Fury 10 EW

Informazioni principali

  • Nome commerciale:
  • Fury 10 EW
  • Forma farmaceutica:
  • EW emulsione, olio in acqua
  • Utilizzare per:
  • Piante
  • Tipo di medicina:
  • Agrochimico

Documenti

  • per i professionisti:
  • Il foglio illustrativo per questo prodotto non è al momento disponibile, é possibile inviare una richiesta al nostro Servizio Clienti ed essere avvisati nel momento in cui è disponibile sulla nostra piattaforma.


    Richiedi il foglio illustrativo per i professionisti.

Localizzazione

  • Disponibile in:
  • Fury 10 EW
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Insetticida

Altre informazioni

Status

  • Fonte:
  • UFAG - Ufficio federale dell'agricoltura. OFAG - Office fédéral de l'agriculture. BLW - Bundesamt für Landwirtschaft.
  • Numero dell'autorizzazione:
  • W-5953
  • Ultimo aggiornamento:
  • 18-11-2018

Foglio illustrativo: composizione, posologia, indicazioni, interazioni, gravidanza, allattamento, effetti indesiderati, controindicazioni

Denominazione commerciale: Fury 10 EW

Elenco dei prodotti fitosanitari (stato: 06.11.2018)

Categoria di prodotti:

Titolare dell'autorizzazione:

Numero federale di omologazione:

Insetticida

Omya (Schweiz) AG

W-5953

Principio:

Tenore:

Codice di formulazione:

Principio attivo: zeta-Cipermetrina 9.6 % 100 g/l

EW emulsione, olio in acqua

Applicazioni

A

Coltura

Agente

patogeno/Efficacia

Dosaggio

Restrizioni

B Fragola

Antonomo delle

fragole o dei lamponi

Tripidi

Concentrazione: 0.01 %

Dose: 0.1 l/ha

Termine d'attesa: 3 Settimane

1, 2, 3, 4, 5,

B Lampone

Antonomo delle

fragole o dei lamponi

Verme del lampone

Concentrazione: 0.01 %

Dose: 0.1 l/ha

Termine d'attesa: 3 Settimane

2, 3, 4, 7, 8,

Aglio

Alchechengio

Carciofi

Carote

Cicoria belga

Cipolle da tavola

Cipolle dolci

Cucurbitacee

Fagioli

Fave

Insalate (Asteracee)

Melanzana

Pastinaca

Peperone

Pepino

Piselli

Pomodori

Porro

Prezzemolo tuberoso

Scalogni

Scorzonera

Sedano rapa

Topinambur

Tuberina

Valerianella

Nottue terricole o

vermi grigi

Concentrazione: 0.02 %

Dose: 0.2 l/ha

Termine d'attesa: 2 Settimane

2, 3, 4, 5, 10

A

Coltura

Agente

patogeno/Efficacia

Dosaggio

Restrizioni

Serra: Alchechengio

Serra: Barbabietola

Serra: Bietola

Serra: Carciofi

Serra: Carote

Serra: Cavoli / rape da taglio

Serra: Cicoria belga

Serra: Cima di rapa

Serra: Crescione

Serra: Crescione acquatico

Serra: Cucurbitacee

Serra: Erbette da cucina

Serra: Fagioli

Serra: Fave

Serra: Insalate (Asteracee)

Serra: Insalate asiatiche

(Brassicacee)

Serra: Mais dolce

Serra: Melanzana

Serra: Pastinaca

Serra: Peperone

Serra: Pepino

Serra: Piselli

Serra: Pomodori

Serra: Portulaca

Serra: Prezzemolo tuberoso

Serra: Rafano rusticana /

Ramolaccio

Serra: Ramolaccio

Serra: Rapa di Brassica rapa

e B. napus

Serra: Ravanello

Serra: Rucola

Serra: Scorzonera

Serra: Sedano rapa

Serra: Specie di cavoli

Serra: Spinaci

Serra: Topinambur

Serra: Tuberina

Serra: Valerianella

Afidi

Aleurodidi

Larve defogliatrici

Tripidi

Concentrazione: 0.01 %

Dose: 0.1 l/ha

Termine d'attesa: 3 Giorni

2, 3, 10

G Asparagi

Criocera a dodici

punti

Dose: 0.1 l/ha

Applicazione: Dopo il raccolto.

2, 3, 4, 5, 9

G Asparagi

Nottue terricole o

vermi grigi

Dose: 0.2 l/ha

Applicazione: Dopo il raccolto.

