Compo Orrtiva Rosen Pilzschutz

Hauptinformation

  • Handelsname:
  • Compo Orrtiva Rosen Pilzschutz
  • Darreichungsform:
  • SC Suspensionskonzentrat
  • 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:
  • Compo Orrtiva Rosen Pilzschutz
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Fungizid

Weitere Informationen

Status

  • Quelle:
  • UFAG - Ufficio federale dell'agricoltura. OFAG - Office fédéral de l'agriculture. BLW - Bundesamt für Landwirtschaft.
  • Zulassungsnummer:
  • D-4162
  • Letzte Änderung:
  • 14-11-2018

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

Handelsbezeichnung: Compo Orrtiva Rosen

Pilzschutz (Parallelimport)

Pflanzenschutzmittelverzeichnis (Stand: 06.11.2018)

Produktkategorie:

Ausl. Bewilligungsinhaber:

Eidg. Zulassungsnummer:

Fungizid

Syngenta Agro GmbH

D-4162

Stoff(e):

Gehalt:

Formulierungscode:

Wirkstoff: Azoxystrobin 22.8 % 250 g/l

SC Suspensionskonzentrat

Anwendungen

A

Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

B Erdbeere

Echter Mehltau der Erdbeere

Teilwirkung:

Graufäule (Botrytis cinerea)

Konzentration: 0.1 %

Aufwandmenge: 1 l/ha

Wartefrist: 2 Woche(n)

1, 2, 3

B Ribes Arten

Echter Mehltau der Ribes-Arten

Konzentration: 0.1 %

Aufwandmenge: 1 l/ha

Wartefrist: 3 Woche(n)

2, 4, 5, 6

Rote Johannisbeere

Schwarze

Johannisbeere

Stachelbeere

Mondscheinigkeit

Konzentration: 0.1 %

Aufwandmenge: 1 l/ha

Wartefrist: 3 Woche(n)

2, 4, 5, 6

B Rubus Arten

Teilwirkung:

Rutenkrankheiten der Brombeere

Rutenkrankheiten der Himbeere

Konzentration: 0.1 %

Aufwandmenge: 1 l/ha

Wartefrist: 3 Woche(n)

2, 5, 6, 7, 8

Aprikose

Pfirsich / Nektarine

Pflaume

Zwetschge

Blüten- und Zweigdürre

Schrotschuss

Konzentration: 0.1 %

Aufwandmenge: 1.6 l/ha

Wartefrist: 3 Woche(n)

Anwendung: Bis

spätestens BBCH 70.

2, 6, 9, 10

O Kirsche

Bitterfäule der Kirsche

Blüten- und Zweigdürre

Schrotschuss

Konzentration: 0.1 %

Aufwandmenge: 1.6 l/ha

Wartefrist: 3 Woche(n)

Anwendung: Bis

spätestens BBCH 70.

2, 6, 9, 10

G Artischocken

Falscher Mehltau der Artischocke

Aufwandmenge: 1 l/ha

Wartefrist: 7 Tage

2, 11, 12

A

Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

Asia-Salate

(Brassicaceae)

Blattfleckenpilze

Aufwandmenge: 1 l/ha

Wartefrist: 7 Tage

Anwendung: Ab Stadium

BBCH 13.

2, 12, 13

Blattkohle

Blumenkohle

Kopfkohle

Rosenkohl

Blattfleckenpilze

Echter Mehltau der Kreuzblütler

Falscher Mehltau der

Kreuzblütengewächse

Ringflecken des Kohls

Weisser Rost

Teilwirkung:

Graufäule (Botrytis cinerea)

Aufwandmenge: 1 l/ha

Wartefrist: 2 Woche(n)

2, 14

G Bohnen mit Hülsen

Braunfleckenkrankheit

Brennfleckenkrankheit der Bohne

Falscher Mehltau der Bohne

Sclerotinia-Fäule

Aufwandmenge: 1 l/ha

Wartefrist: 2 Woche(n)

2, 14

G Chicorée

Echter Mehltau der Asteraceen

Samtfleckenkrankheit

Aufwandmenge: 1 l/ha

Wartefrist: 2 Woche(n)

