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: zusammensetzung, kinische angaben, nebenwirkungen, wechselwirkungen, dosierung, schwangerschaft, stillzeit

Handelsbezeichnung: Gesal Gemüse-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

Himbeerkäfer

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

Chicorée

Cima di Rapa

Erbsen

Karotten

Knoblauch

Knollensellerie

Kohlrabi

Kopfkohle

Kresse

Küchenkräuter

Kürbisgewächse

(Cucurbitaceae)

Lauch

Meerrettich

Nüsslisalat

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

Speisekohlrüben

Spinat

Stachys

Stielmus

Tomaten

Topinambur

Wurzelpetersilie

Zuckermais

Zwiebeln

G Gewächshaus:

Andenbeere

Gewächshaus: Aubergine

Gewächshaus:

Blumenkohle

Gewächshaus: Bohnen

Gewächshaus: Chicorée

Gewächshaus: Erbsen

Gewächshaus:

Gemüsezwiebel

Gewächshaus: Karotten

Gewächshaus:

Knoblauch

Gewächshaus:

Knollensellerie

Gewächshaus: Kohlrabi

Gewächshaus: Kopfkohle

Gewächshaus:

Kürbisgewächse

(Cucurbitaceae)

Gewächshaus:

Meerrettich

Gewächshaus: Paprika

Gewächshaus: Pastinake

Gewächshaus: Pepino

Gewächshaus: Puffbohne

Gewächshaus: Radies

Gewächshaus: Rande

Gewächshaus: Rettich

Gewächshaus: Rosenkohl

Gewächshaus: Schalotten

Gewächshaus:

Schwarzwurzel

Gewächshaus:

Speisekohlrüben

Gewächshaus:

Speisezwiebel

Gewächshaus: Stachys

Gewächshaus: Tomaten

Weisse Fliegen

(Mottenschildläuse)

Konzentration: 0.08 %

Aufwandmenge: 0.8 l/ha

Wartefrist: 3 Tage

3, 4, 6

A

Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

Gewächshaus:

Topinambur

Gewächshaus:

Wurzelpetersilie

Gewächshaus:

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

Leguminosenzünsler

Schwärmer

Aufwandmenge: 0.5 l/ha

Wartefrist: 2 Woche(n)

3, 4, 7, 8

Gewächshaus:

Bundzwiebeln

Weisse Fliegen

(Mottenschildläuse)

Aufwandmenge: 0.8 l/ha

Wartefrist: 1 Woche(n)

3, 4, 6

G Erbsen ohne Hülsen

Erbsenblattrandkäfer

Aufwandmenge: 0.5 l/ha

Wartefrist: 2 Woche(n)

3, 4, 7, 8

G Erbsen ohne Hülsen

Erbsenwickler

Aufwandmenge: 0.5 l/ha

Wartefrist: 2 Woche(n)

3, 4, 6, 7

G Karotten

Blattläuse (Röhrenläuse)

Möhrenblattfloh

Aufwandmenge: 0.5 l/ha

Wartefrist: 2 Woche(n)

3, 4, 6, 7

Karotten

Knollensellerie

Pastinake

Wurzelpetersilie

Möhrenfliege

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

G Kohlarten

Eulenraupen (blattfressend)

Gefleckter Kohltriebrüssler

Kohldrehherzgallmücke

Kohlgallenrüssler

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

A

Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

Gewächshaus: Rhabarber

Gewächshaus: Spargel

Weisse Fliegen

(Mottenschildläuse)

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

Spargelhähnchen

Spargelkäfer

Aufwandmenge: 0.5 l/ha

Anwendung: Nach der Ernte.

3, 4, 7, 10

F Eiweisserbse

Erbsenblattrandkäfer

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

Blattläuse (Röhrenläuse)

Konzentration: 0.05 %

Wartefrist: 3 Woche(n)

3, 4, 5, 13

F Kartoffeln

Kartoffelkäfer

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

Kohlschotenrüssler

Teilwirkung:

Kohlschotengallmücke

Aufwandmenge: 0.5 l/ha

Anwendung: Bis Ende

Entwicklung der Blütenknospen

(BBCH 59).

