Gesal Gemüse-Insektizid Decis

Hauptinformation

  • Handelsname:
  • Gesal Gemüse-Insektizid Decis
  • Darreichungsform:
  • EW Emulsion, Öl in Wasser
  • Verwenden für:
  • Pflanzen
  • Art der Medizin:
  • Agrochemisch

Dokumenten

  • Information für medizinisches Fachpersonal:
  • Das Informationsblatt für dieses Produkt ist derzeit nicht verfügbar, können Sie eine Anfrage an unseren Kundendienst zu senden und wir werden Sie benachrichtigen, sobald wir in der Lage, um es zu erhalten.


    Fordern Sie die Packungsbeilage für medizinisches Fachpersonal.

Lokalisierung

  • Erhältlich in:
  • Gesal Gemüse-Insektizid Decis
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Insektizid

Weitere Informationen

Status

  • Quelle:
  • UFAG - Ufficio federale dell'agricoltura. OFAG - Office fédéral de l'agriculture. BLW - Bundesamt für Landwirtschaft.
  • Zulassungsnummer:
  • W-6381-1
  • Letzte Änderung:
  • 14-11-2018

Packungsbeilage

Handelsbezeichnung: Gesal Gem

se-Insektizid

Decis

Pflanzenschutzmittelverzeichnis (Stand: 06.11.2018)

Produktkategorie:

Bewilligungsinhaber:

Eidg. Zulassungsnummer:

Insektizid

COMPO Jardin AG

W-6381-1

Stoff(e):

Gehalt:

Formulierungscode:

Wirkstoff: Deltamethrin 1.47 % 15 g/l

EW Emulsion, Öl in Wasser

Anwendungen

A

Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

B Himbeere

Himbeerk

Konzentration: 0.065 %

Aufwandmenge: 0.65 l/ha

Wartefrist: 3 Woche(n)

1, 2, 3, 4, 5

G Andenbeere

Artischocken

Asia-Salate (Brassicaceae)

Aubergine

Blumenkohle

Bohnen

Chicor

Cima di Rapa

Erbsen

Karotten

Knoblauch

Knollensellerie

Kohlrabi

Kopfkohle

Kresse

chenkr

uter

rbisgew

chse

(Cucurbitaceae)

Lauch

Meerrettich

sslisalat

Paprika

Pastinake

Pepino

Puffbohne

Radies

Rande

Rettich

Erdraupen

Konzentration: 0.08 %

Aufwandmenge: 0.8 l/ha

Wartefrist: 2 Woche(n)

3, 4, 5, 6

A

Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

Rosenkohl

Rucola

Salate (Asteraceae)

Schalotten

Schwarzwurzel

Speisekohlr

Spinat

Stachys

Stielmus

Tomaten

Topinambur

Wurzelpetersilie

Zuckermais

Zwiebeln

chshaus:

Andenbeere

chshaus:

Aubergine

chshaus:

Blumenkohle

chshaus: Bohnen

chshaus: Chicor

chshaus: Erbsen

chshaus: Gem

sezwiebel

chshaus: Karotten

chshaus:

Knoblauch

chshaus:

Knollensellerie

chshaus: Kohlrabi

chshaus:

Kopfkohle

chshaus: K

rbisgew

chse

(Cucurbitaceae)

chshaus:

Meerrettich

chshaus: Paprika

chshaus: Pastinake

chshaus: Pepino

chshaus:

Puffbohne

chshaus: Radies

chshaus: Rande

chshaus: Rettich

chshaus:

Weisse Fliegen

(Mottenschildl

use)

Konzentration: 0.08 %

Aufwandmenge: 0.8 l/ha

Wartefrist: 3 Tage

3, 4, 6

A

Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

Rosenkohl

chshaus:

Schalotten

chshaus:

Schwarzwurzel

chshaus:

Speisekohlr

chshaus:

Speisezwiebel

chshaus: Stachys

chshaus: Tomaten

chshaus:

Topinambur

chshaus:

Wurzelpetersilie

chshaus:

Zuckermais

G Baby-Leaf

Erdraupen

Konzentration: 0.08 %

Aufwandmenge: 0.8 l/ha

Wartefrist: 2 Woche(n)