2, 3, 4, 5, 9

G Barbabietola

Bietola

Cavoli / rape da taglio

Cima di rapa

Crescione

Altiche

Nottue terricole o

vermi grigi

Dose: 0.2 l/ha

Termine d'attesa: 2 Settimane

2, 3, 4, 5, 10

A

Coltura

Agente

patogeno/Efficacia

Dosaggio

Restrizioni

Crescione acquatico

Erbette da cucina

Insalate asiatiche

(Brassicacee)

Mais dolce

Portulaca

Rafano rusticana /

Ramolaccio

Ramolaccio

Rapa di Brassica rapa e B.

napus

Ravanello

Rucola

Specie di cavoli

Spinaci

G Carote

Afidi

Dose: 0.15 l/ha

Termine d'attesa: 2 Settimane

2, 3, 4, 5, 10

Carote

Pastinaca

Prezzemolo tuberoso

Sedano rapa

Mosca della carota

Dose: 0.2 l/ha

Termine d'attesa: 4 Settimane

2, 3, 4, 5, 11

G Carote

Psilla della carota

Dose: 0.1 l/ha

Termine d'attesa: 2 Settimane

2, 3, 4, 5, 10

Cipolle da tavola

Cipolle dolci

Porro

Tignola del porro

Tripidi

Dose: 0.15 l/ha

Termine d'attesa: 2 Settimane

2, 3, 4, 5, 10

G Fagioli

Piralide del mais

Dose: 0.1 l/ha

Termine d'attesa: 2 Settimane

2, 3, 4, 5, 10

G Piselli senza baccello

Afide del pisello

Dose: 0.15 l/ha

Termine d'attesa: 2 Settimane

2, 3, 4, 5, 10

G Piselli senza baccello

Sitone del pisello

Dose: 0.15 l/ha

Termine d'attesa: 2 Settimane

2, 3, 4, 5, 12

G Rabarbaro

Altiche

Nottue terricole o

vermi grigi

Dose: 0.2 l/ha

Applicazione: Dopo il raccolto.

2, 3, 4, 5, 9

G Specie di cavoli

Afidi

Aleurodidi

Cavolaie

Cecidomia del cavolo

Nottue (defogliatrici)

Punteruolo degli steli

Dose: 0.15 l/ha

Termine d'attesa: 2 Settimane

2, 3, 4, 5, 10

A

Coltura

Agente

patogeno/Efficacia

Dosaggio

Restrizioni

di cavoli

Punteruolo delle galle

dei cavoli

Tignola delle

Crocifere

Barbabietola da foraggio

Barbabietola da zucchero

Altiche della

barbabietola

Dose: 0.1 l/ha

Termine d'attesa: 6 Settimane

2, 3, 4, 5, 12

Barbabietole da foraggio e

da zucchero

Cartamo

Cereali

Colza

Fava

Girasole

Graminacee per la

produzione di sementi

Lino

Lupini

Luppolo

Mais

Patate

Pisello proteico

Riso seminato su terreno

asciutto

Soia

Sorgo

Tabacco

Trifoglio per la produzione

di sementi

Nottue terricole o

vermi grigi

Dose: 0.2 l/ha

Termine d'attesa: 6 Settimane

2, 3, 4, 5, 13

F Cereali

Cloropo del grano

Dose: 0.1 l/ha

Termine d'attesa: 6 Settimane

2, 3, 4, 5, 12

F Colza

Punteruolo delle

silique delle crocifere

Azione parziale:

Cecidomia delle

silique delle crocifere

Dose: 0.1 l/ha

Termine d'attesa: 6 Settimane

Applicazione: Fino allo stadio fine

sviluppo dei bottoni fiorali. (BBCH

59).

2, 3, 4, 5, 13

F Colza

Punteruolo degli steli

della colza

Dose: 0.1 l/ha

Termine d'attesa: 6 Settimane

Applicazione: Stadi 31-53 (BBCH).

2, 3, 4, 5, 13

F Colza autunnale

Altica della colza

Punteruolo nero

d'inverno

Tentredine delle

crocifere

Dose: 0.1 l/ha

Applicazione: In autunno.

2, 3, 4, 5, 13

A

Coltura

Agente

patogeno/Efficacia

Dosaggio

Restrizioni

F Patate

Dorifora della patata

Dose: 0.1 l/ha

Termine d'attesa: 3 Settimane

2, 3, 4, 5, 14

F Pisello proteico

Sitone del pisello

Dose: 0.15 l/ha

Termine d'attesa: 2 Settimane

2, 3, 4, 5, 12

F Soia

Vanessa del cardo

Dose: 0.1 l/ha

Termine d'attesa: 2 Settimane

Applicazione: Nel caso di

importanti infestazioni di larve.