3, 4, 7, 12

F Raps

Rapsstengelrüssler

Aufwandmenge: 0.65 l/ha

Wartefrist: 6 Woche(n)

Anwendung: Stadium 31-53

(BBCH).

3, 4, 5, 12

F Sojabohne

Distelfalter

Aufwandmenge: 0.5 l/ha

Wartefrist: 2 Woche(n)

3, 4, 7, 11

F Wintergetreide

Virusübertragende

Blattläuse

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

F Zuckerrübe

Erdraupen

Aufwandmenge: 0.8 l/ha

Wartefrist: 6 Woche(n)

3, 4, 5, 11

F Zuckerrübe

Rübenerdflöhe

Aufwandmenge: 0.5 l/ha

Wartefrist: 6 Woche(n)

3, 4, 7, 11

Z Blumenkulturen und

Grünpflanzen

Blattfressende Raupen

Blattkäfer

Konzentration: 0.08 %

3, 4, 5, 15,

A

Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

Blattläuse (Röhrenläuse)

Erdraupen

Napfschildläuse

Thripse

Weisse Fliegen

(Mottenschildläuse)

Auflagen und Bemerkungen:

Maximal 2 Behandlungen pro Parzelle und Jahr.

Für Sommerhimbeeren bezieht sich die angegebene Aufwandmenge auf Stadium "Erste Blüten bis

etwa 50% der Blüten offen" sowie eine Referenzbrühmenge von 1000 l/ha. Für Herbsthimbeeren

bezieht sich die Aufwandmenge auf eine Heckenhöhe von 150 - 170 cm sowie eine

Referenzbrühmenge von 1000 l/ha.

SPe 8: Gefährlich für Bienen - Darf nur ausserhalb des Bienenfluges am Abend mit blühenden

oder Honigtau aufweisenden Pflanzen in Kontakt kommen. Anwendung im geschlossenen

Gewächshaus sofern keine Bestäuber zugegen sind.

Ansetzen der Spritzbrühe: Schutzhandschuhe tragen.

SPe 3: Zum Schutz von Gewässerorganismen vor den Folgen von Drift eine unbehandelte

Pufferzone von 100 m zu Oberflächengewässern 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 gemäss den

Weisungen des BLW.

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

Wirkstoff enthält.

SPe 3: Zum Schutz von Gewässerorganismen vor den Folgen von Drift eine unbehandelte

Pufferzone von 50 m zu Oberflächengewässern 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 gemäss den

Weisungen des BLW.

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

Wirkstoff enthält.

Behandlungen nur während dem Flug (gemäss 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 enthält.

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 enthält, nicht mehr als 1 mal pro Kultur ausgebracht

werden.

15.Nur gegen nichtresistente Stämme geeignet.

16.Nicht vernebeln oder verdampfen.

Gefahrenkennzeichnungen:

Darf nicht in die Hände von Kindern gelangen.

EUH 208 Enthält [Name des sensibilisierenden Stoffes]. Kann allergische Reaktionen

hervorrufen.

EUH 401 Zur Vermeidung von Risiken für Mensch und Umwelt die Gebrauchsanleitung

einhalten.

H226 Flüssigkeit und Dampf entzündbar.

H410 Sehr giftig für Wasserorganismen mit langfristiger Wirkung.

SP 1 Mittel und/oder dessen Behälter nicht in Gewässer gelangen lassen.

SPe 8 Bienengefährlich

Signalwort:

Achtung

Gefahrensymbole und -bezeichnungen:

Kurzkennzeichnung

GHS02

GHS09

Symbol

Gefahrenbezeichnung Hochentzündlich Gewässergefährdend

Im Zweifelsfall gelten einzig die Originaldokumente der Zulassung. Die Erwähnung eines Produktes,

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

Verkauf befindet.

Es gibt keine Sicherheitswarnungen betreffend dieses Produktes.