3, 4, 5, 6

G Blattkohle

Erdraupen

Aufwandmenge: 0.5 l/ha

Wartefrist: 2 Woche(n)

3, 4, 6, 7

G Bohnen

Leguminosenz

nsler

Schw

rmer

Aufwandmenge: 0.5 l/ha

Wartefrist: 2 Woche(n)

3, 4, 7, 8

chshaus:

Bundzwiebeln

Weisse Fliegen

(Mottenschildl

use)

Aufwandmenge: 0.8 l/ha

Wartefrist: 1 Woche(n)

3, 4, 6

Erbsen ohne H

lsen

Erbsenblattrandk

Aufwandmenge: 0.5 l/ha

Wartefrist: 2 Woche(n)

3, 4, 7, 8

Erbsen ohne H

lsen

Erbsenwickler

Aufwandmenge: 0.5 l/ha

Wartefrist: 2 Woche(n)

3, 4, 6, 7

G Karotten

Blattl

use (R

hrenl

use)

hrenblattfloh

Aufwandmenge: 0.5 l/ha

Wartefrist: 2 Woche(n)

3, 4, 6, 7

Karotten

Knollensellerie

Pastinake

Wurzelpetersilie

hrenfliege

Aufwandmenge: 1.6 l/ha

Wartefrist: 4 Woche(n)

3, 4, 5, 9

Knoblauch

Schalotten

Lauchmotte

Aufwandmenge: 0.5 l/ha

Wartefrist: 2 Woche(n)

3, 4, 6, 7

A

Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

G Kohlarten

Eulenraupen

(blattfressend)

Gefleckter Kohltriebr

ssler

Kohldrehherzgallm

Kohlgallenr

ssler

Weisslinge

Aufwandmenge: 0.5 l/ha

Wartefrist: 2 Woche(n)

3, 4, 6, 7

Lauch

Zwiebeln

Thripse

Aufwandmenge: 0.5 l/ha

Wartefrist: 2 Woche(n)

3, 4, 6, 7

G Rhabarber

Erdraupen

Aufwandmenge: 0.8 l/ha

Anwendung: Nach der Ernte.

3, 4, 5, 10

chshaus:

Rhabarber

chshaus: Spargel

Weisse Fliegen

(Mottenschildl

use)

Aufwandmenge: 0.8 l/ha

Anwendung: Nach der Ernte.

3, 4, 10

G Spargel

Erdraupen

Spargelfliege

Aufwandmenge: 0.8 l/ha

Anwendung: Nach der Ernte.

3, 4, 5, 10

G Spargel

Spargelh

hnchen

Spargelk

Aufwandmenge: 0.5 l/ha

Anwendung: Nach der Ernte.

3, 4, 7, 10

F Eiweisserbse

Erbsenblattrandk

Erbsenwickler

Aufwandmenge: 0.5 l/ha

Wartefrist: 2 Woche(n)

3, 4, 7, 11

F Getreide

Gelbe

Getreidehalmfliege

Aufwandmenge: 0.5 l/ha

Wartefrist: 6 Woche(n)

3, 4, 7, 12

F Hopfen

Blattl

use (R

hrenl

use)

Konzentration: 0.05 %

Wartefrist: 3 Woche(n)

3, 4, 5, 13

F Kartoffeln

Kartoffelk

Aufwandmenge: 0.5 l/ha

Wartefrist: 3 Woche(n)

3, 4, 7, 14

F Mais

Fritfliege

Aufwandmenge: 0.5 l/ha

Wartefrist: 6 Woche(n)

3, 4, 7, 11

F Raps

Kohlschotenr

ssler

Teilwirkung:

Kohlschotengallm

Aufwandmenge: 0.5 l/ha

Anwendung: Bis Ende Entwicklung

der Bl

tenknospen (BBCH 59).

3, 4, 7, 12

F Raps

Rapsstengelr

ssler

Aufwandmenge: 0.65 l/ha

Wartefrist: 6 Woche(n)

Anwendung: Stadium 31-53

3, 4, 5, 12

A

Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

(BBCH).

F Sojabohne

Distelfalter

Aufwandmenge: 0.5 l/ha

Wartefrist: 2 Woche(n)

3, 4, 7, 11

F Wintergetreide

Virus

bertragende

Blattl

Aufwandmenge: 0.5 l/ha

Anwendung: Im Herbst.

