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

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).

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Birdseed Food Co. Issues Allergy Alert on Undeclared Cashews in Craft Granola Goldenola Turmeric & Ginger

Birdseed Food Co. Issues Allergy Alert on Undeclared Cashews in Craft Granola Goldenola Turmeric & Ginger

BIRDSEED FOOD CO. of Bend, OR is recalling Craft Granola Goldenola Turmeric & Ginger that was sold between the dates of 10/03/18 - 02/07/19, because it contains undeclared cashews. People who have an allergy or severe sensitivity to cashews run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

31-1-2019

January 18, 2019: Medical Company Executive Sentenced for Smuggling $18 Million in Misbranded Pharmaceuticals into United States

January 18, 2019: Medical Company Executive Sentenced for Smuggling $18 Million in Misbranded Pharmaceuticals into United States

January 18, 2019: Medical Company Executive Sentenced for Smuggling $18 Million in Misbranded Pharmaceuticals into United States

FDA - U.S. Food and Drug Administration

25-1-2019

Mrs. Grissom’s Salads Issues a Voluntary Recall

Mrs. Grissom’s Salads Issues a Voluntary Recall

For immediate release- January 18,2019 – Nashville, TN – Mrs. Grissom’s Salads is voluntarily recalling a single days production of Mrs. Grissom’s SELECT Old Fashioned Pimento Cheese because of a labeling issue. Product produced on December 13, 2018 may have been packaged incorrectly, with the correct Pimento Cheese label on top lid, but a Chicken salad label on the container. The Pimento Cheese may contain allergens not listed on the products ingredient label, Specifically Milk.

FDA - U.S. Food and Drug Administration

19-1-2019

Data sources on animal diseases: Country Card of Poland

Data sources on animal diseases: Country Card of Poland

Published on: Fri, 18 Jan 2019 Mapping the ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspond...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

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

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

Published on: Fri, 18 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the competent national authority in Belgium prepared a request to modify the existing maximum residue levels (MRLs) for the active substance spirotetramat in Florence fennels and rhubarbs. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer SAS submitted a request to the competent national authority in Austria to modify the existing MRLs for spirotetramat in the group of ...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Data sources on animal diseases: Country Card of Belgium

Data sources on animal diseases: Country Card of Belgium

Published on: Fri, 18 Jan 2019 Mapping ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresponding ...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Specialized Bicycle Components Canada, Inc. recalls select Specialized-Branded Bicycles with Steerer Tube Collars

Specialized Bicycle Components Canada, Inc. recalls select Specialized-Branded Bicycles with Steerer Tube Collars

The steerer tube collar on the affected products may crack if exposed to corrosion which may cause the rider to loose control, posing fall and injury hazards. As of December 18, 2018, the company has not received any reports of incidents in Canada, and no report of injuries.

Health Canada

14-1-2019

Meer orgaan- en weefseltransplantaties in 2018

Meer orgaan- en weefseltransplantaties in 2018

In 2018 zijn in Nederland 815 orgaantransplantaties geweest en ruim 4000 patiënten geholpen met gedoneerd weefsel. Dit is een stijging van respectievelijk 15 en 18% in vergelijking met het jaar ervoor. Deze positieve jaarcijfers zijn gepubliceerd door de Nederlandse Transplantatie Stichting (NTS).

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

4-1-2019

Shamrock Farms Issues Voluntary Recall of 2% Reduced Fat Vanilla Half Gallon Milk Due to Undeclared Almonds

Shamrock Farms Issues Voluntary Recall of 2% Reduced Fat Vanilla Half Gallon Milk Due to Undeclared Almonds

Shamrock Farms of Phoenix, Arizona is issuing a voluntary recall of Shamrock Farms 2% Reduced Fat Vanilla Half Gallon Milk with Best Before Date 3/16/2019. The recall comes after a product retain of Shamrock Farms 2% Reduced Fat Vanilla Half Gallon Milk with Use By 03/16/19 Time Stamp 08:18-11:13 04-05 #1, tested positive for an undeclared tree nut (almond) allergen.

