Frontect (til hunde 5-10 kg)

Primær information

  • Handelsnavn:
  • Frontect (til hunde 5-10 kg) 67,6+504,8 mg spot-on, opløsning
  • Dosering:
  • 67,6+504,8 mg
  • Lægemiddelform:
  • spot-on, opløsning
  • Brugt til:
  • Dyr
  • Medicin typen:
  • Allopatiske stof

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Lokation

  • Fås i:
  • Frontect (til hunde 5-10 kg) 67,6+504,8 mg spot-on, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 52823
  • Sidste ændring:
  • 18-07-2018

Produktresumé: dosering, interaktioner, bivirkninger

19. februar 2018

PRODUKTRESUMÉ

for

Frontect, spot-on, opløsning

0.

D.SP.NR.

28878

1.

VETERINÆRLÆGEMIDLETS NAVN

Frontect

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

Hver pipette indeholder:

Aktive stoffer

Hjælpestoffer

Frontect spot-

on, opløsning

Indhold

pipette

(ml)

Fipronil

(mg)

Permethrin

(mg)

Butylhydroxytoluen

(E321) (mg)

Hund 2-5 kg

33,8

252,4

0,563

Hund 5-10 kg

67,6

504,8

1,125

Hund 10-20 kg

135,2

1009,6

2,250

Hund 20-40 kg

270,4

2019,2

4,500

Hund 40-60 kg

405,6

3028,8

6,750

Alle hjælpestoffer er anført under pkt. 6.1.

3.

LÆGEMIDDELFORM

Spot-on, opløsning

Klar, farveløs til gulbrun opløsning.

4.

KLINISKE OPLYSNINGER

4.1

Dyrearter

Hund

4.2

Terapeutiske indikationer

Behandling og forebyggelse af loppe- og/eller flåtangreb, hvor repellerende (anti-

blodsugende) virkning mod sandfluer, stikfluer og/eller myg er nødvendig.

52823_spc.docx

Side 1 af 7

Lopper

Behandling og forebyggelse af Ctenocephalides felis loppeangreb samt forebyggelse af

Ctenocephalides canis loppeangreb. En behandling forebygger nye loppeangreb i 4 uger.

Præparatet kan indgå som del af behandlingsstrategien for loppebetinget allergisk

dermatitis, hvor dette tidligere er diagnosticeret af en dyrlæge.

Flåter

Behandling og forebyggelse af flåtangreb (Dermacentor reticulatus, Ixodes ricinus,

Rhipicephalus sanguineus). En behandling dræber (Dermacentor reticulatus, Ixodes

ricinus, Rhipicephalus sanguineus) og repellerer (Ixodes ricinus, Rhipicephalus

sanguineus) flåter i 4 uger efter behandling, samt repellerer Dermacentor reticulatus fra 7

dage og op til 4 uger efter behandling.

Myg og sandfluer

Repellerer (anti-blodsugende virkning) sandfluer (Phlebotomus perniciosus) i 3 uger og

myg (Culex pipiens, Aedes albopictus) i 4 uger. Dræber sandfluer (Phlebotomus

perniciosus) og myg (Aedes albopictus) i 3 uger.

Stikfluer

Repellerer (anti-blodsugende virkning) og dræber stikfluer (Stomoxys calcitrans) i 5 uger.

4.3

Kontraindikationer

Må ikke anvendes til syge eller rekonvalescente dyr.

Præparatet er kun til hunde. Må ikke anvendes til katte eller kaniner, da dette kan forårsage

bivirkninger og muligvis dødsfald.

Bør ikke anvendes i tilfælde af overfølsomhed over for de aktive stoffer eller over for et

eller flere af hjælpestofferne (se også punkt 4.5 ”Særlige forsigtighedsregler for dyret”).

4.4

Særlige advarsler

Tilhæftning af enkelte flåter eller bid af enkelte myg eller sandfluer kan forekomme.

Derfor kan overførsel af patogener fra disse leddyr ikke helt udelukkes, hvis forholdene er

ugunstige. Enkelte flåter kan tilhæfte og give slip igen inden for de første 24 timer efter

infestation. Såfremt flåter er til stede allerede når præparatet påføres, vil alle flåter ikke

nødvendigvis dræbes inden for 48 timer efter behandling.

Præparatets virkning mod lopper påvirkes ikke selv om dyret af og til bliver vådt

(svømning, bad). Hunde skal dog ikke svømme eller vaskes med shampoo inden for 48

timer efter behandling. Undgå hyppig svømning eller shamponering af behandlede hunde,

da dette kan reducere præparatets virkningsvarighed.

For at mindske risikoen for nye loppeangreb anbefales det at behandle alle hunde i

husholdningen. Andre dyr i samme husholdning bør også behandles med et passende

præparat. For at reducere smittetrykket fra omgivelserne anbefales det, at omgivelserne

behandles med et passende middel, som virker mod voksne lopper og deres

udviklingsstadier.