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20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0354/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0354/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0354/2018

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Liposomal combination of cytarabine and daunorubicin, decision type: , therapeutic area: , PIP number: P/0388/2018

Opinion/decision on a Paediatric investigation plan (PIP): Liposomal combination of cytarabine and daunorubicin, decision type: , therapeutic area: , PIP number: P/0388/2018

Opinion/decision on a Paediatric investigation plan (PIP): Liposomal combination of cytarabine and daunorubicin, decision type: , therapeutic area: , PIP number: P/0388/2018

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Risdiplam (RO7034067), decision type: , therapeutic area: , PIP number: P/0360/2018

Opinion/decision on a Paediatric investigation plan (PIP): Risdiplam (RO7034067), decision type: , therapeutic area: , PIP number: P/0360/2018

Opinion/decision on a Paediatric investigation plan (PIP): Risdiplam (RO7034067), decision type: , therapeutic area: , PIP number: P/0360/2018

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): (RS)-Bacoflen,Naltrexone HCl,D-Sorbitol (PXT3003), decision type: , therapeutic area: , PIP number: P/0363/2018

Opinion/decision on a Paediatric investigation plan (PIP): (RS)-Bacoflen,Naltrexone HCl,D-Sorbitol (PXT3003), decision type: , therapeutic area: , PIP number: P/0363/2018

Opinion/decision on a Paediatric investigation plan (PIP): (RS)-Bacoflen,Naltrexone HCl,D-Sorbitol (PXT3003), decision type: , therapeutic area: , PIP number: P/0363/2018

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2),Influenza virus surfa

Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2),Influenza virus surfa

Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage) [QIVc], decision type: , therapeutic area: , PIP number: P/0387/2018

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Complex of povidone and iodine,dexamethasone (SHP640), decision type: , therapeutic area: , PIP number: P/0369/2018

Opinion/decision on a Paediatric investigation plan (PIP): Complex of povidone and iodine,dexamethasone (SHP640), decision type: , therapeutic area: , PIP number: P/0369/2018

Opinion/decision on a Paediatric investigation plan (PIP): Complex of povidone and iodine,dexamethasone (SHP640), decision type: , therapeutic area: , PIP number: P/0369/2018

Europe - EMA - European Medicines Agency

19-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): filgotinib, decision type: , therapeutic area: , PIP number: P/0371/2018

Opinion/decision on a Paediatric investigation plan (PIP): filgotinib, decision type: , therapeutic area: , PIP number: P/0371/2018

Opinion/decision on a Paediatric investigation plan (PIP): filgotinib, decision type: , therapeutic area: , PIP number: P/0371/2018

Europe - EMA - European Medicines Agency

19-2-2019

Besremi (AOP Orphan Pharmaceuticals AG)

Besremi (AOP Orphan Pharmaceuticals AG)

Besremi (Active substance: ropeginterferon alfa-2b) - Centralised - Authorisation - Commission Decision (2019)1455 of Tue, 19 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4128/00

Europe -DG Health and Food Safety

19-2-2019

Efavirenz

Efavirenz

Efavirenz (Active substance: efavirenz) - Centralised - Art 28 - (PSUR - Commission Decision (2019) 1514 of Tue, 19 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C//PSUSA/00001200/201804

Europe -DG Health and Food Safety

19-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Phenylephrine hydrochloride,ketorolac trometamol (OMS302), decision type: , therapeutic area: , PIP number: P/0362/2018

Opinion/decision on a Paediatric investigation plan (PIP): Phenylephrine hydrochloride,ketorolac trometamol (OMS302), decision type: , therapeutic area: , PIP number: P/0362/2018

Opinion/decision on a Paediatric investigation plan (PIP): Phenylephrine hydrochloride,ketorolac trometamol (OMS302), decision type: , therapeutic area: , PIP number: P/0362/2018

Europe - EMA - European Medicines Agency

19-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): 4-((2R,3S,4R,5S)-3-(3-Chloro-2-fluorophenyl)-4-(4-chloro-2-fluorophenyl)-4-cyano-5-neopentylpyrrolidine-2-carboxamido)-3-methoxybenzoic acid (RO5503781), decision type: , therapeutic area: , PIP

Opinion/decision on a Paediatric investigation plan (PIP): 4-((2R,3S,4R,5S)-3-(3-Chloro-2-fluorophenyl)-4-(4-chloro-2-fluorophenyl)-4-cyano-5-neopentylpyrrolidine-2-carboxamido)-3-methoxybenzoic acid (RO5503781), decision type: , therapeutic area: , PIP