FDA - U.S. Food and Drug Administration

19-12-2018

Wegmans Issues Voluntary Recall of Fresh Cauliflower Rice, Veggie/Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower

Wegmans Issues Voluntary Recall of Fresh Cauliflower Rice, Veggie/Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower

Rochester, NY – Wegmans Food Markets, Inc. has issued a voluntary recall of fresh Cauliflower Rice, Veggie Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower, sold in the produce department between 12/7/18 and 12/18/18, because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7). E. coli O157:H7 causes a diarrheal illness often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called He...

FDA - U.S. Food and Drug Administration

19-12-2018

Pest categorisation of Phyllosticta solitaria

Pest categorisation of Phyllosticta solitaria

Published on: Tue, 18 Dec 2018 The European Commission requested EFSA to conduct a pest categorisation of Grapholita prunivora (Lepidoptera: Tortricidae), an oligophagous moth whose larvae feed mostly on leaves and fruit of different Rosaceae including cultivated apples, plums, cherries and pecans. It overwinters in soil and bark crevices of its host plants. G. prunivora has reliable identification methods, both for adults and immature stages. It occurs in North America, where it can impact pome and sto...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-12-2018

Safety and efficacy of vitamin B2 (riboflavin 5′‐phosphate ester monosodium salt) for all animal species when used in water for drinking

Safety and efficacy of vitamin B2 (riboflavin 5′‐phosphate ester monosodium salt) for all animal species when used in water for drinking

Published on: Tue, 18 Dec 2018 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on vitamin B2 in the form of riboflavin 5′‐phosphate ester monosodium salt as an additive for all animal species for use in water for drinking. The additive under assessment is obtained from ■■■■■ a source of riboflavin produced by Ashbya gossypii. No information was provided on the identity and character...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-12-2018

Pest categorisation of Grapholita prunivora

Pest categorisation of Grapholita prunivora

Published on: Tue, 18 Dec 2018 The European Commission requested EFSA to conduct a pest categorisation of Grapholita prunivora (Lepidoptera: Tortricidae), an oligophagous moth whose larvae feed mostly on leaves and fruit of different Rosaceae including cultivated apples, plums, cherries and pecans. It overwinters in soil and bark crevices of its host plants. G. prunivora has reliable identification methods, both for adults and immature stages. It occurs in North America, where it can impact pome and sto...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-2-2019

EU/3/18/2116 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/18/2116 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/18/2116 (Active substance: Ivacaftor, N-(1,3-dimethyl-1H-pyrazole-4-sulfonyl)-6-[3-(3,3,3-trifluoro-2,2-dimethylpropoxy)-1H-pyrazol-1-yl]-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridine-3-carboxamide, tezacaftor) - Transfer of orphan designation - Commission Decision (2019)1362 of Mon, 18 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003732

Europe -DG Health and Food Safety

18-2-2019

Jardiance (Boehringer Ingelheim International GmbH)

Jardiance (Boehringer Ingelheim International GmbH)

Jardiance (Active substance: Empagliflozin) - Centralised - Renewal - Commission Decision (2019)1427 of Mon, 18 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2677/R/40

Europe -DG Health and Food Safety

18-2-2019

Fotivda (EUSA Pharma (Netherlands) B.V.)

Fotivda (EUSA Pharma (Netherlands) B.V.)

Fotivda (Active substance: tivozanib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1435 of Mon, 18 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4131/T/05

Europe -DG Health and Food Safety

18-2-2019

Aripiprazole Mylan Pharma (Mylan S.A.S.)

Aripiprazole Mylan Pharma (Mylan S.A.S.)

Aripiprazole Mylan Pharma (Active substance: aripiprazole) - Centralised - Yearly update - Commission Decision (2019)1438 of Mon, 18 Feb 2019

Europe -DG Health and Food Safety

18-2-2019

Modigraf (Astellas Pharma Europe B.V.)