4.5

Særlige forsigtighedsregler vedrørende brugen

Særlige forsigtighedsregler for dyret

Da der ikke foreligger specifikke studier, anbefales det, at man ikke anvender præparatet til

hunde, som er yngre end 8 uger eller som vejer under 2 kg.

Undgå at produktet kommer i kontakt med hundens øjne.

52823_spc.docx

Side 2 af 7

Vær omhyggelig med at påføre præparatet på et sted, hvor dyret ikke kan slikke det af, og

sørg for, at andre dyr ikke slikker på behandlingsstedet efter påføringen.

Præparatet kan fremkalde kramper hos katte, som kan være dødelige på grund af kattes

unikke fysiologi, der gør at de ikke kan metabolisere visse stoffer, heriblandt permethrin.

Ved utilsigtet hudeksponering vaskes katten med shampoo eller sæbe, og der søges hurtig

dyrlægehjælp. For at forhindre at katte eksponeres for præparatet, skal behandlede hunde

holdes adskilt fra katte, indtil påføringsstedet er tørt. Det er vigtigt at sørge for, at katte

ikke slikker på påføringsstedet på en hund, som er behandlet med dette præparat. Søg

straks dyrlægehjælp i tilfælde af denne type eksponering.

Særlige forsigtighedsregler for personer, der administrerer lægemidlet

Præparatet kan forårsage hud- og øjenirritation, og det skal derfor undgås at præparatet

kommer i kontakt med hud og øjne. Pipetten skal ikke åbnes i nærheden eller i retning af

ansigtet. Skyl straks øjnene med rigeligt vand, hvis præparatet kommer i øjet, eller hvis

øjnene bliver irriterede under administrationen. Søg lægehjælp hvis øjenirritationen varer

ved. Vask straks huden med rigeligt vand og sæbe i tilfælde af hudeksponering, eller hvis

huden bliver irriteret under administrationen. Søg lægehjælp hvis hudirritationen varer ved

eller kommer igen.

Personer med kendt overfølsomhed over for fipronil og/eller permethrin skal undgå

kontakt med præparatet.

Præparatet er skadeligt, hvis det sluges. Undgå hånd-til-mund kontakt. Undgå at ryge, spise

eller drikke under påføringen. Vask hænder efter brug. Skyl munden hvis præparatet sluges

og søg læge, hvis du bliver utilpas.

Da hjælpestoffet N-methylpyrrolidon kan fremkalde føtotoxicitet og teratogenicitet efter

signifikant eksponering, skal gravide kvinder bruge beskyttelseshandsker for at undgå

kontakt med præparatet.

Behandlede dyr bør ikke håndteres, før påføringsstedet er tørt, og børn skal ikke gives lov

til at lege med behandlede dyr, før påføringsstedet er tørt. Det anbefales derfor, at man ikke

behandler dyr i løbet af dagen, men venter til tidligt på aftenen, og at nyligt behandlede dyr

ikke får lov at sove sammen med ejeren, især ikke med børn.

Opbevar pipetterne i original blisterpakning og bortskaf tomme pipetter på passende måde

straks efter anvendelsen for at forhindre yderligere adgang til dem.

Andre forsigtighedsregler

Præparatet kan være skadeligt for organismer, der lever i vand. Behandlede hunde skal

ikke gives lov til at bade i stillestående vand i 2 dage efter behandling.

4.6

Bivirkninger

Efter anvendelse er der i meget sjældne tilfælde set forbigående hudreaktioner på

påføringsstedet (misfarvning af huden, lokalt hårtab, kløe, rødmen) samt generel kløe og

hårtab. Udtalt savlen, reversible nervøse symptomer (øget følsomhed over for berøring,

hyperaktivitet, muskelrysten, depression, andre nervøse symptomer) eller opkastning er

ligeledes observeret efter anvendelse.

Hvis hunden slikker på påføringsstedet, kan der ses kraftig savlen og opkastning.

4.7

Drægtighed, diegivning eller æglægning

Laboratorieundersøgelser med fipronil eller permethrin har ikke afsløret teratogene

virkninger eller føtal toksicitet. Der er ikke udført undersøgelser af dette præparat hos

drægtige og diegivende dyr (se 4.5 ”Særlige forsigtighedsregler for dyret”).

52823_spc.docx

Side 3 af 7

N-methylpyrrolidon, et hjælpestof i veterinærpræparatet, har vist at være teratogent hos

laboratoriedyr efter gentagen eksponering ved høje doser.

Må kun anvendes i overensstemmelse med den ansvarlige dyrlæges vurdering af risk-

benefit-forholdet.