2, 11, 12

G Erbsen ohne Hülsen

Brennfleckenkrankheit der Erbse

Falscher Mehltau der Erbse

Graufäule (Botrytis cinerea)

Aufwandmenge: 1 l/ha

Wartefrist: 2 Woche(n)

2, 11, 15

Gurken

Kürbisse mit

geniessbarer Schale

Melonen

Anthraknose der Kürbisgewächse

Krätze der Kürbisgewächse

Konzentration: 0.08 %

Aufwandmenge: 0.8 l/ha

Wartefrist: 3 Tage

2, 11, 12

Gewächshaus:

Gurken

Gewächshaus:

Kürbisse mit

geniessbarer Schale

Gewächshaus:

Melonen

Echter Mehltau der Kürbisgewächse

Falscher Mehltau der Kürbisgewächse

Konzentration: 0.1 %

Aufwandmenge: 1 l/ha

Wartefrist: 3 Tage

2, 11

G Karotten

Alternaria-Möhrenschwärze

Aufwandmenge: 1 l/ha

Wartefrist: 2 Woche(n)

2, 14

Knoblauch

Schalotten

Zwiebeln

Falscher Mehltau der Zwiebel

Aufwandmenge: 1 l/ha

Wartefrist: 2 Woche(n)

2, 14

G Knollenfenchel

Cercospora- und Ramularia-

Blattfleckenkrankheiten

Falscher Mehltau der Doldenblütler

Aufwandmenge: 1 l/ha

Wartefrist: 1 Woche(n)

2, 14

G Kohlrabi

Alternaria-Kohlschwärze

Aufwandmenge: 1 l/ha

2, 14

A

Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

Speisekohlrüben

Wartefrist: 2 Woche(n)

Kürbisgewächse

(Cucurbitaceae)

Echter Mehltau der Kürbisgewächse

Falscher Mehltau der Kürbisgewächse

Aufwandmenge: 1 l/ha

Wartefrist: 3 Woche(n)

2, 11

G Lauch

Alternaria-Purpurfleckenkrankheit

Papierfleckenkrankheit des Lauchs

Aufwandmenge: 1 l/ha

Wartefrist: 2 Woche(n)

2, 14

G Mangold

Cercospora- und Ramularia-

Blattfleckenkrankheiten

Aufwandmenge: 1 l/ha

Wartefrist: 3 Woche(n)

2, 12, 14

Meerrettich

Radies

Rettich

Alternaria-Kohlschwärze

Falscher Mehltau der

Kreuzblütengewächse

Weisser Rost

Aufwandmenge: 1 l/ha

Wartefrist: 2 Woche(n)

Anwendung: Ab Stadium

BBCH 10 (Keimblätter

voll entfaltet).

2, 11, 12

G Petersilie

Septoria-Blattfleckenkrankheit der

Petersilie

Aufwandmenge: 1 l/ha

Wartefrist: 2 Woche(n)

2, 14

G Rucola

Blattfleckenpilze

Falscher Mehltau der

Kreuzblütengewächse

Teilwirkung:

Graufäule (Botrytis cinerea)

Aufwandmenge: 1 l/ha

Wartefrist: 2 Woche(n)

2, 11

G Salate (Asteraceae)

Falscher Mehltau des Salats

Rhizoctonia-Fäule des Salats

Teilwirkung:

Graufäule (Botrytis cinerea)

Aufwandmenge: 1 l/ha

Wartefrist: 2 Woche(n)

2, 11

G Schnittlauch

Alternaria spp.

Rost auf Zwiebel-Arten

Aufwandmenge: 1 l/ha

Wartefrist: 2 Woche(n)

2, 3, 12

G Sellerie

Septoria-Blattfleckenkrankheit des

Selleries

Aufwandmenge: 1 l/ha

Wartefrist: 2 Woche(n)

2, 14

G Spargel

Blattschwärze der Spargel

Spargelrost

Aufwandmenge: 1 l/ha

Anwendung: In

Junganlagen oder in

Ertragsanlagen nach der

Ernte.