Modigraf (Astellas Pharma Europe B.V.)

Modigraf (Active substance: Tacrolimus) - PSUSA - Modification - Commission Decision (2019)1426 of Mon, 18 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/954/PSUSA/2839/201803

Europe -DG Health and Food Safety

18-2-2019

Zirabev (Pfizer Europe MA EEIG)

Zirabev (Pfizer Europe MA EEIG)

Zirabev (Active substance: bevacizumab) - Centralised - Authorisation - Commission Decision (2019)1424 of Mon, 18 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4697

Europe -DG Health and Food Safety

14-2-2019

EU/3/18/1975 (Nightstar Europa Limited)

EU/3/18/1975 (Nightstar Europa Limited)

EU/3/18/1975 (Active substance: Adenovirus-associated viral vector serotype 8 containing the human RPGR gene) - Transfer of orphan designation - Commission Decision (2019)1376 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003405

Europe -DG Health and Food Safety

14-2-2019

EU/3/18/2117 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/18/2117 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/18/2117 (Active substance: Ivacaftor, potassium(benzenesulfonyl)({[6-(3-{2-[1-(trifluoromethyl) cyclopropyl]ethoxy}-1H-pyrazol-1-yl)-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridin-3-yl]carbonyl})azanide, tezacaftor) - Transfer of orphan designation - Commission Decision (2019)1363 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003788

Europe -DG Health and Food Safety

14-2-2019

EU/3/18/2011 (Kyowa Kirin Holdings B.V.)

EU/3/18/2011 (Kyowa Kirin Holdings B.V.)

EU/3/18/2011 (Active substance: Burosumab) - Transfer of orphan designation - Commission Decision (2019)1344 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003746

Europe -DG Health and Food Safety

14-2-2019

EU/3/18/2099 (Celgene Europe B.V.)

EU/3/18/2099 (Celgene Europe B.V.)

EU/3/18/2099 (Active substance: Lisocabtagene maraleucel) - Transfer of orphan designation - Commission Decision (2019)1351 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003330

Europe -DG Health and Food Safety

14-2-2019

EU/3/18/2018 (Celgene Europe B.V.)

EU/3/18/2018 (Celgene Europe B.V.)

EU/3/18/2018 (Active substance: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor) - Transfer of orphan designation - Commission Decision (2019)1350 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003327

Europe -DG Health and Food Safety

14-2-2019

EU/3/18/2012 (IDEA Innovative Drug European Associates (Ireland) Limited)

EU/3/18/2012 (IDEA Innovative Drug European Associates (Ireland) Limited)

EU/3/18/2012 (Active substance: Genetically modified replication-incompetent herpes simplex virus-1 expressing collagen VII) - Transfer of orphan designation - Commission Decision (2019)1356 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003115

Europe -DG Health and Food Safety

11-2-2019

Manufacture of sterile radiopharmaceuticals labelled with fluorine-18

Manufacture of sterile radiopharmaceuticals labelled with fluorine-18

Guidance updated to reflect expectations of the new PIC/S guide to GMP PE009-13

Therapeutic Goods Administration - Australia

5-2-2019


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

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

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

Europe - EMA - European Medicines Agency

1-2-2019


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

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

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

Europe - EMA - European Medicines Agency

17-1-2019

EU/3/18/2129 (Amicus Therapeutics UK Ltd)

EU/3/18/2129 (Amicus Therapeutics UK Ltd)

EU/3/18/2129 (Active substance: Miglustat) - Orphan designation - Commission Decision (2019)225 of Thu, 17 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002050

Europe -DG Health and Food Safety

17-1-2019

Hemangiol (Pierre Fabre Dermatologie)

Hemangiol (Pierre Fabre Dermatologie)

Hemangiol (Active substance: propranolol) - Centralised - Renewal - Commission Decision (2019)273 of Thu, 17 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2621/R/18