4.8

Interaktion med andre lægemidler og andre former for interaktion

Ingen kendte.

4.9

Dosering og indgivelsesmåde

Den anbefalede minimumsdosis er 6,76 mg fipronil/kg kropsvægt og 50,48 mg

permethrin/kg kropsvægt svarende til 0,1 ml spot-on opløsning pr. kg kropsvægt.

Brugen af præparatet skal baseres på en bekræftet infestation eller risiko for infestation

med lopper og/eller flåter, hvor repellerende (anti-blodsugende) virkning mod sandfluer

og/eller stikfluer og/eller myg også er nødvendig. Afhængig af ektoparasitforekomsten kan

gentaget behandling være indiceret. I sådanne tilfælde skal intervallet mellem to

behandlinger være mindst 4 uger.

Administrationsmåde

Vælg korrekt pipettestørrelse i henhold til hundens vægt. Til hunde over 60 kg anvendes

den kombination af to pipettestørrelser, som tilsammen passer bedst til kropsvægten.

Præparatet skal påføres på to steder, hvor hunden ikke kan slikke sig. Disse steder er lige

foran skulderbladene og i nakken midt mellem hoved og skulderblade.

Tag blisteret ud af pakningen og adskil 1 blister. Tag pipetten ud ved at klippe langs den

stiplede linie med en saks eller ved at rive folien af efter at have bøjet det markerede

hjørne. Hold pipetten lodret og væk fra ansigtet – den åbnes ved at klippe spidsen af med

en saks. Del pelsen i hundens nakke indtil huden er synlig. Placer pipettens spids på huden

og tryk på pipetten for at påføre ca. halvdelen af indholdet midt på nakken midt mellem

hoved og skulderblade. Gentag påføringen lige foran skulderbladene for at tømme pipetten.

Sørg for at præparatet påføres direkte på huden og ikke i pelsen for at opnå det bedste

resultat.

4.10

Overdosering

Sikkerheden er undersøgt hos raske voksne hunde med op til 5 gange den maksimale dosis

(behandlet op til 3 gange med månedlige intervaller), samt hos hvalpe (8-uger gamle

behandlet én gang). Kendte bivirkninger kan være lette neurologiske symptomer,

opkastning og diaré. Disse er forbigående og forsvinder normalt uden behandling i løbet af

1-2 dage.

Risikoen for bivirkninger (se punkt 4.6) kan forøges ved overdosering, derfor skal dyr altid

behandles med korrekt pipettestørrelse i henhold til deres kropsvægt.

4.11

Tilbageholdelsestid

Ikke relevant.

5.

FARMAKOLOGISKE EGENSKABER

Farmakoterapeutisk gruppe: Ectoparasiticider til udvortes brug.

ATCvet-kode: QP 53 AX 65 (fipronil, kombination).

52823_spc.docx

Side 4 af 7

5.1

Farmakodynamiske egenskaber

Fipronil er et insekticid og acaricid hørende til phenylpyrazolfamilien. Fipronil og dets

metabolit fipronilsulfon virker ved at påvirke de ligand-styrede chloridkanaler, især de, der

styres af neurotransmitteren GABA (gamma-aminosmørsyre), såvel de desensibiliserende

(D) som de ikke-desensibiliserende (N) kanaler styret af glutamat (Glu, unikke invertebrat

ligand-styrede chloridkanaler), hvorved de blokerer den præ- og postsynaptiske overførsel

af chlorioner over cellemembraner. Dette resulterer i en ukontrolleret CNS-aktivitet med

deraf følgende drab af insekter og mider.

Permethrin tilhører type I klassen af pyrethroider. Pyrethroider er acaricider og insekticider

med repellerende virkning. Pyrethroider påvirker de elektrisk ladede natriumkanaler hos

hvirveldyr og hvirvelløse dyr. Pyrethroider er såkaldte "åben kanal-blokkere" som påvirker

natriumkanalen ved at forsinke både aktiverings- og inaktiveringsegenskaber og således

medføre hyperexcitabilitet og død hos parasitten. Permethrin i præparatet har

afskrækkende (anti-blodsugende) virkning mod sandfluer (> 80 % i 4 uger), myg og flåter.

I en eksperimentel undersøgelse havde præparatet hurtigere dræbende virkning på voksne

lopper end fipronil alene hhv. 7 og 14 dage efter behandling.

”Speed of kill”

Præparatet dræber nye lopper (C. canis, C. felis) inden for 6 timer fra 2 dage efter

behandling og i en hel måned. C. felis lopper, som allerede findes på hunden når

behandlingen påføres, dræbes inden for 24 timer. ”Speed of kill” på C. canis, som allerede

er til stede ved behandlingsstart, er ikke blevet evalueret.

