of the tolerable upper intake level for vitamin D for infants

Published on: Tue, 07 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on the draft Scientific Opinion on the update of the tolerable upper intake level for vitamin D for infants. This draft Scientific Opinion was prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) and endorsed by the Panel for public consultation by written procedure on 9 April 20...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food, Inc. of Portland, OR is expanding its voluntary recall to include an additional quantity of Rad Cat Raw Diet across all varieties with Best By dates of 10/19/18 through 12/3/19 because it has the potential to be contaminated with Listeria monocytogenes. Radagast Pet Food is conducting this voluntary recall out of an abundance of caution because of its strong commitment to food safety and quality.

FDA - U.S. Food and Drug Administration

17-8-2018

Animal Drug Under Fee Amendments Reauthorized Through September 2023 to Allow for FDA’s Continued Timely Review of Animal Drug Applications

Animal Drug Under Fee Amendments Reauthorized Through September 2023 to Allow for FDA’s Continued Timely Review of Animal Drug Applications

On 8/14/18, the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 was signed into law to reauthorize ADUFA and AGDUFA. These programs help FDA maintain a predictable and timely animal drug review process, foster innovation, and expedite access to new therapies for animals.

FDA - U.S. Food and Drug Administration

26-9-2018

Comfortis (Elanco GmbH)

Comfortis (Elanco GmbH)

Comfortis (Active substance: Spinosad) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6323 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2233/T/18

Europe -DG Health and Food Safety

24-9-2018

Inhixa (Techdow Europe AB)

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

Europe -DG Health and Food Safety

24-9-2018

Cinqaero (Teva B.V.)

Cinqaero (Teva B.V.)

Cinqaero (Active substance: reslizumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6218 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3912T/18

Europe -DG Health and Food Safety

19-9-2018

Reminder: #FDA site visit proposal solicitation period for the 2018  Experiential Learning Program is currently OPEN through Wednesday,  9/26/18 @ 12 pm EST. Click the link to find more about the  program & to submit your application  https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/FN1mNN65dD

FDA - U.S. Food and Drug Administration

18-9-2018

 Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

This third meeting between regulators and representatives of industry stakeholder organisations addresses all areas of product-development support, including scientific advice, specifics for paediatric and orphan medicines and support for innovation. The meeting focuses on the implementation of the orphan notice, ‘histology-independent indications’ in the context of orphan designations, the upcoming rollout of a new tool for orphan designation applications, digital technology proposals in medicine develo...

Europe - EMA - European Medicines Agency

18-9-2018

Agenda:  Agenda - PDCO agenda of the 18-21 September 2018 meeting

Agenda: Agenda - PDCO agenda of the 18-21 September 2018 meeting

Europe - EMA - European Medicines Agency

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/3/18/2066 (Incyte Biosciences Distribution B.V.)

EU/3/18/2066 (Incyte Biosciences Distribution B.V.)

EU/3/18/2066 (Active substance: Pemigatinib) - Orphan designation - Commission Decision (2018)5736 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/038/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2065 (SFL Regulatory Services GmbH)

EU/3/18/2065 (SFL Regulatory Services GmbH)

EU/3/18/2065 (Active substance: Obiltoxaximab) - Orphan designation - Commission Decision (2018)5735 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/080/18

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/3/18/2059 (IntraBio Ltd)

EU/3/18/2059 (IntraBio Ltd)

EU/3/18/2059 (Active substance: Acetylleucine) - Orphan designation - Commission Decision (2018)5731 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/095/18

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/3/18/2064 (Bayer AG)

EU/3/18/2064 (Bayer AG)

EU/3/18/2064 (Active substance: Copanlisib) - Orphan designation - Commission Decision (2018)5734 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/071/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2069 (Professor Marjukka MyllArniemi)

EU/3/18/2069 (Professor Marjukka MyllArniemi)

EU/3/18/2069 (Active substance: Tilorone) - Orphan designation - Commission Decision (2018)5738 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/039/18

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/3/18/2068 (Novo Nordisk A/S)

EU/3/18/2068 (Novo Nordisk A/S)

EU/3/18/2068 (Active substance: Somapacitan) - Orphan designation - Commission Decision (2018)5741 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/041/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Active substance: Autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor) - Orphan designation - Commission Decision (2018)5739 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/049/18

