Capito Multi Insektizid

Hauptinformation

  • Handelsname:
  • Capito Multi Insektizid
  • 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:
  • Capito Multi Insektizid
    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-6043-1
  • Letzte Änderung:
  • 06-09-2017

Packungsbeilage

Produkt:

Handelsbezeichnung: Capito Multi Insektizid

Produktekategorie

Bewilligungsinhaber Eidg. Zulassungsnummer

Insektizid

Stähler Suisse SA

W-6043-1

Stoff(e)

Gehalt

Formulierungscode

Wirkstoff:

Bifenthrin

7.86 % 80 g/l

SC Suspensionskonzentrat

Anwendungen

A Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

B Himbeere

Himbeerkäfer

Konzentration: 0.025 %

Aufwandmenge: 0.25 l/ha

Wartefrist: 3 Woche(n)

Anwendung: Vor- und Nachblüte.

1, 2, 3, 4,

5, 6

G Andenbeere

Asia-Salate (Brassicaceae)

Aubergine

Blumenkohle

Bohnen

Chicorée

Cima di Rapa

Erbsen ohne Hülsen

Karotten

Knollensellerie

Kopfkohle

Kresse

Meerrettich

Nüsslisalat

Paprika

Pastinake

Pepino

Puffbohne

Radies

Rande

Rettich

Blattläuse (Röhrenläuse)

Thripse

Weisse Fliegen

(Mottenschildläuse)

Konzentration: 0.025 %

Aufwandmenge: 0.25 l/ha

Wartefrist: 3 Tage

2, 4, 5, 7, 8

A Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

Rosenkohl

Rucola

Salate (Asteraceae)

Schwarzwurzel

Speisekohlrüben

Stachys

Stielmus

Tomaten

Topinambur

Wurzelpetersilie

Zuckermais

Blumenkohle

Kopfkohle

Rosenkohl

Erdflöhe

Eulenraupen

(blattfressend)

Gefleckter

Kohltriebrüssler

Kohlgallenrüssler

Weisslinge

Aufwandmenge: 0.3 l/ha

Wartefrist: 2 Woche(n)

2, 4, 5, 7, 8

G Erbsen ohne Hülsen

Erbsenblattrandkäfer

Aufwandmenge: 0.15 l/ha

Wartefrist: 2 Woche(n)

4, 5, 8, 9,

Gemüsezwiebel

Knoblauch

Schalotten

Speisezwiebel

Blattläuse (Röhrenläuse)

Lauchmotte

Thripse

Weisse Fliegen

(Mottenschildläuse)

Aufwandmenge: 0.25 l/ha

Wartefrist: 2 Woche(n)

2, 4, 5, 7, 8

Karotten

Knollensellerie

Pastinake

Wurzelpetersilie

Möhrenfliege

Aufwandmenge: 0.5 l/ha

Wartefrist: 4 Woche(n)

2, 4, 5, 8,

F Eiweisserbse

Erbsenblattrandkäfer

Aufwandmenge: 0.1 l/ha

4, 5, 8, 12,

Futterrübe

Zuckerrübe

Rübenerdflöhe

Aufwandmenge: 0.2 l/ha

Wartefrist: 4 Woche(n)

4, 5, 7, 8,

F Getreide

Gelbe Getreidehalmfliege

Aufwandmenge: 0.2 l/ha

Wartefrist: 6 Woche(n)

4, 5, 7, 8,

F Kartoffeln

Kartoffelkäfer

Aufwandmenge: 0.2 l/ha

Wartefrist: 3 Woche(n)

4, 5, 7, 8,

F Raps

Rapsglanzkäfer

Teilwirkung:

Kohlschotengallmücke

Aufwandmenge: 0.2 l/ha

Wartefrist: 6 Woche(n)

Anwendung: Bis Ende Entwicklung

der Blütenknospen (BBCH 59).

4, 5, 8, 10,

F Raps

Rapsstengelrüssler

Aufwandmenge: 0.2 l/ha

Wartefrist: 6 Woche(n)

Anwendung: Stadium 31-53

4, 5, 8, 10,

A Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

(BBCH).

F Winterraps

Rapserdfloh

Aufwandmenge: 0.2 l/ha

Anwendung: Im Herbst.