Præparatet dræber nye flåter (R. sanguineus og I. ricinus) inden for 6 timer fra 2 dage efter

behandling og i en hel måned. Flåter (R. sanguineus, I. ricinus, D.reticulatus), som allerede

findes på hunden når behandlingen påføres, dræbes inden for 48 timer.

I en eksperimentel undersøgelse blev det vist, at præparatet indirekte reducerer risikoen for

overførsel af Babesia canis fra inficerede Dermacentor reticulatus flåter

fra 7 dage og op til

4 uger efter behandling. Derved reduceredes risikoen for babesiose hos de behandlede hunde i

denne undersøgelse.

I en eksperimentel undersøgelse blev det vist, at præparatet indirekte reducerer risikoen for

overførsel af Ehrlichia canis fra inficerede Rhipicephalus sanguineus flåter

fra 7 dage og

op til 4 uger efter behandling. Derved reduceredes risikoen for ehrlichiose hos de behandlede

hunde i denne undersøgelse.

Præparatets virkning med hensyn til at reducere overførsel af infektiøse agens efter naturlig

eksponering under feltforhold er imidlertid ikke undersøgt.

5.2

Farmakokinetiske egenskaber

Den farmakokinetiske profil af fipronil og permethrin i kombination blev undersøgt efter

udvortes påføring hos hund ved at måle koncentrationen i plasma og hår i 58 dage efter

behandling. Både permethrin og fipronil, sammen med hovedmetabolitten fipronilsulfon,

fordeles godt i hundens pels i løbet af den første dag efter påføringen. Koncentrationen af

fipronil, fipronilsulfon og permethrin i pelsen aftager over tid og kan påvises i minimum

58 dage efter påføringen.

Fipronil og permethrin virker topikalt ved kontakt med eksterne parasitter, og den lave

systemiske absorption af fipronil og permethrin er ikke relevant for den kliniske virkning.

Spot-on påføringen medførte ubetydelig systemisk absorption af permethrin med sporadisk

målbar koncentrationer af cis-permethrin mellem 11,4 ng/ml og 33,9 ng/ml observeret 5 til

48 timer efter behandling.

52823_spc.docx

Side 5 af 7

Gennemsnitlig maksimal plasmakoncentration (C

) på 30,1 ± 10,3 ng/ml fipronil og 58,5

± 20,7 ng/ml fipronilsulfon blev observeret mellem dag 2 og 5 (T

) efter påføring.

Fipronil plasmakoncentration aftager derefter med en gennemsnitlig halveringstid på 4,8 ±

1,4 dage.

5.3

Miljømæssige forhold

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

N-methylpyrrolidon

Butylhydroxytoluen (E321)

Triglycerider, middelkædelængde

6.2

Uforligeligheder

Ingen kendte.

6.3

Opbevaringstid

Pipette à 0,5 ml (33,8+252,4 mg, til hund 2-5 kg)

2 år.

Pipette à 1 ml (67,6+504,8 mg, til hund 5-10 kg)

30 måneder.

Pipette á 2 ml (135,2+1009,6 mg, til hund 10-20 kg)

30 måneder.

Pipette á 4 ml (270,4+2019,2 mg, til hund 20-40 kg)

30 måneder.

Pipette á 6 ml (405,6+3028,8 mg, til hund 40-60 kg)

30 måneder.

6.4

Særlige opbevaringsforhold

Opbevares i den originale blisterpakning.

Må ikke opbevares over 25

°C.

6.5

Emballage

Primærpakningen er en varmeformet film af polyethylen-ethylenvinylalkohol-

polyethylen/polypropylen.

Sekundærpakningen består af et plast/aluminiumblister med plast/aluminiumbagside.

Plastblisterkort med 1 pipette indeholdende 0,5 ml, 1 ml, 2 ml, 4 ml eller 6 ml.

Æske med 3 eller 6 pipetter (som hver indeholder 0,5 ml, 1 ml, 2 ml, 4 ml eller 6 ml).

Kun én pipettestørrelse pr. æske.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

52823_spc.docx

Side 6 af 7

6.6

Særlige forholdsregler ved bortskaffelse af rester af lægemidlet eller affald

Ikke anvendte veterinærlægemidler samt affald heraf bør destrueres i henhold til lokale

retningslinjer.

Præparatet må ikke udledes i vandløb, da dette kan være farligt for fisk og andre

organismer i vandet.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

Merial Norden A/S

Strødamvej 52

2100 København Ø

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

33,8+252,4 mg:

52822

67,6+504,8 mg:

52823

135,2+1009,6 mg: 52824

270,4+2019,2 mg: 52825

405,6+3028,8 mg: 52826

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

30. september 2014

10.

DATO FOR ÆNDRING AF TEKSTEN

19. februar 2018

11.

UDLEVERINGSBESTEMMELSE

52823_spc.docx

Side 7 af 7

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    Anmode informationsbrochure for offentligheden.