Opinion/decision on a Paediatric investigation plan (PIP): 4-((2R,3S,4R,5S)-3-(3-Chloro-2-fluorophenyl)-4-(4-chloro-2-fluorophenyl)-4-cyano-5-neopentylpyrrolidine-2-carboxamido)-3-methoxybenzoic acid (RO5503781), decision type: , therapeutic area: , PIP number: P/0366/2018

Europe - EMA - European Medicines Agency

19-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ninlaro,Ixazomib, decision type: , therapeutic area: , PIP number: P/0376/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ninlaro,Ixazomib, decision type: , therapeutic area: , PIP number: P/0376/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ninlaro,Ixazomib, decision type: , therapeutic area: , PIP number: P/0376/2018

Europe - EMA - European Medicines Agency

19-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated,Potassium hydrogen carbonate, decision type: , therapeutic area: , PIP number: P/0355/2018

Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated,Potassium hydrogen carbonate, decision type: , therapeutic area: , PIP number: P/0355/2018

Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated,Potassium hydrogen carbonate, decision type: , therapeutic area: , PIP number: P/0355/2018

Europe - EMA - European Medicines Agency

19-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Lenvima,Lenvatinib, decision type: , therapeutic area: , PIP number: P/0389/2018

Opinion/decision on a Paediatric investigation plan (PIP): Lenvima,Lenvatinib, decision type: , therapeutic area: , PIP number: P/0389/2018

Opinion/decision on a Paediatric investigation plan (PIP): Lenvima,Lenvatinib, decision type: , therapeutic area: , PIP number: P/0389/2018

Europe - EMA - European Medicines Agency

19-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Tolvaptan, decision type: , therapeutic area: , PIP number: P/0378/2018

Opinion/decision on a Paediatric investigation plan (PIP): Tolvaptan, decision type: , therapeutic area: , PIP number: P/0378/2018

Opinion/decision on a Paediatric investigation plan (PIP): Tolvaptan, decision type: , therapeutic area: , PIP number: P/0378/2018

Europe - EMA - European Medicines Agency

18-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Cimzia,Certolizumab pegol, decision type: , therapeutic area: , PIP number: P/0397/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cimzia,Certolizumab pegol, decision type: , therapeutic area: , PIP number: P/0397/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cimzia,Certolizumab pegol, decision type: , therapeutic area: , PIP number: P/0397/2018

Europe - EMA - European Medicines Agency

18-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Taltz,ixekizumab, decision type: , therapeutic area: , PIP number: P/0351/2018

Opinion/decision on a Paediatric investigation plan (PIP): Taltz,ixekizumab, decision type: , therapeutic area: , PIP number: P/0351/2018

Opinion/decision on a Paediatric investigation plan (PIP): Taltz,ixekizumab, decision type: , therapeutic area: , PIP number: P/0351/2018

Europe - EMA - European Medicines Agency

18-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Holoclar,Ex-vivo expanded human autologous epithelium containing stem cells, decision type: , therapeutic area: , PIP number: P/0370/2018

Opinion/decision on a Paediatric investigation plan (PIP): Holoclar,Ex-vivo expanded human autologous epithelium containing stem cells, decision type: , therapeutic area: , PIP number: P/0370/2018

Opinion/decision on a Paediatric investigation plan (PIP): Holoclar,Ex-vivo expanded human autologous epithelium containing stem cells, decision type: , therapeutic area: , PIP number: P/0370/2018

Europe - EMA - European Medicines Agency

18-2-2019

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

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

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

Europe -DG Health and Food Safety

18-2-2019

Jardiance (Boehringer Ingelheim International GmbH)

Jardiance (Boehringer Ingelheim International GmbH)

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

Europe -DG Health and Food Safety

18-2-2019

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

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

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

Europe -DG Health and Food Safety

18-2-2019

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

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

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

Europe -DG Health and Food Safety

18-2-2019

Modigraf (Astellas Pharma Europe B.V.)

Modigraf (Astellas Pharma Europe B.V.)