4, 5, 8, 10,

Gewächshaus:

Blumenkulturen und

Grünpflanzen

Blattfressende Raupen

Erdraupen

Konzentration: 0.025 %

4, 5, 14

Gewächshaus:

Blumenkulturen und

Grünpflanzen

Blattläuse (Röhrenläuse)

Konzentration: 0.025 %

4, 5, 14, 15

Gewächshaus:

Blumenkulturen und

Grünpflanzen

Thripse

Weisse Fliegen

(Mottenschildläuse)

Konzentration: 0.04 %

4, 5, 14, 15

Gewächshaus: Buchsbäume

(Buxus)

Buchsbaum-Zünsler

Konzentration: 0.025 %

4, 5, 9, 14,

Auflagen und Bemerkungen:

Maximal 2 Behandlungen pro Parzelle und Jahr.

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

Pufferzone von 100 m zu Oberflächengewässern einhalten. Diese Distanz kann beim Einsatz von

driftreduzierenden Massnahmen gemäss den Weisungen des BLW reduziert werden.

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.

Nachfolgearbeiten in behandelten Kulturen: bis 48 Stunden nach Ausbringung des Mittels

Schutzhandschuhe + Schutzanzug tragen.

Ansetzen der Spritzbrühe: Schutzhandschuhe + Schutzanzug tragen. Ausbringen der Spritzbrühe:

Schutzhandschuhe + Schutzanzug tragen. Technische Schutzvorrichtungen während des

Ausbringens (z.B. geschlossene Traktorkabine) können die vorgeschriebene persönliche

Schutzausrüstung ersetzen, wenn gewährleistet ist, dass sie einen vergleichbaren oder höheren

Schutz bieten.

SPe 8: Gefährlich für Bienen - Darf nicht mit blühenden oder Honigtau aufweisenden Pflanzen in

Kontakt kommen. Blühende Einsaaten oder Unkräuter vor der Behandlung entfernen (mähen oder

mulchen). Darf nicht angewendet werden, wenn sich blühende Pflanzen in benachbarten Parzellen

befinden.

Maximal 2 Behandlungen pro Kultur.

SPe 8 - Gefährlich für Bienen: Darf nicht mit blühenden oder Honigtau aufweisenden Pflanzen

(z.B. Kulturen, Einsaaten, Unkräutern) in Kontakt kommen oder nur im geschlossenen

Gewächshaus eingesetzt werden, sofern keine Bestäuber zugegen sind. Darf nicht angewendet

werden, wenn sich in benachbarten Parzellen blühende Pflanzen befinden.

Maximal 1 Behandlung pro Kultur und Jahr.

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

Pufferzone von 50 m zu Oberflächengewässern einhalten. Diese Distanz kann beim Einsatz von

driftreduzierenden Massnahmen gemäss den Weisungen des BLW reduziert werden.

11.Nur während dem Flug und bei schwachem Befall alle 10-14 Tage spritzen.

12.Maximal 1 Behandlung pro Kultur.

13.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.

14.SPe 8: Gefährlich für Bienen - Anwendung im geschlossenen Gewächshaus sofern keine

Bestäuber zugegen sind.

15.Nur gegen nichtresistente Stämme geeignet.

16.Nur für Topf- und Containerpflanzen.

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.

H302 Gesundheitsschädlich bei Verschlucken.

H351 Kann vermutlich Krebs erzeugen.

H373 Kann die Organe schädigen bei längerer oder wiederholter Exposition.

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

GHS07

GHS08

GHS09

Symbol

Gefahrenbezeichnung Vorsicht gefährlich Gesundheitsschädigend 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.

1-10-2018

Minister Bruno Bruins naar ministeriële G20-bijeenkomst over gezondheid

Minister Bruno Bruins naar ministeriële G20-bijeenkomst over gezondheid

Op woensdag 3 en donderdag 4 oktober is minister Bruno Bruins (Medische Zorg) namens Nederland aanwezig bij de G20-bijeenkomst over gezondheid. Tijdens deze bijeenkomst in Argentinië komen alle gezondheidsministers van de grootste economieën van de wereld samen. Op de agenda staat onder andere de gezamenlijke strijd tegen antibioticaresistentie. Onderdeel hiervan is een crisissimulatie over een internationale infectieziekte-uitbraak met een multiresistente bacterie. Ook wordt er gesproken over het verste...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