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Scientific Opinion on Flavouring Group Evaluation 217 Revision 2 (FGE.217Rev2), consideration of genotoxic potential for α,β‐unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones

Scientific Opinion on Flavouring Group Evaluation 217 Revision 2 (FGE.217Rev2), consideration of genotoxic potential for α,β‐unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones

Published on: Fri, 25 Jan 2019 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 12 flavouring substances from subgroup 4.1 of FGE.19 in the Flavouring Group Evaluation 217 (FGE.217). Based on experimental data, in previous versions of this FGE (FGE.217 and FGE217Rev1), for 6‐methylcoumarin [FL‐no: 13.012] and 5‐ethyl‐3‐hydroxy‐4‐methylfuran‐2(5H)‐one [FL‐no: 10.023] the concern for genotoxicity was ruled out. 6‐Methylc...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-1-2019

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Published on: Fri, 25 Jan 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) (PHBH), CAS No 147398‐31‐0 and food contact material (FCM) substance No 1059. This biodegradable copolymer is produced by fermentation of palm oil using a genetically modified microorganism (Cupriavidus necator). Overall migration was up to 5.4 mg/kg. Oligomers are hydroxyl‐terminated or with crotyl‐ and hexenyl end‐...

Europe - EFSA - European Food Safety Authority EFSA Journal

23-1-2019

Safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206)

Safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206)

Published on: Tue, 22 Jan 2019 The food enzyme lysophospholipase (EC 3.1.1.5) is produced with the genetically modified Trichoderma reesei strain RF7206 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The lysophospholipase food enzyme is intended to be used in starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP

Torrent Pharmaceuticals Limited is expanding its voluntary recall from 10 lots of Losartan potassium tablets USP to include 6 lots of Losartan potassium and hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

FDA - U.S. Food and Drug Administration

22-1-2019

Modification of the existing maximum residue level for trifloxystrobin in broccoli

Modification of the existing maximum residue level for trifloxystrobin in broccoli

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer Hellas AG submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance trifloxystrobin in broccoli. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for broccoli. Adequate analytical methods for enforcement are available to control the residues of trifloxystrobin o...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Landesanstalt für Landwirtschaft und Gartenbau Sachsen‐Anhalt (LSA) and Dienstleistungszentrum Ländlicher Raum Rheinpfalz (DLR), respectively, submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRL) for the active substance aclonifen in chives, parsley, celery leaves/dill leaves, thyme/savoury and in celeriacs/turnip‐rooted celery. The ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for aminopyralid in certain cereals

Modification of the existing maximum residue levels for aminopyralid in certain cereals

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences Denmark submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance aminopyralid in cereals. The data submitted in support of the request were found to be sufficient to derive MRL proposals for barley, rye, sorghum, millet and oats. A modification of the existing MRL of aminopyralid in wh...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Safety for the environment of vitamin D3 for salmonids

Safety for the environment of vitamin D3 for salmonids

Published on: Thu, 17 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) of EFSA assessed the safety for the target species and the consumer of the use of a maximum total level of 1.5 mg vitamin D3/kg feed in fish nutrition (2017). The assessment was based on data that had been provided by the Norwegian Food Safety Authority (NFSA). Since the data set provided by the NFSA did not include any new information concerning the safety for the user and the environment...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-1-2019

34 nieuwe maatschappelijke diensttijdprojecten van start

34 nieuwe maatschappelijke diensttijdprojecten van start

Vandaag hebben 34 nieuwe maatschappelijke diensttijdprojecten door heel Nederland bericht gekregen dat ze financiering krijgen en van start kunnen gaan. In de maatschappelijke diensttijd krijgen jongeren de mogelijkheid om hun eigen talenten te ontdekken en ontwikkelen tijdens een periode waarin ze zich vrijwillig inzetten voor een ander of voor de samenleving. Bij de nieuwe projecten kunnen jongeren hun talenten inzetten op terreinen als media, cultuur en musea, onderwijs, techniek en ICT, zorg en klima...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

17-1-2019

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Published on: Wed, 16 Jan 2019 The additive cassia gum consists mainly of high-molecular weight polysaccharides composed primarily of a linear chain of 1,4-b-D-mannopyranose units with 1,6-linked a-D-galactopyranose units. In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of cassia gum in cats and dogs. The Panel concluded, based on positive findings observed in a bacterial reverse mutation test with a semi-refined cassia...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Published on: Wed, 16 Jan 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of two compounds belonging to chemical group 20 (aliphatic and aromatic mono‐ and di‐thiols and mono‐, di‐, tri‐, and polysulfides with or without additional oxygenated functional groups). 8‐Mercapto‐p‐menthan‐3‐one [12.038] and p‐menth‐1‐ene‐8‐thiol [12.085] are currently ...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Safety and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Published on: Wed, 16 Jan 2019 The additive under assessment is pure benzoic acid (> 99.8%), manufactured in the form of flakes. It is intended to be used as a technological feed additive (acidity regulator) in feedingstuffs for weaned piglets and pigs for fattening, with maximum contents of 5,000 and 10,000 mg/kg complete feed, respectively. Benzoic acid is safe for weaned piglets at 5,000 mg/kg complete feed, and at 10,000 mg/kg complete feed for pigs for fattening. The use of benzoic acid in feedings...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