3, 4, 7, 12

F Winterraps

Rapsblattwespe

Rapserdfloh

Aufwandmenge: 0.5 l/ha

Anwendung: Im Herbst.

3, 4, 7, 12

Zuckerr

Erdraupen

Aufwandmenge: 0.8 l/ha

Wartefrist: 6 Woche(n)

3, 4, 5, 11

Zuckerr

benerdfl

Aufwandmenge: 0.5 l/ha

Wartefrist: 6 Woche(n)

3, 4, 7, 11

Blumenkulturen und Gr

npflanzen

Blattfressende Raupen

Blattk

Blattl

use (R

hrenl

use)

Erdraupen

Napfschildl

Thripse

Weisse Fliegen

(Mottenschildl

use)

Konzentration: 0.08 %

3, 4, 5, 15,

Auflagen und Bemerkungen:

Maximal 2 Behandlungen pro Parzelle und Jahr.

r Sommerhimbeeren bezieht sich die angegebene Aufwandmenge auf Stadium "Erste Bl

ten bis etwa 50% der Bl

ten offen" sowie eine Referenzbr

hmenge von 1000 l/ha. F

Herbsthimbeeren bezieht sich die Aufwandmenge auf eine Heckenh

he von 150 - 170 cm sowie

eine Referenzbr

hmenge von 1000 l/ha.

SPe 8: Gef

hrlich f

r Bienen - Darf nur ausserhalb des Bienenfluges am Abend mit bl

henden oder Honigtau aufweisenden Pflanzen in Kontakt kommen. Anwendung im geschlossenen

chshaus sofern keine Best

uber zugegen sind.

Ansetzen der Spritzbr

he: Schutzhandschuhe tragen.

SPe 3: Zum Schutz von Gew

sserorganismen vor den Folgen von Drift eine unbehandelte

Pufferzone von 100 m zu Oberfl

chengew

ssern einhalten. Zum Schutz vor den Folgen einer

Abschwemmung eine mit einer geschlossenen Pflanzendecke bewachsene Pufferzone von

mindestens 6 m einhalten. Reduktion der Distanz aufgrund von Drift und Ausnahmen gem

den Weisungen des BLW.

Maximal 2 Behandlungen pro Kultur mit diesem Produkt oder einem anderen Produkt, das diesen

Wirkstoff enth

SPe 3: Zum Schutz von Gew

sserorganismen vor den Folgen von Drift eine unbehandelte

Pufferzone von 50 m zu Oberfl

chengew

ssern einhalten. Zum Schutz vor den Folgen einer

Abschwemmung eine mit einer geschlossenen Pflanzendecke bewachsene Pufferzone von

mindestens 6 m einhalten. Reduktion der Distanz aufgrund von Drift und Ausnahmen gem

den Weisungen des BLW.

Maximal 1 Behandlung pro Kultur mit diesem Produkt oder einem anderen Produkt, das diesen

Wirkstoff enth

Behandlungen nur w

hrend dem Flug (gem

ss kritischer Fangzahl) im Abstand von

mindestens 7 Tagen.

10.Maximal 2 Behandlungen pro Parzelle und Jahr mit diesem Produkt oder einem anderen Produkt,

das diesen Wirkstoff enth

11.Maximal 1 Behandlung pro Kultur.

12.Maximal 1 Behandlung pro Kultur und Jahr.

13.Maximal 3 Behandlungen pro Kultur.

14.SPa 1: Zur Vermeidung einer Resistenzbildung darf dieses oder irgendein anderes

Pflanzenschutzmittel, welches ein Pyrethroid enth

lt, nicht mehr als 1 mal pro Kultur

ausgebracht werden.

15.Nur gegen nichtresistente St

mme geeignet.

16.Nicht vernebeln oder verdampfen.

Gefahrenkennzeichnungen:

Darf nicht in die H

nde von Kindern gelangen.

EUH 208 Enth

lt [Name des sensibilisierenden Stoffes]. Kann allergische Reaktionen

hervorrufen.

EUH 401 Zur Vermeidung von Risiken f

r Mensch und Umwelt die Gebrauchsanleitung

einhalten.