28-9-2018

FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma

FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma

FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma

FDA - U.S. Food and Drug Administration

20-9-2018

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Published on: Wed, 19 Sep 2018 00:00:00 +0200 The third Joint Meeting of the ECDC's Food‐ and Waterborne Disease and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network was held on 16 and 17 October 2017 in Parma. The meeting was constructed around the principle of ‘One health approach to collaborative response to foodborne disease outbreaks in EU/EEA’ and served as an opportunity for public health authorities and food safety/veterinary authorities to meet and exchange information on the...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Les Distributions Orca Lite Inc. recalls FLEXI LIGHT multi-purpose utility lighters

Les Distributions Orca Lite Inc. recalls FLEXI LIGHT multi-purpose utility lighters

Health Canada's sampling and evaluation program has determined that these lighters do not meet the Lighters Regulations in Canada and may pose a fire or burn hazard. Specifically, the child-resistant mechanism may not work properly.

Health Canada

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

10-9-2018

FDA Investigating Multistate Outbreak of Salmonella Enteritidis Linked to Shell Eggs from Gravel Ridge Farms

FDA Investigating Multistate Outbreak of Salmonella Enteritidis Linked to Shell Eggs from Gravel Ridge Farms

Outbreak of Salmonella Enteritidis Linked to Shell Eggs

FDA - U.S. Food and Drug Administration

1-9-2018

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Health Canada is advising consumers and pet owners not to use homeopathic and veterinary products made by King Bio Inc. and labeled as "Dr. King's," "Dr King's Natural Pet" or "Natural Pet." These products may pose a health risk to people and pets, especially children, pregnant women and those with compromised immune systems, because of potential microbial contamination. According to the United States Food and Drug Administration, high levels of microbial contamination were identified at the manufacturin...

Health Canada

29-8-2018

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Published on: Tue, 21 Aug 2018 00:00:00 +0200 Abstract In May 2018, EFSA and ECDC co‐facilitated a workshop on preparedness for a multi‐national food safety/public health incident. The workshop, hosted at AGES in Vienna, was conceived to closely align with EFSA's Strategy 2020 commitment to prepare for future risk assessment challenges. EFSA, ECDC, AGES and BfR worked together closely to develop a workshop and associated training materials to be delivered over a 2.5‐day agenda. The workshop was attended...

Europe - EFSA - European Food Safety Authority Publications

17-8-2018

Middel tegen ziekte van Kahler in basispakket na succesvolle prijsonderhandelingen

Middel tegen ziekte van Kahler in basispakket na succesvolle prijsonderhandelingen

Minister Bruno Bruins (Medische Zorg) heeft met succes onderhandeld over de prijs van het middel daratumumab in twee verschillende combinatietherapieën voor de vervolgbehandeling van de ziekte van Kahler (multipel myeloom). Bij deze ziekte is er sprake van kwaadaardige woekering van plasmacellen in het beenmerg. Daratumumab was al beschikbaar als zogenaamde monotherapie voor patiënten die al eerder zijn behandeld. Door de prijsafspraken wordt het middel vanaf 1 september voor deze patiënten ook vergoed u...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

10-8-2018

Dringende Sicherheitsinformation zu AXIOM MULTIX, MT, ACSS,P,N, AXIOM MULTIX, MT, ACSS,N, AXIOM MULTIX, MT, AXIOM Vertix Solitaire M-System_T, AXIOM ARISTOS VX Plus von Siemens Healthcare GmbH, X-Ray Products (XP)

Dringende Sicherheitsinformation zu AXIOM MULTIX, MT, ACSS,P,N, AXIOM MULTIX, MT, ACSS,N, AXIOM MULTIX, MT, AXIOM Vertix Solitaire M-System_T, AXIOM ARISTOS VX Plus von Siemens Healthcare GmbH, X-Ray Products (XP)

Weitere Informationen sowie Details zum Produkt entnehmen Sie bitte der anliegenden Kundeninformation des Herstellers.

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

9-8-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

7-8-2018

Argatroban 1 mg/ml Infusionslösung, neue Darreichungsformen als gebrauchsfertige Lösungen: Sicherheitshinweise zum Risiko einer möglichen Verwechselung mit Argatroban 100 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Argatroban 1 mg/ml Infusionslösung, neue Darreichungsformen als gebrauchsfertige Lösungen: Sicherheitshinweise zum Risiko einer möglichen Verwechselung mit Argatroban 100 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Risiko von Medikationsfehlern im Zusammenhang mit einer möglichen Verwechslung zwischen dem bisher im Markt verfügbaren Argatra® Multidose 100 mg/ml.