Published on: Tue, 15 Jan 2019 The additive 3‐phytase FSF10000 is a solid product that contains a 3‐phytase produced by a genetically modified strain of Komagataella phaffii. A liquid formulation of the additive has been previously assessed by the EFSA Panel on Additives and Products of Substances used in Animal Feed (FEEDAP) and is currently authorised as a feed additive for poultry species. The applicant requested for the use of this new formulation of the additive in chickens for fattening or reared ...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of B‐Act® (Bacillus licheniformis DSM 28710) as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised for laying

Safety and efficacy of B‐Act® (Bacillus licheniformis DSM 28710) as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised for laying

Published on: Mon, 14 Jan 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of B‐Act® when used in feed for turkeys for fattening, reared for breeding and minor poultry species for fattening or raised for laying. B‐Act® is a preparation containing viable spores of a Bacillus licheniformis strain. This species is considered by EFSA to be suitable for the qua...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Published on: Mon, 14 Jan 2019 Deccox®, containing decoquinate as the active substance, is a feed additive intended to be used for the prevention of coccidiosis in chickens for fattening at a dose range of 20–40 mg/kg complete feed. Decoquinate from Deccox® is safe for chickens for fattening at the highest applied concentration in complete feed of 40 mg/kg. No practically relevant interactions with other additives or veterinary drugs exist except with bentonite. Decoquinate does not have antibacterial a...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Setting of an import tolerance for spiromesifen in coffee beans

Setting of an import tolerance for spiromesifen in coffee beans

Published on: Mon, 14 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted a request to the competent national authority in Greece to set an import tolerance for the active substance spiromesifen in coffee beans. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for coffee beans. Adequate analytical methods for enforcement are available to control the residues of spiromesife...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Published on: Fri, 11 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of organic form of selenium produced by Saccharomyces cerevisiae NCYC R397 (Alkosel®) for all animal species. The FEEDAP Panel has delivered two opinions (on 2007 and 2016) on the safety and efficacy of the additive. The additive is characterised as organic selenium mainly selenomethionine (63%); it was ini...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Assessment of the application for renewal of authorisation of Lantharenol® (lanthanum carbonate octahydrate) for cats

Assessment of the application for renewal of authorisation of Lantharenol® (lanthanum carbonate octahydrate) for cats

Published on: Fri, 11 Jan 2019 Lantharenol® is a feed additive consisting of lanthanum carbonate octahydrate. It is currently authorised as a zootechnical additive (decrease in phosphorous excretion via urine) for cats; this opinion concerns the renewal of the authorisation. In 2007, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of Lantharenol® as a feed additive for cats. The applicant has provided data demonstrating th...

Europe - EFSA - European Food Safety Authority EFSA Journal

10-1-2019

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Trichoderma reesei (strain DP‐Nzb48)

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Trichoderma reesei (strain DP‐Nzb48)

Published on: Wed, 09 Jan 2019 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with a genetically modified strain of Trichoderma reesei by Danisco US Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organic solids (TOS) are removed by distill...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-1-2019

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass.

FDA - U.S. Food and Drug Administration

6-1-2019

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g

Lupin Pharmaceuticals, Inc. is voluntarily recalling 5 lots of Ceftriaxone for Injection, USP, 250mg, 10 lots of Ceftriaxone for Injection, USP, 500mg, 24 lots of Ceftriaxone for Injection, USP, 1g and 3 lots of Ceftriaxone for Injection, USP 2g, to the hospital/physician level. The products have been found to contain visual grey particulate matter in reconstituted vials.

FDA - U.S. Food and Drug Administration

4-1-2019

Olde York Potato Chips Issues Allergy Alert on Undeclared Milk in One Lot of Clancy's Wavy Potato Chips 10 Oz

Olde York Potato Chips Issues Allergy Alert on Undeclared Milk in One Lot of Clancy's Wavy Potato Chips 10 Oz

Olde York Potato Chips of Brampton, Ontario is recalling Clancy's Wavy Potato Chips 10 oz (UPC 0 41498 16306 8) with the specific lot code BEST If Used By FEB 22 19 1A6 because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. No other lot codes and no other products are involved in this action.