H226 Fl

ssigkeit und Dampf entz

ndbar.

H410 Sehr giftig f

r Wasserorganismen mit langfristiger Wirkung.

SP 1 Mittel und/oder dessen Beh

lter nicht in Gew

sser gelangen lassen.

SPe 8 Bienengef

hrlich

Signalwort:

Achtung

Gefahrensymbole und -bezeichnungen:

Kurzkennzeichnung

GHS02

GHS09

Symbol

Gefahrenbezeichnung

Hochentz

ndlich

ssergef

hrdend

Im Zweifelsfall gelten einzig die Originaldokumente der Zulassung. Die Erw

hnung eines Produktes,

Wirkstoffes oder einer Firma stellt keine Empfehlung dar und bedeutet nicht, dass sich das Produkt im

Verkauf befindet.

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

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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

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

12-11-2018

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Active substance: efavirenz / emtricitabine / tenofovir disoproxil) - Centralised - Yearly update - Commission Decision (2018)7547 of Mon, 12 Nov 2018

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6-11-2018

Symkevi (Vertex Pharmaceuticals (Europe) Limited)

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Symkevi (Active substance: tezacaftor/ivacaftor) - Centralised - Authorisation - Commission Decision (2018)7415 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4682

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6-11-2018

Trelegy Ellipta (GlaxoSmithKline Trading Services Limited)

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Trelegy Ellipta (Active substance: fluticasone furoate/umeclidinium/vilanterol) - Centralised - 2-Monthly update - Commission Decision (2018)7416 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4363/WS/1369

Europe -DG Health and Food Safety

6-11-2018

Elebrato Ellipta (GlaxoSmithKline Trading Services Limited)

Elebrato Ellipta (GlaxoSmithKline Trading Services Limited)

Elebrato Ellipta (Active substance: fluticasone furoate/umeclidinium/vilanterol) - Centralised - 2-Monthly update - Commission Decision (2018)7417 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4781/WS/1369

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6-11-2018

Neulasta (Amgen Europe B.V.)

Neulasta (Amgen Europe B.V.)

Neulasta (Active substance: Pegfilgrastim) - Centralised - Yearly update - Commission Decision (2018)7420 of Tue, 06 Nov 2018

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5-11-2018

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

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EU/3/18/2070 (Active substance: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid) - Orphan designation - Commission Decision (2018)7271 of Mon, 05 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/114/18

Europe -DG Health and Food Safety

5-11-2018

Improvac (Zoetis Belgium S.A.)

Improvac (Zoetis Belgium S.A.)

Improvac (Active substance: Not available) - Centralised - Yearly update - Commission Decision (2018)7381 of Mon, 05 Nov 2018

Europe -DG Health and Food Safety

1-11-2018

Zolvix (Elanco GmbH)

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Zolvix (Active substance: monepantel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7383 of Thu, 01 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/000154/T/0024

Europe -DG Health and Food Safety

1-11-2018

Protopic (Leo Pharma A/S)

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1-11-2018

Dexdomitor (Orion Corporation)

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Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

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1-11-2018

Taxespira (Hospira UK Limited)

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Taxespira (Active substance: docetaxel) - Centralised - Withdrawal - Commission Decision (2018)7368 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Integrilin (GlaxoSmithKline (Ireland) Limited)

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Integrilin (Active substance: Eptifibatide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7340 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/230/T/79

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31-10-2018

Volibris (GlaxoSmithKline (Ireland) Limited)

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Volibris (Active substance: Ambrisentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7339 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/839/T/56

Europe -DG Health and Food Safety

31-10-2018

AMGEVITA (Amgen Europe B.V.)

