Fludeoxyglucose (F-18) "Risø"

Primær information

  • Handelsnavn:
  • Fludeoxyglucose (F-18) "Risø" 400 MBq - 90 GBq injektionsvæske
  • Dosering:
  • 400 MBq - 90 GBq
  • Lægemiddelform:
  • injektionsvæske
  • 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 (F-18) "Risø" 400 MBq - 90 GBq injektionsvæske
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 02232
  • Sidste ændring:
  • 02-02-2018

Indlægsseddel

Side 1 of 4

INDLÆGSSEDDEL: INFORMATION TIL PATIENTEN

Fludeoxyglukose (F-18) ”Risø”, 400 Mbq til 90 GBq, injektionsvæske

Fludeoxyglucose (

F)

Læs hele denne indlægsseddel grundigt, inden du skal undersøges med denne medicin.

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

Har du yderligere spørgsmål, spørg den læge, der har henvist dig til undersøgelsen eller

den nuklearmedicinske læge som har ansvaret for undersøgelsen.

Tal med den henvisende læge eller den nuklearmedicinske læge eller det øvrige

sundhedspersonale, hvis en bivirkning bliver værre, eller hvis du får bivirkninger, som ikke

er nævnt her.

Oversigt over indlægssedlen

Virkning og Anvendelse

Det skal du vide om Fludeoxyglukose (F-18) “Risø”

Hvordan bruges Fludeoxyglukose (F-18) “Risø”

Bivirkninger

Hvordan opbevares Fludeoxyglucose (F-18) ”Risø”

Pakningsstørrelse og yderligere oplysninger

1. VIRKNING OG ANVENDELSE

Denne medicin er et radioaktivt lægemiddel, som kun er beregnet til diagnostisk brug.

Det aktive stof i Fludeoxyglukose (F-18) “Risø” er beregnet til at give billeder af sukkeromsætningen i

de forskellige dele af kroppen.

Du kan få Fludeoxyglucose (F-18) ”Risø” i forbindelse med undersøgelse af:

Forskellige typer af kræft

Hjertet

Årsagen til epilepsi

Blandt læger og det øvrige sundhedspersonale vil man ofte anvende forkortelsen ”FDG” for dette

præparat. Den undersøgelse, hvor stoffet anvendes vil ofte blive kaldt en ”FDG-skanning” eller en

”PET skanning med FDG”.

Efter at Fludeoxyglukose (F-18) “Risø” er sprøjtet ind i en blodåre, kan man ved hjælp af en såkaldt

PET-skanner fremstille billeder af hvordan lægemidlet har fordelt sig i kroppen. Ved analyse af

billederne kan man finde en eventuel sygdom eller følge en sygdoms udvikling.

2. DET SKAL DU OM FLUDEOXYGLUCOSE (F-18) “RISØ”

Du må ikke få Fludeoxyglukose (F-18) “Risø” hvis du:

Er overfølsom over for Fludeoxyglukose (F-18) eller et af de andre indholdsstoffer i

Fludeoxyglukose (F-18) “Risø”.

Lægen eller sundhedspersonalet vil være ekstra forsigtig med at undersøge dig med

Fludeoxyglukose (F-18) “Risø” hvis:

Du har sukkersyge og din sukkersyge ikke her helt velkontrolleret (Sukkersyge kaldes også

diabetes).

Du lider af en nyresygdom.

Du lider af en infektion eller har andre, betændelseslignede tilstande.

Side 2 of 4

Informer den henvisende læge og den nuklearmedicinske læge eller det øvrige

sundhedspersonale før undersøgelsen, hvis:

Du er gravid eller tror du eventuelt kan være det.

Du ammer.

Børn og unge under 18 år.

Hvis du er under 18 år bør tale med lægen inden undersøgelsens start

Brug af anden medicin sammen med Fludeoxyglucose (F-18) ”Risø”

Fortæl altid lægen eller sundhedspersonalet hvis du bruger anden medicin eller har brugt det for nyligt.

Dette gælder også medicin, som ikke er købt på recept, medicin købt i udlandet, naturlægemidler,

stærke vitaminer og mineraler samt kosttilskud. Dette skyldes at anden medicin kan påvirke udfaldet

og tolkningen af undersøgelsen.

Tal med lægen, hvis du bruger:

medicin der kan have indflydelse på blodsukkeret (insulin-præparater)

medicin brugt mod inflammation (binyrebark-hormoner)

medicin mod kramper og rystelser (valproate, carbamazepine, phenytoin, phenobarbital)

medicin som har indflydelse på centralnervesystemet (adrenalin, noradrenalin, dopamin)

glukose (druesukker)

Medicin der fremmer dannelsen af blodceller (CSF).