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

ACCM meeting statement, Meeting 18, 8 December 2017

ACCM meeting statement, Meeting 18, 8 December 2017

Advisory Committee on Complementary Medicines Meeting 18 meeting statement

Therapeutic Goods Administration - Australia

23-8-2018

 Minutes of the CAT meeting 18-20 April 2018

Minutes of the CAT meeting 18-20 April 2018

Europe - EMA - European Medicines Agency

23-8-2018

EU/3/18/1979 (Bayer AG)

EU/3/18/1979 (Bayer AG)

EU/3/18/1979 (Active substance: Human monoclonal IgG2 antibody against tissue factor pathway inhibitor) - Corrigendum - Commission Decision (2018)1246 of Thu, 23 Aug 2018

Europe -DG Health and Food Safety

23-8-2018

Public submissions on scheduling matters referred to the ACMS #23, ACCS #22 and Joint ACMS-ACCS #18 meetings held in March 2018

Public submissions on scheduling matters referred to the ACMS #23, ACCS #22 and Joint ACMS-ACCS #18 meetings held in March 2018

Public submissions on scheduling matters referred to ACMS/ACCS meetings held in March 2018

Therapeutic Goods Administration - Australia

18-8-2018

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2018)4806 of Sat, 18 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/248/15/T/01

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

13-8-2018

EU/3/18/2045 (Dystrogen Therapeutics S.A.)

EU/3/18/2045 (Dystrogen Therapeutics S.A.)

EU/3/18/2045 (Active substance: Ex-vivo fused autologous human bone marrow-derived mesenchymal stem cell with allogenic human myoblast) - Orphan designation - Commission Decision (2018)5277 of Mon, 13 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/028/18

Europe -DG Health and Food Safety

7-8-2018

EU/3/18/2049 (Inozyme Pharma Ireland Ltd)

EU/3/18/2049 (Inozyme Pharma Ireland Ltd)

EU/3/18/2049 (Active substance: Recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1) - Orphan designation - Commission Decision (2018)5281 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/053/18

Europe -DG Health and Food Safety

7-8-2018

EU/3/18/1996 (Worphmed Srl)

EU/3/18/1996 (Worphmed Srl)

EU/3/18/1996 (Active substance: Melatonin) - Transfer of orphan designation - Commission Decision (2018)5409 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/227/17/T/01

Europe -DG Health and Food Safety

6-8-2018

DUAVIVE (Pfizer Europe MA EEIG)

DUAVIVE (Pfizer Europe MA EEIG)

DUAVIVE (Active substance: oestrogens conjugated / bazedoxifene) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5379 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2314/T/18

Europe -DG Health and Food Safety

4-8-2018

EU/3/18/2053 (Lakeside Regulatory Consulting Services Ltd)

EU/3/18/2053 (Lakeside Regulatory Consulting Services Ltd)

EU/3/18/2053 (Active substance: Tamibarotene) - Orphan designation - Commission Decision (2018)5285 of Sat, 04 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/026/18

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/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Active substance: N-acetylgalactosamine-conjugated synthetic double-stranded oligomer specific to serpin family A member 1 gene) - Orphan designation - Commission Decision (2018)5280 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/061/18

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/3/18/2047 (Glycomine SARL)

EU/3/18/2047 (Glycomine SARL)

EU/3/18/2047 (Active substance: Liposomal mannose-1-phosphate) - Orphan designation - Commission Decision (2018)5279 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/055/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2046 (Italfarmaco S.p.A.)

EU/3/18/2046 (Italfarmaco S.p.A.)

EU/3/18/2046 (Active substance: Givinostat) - Orphan designation - Commission Decision (2018)5278 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/062/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2044 (medac Gesellschaft fUr klinische SpezialprAparate mbH)

EU/3/18/2044 (medac Gesellschaft fUr klinische SpezialprAparate mbH)

EU/3/18/2044 (Active substance: Allogeneic bone marrow derived mesenchymal stromal cells, ex-vivo expanded) - Orphan designation - Commission Decision (2018)5276 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/023/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Active substance: Combination of carboplatin and sodium valproate) - Orphan designation - Commission Decision (2018)5275 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/036/18

Europe -DG Health and Food Safety