2, 3, 4, 5, 12

Colture da fiore e piante

verdi

Afidi

Aleurodidi

Crisomelidi

Larve defogliatrici

Nottue terricole o

vermi grigi

Tripidi

Concentrazione: 0.01 %

2, 3, 4, 8

Tronchi abbattuti nella

foresta e presso piazzali di

deposito

Scolitidi

Concentrazione: 0.1 %

Applicazione: 2 - 3 l di poltiglia/m³.

3, 8, 15

Restrizioni e osservazioni:

La dose indicata si riferisce allo stadio "piena fioritura fino all'inizio dell'arrossamento dei

frutticini", 4 piante/m², trattamento con una quantità standard di poltiglia di 1000 l/ha.

SPe 8: Pericoloso per le api - Può entrare in contatto con piante in fiore o che presentano melata

soltanto di sera, al di fuori del periodo di volo delle api. Applicazione soltanto in serre chiuse, a

condizione che non siano presenti impollinatori.

Durante la preparazione della poltiglia: Indossare guanti di protezione.

SPe 3: Per proteggere organismi acquatici dagli effetti della deriva rispettare una zona tampone

non trattata di 100 metri dalle acque superficiali. Per la protezione contro gli effetti di un

dilavamento, rispettare una zona tampone con copertura vegetale a una distanza di almeno 6 metri.

Riduzione della distanza a causa di deriva ed eccezioni secondo le istruzioni dell'UFAG.

SPe 3: per la protezione di artropodi non target dagli effetti della deriva rispettare una zona

tampone non trattata di 6 m dai biotopi in virtù degli art. 18a e 18b LNP. Tale distanza può essere

ridotta attuando misure di riduzione della deriva secondo le istruzioni dell'UFAG.

Al massimo 2 trattamenti per coltura e anno con questo prodotto o qualsiasi altro prodotto

contenente tale sostanza attiva.

Per i lamponi estivi la dose indicata si riferisce allo stadio "inizio fioritura fino a 50% dei fiori

aperti", trattamento con una quantità standard di poltiglia di 1000 l/ha. Per i lamponi autunnali la

dose si riferisce ad una siepe di 150 - 170 cm d'altezza, trattamento con una quantità standard di

poltiglia di 1000 l/ha.

SPe 3: per la protezione di artropodi non target dagli effetti della deriva rispettare una zona

tampone non trattata di 20 m dai biotopi in virtù degli art. 18a e 18b LNP. Tale distanza può essere

ridotta attuando misure di riduzione della deriva secondo le istruzioni dell'UFAG.

Al massimo 2 trattamenti per anno e particella con questo prodotto o qualsiasi altro prodotto

contenente tale sostanza attiva

10.Al massimo 2 trattamenti per coltura con questo prodotto o qualsiasi altro prodotto contenente tale

sostanza attiva.

11.Trattamenti solo durante il volo (secondo numero critico delle catture) a intervalli di almeno 7

giorni.

12.Al massimo 1 trattamento per coltura con questo prodotto o qualsiasi altro prodotto contenente

tale sostanza attiva

13.Al massimo 1 trattamento per coltura e particella con questo prodotto o qualsiasi altro prodotto

contenente tale sostanza attiva

14.SPa 1: Per evitare l'insorgere di resistenza non applicare questo o altri prodotti contenenti un

piretroide per più di 1 volta per coltura.

15.SPe 3: per proteggere organismi acquatici dagli effetti della deriva rispettare una zona tampone

non trattata di 20 m dalle acque superficiali. Tale distanza può essere ridotta attuando misure di

riduzione della deriva secondo le istruzioni dell'UFAG.

Caratterizzazione di pericolo:

Tenere fuori dalla portata dei bambini.

EUH 401 Per evitare rischi per la salute umana e per l'ambiente, seguire le istruzioni per l'uso.

H302 Nocivo se ingerito.

H317 Può provocare una reazione allergica cutanea.

H332 Nocivo se inalato.

H410 Molto tossico per gli organismi acquatici con effetti di lunga durata.

SP 1 Non contaminare l'acqua con il prodotto o il suo imballaggio.

SPe 8 Pericoloso per le api

Avvertenza:

Attenzione

Simboli e indicazioni di pericolo:

Identificatore chiave

GHS07

GHS09

Simbolo

Indicazione di pericolo Attenzione pericolo Pericoloso per l'ambiente acquatico

In caso di dubbio valgono soltanto i documenti originali dell'omologazione. La menzione di un prodotto,

principio attivo o di una ditta non rappresenta alcuna raccomandazione.