Europe -DG Health and Food Safety

16-1-2019

EU/3/18/2132 (Silence Therapeutics GmbH)

EU/3/18/2132 (Silence Therapeutics GmbH)

EU/3/18/2132 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against TMPRSS6 mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Orphan designation - Commission Decision (2019)226 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001845

Europe -DG Health and Food Safety

16-1-2019

EU/3/18/2125 (Isabelle Ramirez)

EU/3/18/2125 (Isabelle Ramirez)

EU/3/18/2125 (Active substance: Benserazide hydrochloride) - Orphan designation - Commission Decision (2019)221 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001719

Europe -DG Health and Food Safety

15-1-2019

EU/3/18/2133 (TLC Biopharmaceuticals B.V.)

EU/3/18/2133 (TLC Biopharmaceuticals B.V.)

EU/3/18/2133 (Active substance: Vinorelbine tartrate) - Orphan designation - Commission Decision (2019)227 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001988

Europe -DG Health and Food Safety

15-1-2019

EU/3/18/2131 (UCB Biopharma SPRL)

EU/3/18/2131 (UCB Biopharma SPRL)

EU/3/18/2131 (Active substance: Rozanolixizumab) - Orphan designation - Commission Decision (2019)240 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002029

Europe -DG Health and Food Safety

15-1-2019

EU/3/18/2130 (Arena Pharmaceuticals Limited)

EU/3/18/2130 (Arena Pharmaceuticals Limited)

EU/3/18/2130 (Active substance: Ralinepag) - Orphan designation - Commission Decision (2019)239 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002037

Europe -DG Health and Food Safety

15-1-2019

EU/3/18/2128 (Thiogenesis Therapeutics S.A.R.L)

EU/3/18/2128 (Thiogenesis Therapeutics S.A.R.L)

EU/3/18/2128 (Active substance: Mercaptamine-pantetheine disulfide) - Orphan designation - Commission Decision (2019)224 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002209

Europe -DG Health and Food Safety

15-1-2019

EU/3/18/2127 (Therapicon Srl)

EU/3/18/2127 (Therapicon Srl)

EU/3/18/2127 (Active substance: Melatonin) - Orphan designation - Commission Decision (2019)223 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001921

Europe -DG Health and Food Safety

15-1-2019

EU/3/18/2126 (Hanmi Europe Limited)

EU/3/18/2126 (Hanmi Europe Limited)

EU/3/18/2126 (Active substance: Human glucagon-like peptide-2 analogue linked to a human immunoglobulin Fc fragment) - Orphan designation - Commission Decision (2019)222 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001592

Europe -DG Health and Food Safety

15-1-2019

EU/3/18/2124 (IntraBio Ltd)

EU/3/18/2124 (IntraBio Ltd)

EU/3/18/2124 (Active substance: Acetylleucine) - Orphan designation - Commission Decision (2019)220 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001741

Europe -DG Health and Food Safety

15-1-2019

Vizamyl (GE Healthcare AS)

Vizamyl (GE Healthcare AS)

Vizamyl (Active substance: flutemetamol (18F)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)201 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2557/T/18

Europe -DG Health and Food Safety

7-1-2019

Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia

Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia

The TGA is seeking your comments on the proposal to introduce new and amended definitions, and a revised scope of the products regulated as medical devices in Australia. Closing date: 18 February 2019

Therapeutic Goods Administration - Australia

7-1-2019

Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy

Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy

The TGA seeks comments on the extent to which a similar approach will be appropriate in the Australian regulatory context. Closing date: 18 February 2019

Therapeutic Goods Administration - Australia

7-1-2019

Consultation: Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia

Consultation: Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia

We seek your views on the proposed regulatory changes that would facilitate the adoption of the internationally harmonised principles for introduction of the UDI system in Australia. Closing date: 18 February 2019