Antabus eller metronidazol (mod betændelse). Fludeoxyglukose (F-18) “Risø” indeholder en lille

mængde alkohol og kan give en let reaktion med de omtalte lægemidler. Du må derfor ikke få

Fludeoxyglukose (F-18) “Risø” uden først at have omtalt dette for lægen eller

sundhedspersonalet.

Brug af Fludeoxyglukose (F-18) “Risø” sammen med mad og drikke

Du må ikke spise i en periode på mindst 4 timer før undersøgelsen. Du må gerne drikke, men ikke

væsker, der indeholder sukker (sodavand, juice). Den undersøgende afdeling vil give dig mere

information herom og eventuelt stille yderligere krav til faste.

I specielle tilfælde kan det være nødvendigt at kontrollere blodsukkeret før undersøgelsen da forhøjet

blodsukker kan påvirke udfaldet og tolkningen af undersøgelsen.

Graviditet og amning

Du skal informere den nuklearmedicinske læge eller det øvrige sundhedspersonale før indsprøjtningen

med Fludeoxyglukose (F-18) “Risø” hvis:

der er mulighed, for at du kan være gravid

du har sprunget en menstruation over

du ammer

Hvis du er i tvivl, er det vigtigt du taler med lægen, som vil rådgive dig angående undersøgelsen.

Hvis du er gravid:

Din læge vil kun, hvis det er meget nødvendigt, undersøge dig med Fludeoxyglukose (F-18) “Risø”

mens du er gravid. I øvrigt skal du altid rådføre dig med lægen, hvis du tager medicin under graviditet.

Hvis du ammer:

Du må ikke amme i 12 timer efter indsprøjtningen og modermælken skal i dette tidsrum pumpes ud og

kasseres, da den ikke må bruges. Speciallægen i Nuklearmedicin kan rådgive dig angående

genoptagning af amning.

Trafik og arbejdssikkerhed

Det anses for usandsynligt at Fludeoxyglukose (F-18) “Risø” kan påvirke din evne til at færdes i

trafikken eller betjene maskiner.

Før du møder på afdelingen til undersøgelse med Fludeoxyglukose (F-18) “Risø” skal du:

Undgå høj fysisk aktivitet

Drikke rigeligt med vand (uden sukker) de sidste 4 timer før undersøgelsen

Faste de sidste 4 timer før undersøgelsen

Side 3 of 4

Vigtig information om nogle af de øvrige indholdsstoffer i Fludeoxyglukose (F-18) “Risø”

Fludeoxyglukose (F-18) “Risø” indeholder en lille mængde natrium, mindre end 35 mg pr. dosis.

Hvis du er på natrium- eller saltfattig diæt, skal du tage hensyn hertil og eventuelt spørge lægen

til råds.

Fludeoxyglukose (F-18) “Risø” indeholder en lille mængde alkohol. Hvis du er i behandling med

Antabus eller metronidazol (mod betændelse), må du ikke få Fludeoxyglukose (F-18) “Risø”

uden først at tale med lægen eller sundhedspersonalet.

3. SÅDAN BRUGES FLUDEOXYGLUCOSE (F-18) “RISØ”

Det er Speciallægen i Nuklearmedicin der har ansvaret for undersøgelsen og bestemmer hvor stor

dosis Fludeoxyglukose (F-18) “Risø” du skal have. Man vil altid anvende den lavest mulige dosis, der

stadig kan give den ønskede kvalitet af undersøgelsen.

Den anbefalede dosis til voksne ligger mellem 100 til 400 MBq. Dosis afhænger af din kropsvægt og

hvilken type skanner, der bruges til undersøgelsen. MegaBecquerel (MBq) er en måleenhed for

radioaktivitet.

Børn og unge under 18 år

Dosis til børn og unge bliver beregnet i forhold til kropsvægten.

Indsprøjtning og undersøgelse med Fludeoxyglukose (F-18) “Risø”

Fludeoxyglukose (F-18) “Risø” bliver indsprøjtet i en blodåre (vene).

En enkelt indsprøjtning er nok til at udføre undersøgelsen.

Efter indsprøjtningen vi du blive bedt om at drikke væske, men i øvrigt forholde dig i ro. Umiddelbart

inden selve skanningen bliver du bedt om at lade vandet.

Mens du bliver skannet skal du ligge behageligt, helt stille uden at læse eller tale.

Varighed af undersøgelsen

Lægen eller sundhedspersonalet vil informere dig om varigheden af undersøgelsen.

Sædvanligvis vil Fludeoxyglukose (F-18) “Risø” blive indsprøjtet 45-60 minutter før skanningen starter.

Selve skanningen tager mellem 30 og 60 minutter.

Efter undersøgelsen skal du:

Undgå er tæt kontakt med børn de første 12 timer efter indsprøjtningen.