2, 6

G Tomaten

Alternaria-Dürrfleckenkrankheit

Echter Mehltau der Solanaceae

Kraut- und Fruchtfäule

Konzentration: 0.1 %

Wartefrist: 3 Tage

2, 5, 14

F Eiweisserbse

Brennfleckenkrankheit der Erbse

Falscher Mehltau der Erbse

Graufäule (Botrytis cinerea)

Aufwandmenge: 1 l/ha

Wartefrist: 2 Woche(n)

2, 11, 15

A

Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

F Gerste

Echter Mehltau des Getreides

Netzfleckenkrankheit der Gerste

Rhynchosporium-Blattfleckenkrankheit

Aufwandmenge: 0.4 l/ha

Anwendung: Stadium 31-

51 (BBCH).

2, 16, 17

F Gerste

Echter Mehltau des Getreides

Netzfleckenkrankheit der Gerste

Rhynchosporium-Blattfleckenkrankheit

Zwergrost der Gerste

Aufwandmenge: 1 l/ha

Anwendung: Stadium 31-

51 (BBCH).

2, 17

F Hopfen

Falscher Mehltau des Hopfens

Teilwirkung:

Echter Mehltau des Hopfens

Konzentration: 0.1 %

Wartefrist: 4 Woche(n)

2, 18, 19,

20, 21

F Kartoffeln

Alternaria-Dürrfleckenkrankheit

Kraut- und Knollenfäule

Aufwandmenge: 0.75 l/ha

Wartefrist: 1 Woche(n)

Anwendung:

Behandlungen bei vollem

Krautwachstum.

2, 14, 22,

F Lupinen

Anthraknose der Lupine

Aufwandmenge: 0.8 l/ha

Wartefrist: 42 Tage

2, 11, 12,

F Raps

Sclerotinia-Fäule

Aufwandmenge: 1 l/ha

Anwendung: Stadium 61-

65 (BBCH).

2, 17

F Roggen

Braunrost

Aufwandmenge: 0.4 l/ha

Anwendung: Stadium 37-

61 (BBCH).

2, 16, 17

F Roggen

Braunrost

Aufwandmenge: 1 l/ha

Anwendung: Stadium 37-

61 (BBCH).

2, 17

F Triticale

Braunrost

Gelbrost

Septoria-Blattdürre (S. tritici oder S.

nodorum)

Aufwandmenge: 0.4 l/ha

Anwendung: Stadium 31-

61 (BBCH).

2, 16, 17

F Triticale

Rhynchosporium-Blattfleckenkrankheit

Aufwandmenge: 1 l/ha

Anwendung: Stadium 37-

61 (BBCH).

2, 17

F Trockenreis

Braunfleckigkeit des Reises

Reisbräune

Aufwandmenge: 1 l/ha

Wartefrist: 4 Woche(n)

Anwendung: Stadium 24-

55 (BBCH).

2, 12, 25

F Weizen

Braunrost

Echter Mehltau des Getreides

Gelbrost

Aufwandmenge: 0.4 l/ha

Anwendung: Stadium 31-

2, 16, 17

A

Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

Septoria-Spelzenbräune (S. nodorum)

61 (BBCH).

F Weizen

Braunrost

Echter Mehltau des Getreides

Gelbrost

Septoria-Blattdürre (S. tritici oder S.

nodorum)

Septoria-Spelzenbräune (S. nodorum)

Aufwandmenge: 1 l/ha

Anwendung: Stadium 31-

61 (BBCH).