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Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Vita Health Products Recall (2018-10-24)

Vita Health Products Recall (2018-10-24)

Health Canada

18-10-2018

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

The recalled products may contain phthalate levels that exceed the allowable levels.

Health Canada

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Published on: Wed, 10 Oct 2018 00:00:00 +0200 This report provides a review of existing models for predicting the spatial distribution and abundance of wild boar at various scales (global, continental, national and regional) in order to inform the development of a new model to produce estimates of wild boar abundance at European level. The review identifies and discusses a range of models based on a wide variety of data types, corresponding to those targeted by the data collection model set by ENETwild,...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

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

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

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

FDA - U.S. Food and Drug Administration

10-10-2018

Enforcement Report for the Week of October 10, 2018

Enforcement Report for the Week of October 10, 2018

Recently Updated Records for the Week of October 10, 2018 Last Modified Date: Tuesday, October 09, 2018

FDA - U.S. Food and Drug Administration

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

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

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

10-12-2018

Exondys (AVI BioPharma International Ltd)

Exondys (AVI BioPharma International Ltd)

Exondys (Active substance: eteplirsen) - Centralised - Refusal of marketing authorisation - Commission Decision (2018)8620 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4355

Europe -DG Health and Food Safety

10-12-2018

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (Active substance: ivabradine) - Centralised - Withdrawal - Commission Decision (2018)8623 of Mon, 10 Dec 2018

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1662 (QRC Ireland)

EU/3/16/1662 (QRC Ireland)

EU/3/16/1662 (Active substance: H-Phe-Ser-Arg-Tyr-Ala-Arg-OH acetate) - Transfer of orphan designation - Commission Decision (2018)8626 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/011/16/T/01

Europe -DG Health and Food Safety

10-12-2018

EU/3/17/1906 (PTC Therapeutics International Limited)

EU/3/17/1906 (PTC Therapeutics International Limited)

EU/3/17/1906 (Active substance: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein) - Transfer of orphan designation - Commission Decision (2018)8634 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002509

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)8630 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002507

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1651 (PTC Therapeutics International Limited)

EU/3/16/1651 (PTC Therapeutics International Limited)

EU/3/16/1651 (Active substance: Recombinant adeno-associated viral vector serotype 9 carrying the gene for the human E6-AP ubiquitin protein ligase) - Transfer of orphan designation - Commission Decision (2018)8632 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002508

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1802 (FGK Representative Service GmbH)

EU/3/16/1802 (FGK Representative Service GmbH)

EU/3/16/1802 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)8627 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002422

Europe -DG Health and Food Safety

10-12-2018

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (Active substance: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt) - Transfer of orphan designation - Commission Decision (2018)8636 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002385

Europe -DG Health and Food Safety

10-12-2018

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (Active substance: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1?3)-beta-D-galactopyranoside) - Transfer of orphan designation - Commission Decision (2018)8628 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/17/T/01

Europe -DG Health and Food Safety

10-12-2018

EU/3/09/628 (Nova Laboratories Ireland Limited)

EU/3/09/628 (Nova Laboratories Ireland Limited)

EU/3/09/628 (Active substance: Mercaptopurine (oral suspension)) - Transfer of orphan designation - Commission Decision (2018)8629 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002301

Europe -DG Health and Food Safety

10-12-2018

EU/3/11/933 (Les Laboratoires Servier)

EU/3/11/933 (Les Laboratoires Servier)

EU/3/11/933 (Active substance: Nanoliposomal irinotecan) - Transfer of orphan designation - Commission Decision (2018)8625 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/11/T/02

Europe -DG Health and Food Safety

7-12-2018


Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Europe - EMA - European Medicines Agency

7-12-2018


Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Europe - EMA - European Medicines Agency

26-11-2018

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware of those technologies.

FDA - U.S. Food and Drug Administration

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

22-11-2018

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Active substance: emtricitabine / tenofovir disoproxil) - Centralised - 2-Monthly update - Commission Decision (2018)7884 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4215/IB/10G

Europe -DG Health and Food Safety

22-11-2018


Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Europe - EMA - European Medicines Agency

13-11-2018

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

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

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

Europe -DG Health and Food Safety

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

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

Europe -DG Health and Food Safety

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Active substance: Sildenafil citrate) - Transfer of orphan designation - Commission Decision (2018)6993 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/068/10/T/01

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

Recocam (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6954 of Fri, 19 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2247/T/10

Europe -DG Health and Food Safety

2-10-2018

Retacrit (Pfizer Europe MA EEIG)

Retacrit (Pfizer Europe MA EEIG)

Retacrit (Active substance: epoetin zeta) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6481 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/872/T/86

Europe -DG Health and Food Safety