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AMGEVITA (Active substance: adalimumab) - Centralised - Yearly update - Commission Decision (2018)7341 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

31-10-2018

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Active substance: adalimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7344 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/T/15

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31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

30-10-2018

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Active substance: Phosphorothioate oligonucleotide targeted to transthyretin) - Transfer of orphan designation - Commission Decision (2018)7282 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/098/13/T/01

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Active substance: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant) - Orphan designation - Commission Decision (2018)7281 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/127/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Active substance: 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) - Orphan designation - Commission Decision (2018)7280 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/104/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Active substance: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG) - Orphan designation - Commission Decision (2018)7279 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/091/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Active substance: Melatonin) - Orphan designation - Commission Decision (2018)7278 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/077/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: 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) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Active substance: Gefitinib) - Orphan designation - Commission Decision (2018)7276 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/090/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (Active substance: Avapritinib) - Orphan designation - Commission Decision (2018)7275 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/079/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Active substance: Autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA) - Orphan designation - Commission Decision (2018)7274 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/113/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Active substance: 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) - Orphan designation - Commission Decision (2018)7272 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/125/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate) - Orphan designation - Commission Decision (2018)7273 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/102/18

Europe -DG Health and Food Safety

29-10-2018

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7249 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1144/WS1433/0051

Europe -DG Health and Food Safety

29-10-2018

Replagal (Shire Human Genetic Therapies AB)

Replagal (Shire Human Genetic Therapies AB)

Replagal (Active substance: Agalsidase alfa) - Centralised - Yearly update - Commission Decision (2018)7250 of Mon, 29 Oct 2018

Europe -DG Health and Food Safety

25-10-2018

Canigen L4 (Intervet International B.V.)

Canigen L4 (Intervet International B.V.)

Canigen L4 (Active substance: Leptospira interrogans serogroup Canicola serovar Portland-vere/Leptospira interrogans serogroup Icterohaemorrhagiae serovar Copenhageni/Leptospira interrogans serogroup Australis serovar Bratislava/Leptospira kirschneri serogroup Grippotyphosa serovar Dadas) - Centralised - Yearly update - Commission Decision (2018)7138 of Thu, 25 Oct 2018

Europe -DG Health and Food Safety

25-10-2018

Xtandi (Astellas Pharma Europe B.V.)

Xtandi (Astellas Pharma Europe B.V.)

Xtandi (Active substance: enzalutamide) - Centralised - 2-Monthly update - Commission Decision (2018)7132 of Thu, 25 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2639/II/39G

Europe -DG Health and Food Safety

25-10-2018

Micardis (Boehringer Ingelheim International GmbH)

Micardis (Boehringer Ingelheim International GmbH)

Micardis (Active substance: telmisartan) - Centralised - Yearly update - Commission Decision (2018)7136 of Thu, 25 Oct 2018

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

NEXGARD SPECTRA (Merial)

NEXGARD SPECTRA (Merial)

NEXGARD SPECTRA (Active substance: Afoxolaner / milbemycin oxime) - Centralised - 2-Monthly update - Commission Decision (2018)6977 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/003842/WS1338/0015/G

Europe -DG Health and Food Safety

22-10-2018

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Active substance: 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate) - Transfer of orphan designation - Commission Decision (2018)6989 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/253/15/T/01

Europe -DG Health and Food Safety

22-10-2018

EU/3/16/1689 (Alan Boyd Consultants Ltd)

EU/3/16/1689 (Alan Boyd Consultants Ltd)

EU/3/16/1689 (Active substance: Teriparatide) - Transfer of orphan designation - Commission Decision (2018)6987 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/031/16/T/01

Europe -DG Health and Food Safety

22-10-2018

EU/3/01/075 (Eisai GmbH)

EU/3/01/075 (Eisai GmbH)

EU/3/01/075 (Active substance: Denileukin diftitox) - Transfer of orphan designation - Commission Decision (2018)6991 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/038/01/T/02

Europe -DG Health and Food Safety

22-10-2018

Pemetrexed Hospira (Pfizer Europe MA EEIG)

Pemetrexed Hospira (Pfizer Europe MA EEIG)

Pemetrexed Hospira (Active substance: pemetrexed) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6971 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3970/T/14

Europe -DG Health and Food Safety

22-10-2018

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Active substance: mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches) - Centralised - Yearly update - Commission Decision (2018)6972 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/05/264 (Roche Registration GmbH)

EU/3/05/264 (Roche Registration GmbH)

EU/3/05/264 (Active substance: Cholest-4-en-3-one, oxime) - Transfer of orphan designation - Commission Decision (2018)6995 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/081/04/T/02

Europe -DG Health and Food Safety

22-10-2018

EU/3/11/901 (Merck Sharp and Dohme B.V.)