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

2-8-2018

Orphan designation:  Pomalidomide,  for the: Treatment of multiple myeloma

Orphan designation: Pomalidomide, for the: Treatment of multiple myeloma

Europe - EMA - European Medicines Agency

26-7-2018

Multi country Salmonella Agona outbreak possibly linked to ready-to-eat food

Multi country Salmonella Agona outbreak possibly linked to ready-to-eat food

Multi country Salmonella Agona outbreak possibly linked to ready-to-eat food

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

21-7-2018

Dringende Sicherheitsinformation zu Arrow HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip von Arrow International Inc.

Dringende Sicherheitsinformation zu Arrow HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip von Arrow International Inc.

Weitere Informationen sowie Details zum Produkt entnehmen Sie bitte der anliegenden Kundeninformation des Herstellers.

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

21-7-2018

King Bio Issues Voluntary Nationwide Recall of Aquaflora Candida HP9, Lymph Detox, and Baby Teething Liquids Due to Microbial Contamination

King Bio Issues Voluntary Nationwide Recall of Aquaflora Candida HP9, Lymph Detox, and Baby Teething Liquids Due to Microbial Contamination

King Bio is voluntarily recalling four lots of Aquaflora Candida HP9, Lymph Detox, and Baby Teething liquids to the consumer level. During a routine inspection by the U.S. Food and Drug Administration, the products were found to contain microbial contaminants Pseudomonas Brenneri, Pseudomonas Fluroescens and Burkholderia Multivorans.

FDA - U.S. Food and Drug Administration

18-7-2018

FDA Investigating Multistate Outbreak of Salmonella Sandiego Infections Linked to Hy-Vee Spring Pasta Salad

FDA Investigating Multistate Outbreak of Salmonella Sandiego Infections Linked to Hy-Vee Spring Pasta Salad

The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, is investigating a multi-state outbreak of Salmonella Sandiego illnesses linked to Spring Pasta Salad sold at Hy-Vee locations in Iowa, Illinois, Kansas, Minnesota, Missouri, Nebraska, South Dakota, and Wisconsin.

FDA - U.S. Food and Drug Administration

18-7-2018

Orphan designation:  Thalidomide,  for the: Treatment of multiple myeloma

Orphan designation: Thalidomide, for the: Treatment of multiple myeloma

Europe - EMA - European Medicines Agency

14-7-2018

FDA Investigates Multistate Outbreak of Cyclospora Illnesses Linked to Fresh Express Salad Mix Served at McDonald’s

FDA Investigates Multistate Outbreak of Cyclospora Illnesses Linked to Fresh Express Salad Mix Served at McDonald’s

The FDA confirms the presence of Cyclospora in Fresh Express salad mix through new laboratory method; Fresh Express recalls expired products containing romaine lettuce.

FDA - U.S. Food and Drug Administration

26-6-2018

Home Hardware Stores Ltd. recalls Home Flexible Multi-Purpose Lighter

Home Hardware Stores Ltd. recalls Home Flexible Multi-Purpose Lighter

Health Canada's sampling and evaluation program has determined that these lighters do not meet the Lighters Regulations in Canada and may pose a fire or burn hazard. Specifically the lighters:

Health Canada

16-6-2018

Del Monte Fresh Produce N.A., Inc. Voluntarily Recalls Limited Quantity of Vegetable Trays in a Multistate Outbreak of Cyclospora Illnesses in Select Retailers in Illinois, Indiana, Iowa, Michigan, Minnesota, and Wisconsin, Because of Possible Health Risk

Del Monte Fresh Produce N.A., Inc. Voluntarily Recalls Limited Quantity of Vegetable Trays in a Multistate Outbreak of Cyclospora Illnesses in Select Retailers in Illinois, Indiana, Iowa, Michigan, Minnesota, and Wisconsin, Because of Possible Health Risk

Del Monte Fresh Produce N.A., Inc. ("Del Monte Fresh") announced today, the voluntary recall of a limited quantity of 6 oz., 12 oz. and 28 oz. vegetable trays containing fresh broccoli, cauliflower, celery sticks, carrots, and dill dip sold to select retailers in Illinois, Indiana, Iowa, Michigan, Minnesota and Wisconsin. Del Monte was notified by state agencies of the outbreak and its potential involvement.