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

Europe -DG Health and Food Safety

18-2-2019

Zirabev (Pfizer Europe MA EEIG)

Zirabev (Pfizer Europe MA EEIG)

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

Europe -DG Health and Food Safety

18-2-2019

Imatinib Accord (Accord Healthcare S.L.U.)

Imatinib Accord (Accord Healthcare S.L.U.)

Imatinib Accord (Active substance: Imatinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1434 of Mon, 18 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2681/T/25

Europe -DG Health and Food Safety

18-2-2019

Pioglitazone Accord (Accord Healthcare S.L.U.)

Pioglitazone Accord (Accord Healthcare S.L.U.)

Pioglitazone Accord (Active substance: pioglitazone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1432 of Mon, 18 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2277/T/16

Europe -DG Health and Food Safety

18-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Soliris,Eculizumab, decision type: , therapeutic area: , PIP number: P/0364/2018

Opinion/decision on a Paediatric investigation plan (PIP): Soliris,Eculizumab, decision type: , therapeutic area: , PIP number: P/0364/2018

Opinion/decision on a Paediatric investigation plan (PIP): Soliris,Eculizumab, decision type: , therapeutic area: , PIP number: P/0364/2018

Europe - EMA - European Medicines Agency

18-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Lyxumia ,lixisenatide, decision type: , therapeutic area: , PIP number: P/0380/2018

Opinion/decision on a Paediatric investigation plan (PIP): Lyxumia ,lixisenatide, decision type: , therapeutic area: , PIP number: P/0380/2018

Opinion/decision on a Paediatric investigation plan (PIP): Lyxumia ,lixisenatide, decision type: , therapeutic area: , PIP number: P/0380/2018

Europe - EMA - European Medicines Agency

18-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Sirturo,Bedaquiline (fumarate), decision type: , therapeutic area: , PIP number: P/0403/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sirturo,Bedaquiline (fumarate), decision type: , therapeutic area: , PIP number: P/0403/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sirturo,Bedaquiline (fumarate), decision type: , therapeutic area: , PIP number: P/0403/2018

Europe - EMA - European Medicines Agency

18-2-2019

What is the patient impact of my medicine shortage and do I have to report it to the TGA?

What is the patient impact of my medicine shortage and do I have to report it to the TGA?

Medicine sponsor decision tree

Therapeutic Goods Administration - Australia

15-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Otezla,apremilast, decision type: , therapeutic area: , PIP number: P/0398/2018

Opinion/decision on a Paediatric investigation plan (PIP): Otezla,apremilast, decision type: , therapeutic area: , PIP number: P/0398/2018

Opinion/decision on a Paediatric investigation plan (PIP): Otezla,apremilast, decision type: , therapeutic area: , PIP number: P/0398/2018

Europe - EMA - European Medicines Agency

15-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Kalydeco,ivacaftor, decision type: , therapeutic area: , PIP number: P/0353/2018

Opinion/decision on a Paediatric investigation plan (PIP): Kalydeco,ivacaftor, decision type: , therapeutic area: , PIP number: P/0353/2018

Opinion/decision on a Paediatric investigation plan (PIP): Kalydeco,ivacaftor, decision type: , therapeutic area: , PIP number: P/0353/2018

Europe - EMA - European Medicines Agency

15-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Europe - EMA - European Medicines Agency

15-2-2019

Circadin (RAD Neurim Pharmaceuticals EEC SARL)

Circadin (RAD Neurim Pharmaceuticals EEC SARL)

Circadin (Active substance: Melatonin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1079 of Fri, 15 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/695/T/58

Europe -DG Health and Food Safety

15-2-2019

tacrolimus (systemic formulations)

tacrolimus (systemic formulations)

tacrolimus (systemic formulations) (Active substance: tacrolimus) - Centralised - Art 28 - (PSUR - Commission Decision (2019)1437 of Fri, 15 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00002839/201803

Europe -DG Health and Food Safety

15-2-2019

Caspofungin Accord (Accord Healthcare S.L.U.)

Caspofungin Accord (Accord Healthcare S.L.U.)

Caspofungin Accord (Active substance: caspofungin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1334 of Fri, 15 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4134/T/07

Europe -DG Health and Food Safety