FDA - U.S. Food and Drug Administration

3-1-2019

Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited is expanding its voluntary recall from 2 lots of Losartan potassium tablets USP to a total of 10 lots, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. Torrent is only recalling lots of losartan-containing products that contain N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.

FDA - U.S. Food and Drug Administration

22-12-2018

Modification of the existing maximum residue level for captan in cranberries

Modification of the existing maximum residue level for captan in cranberries

Published on: Fri, 21 Dec 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the Belgian Federal Public Service (FPS) for Health, Food chain safety and Environment, submitted an application as the competent national authority in Belgium to modify the existing maximum residue level (MRL) for the active substance captan in cranberries. The data submitted in support of the request were found to be sufficient to derive MRL proposal for cranberries. Adequate analytical methods for enforcement ...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-12-2018

Funky Chunky, Llc Issues Allergy Alert on Undeclared Almond and Cashew Tree-Nut in 10 Oz. Nutty Choco Pop Found in Chocolate Popcorn Gift Box, Holiday Crowd Pleaser and Crowd Pleaser Gifts

Funky Chunky, Llc Issues Allergy Alert on Undeclared Almond and Cashew Tree-Nut in 10 Oz. Nutty Choco Pop Found in Chocolate Popcorn Gift Box, Holiday Crowd Pleaser and Crowd Pleaser Gifts

Funky Chunky, LLC of Eden Prairie, MN is recalling 10 oz Nutty Choco Pop Gift Box, 50 oz. Holiday Crowd Pleaser and 50 oz. Crowd Pleaser, because it may contain undeclared Almond and Cashew Tree Nut. People who have an allergy or severe sensitivity to Almonds and Cashews run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

21-12-2018

Verbetering voedselveiligheid door geleerde lessen Fipronil

Verbetering voedselveiligheid door geleerde lessen Fipronil

Minister Bruno Bruins (Medische Zorg en Sport, VWS) en minister Carola Schouten (Landbouw, Natuur en Voedselkwaliteit, LNV) hebben vandaag het Actieplan Voedselveiligheid aan de Tweede Kamer aangeboden. Het plan bevat maatregelen om de voedselveiligheid verder te verbeteren en volgt in reactie op de aanbevelingen van de Commissie Sorgdrager. Deze commissie onderzocht welke lessen geleerd moeten worden uit het Fipronil-incident in de zomer van 2017. Veel verbeteringen zijn inmiddels al in de praktijk toeg...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

17-12-2018

Blokhuis stelt prioriteiten van actieprogramma Zwerfjongeren vast

Blokhuis stelt prioriteiten van actieprogramma Zwerfjongeren vast

Een betaalbare woonplek, voldoende kansen op een opleiding en een baan, financiële zelfredzaamheid en voldoende zorg en ondersteuning. Basisbehoeften voor ieder mens, maar waaraan de 10.700 zwerfjongeren (18 – 27 jaar) in Nederland nog te vaak tekortkomen. Op die vier ‘levensbrede’ prioriteiten zal de staatssecretaris zich richten met zijn actieprogramma Zwerfjongeren, dat hij afgelopen oktober in Tweede Kamer aankondigde. Met het actieprogramma brengt hij lokale partijen en gemeenten, maar ook andere ve...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

17-12-2018


Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

14-12-2018

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Published on: Thu, 13 Dec 2018 The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) in food. Regarding PFOS and PFOA occurrence, the final data set available for dietary exposure assessment contained a total of 20,019 analytical results (PFOS n = 10,191 and PFOA n = 9,828). There were large differences between upper and lower bound exposure due to analytical methods with i...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Statement on the safety of d‐ribose

Statement on the safety of d‐ribose

Published on: Thu, 13 Dec 2018 In 2018, the EFSA NDA Panel adopted the Scientific Opinion on the safety of d‐ribose as a novel food pursuant to Regulation (EU) 2015/2283 when used in a variety of food, concluding that d‐ribose is safe for the general population at intake levels up to 36 mg/kg body weight (bw) per day, but that its safety at the intended uses and use levels as proposed by the applicant could not be established. Following a request from the European Commission, the EFSA NDA Panel was aske...

Europe - EFSA - European Food Safety Authority Publications

12-12-2018

December 10, 2018: Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections

December 10, 2018: Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections

December 10, 2018: Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections

FDA - U.S. Food and Drug Administration

11-12-2018


The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 08/04/2019 to 10/04/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 08/04/2019 to 10/04/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 08/04/2019 to 10/04/2019

Europe - EMA - European Medicines Agency

10-12-2018


Agenda - CHMP agenda of the 10-13 December 2018

Agenda - CHMP agenda of the 10-13 December 2018

Agenda - CHMP agenda of the 10-13 December 2018

Europe - EMA - European Medicines Agency

20-2-2019


Orphan designation: Rufinamide, Treatment of Lennox-Gastaut syndrome, 20/10/2004, Expired