2, 17

Z Blaudistel

Blattfleckenkrankheit der Blaudisteln

Konzentration: 0.1 %

2, 14, 26

Z Chrysantheme

Echte Mehltaupilze der Zierpflanzen

Teilwirkung:

Graufäule (Botrytis cinerea)

Konzentration: 0.1 %

2, 14, 26

Liliengewächse

(Zierpflanzen)

Rostpilze der Zierpflanzen

Teilwirkung:

Graufäule (Botrytis cinerea)

Konzentration: 0.1 %

2, 14, 26

Z Nelken

Echte Mehltaupilze der Zierpflanzen

Rostpilze der Zierpflanzen

Teilwirkung:

Graufäule (Botrytis cinerea)

Konzentration: 0.1 %

2, 14, 26

Z Rosen

Echter Mehltau der Rosen

Rost der Rose

Teilwirkung:

Graufäule (Botrytis cinerea)

Konzentration: 0.1 %

2, 3, 26

Z Zier- und Sportrasen

Blattfleckenkrankheit

Fusarium culmorum

Gaeumannomyces graminis var. avenae

(Rasen)

Ophiosphaerella herpotricha

Pythium spp.

Rasenanthracnose

Rhizoctonia-Krankheiten des Rasens

Rotfadenkrankheit des Rasens

Schneeschimmel

Sommerflecken

Aufwandmenge: 1 l/ha

2, 6, 27

Auflagen und Bemerkungen:

Die angegebene Aufwandmenge bezieht sich auf Stadium "Vollblüte bis Beginn Rotfärbung der

Früchte", 4 Pflanzen pro m² sowie eine Referenzbrühmenge von 1000 l/ha.

Ansetzen der Spritzbrühe: Schutzhandschuhe tragen.

SPa 1: Zur Vermeidung einer Resistenzbildung maximal 3 Behandlungen pro Kultur und Jahr mit

Produkten aus der Wirkstoffgruppe FRAC C3 (u.a. Strobilurine).

Die angegebene Aufwandmenge bezieht sich auf Stadium "50 - 90% der Blütenstände mit

sichtbaren Früchten" sowie eine Referenzbrühmenge von 1000 l/ha.

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

Pufferzone von 6 m zu Oberflächengewässern einhalten. Diese Distanz kann beim Einsatz von

driftreduzierenden Massnahmen gemäss den Weisungen des BLW reduziert werden.

SPa 1: Zur Vermeidung einer Resistenzbildung maximal 3 Behandlungen pro Parzelle und Jahr

mit Produkten aus der Wirkstoffgruppe FRAC C3 (u.a. Strobilurine).

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.

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

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

Die angegebene Aufwandmenge bezieht sich auf ein Baumvolumen von 10'000 m³ pro ha.

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

Pufferzone von 20 m zu Oberflächengewässern einhalten. Diese Distanz kann beim Einsatz von

driftreduzierenden Massnahmen gemäss den Weisungen des BLW reduziert werden.

11.SPa 1: Zur Vermeidung einer Resistenzbildung maximal 2 Behandlungen pro Kultur mit

Produkten aus der Wirkstoffgruppe FRAC C3 (u.a. Strobilurine).

12.Bewilligt als geringfügige Verwendung nach Art. 35 PSMV (minor use).

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

Wirkstoff enthält.

14.SPa 1: Zur Vermeidung einer Resistenzbildung maximal 3 Behandlungen pro Kultur mit

Produkten aus der Wirkstoffgruppe FRAC C3 (u.a. Strobilurine).

15.Behandlungen im Abstand von 8-12 Tagen.

16.In Tankmischung mit 1.2 l/ha Sirocco (60 g/l Metconazole).

17.Maximal 1 Behandlung pro Kultur.

18.Vorsicht: Resistenzgefahr! Produkt im Wechsel mit Produkten anderer Wirkstoffgruppen

einsetzen.

19.Die maximale Aufwandmenge von 1.6 l/ha pro Applikation darf nicht überschritten werden.

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

Pufferzone von 20 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.

21.SPa 1: Zur Vermeidung einer Resistenzbildung maximal 2 Behandlungen pro Parzelle und Jahr

mit Produkten aus der Wirkstoffgruppe FRAC C3 (u.a. Strobilurine).

22.Behandlungen im Abstand von 7-10 Tagen.

23.Bei Frühkartoffeln 2 Wochen Wartefrist.

24.Behandlungen im Abstand von 14 Tagen.

25.Maximal 2 Behandlungen pro Kultur im Abstand von 10-14 Tagen.

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

Pufferzone von 6 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.