EU/3/11/901 (Merck Sharp and Dohme B.V.)

EU/3/11/901 (Active substance: Dinaciclib) - Transfer of orphan designation - Commission Decision (2018)6990 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/052/11/T/01

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Active substance: Triheptanoin) - Transfer of orphan designation - Commission Decision (2018)6992 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/007/15/T/02

Europe -DG Health and Food Safety

22-10-2018

Evoltra (Genzyme Europe B.V.)

Evoltra (Genzyme Europe B.V.)

Evoltra (Active substance: clofarabine) - Centralised - Yearly update - Commission Decision (2018)6973 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

Irbesartan / Hydrochlorothiazide Teva (Teva B.V.)

Irbesartan / Hydrochlorothiazide Teva (Teva B.V.)

Irbesartan / Hydrochlorothiazide Teva (Active substance: irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018) 6974 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

Forsteo (Eli Lilly Nederland B.V.)

Forsteo (Eli Lilly Nederland B.V.)

Forsteo (Active substance: Teriparatide) - Centralised - Yearly update - Commission Decision (2018) 6975 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/17/1966 (Sirius Regulatory Consulting EU Limited)

EU/3/17/1966 (Sirius Regulatory Consulting EU Limited)

EU/3/17/1966 (Active substance: N-(bromoacetyl)-3,3-dinitroazetidine) - Transfer of orphan designation - Commission Decision (2018)6986 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Active substance: Insulin human) - Transfer of orphan designation - Commission Decision (2018)6985 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/16/1704 (Drug Development and Regulation S.L.)

EU/3/16/1704 (Drug Development and Regulation S.L.)

EU/3/16/1704 (Active substance: Sirolimus) - Transfer of orphan designation - Commission Decision (2018)6988 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/045/16/T/01

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

22-10-2018

NexGard (Merial)

NexGard (Merial)

NexGard (Active substance: afoxolaner) - Centralised - 2-Monthly update - Commission Decision (2018)6976 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/002729/WS1338/0018/G

Europe -DG Health and Food Safety

21-10-2018

We know that cancer is harder to find in women with dense breasts – some women may need other imaging tests. Breast density reporting is already required in some states. Expanding this nationwide will empower patients and providers to make more informed h

We know that cancer is harder to find in women with dense breasts – some women may need other imaging tests. Breast density reporting is already required in some states. Expanding this nationwide will empower patients and providers to make more informed h

We know that cancer is harder to find in women with dense breasts – some women may need other imaging tests. Breast density reporting is already required in some states. Expanding this nationwide will empower patients and providers to make more informed health decisions.

FDA - U.S. Food and Drug Administration

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

18-10-2018

Kivexa (ViiV Healthcare BV)

Kivexa (ViiV Healthcare BV)

Kivexa (Active substance: abacavir / Lamivudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6924 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000581/T/0076

Europe -DG Health and Food Safety

18-10-2018

Leflunomide Zentiva (Zentiva k.s.)

Leflunomide Zentiva (Zentiva k.s.)

Leflunomide Zentiva (Active substance: leflunomide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6923 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/001129/T/0032

Europe -DG Health and Food Safety

18-10-2018

Sutent (Pfizer Europe MA EEIG)

Sutent (Pfizer Europe MA EEIG)

Sutent (Active substance: sunitinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6922 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/687/T/72

Europe -DG Health and Food Safety

18-10-2018

ABILIFY MAINTENA (Otsuka Pharmaceutical Netherlands B.V.)

ABILIFY MAINTENA (Otsuka Pharmaceutical Netherlands B.V.)

ABILIFY MAINTENA (Active substance: Aripiprazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6925 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002755/T/0026

Europe -DG Health and Food Safety

18-10-2018

Rapamune (Pfizer Europe MA EEIG)

Rapamune (Pfizer Europe MA EEIG)

Rapamune (Active substance: sirolimus) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6921 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/273/T/168

Europe -DG Health and Food Safety

16-10-2018

Dexxience (Portola Pharma UK Limited)

Dexxience (Portola Pharma UK Limited)

Dexxience (Active substance: betrixaban) - Refusal of authorisation - Commission Decision (2018)6226 of Tue, 16 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4309

Europe -DG Health and Food Safety