Orphan designation: Rufinamide, Treatment of Lennox-Gastaut syndrome, 20/10/2004, Expired

Orphan designation: Rufinamide, Treatment of Lennox-Gastaut syndrome, 20/10/2004, Expired

Europe - EMA - European Medicines Agency

19-2-2019


Orphan designation: Rucaparib, Treatment of ovarian cancer, 10/10/2012, Withdrawn

Orphan designation: Rucaparib, Treatment of ovarian cancer, 10/10/2012, Withdrawn

Orphan designation: Rucaparib, Treatment of ovarian cancer, 10/10/2012, Withdrawn

Europe - EMA - European Medicines Agency

14-2-2019

EU/3/10/798 (Diurnal Europe B.V.)

EU/3/10/798 (Diurnal Europe B.V.)

EU/3/10/798 (Active substance: Synthetic double-stranded short interfering RNA oligonucleotide directed against proopiomelanocortin) - Transfer of orphan designation - Commission Decision (2019)1360 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003061

Europe -DG Health and Food Safety

13-2-2019


Orphan designation: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide, Treatment of acute myeloid leukaemia, 14/10/2016, Positive

Orphan designation: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide, Treatment of acute myeloid leukaemia, 14/10/2016, Positive

Orphan designation: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide, Treatment of acute myeloid leukaemia, 14/10/2016, Positive

Europe - EMA - European Medicines Agency

13-2-2019


Orphan designation: Seladelpar, Treatment of primary biliary cholangitis, 16/10/2017, Positive

Orphan designation: Seladelpar, Treatment of primary biliary cholangitis, 16/10/2017, Positive

Orphan designation: Seladelpar, Treatment of primary biliary cholangitis, 16/10/2017, Positive

Europe - EMA - European Medicines Agency

28-1-2019


Orphan designation: Mogamulizumab, Treatment of cutaneous T-cell lymphoma, 14/10/2016, Positive

Orphan designation: Mogamulizumab, Treatment of cutaneous T-cell lymphoma, 14/10/2016, Positive

Orphan designation: Mogamulizumab, Treatment of cutaneous T-cell lymphoma, 14/10/2016, Positive

Europe - EMA - European Medicines Agency

25-1-2019


Orphan designation: Glucagon, Treatment of congenital hyperinsulinism, 08/10/2009, Positive

Orphan designation: Glucagon, Treatment of congenital hyperinsulinism, 08/10/2009, Positive

Orphan designation: Glucagon, Treatment of congenital hyperinsulinism, 08/10/2009, Positive

Europe - EMA - European Medicines Agency

23-1-2019

EU/3/10/777 (Voisin Consulting S.A.R.L.)

EU/3/10/777 (Voisin Consulting S.A.R.L.)

EU/3/10/777 (Active substance: Cyclic pyranopterin monophosphate) - Transfer of orphan designation - Commission Decision (2019)574 of Wed, 23 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003164

Europe -DG Health and Food Safety

22-1-2019

EU/3/10/841 (Vanda Pharmaceuticals Germany GmbH)

EU/3/10/841 (Vanda Pharmaceuticals Germany GmbH)

EU/3/10/841 (Active substance: Tasimelteon) - Transfer of orphan designation - Commission Decision (2019)573 of Tue, 22 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002557

Europe -DG Health and Food Safety

16-1-2019

EU/3/10/833 (FGK Representative Service GmbH)

EU/3/10/833 (FGK Representative Service GmbH)

EU/3/10/833 (Active substance: Doxorubicin hydrochloride (in heat-sensitive liposomes)) - Transfer of orphan designation - Commission Decision (2019)237 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003113

Europe -DG Health and Food Safety

11-1-2019


Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia A, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine, Treatment

Orphan designation: glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine, Treatment

Orphan designation: glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine, Treatment of maple syrup urine disease, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019

Strensiq (Alexion Europe SAS)

Strensiq (Alexion Europe SAS)

Strensiq (Active substance: asfotase alfa) - Centralised - Yearly update - Commission Decision (2019)69 of Thu, 10 Jan 2019

Europe -DG Health and Food Safety

4-1-2019


Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Recommendations on eligibility to PRIME scheme -  Adopted at the CHMP meeting of 10-13 December 2018

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 December 2018

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 December 2018

Europe - EMA - European Medicines Agency

18-12-2018

EU/3/18/2111 (Rheacell GmbH and Co. KG)

EU/3/18/2111 (Rheacell GmbH and Co. KG)

EU/3/18/2111 (Active substance: Allogeneic ABCB5-positive limbal stem cells) - Orphan designation - Commission Decision (2018)9026 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/155/18

Europe -DG Health and Food Safety

14-12-2018


Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Europe - EMA - European Medicines Agency