27.SPe 3: Zum Schutz von Gewässerorganismen vor den Folgen einer Abschwemmung eine mit

einer geschlossenen Pflanzendecke bewachsene unbehandelte Pufferzone von mindestens 6 m zu

Oberflächengewässern einhalten. Ausnahmen sind in den Weisungen des BLW festgelegt.

Gefahrenkennzeichnungen:

Es gilt die Einstufung und Kennzeichnung der ausländischen Originaletikette..

Zusätzliche Schweizerische Gefahrenkennzeichnungen:

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

SPe 2 Zum Schutz von Grundwasser nicht in Grundwasserschutzzonen (S2) ausbringen.

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.

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17-12-2018

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14-12-2018

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

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10-12-2018

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4-12-2018

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15-11-2018

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Published on: Wed, 14 Nov 2018 The scope of application EFSA‐GMO‐DE‐2016‐133 is for food and feed uses, import and processing of genetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed to confer tolerance to the herbicidal active substances glyphosate and glufosinate‐ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and com...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Pyrogenium compositum ad us. vet., fluessige Verduennung

Pyrogenium compositum ad us. vet., fluessige Verduennung

● Änderung Präparatenamen sowie Text "Zusammensetzung", "Indikationen", "Anwendungseinschränkungen", "Sonstige Hinweise" und "Packungen"

Institut für Veterinärpharmakologie und toxikologie

9-11-2018

Sargassum seaweed: limit the exposure of residents and workers to hydrogen sulphide

Sargassum seaweed: limit the exposure of residents and workers to hydrogen sulphide

Since August 2014, the French Caribbean and French Guiana have been experiencing successive waves of Sargassum seaweed washing up on their coastlines. Despite the efforts made to clean it up, the seaweed decomposes in situ. This leads to the production of hydrogen sulphide (H2S), which can sometimes be detected at high concentrations. Doctors' reports concerning the health effects suffered by people exposed to H2S, and complaints from the general public relating to the problem of odours, have increased s...

France - Agence Nationale du Médicament Vétérinaire

25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

Safety of zinc chelate of methionine sulfate for the target species

Published on: Wed, 24 Oct 2018 00:00:00 +0200 Zinc chelate of methionine sulfate is intended to be used as a nutritional additive (functional group: compounds of trace elements). The additive is zinc chelated with methionine in a molar ratio 1:1. It is intended to supply zinc as a nutritional additive to all animal species/categories. In 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of zinc chelate of methionine su...

Europe - EFSA - European Food Safety Authority Publications

22-10-2018

October 22, 2018: Medical Equipment Company Agrees to Pay $5.25 Million to Resolve Allegations of Fraudulent Claims for Compounded Medical Creams

October 22, 2018: Medical Equipment Company Agrees to Pay $5.25 Million to Resolve Allegations of Fraudulent Claims for Compounded Medical Creams

October 22, 2018: Medical Equipment Company Agrees to Pay $5.25 Million to Resolve Allegations of Fraudulent Claims for Compounded Medical Creams

FDA - U.S. Food and Drug Administration

27-9-2018

Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Me...

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Remarks from Anna Abram as prepared for delivery to the 2018 Intergovermental Meeting on Drug Compounding

Remarks from Anna Abram as prepared for delivery to the 2018 Intergovermental Meeting on Drug Compounding

Remarks by FDA’s Anna Abram to the 2018 Intergovermental Meeting on Drug Compounding

FDA - U.S. Food and Drug Administration

21-9-2018

FDA Animal Drug Safety Communication: FDA Reminds Veterinarians of the Differences Between Approved and Compounded Formulas of Transdermal Mirtazapine for the Management of Weight Loss in Cats

FDA Animal Drug Safety Communication: FDA Reminds Veterinarians of the Differences Between Approved and Compounded Formulas of Transdermal Mirtazapine for the Management of Weight Loss in Cats

CVM Update describing FDA Dear Veterinarian Letter about the differences between FDA-approved Mirataz (mirtazapine transdermal ointment), an animal drug with demonstrated safety and effectiveness to manage undesired weight loss in cats, and compounded formulations of transdermal mirtazapine.