FDA - U.S. Food and Drug Administration

16-6-2018

FDA Investigates Multistate Outbreak of Cyclospora illnesses linked to Del Monte Vegetable Trays

FDA Investigates Multistate Outbreak of Cyclospora illnesses linked to Del Monte Vegetable Trays

The U.S. Food and Drug Administration (FDA) along with the Centers for Disease Control and Prevention (CDC) and state and local officials have been investigating a cluster of cyclosporiasis illnesses associated with recalled Del Monte vegetable trays from Kwik Trip/Kwik Star locations in the United States.

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

15-6-2018

FDA Investigating Multistate Outbreak of Salmonella Mbandaka Infections Likely Linked to Kellogg’s Honey Smacks Cereal

FDA Investigating Multistate Outbreak of Salmonella Mbandaka Infections Likely Linked to Kellogg’s Honey Smacks Cereal

The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, are investigating a multistate outbreak of Salmonella Mbandaka illnesses that may be linked to Kellogg’s Honey Smacks cereal.

FDA - U.S. Food and Drug Administration

9-6-2018

FDA Investigating Multistate Outbreak of Salmonella Adelaide Infections Linked to Pre-Cut Melons

FDA Investigating Multistate Outbreak of Salmonella Adelaide Infections Linked to Pre-Cut Melons

The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, are investigating a multistate outbreak of Salmonella Adelaide illnesses that may be linked to cut melons.

FDA - U.S. Food and Drug Administration

7-6-2018

Dringende Sicherheitsinformation zu Activa PC Neurostimulator, Activa S. Multi-program Neurostimulator, Activa PC+S, Activa RC Multi-Program Rechargable Neurostimulator von Medtronic Inc

Dringende Sicherheitsinformation zu Activa PC Neurostimulator, Activa S. Multi-program Neurostimulator, Activa PC+S, Activa RC Multi-Program Rechargable Neurostimulator von Medtronic Inc

Weitere Informationen sowie Details zum Produkt entnehmen Sie bitte der anliegenden Kundeninformation des Herstellers.

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

29-5-2018

Orphan designation:  Panobinostat,  for the: Treatment of multiple myeloma

Orphan designation: Panobinostat, for the: Treatment of multiple myeloma

Europe - EMA - European Medicines Agency

29-5-2018

Orphan designation:  Venetoclax,  for the: Treatment of multiple myeloma

Orphan designation: Venetoclax, for the: Treatment of multiple myeloma

Europe - EMA - European Medicines Agency

11-5-2018

FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients

FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients

FDA approves Gilenya (fingolimod) to treat multiple sclerosis MS in children age 10 and older. This is the first FDA approval of a drug to treat MS in pediatric patients

FDA - U.S. Food and Drug Administration

10-5-2018

Medline Remedy Essentials No-Rinse Cleansing Foam: Avoid Using - Multistate Outbreak of Burkholderia Cepacia Complex

Medline Remedy Essentials No-Rinse Cleansing Foam: Avoid Using - Multistate Outbreak of Burkholderia Cepacia Complex

CDC reports that there are 10 confirmed cases of infection caused by bacteria within the Burkholderia cepacia complex, also commonly called B. cepacia, in three states: California (2), Pennsylvania (7), and New Jersey (1). These patients were already hospitalized for acute conditions and acquired the infections while hospitalized. The infections have been linked to the Medline product, Remedy Essentials No-Rinse Cleansing Foam.