Therapeutic Goods Administration - Australia

4-1-2019

GMP clearance guidance update - Version 18.1

GMP clearance guidance update - Version 18.1

Updated version of GMP clearance guidance (Version 18.1)

Therapeutic Goods Administration - Australia

4-1-2019

GMP clearance guidance

GMP clearance guidance

Updated version of GMP clearance guidance (Version 18.1)

Therapeutic Goods Administration - Australia

19-12-2018

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall:  https://go.usa.gov/

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall: https://go.usa.gov/

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall: https://go.usa.gov/xE383  #MedicalDevice #FDA pic.twitter.com/S2EbMdmwpe

FDA - U.S. Food and Drug Administration

19-12-2018

EU/3/18/2122 (Genzyme Europe B.V.)

EU/3/18/2122 (Genzyme Europe B.V.)

EU/3/18/2122 (Active substance: Venglustat) - Orphan designation - Commission Decision (2018)9037 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/148/18

Europe -DG Health and Food Safety

19-12-2018

EU/3/18/2120 (Takeda Pharma A/S)

EU/3/18/2120 (Takeda Pharma A/S)

EU/3/18/2120 (Active substance: Pevonedistat) - Orphan designation - Commission Decision (2018)9035 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/164/18

Europe -DG Health and Food Safety

19-12-2018

EU/3/18/1987 (Richardson Associates Regulatory Affairs Ltd)

EU/3/18/1987 (Richardson Associates Regulatory Affairs Ltd)

EU/3/18/1987 (Active substance: Vocimagene amiretrorepvec) - Transfer of orphan designation - Commission Decision (2018)9006 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002643

Europe -DG Health and Food Safety

19-12-2018

EU/3/18/1978 (Richardson Associates Regulatory Affairs Ltd)

EU/3/18/1978 (Richardson Associates Regulatory Affairs Ltd)

EU/3/18/1978 (Active substance: Flucytosine) - Transfer of orphan designation - Commission Decision (2018)9005 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002608

Europe -DG Health and Food Safety

19-12-2018

Regulator Performance Framework: Self-assessment Report, July 2017 to June 2018

Regulator Performance Framework: Self-assessment Report, July 2017 to June 2018

The TGA has published its Self-Assessment Report for 2017-18

Therapeutic Goods Administration - Australia

18-12-2018

EU/3/18/2123 (IQVIA RDS Ireland Limited)

EU/3/18/2123 (IQVIA RDS Ireland Limited)

EU/3/18/2123 (Active substance: 6,8-bis(benzylthio)octanoic acid) - Orphan designation - Commission Decision (2018)9038 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/169/18

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2121 (Ability Pharmaceuticals SL)

EU/3/18/2121 (Ability Pharmaceuticals SL)

EU/3/18/2121 (Active substance: Sodium 2-hydroxylinoleate) - Orphan designation - Commission Decision (2018)9036 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/142/18

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2119 (Celgene Europe B.V.)

EU/3/18/2119 (Celgene Europe B.V.)

EU/3/18/2119 (Active substance: Marizomib) - Orphan designation - Commission Decision (2018)9034 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/161/18

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2118 (Eiger Biopharmaceuticals Europe Limited)

EU/3/18/2118 (Eiger Biopharmaceuticals Europe Limited)

EU/3/18/2118 (Active substance: Lonafarnib) - Orphan designation - Commission Decision (2018)9033 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/159/18

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2117 (Vertex Pharmaceuticals (Europe) Limited)

EU/3/18/2117 (Vertex Pharmaceuticals (Europe) Limited)

EU/3/18/2117 (Active substance: Ivacaftor, potassium(benzenesulfonyl)({[6-(3-{2-[1-(trifluoromethyl) cyclopropyl]ethoxy}-1H-pyrazol-1-yl)-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridin-3-yl]carbonyl})azanide, tezacaftor) - Orphan designation - Commission Decision (2018)9032 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/137/18

Europe -DG Health and Food Safety