FDA - U.S. Food and Drug Administration

14-9-2018

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The goal of this research is to better address the problems related to the widespread presence of pesticides in the environment. Despite the unquestionable utility of the pesticides against various pests in the agricultural field, most pesticides and the corresponding pesticide residues are toxic to the environment and hazardous to human health. The recent literature on organophosphate compounds emphasises a clear correlation between their use and the occurr...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of white willow (Salix alba) in food

Risk assessment of white willow (Salix alba) in food

Published on: Tue, 28 Aug 2018 00:00:00 +0200 This Technical Report contains a description of the activities within the work programme of the EU‐FORA Fellowship on the risk assessment of white willow in food. The bark of different varieties of willow has had a long history of medical use as a means to reduce fever and as a painkiller. Willow bark is also used in weight loss and sports performance food supplements. The labelling of these products usually does not mention any restrictions to the length of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk ranking of chemical and microbiological hazards in food

Risk ranking of chemical and microbiological hazards in food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Risk ranking is a versatile tool used to prioritise activities performed by public health regulatory bodies. It also allows efficient communication between all stakeholders in the process of risk analysis. However, risk ranking methods are still not optimal. Because of the different approaches employed in the risk assessment of microbiological agents and chemicals, it is difficult to rank them together using the same metrics. In our work, we first discuss di...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Heat processing of food gives rise to a plethora of chemical compounds whose toxicological effects are largely unknown. Due to a general lack of experimental toxicological data, assessing the risks associated with the consumption of these substances remains a challenge. Computer models that allow for an in silico prediction of physicochemical and toxicological characteristics, may be able to fill current data gaps and facilitate the risk assessment of toxico...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

7-9-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help ensure the quality of and preserve access to compounded drugs by pursuing closer collaboration with states

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help ensure the quality of and preserve access to compounded drugs by pursuing closer collaboration with states

FDA announces revised draft memorandum of understanding between FDA and the states to help ensure the quality of and preserve access to compounded drugs

FDA - U.S. Food and Drug Administration

29-8-2018

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

Europe - EFSA - European Food Safety Authority Publications

20-8-2018

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

FDA - U.S. Food and Drug Administration

28-7-2018

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

Ranier’s Rx Laboratory is voluntarily recalling all sterile compounded drug products within expiry to the hospital or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

23-7-2018

FDA continues taking key actions on bulk drug substances used for compounding to advance the regulatory framework governing compounded drugs and to protect patients

FDA continues taking key actions on bulk drug substances used for compounding to advance the regulatory framework governing compounded drugs and to protect patients

FDA continues making progress on bulk drug substances for compounding

FDA - U.S. Food and Drug Administration

28-6-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug

FDA - U.S. Food and Drug Administration

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

27-4-2018

ANSES assesses the efficacy and safety of alternatives to antibiotics in animal husbandry and considers the need for a specific status for these products

ANSES assesses the efficacy and safety of alternatives to antibiotics in animal husbandry and considers the need for a specific status for these products

Today, the Agency is publishing an inventory of alternatives to antibiotics aimed at reducing their use in animal husbandry and based on an original method for evaluating the diverse scientific publications in the field. In its report, ANSES identifies numerous products and substances including compounds, plants, plant extracts and micro-organisms, which are used as alternatives to antibiotics. However, it emphasises the diversity of the data available to assess their safety and efficacy, and their abili...

France - Agence Nationale du Médicament Vétérinaire

17-4-2018

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

FDA - U.S. Food and Drug Administration

8-9-2009

Decision on future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds)

Decision on future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds)

On 3 september 2009, the Danish Medicines Agency decided on the future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds).

Danish Medicines Agency

29-11-2018


Orphan designation: Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s, Treatment of autoimmune haemolytic anaemia, 17/02/2016, Positive

Orphan designation: Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s, Treatment of autoimmune haemolytic anaemia, 17/02/2016, Positive

Orphan designation: Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s, Treatment of autoimmune haemolytic anaemia, 17/02/2016, Positive

Europe - EMA - European Medicines Agency