Lade vandet så ofte som muligt, da stoffet udskilles gennem nyrerne.

Hvis du har fået mere Fludeoxyglukose (F-18) “Risø” end du skulle have.

En overdosis er næsten umulig, fordi du kun får en enkelt indsprøjtning med Fludeoxyglukose (F-18)

“Risø”. Dosis bliver nøje kontrolleret af det specialuddannede personale. Hvis der alligevel er givet en

overdosis, vil du modtage passende behandling. Den nuklearmedicinske læge kan bede dig om at

drikke rigeligt med væske for at øge udskillelsen af Fludeoxyglukose (F-18) “Risø” fra kroppen.

Har du yderligere spørgsmål angående brugen af Fludeoxyglukose (F-18) “Risø”, spørg den

henvisende læge eller den nuklearmedicinske læge, som har ansvaret for undersøgelsen.

4. BIVIRKNINGER

Fludeoxyglukose (F-18) “Risø” kan som al anden medicin give bivirkninger, men ikke alle får

bivirkninger.

Stoffet er radioaktivt og vil derfor give dig en lille stråledosis som følge af undersøgelsen. Indholdet af

radioaktivitet er nødvendigt for undersøgelsen, og vil kun medføre en meget lille øget risiko for

udvikling af cancer (kræft) senere i livet. Der findes også svag teoretisk risiko for at stråledosis kan

medføre arvelige effekter. De arvelige effekter er aldrig observeret og vurderes til at være mange

gange mindre sandsynlige end den øgede risiko for kræft.

Side 4 of 4

Det er den henvisende læge og den nuklearmedicinske læge, der vurderer om undersøgelsen skal

gennemføres på grundlag af den fordel, du kan få af undersøgelsen i forhold risikoen ved den lille

stråledosis.

Hvis du får bivirkninger, skal du informere din henvisende læge eller den nuklearmedicinske læge,

som har ansvaret for undersøgelsen.

Du eller dine pårørende kan også selv indberette bivirkninger direkte til Sundhedsstyren på

www.meldenbivirkning.dk , ved at kontakte Sundhedsstyrelsen via mail på sst@sst.dk eller med

almindeligt brev til Sundhedsstyrelsen, Axel Heides Gade 1, 2300 København S.

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

af dette lægemiddel.

5. HVORDAN OPBEVARES FLUDEOXYGLUCOSE (F-18) ”RISØ”

Der gælder specielle regler for håndtering, anvendelse og bortskaffelse af radioaktive lægemidler.

Fludeoxyglucose (F-18) ”Risø” vil kun blive anvendt på sygehuse. Her vil det udelukkende blive

håndteret og indgivet af personale som er specielt uddannet og godkendt til denne opgave.

Fludeoxyglukose (F-18) “Risø” opbevares utilgængeligt for børn.

Opbevar ikke Fludeoxyglukose (F-18) “Risø” ved temperature over 25 ºC.

Frys ikke Fludeoxyglukose (F-18) “Risø”.

Opbevar Fludeoxyglukose (F-18) “Risø” bag blyafskærmning.

Fludeoxyglukose (F-18) “Risø” skal indgives inden 10 timer efter fremstilling. Se etiket.

Brug ikke Fludeoxyglukose (F-18) “Risø” efter den udløbsdato, der star på pakningen.

Sygehuspersonalet vil sikre, at Fludeoxyglukose (F-18) “Risø” opbevares og bortskaffes korrekt.

6. PAKNINGSSTØRRELSE OG YDERLIGERE OPLYSNINGER

Hvad indeholder Fludeoxyglukose (F-18) ”Risø”:

Aktivt stof:

Fluor-18 Fludeoxyglukose (Fluor-18 FDG)

Øvrige indholdsstoffer:

Natriumcitrat

Di-natrium-hydrogen-citrate-1,5-hydrat

Ethanol (mindre end 100 mg pr dosis)

Natriumklorid

Sterilt vand

Udseende og indhold af Fludeoxyglukose (F-18) ”Risø”

Hætteglas indeholdende en klar farveløs eller svagt gullig injektionsvæske som indeholder 400 MBq –

90 GBq på referencetidspunktet (dato og tid).

Indehaver af markedsføringstilladelsen og fremstiller

Hevesy Laboratoriet

Bygning 202

Risø-DTU

Postboks 49

DK-4000 Roskilde

Denne indlægsseddel blev senest revideret den 12. juni 2014.

Følgende information er kun til læger og andet sundhedspersonale:

Produktresumeet (SPC) for Fludeoxyglukose (F-18) “Risø” foreligger som separat dokument og er

vedlagt hver enkelt sending af produktet. Produktresumeet giver sundhedspersonalet yderligere

detaljer og praktisk information angående håndtering og brug af dette radioaktive lægemiddel.

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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