FDA - U.S. Food and Drug Administration

9-5-2018

FDA Investigates Multistate Outbreak of B. cepacia Complex Linked to Medline Remedy Essentials No-Rinse Cleansing Foam (FDA Announcement)

FDA Investigates Multistate Outbreak of B. cepacia Complex Linked to Medline Remedy Essentials No-Rinse Cleansing Foam (FDA Announcement)

FDA Investigates Multistate Outbreak of B. cepacia Complex Linked to Medline Remedy Essentials No-Rinse Cleansing Foam (FDA Announcement)

FDA - U.S. Food and Drug Administration

19-4-2018

April 4, 2018: Fences Indicted in Multi-Million Dollar, Multi-State Criminal Theft Operations

April 4, 2018: Fences Indicted in Multi-Million Dollar, Multi-State Criminal Theft Operations

April 4, 2018: Fences Indicted in Multi-Million Dollar, Multi-State Criminal Theft Operations

FDA - U.S. Food and Drug Administration

16-3-2018

"Beyond Yourself Multi Athlete" and unauthorized bulk "Multi-Vitamines" seized from Shop Santé stores in Quebec may pose serious health risks

"Beyond Yourself Multi Athlete" and unauthorized bulk "Multi-Vitamines" seized from Shop Santé stores in Quebec may pose serious health risks

Health Canada is advising Canadians that "Beyond Yourself Multi Athlete" multivitamin and unauthorized "Multi-Vitamines" sold in bulk were seized from several Shop Santé stores in Quebec because they may pose serious health risks.

Health Canada

22-1-2018

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

Ocean Township, NJ. In accordance with a Consent Decree of Permanent Injunction ordered in the United States District Court for the District of New Jersey, Flawless Beauty, LLC is voluntarily recalling all lots of nineteen different products sold individually or as part of multi-unit kits alleged by the U.S. Food and Drug Administration ("FDA") to be misbranded or unapproved new drugs pursuant to the Federal Food, Drug, and Cosmetic Act. The FDA believes that these drugs present serious public health risks.

FDA - U.S. Food and Drug Administration

9-7-2013

Voluntary Harmonisation Procedure (VHP) for the assessment of multinational clinical trial applications

Voluntary Harmonisation Procedure (VHP) for the assessment of multinational clinical trial applications

The Voluntary Harmonisation Procedure is a procedure which makes it possible to obtain a coordinated assessment of an application for a clinical trial that is to take place in several European countries.

Danish Medicines Agency

27-6-2011

Danish Pharmacovigilance Update, 16 June 2011

Danish Pharmacovigilance Update, 16 June 2011

Among the articles in this issue of Danish Pharmacovigilance Update, you can read about the removal of contraindication for Velcade® (bortezomib) used for the treatment of multiple myeloma.

Danish Medicines Agency

25-9-2018

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices:  http

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices: http

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices: https://go.usa.gov/xPjCj  pic.twitter.com/yVSNlc5Qb0

FDA - U.S. Food and Drug Administration

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety

6-8-2018

Scientific guideline:  Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies, draft: consultation open

Scientific guideline: Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies, draft: consultation open

The guideline aims to address the use of undetectable minimal residual disease (MRD) as an intermediate efficacy endpoint in controlled randomised clinical studies in patients with multiple myeloma (MM), adequately designed to demonstrate efficacy by relevant hard endpoints. MRD as an endpoint in this context would allow earlier approval of new drugs pending final confirmatory data.

Europe - EMA - European Medicines Agency

6-8-2018

Scientific guideline:  ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version, draft: consultation open

Scientific guideline: ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version, draft: consultation open

This new multidisciplinary guideline is proposed to address biopharmaceutics classification system (BCS)-based biowaivers. BCS-based biowaivers may be applicable to BCS Class I and III drugs, however BCS-based biowaivers for these two classes are not recognized worldwide. This means that pharmaceutical companies have to follow different approaches in the different regions. This guideline will provide recommendations to support the biopharmaceutics classification of medicinal products and will provide rec...

Europe - EMA - European Medicines Agency

19-7-2018

Regulatory and procedural guideline:  Qualification opinion on dopamine transporter imaging as an enrichment biomarker for Parkinson’s disease clinical trials in patients with early Parkinsonian symptoms, adopted

Regulatory and procedural guideline: Qualification opinion on dopamine transporter imaging as an enrichment biomarker for Parkinson’s disease clinical trials in patients with early Parkinsonian symptoms, adopted

Critical Path Global Ltd.’s Critical Path for Parkinson’s (CPP) is a multinational consortium of the Critical Path Institute supported by Parkinson’s UK and industry. This broad collaboration of pharmaceutical companies, government agencies, academic institutions, and charities aims to accelerate the development of therapies for Parkinson’s disease (PD).

Europe - EMA - European Medicines Agency

22-6-2018

Fraxiparine® multi

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