Clinic free

Hauptinformation

  • Handelsname:
  • Clinic free
  • 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:
  • Clinic free
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Herbizid

Weitere Informationen

Status

  • Quelle:
  • UFAG - Ufficio federale dell'agricoltura. OFAG - Office fédéral de l'agriculture. BLW - Bundesamt für Landwirtschaft.
  • Zulassungsnummer:
  • W-7147
  • Letzte Änderung:
  • 06-09-2017

Packungsbeilage

Produkt:

Handelsbezeichnung: Clinic free

Produktekategorie

Bewilligungsinhaber

Eidg. Zulassungsnummer

Herbizid

Nufarm Suisse Sàrl

W-7147

Stoff(e)

Gehalt

Formulierungscode

Wirkstoff:

Glyphosat

30.6 % 360 g/l

[als 41.8% Glyphosat-isopropylammoniumsalz (486 g

/l)]

SL Wasserlösliches

Konzentrat

Anwendungen

A Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

B Brombeere

Einjährige Dicotyledonen

(Unkräuter)

Einjährige

Monocotyledonen

(Ungräser)

Gemeine Quecke

Aufwandmenge: 2 - 3 l/ha

1, 2

B Brombeere

Mehrjährige

Dicotyledonen

(Unkräuter)

Mehrjährige

Monocotyledonen

(Ungräser)

Aufwandmenge: 4 - 10 l/ha

1, 2

Hartschalenobst

Kernobst

Steinobst

Einjährige Dicotyledonen

(Unkräuter)

Einjährige

Monocotyledonen

(Ungräser)

Gemeine Quecke

Aufwandmenge: 2 - 3 l/ha

1, 2

O Hartschalenobst

Kernobst

Steinobst

Mehrjährige

Dicotyledonen

(Unkräuter)

Mehrjährige

Aufwandmenge: 4 - 10 l/ha

1, 2

A Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

Monocotyledonen

(Ungräser)

O Olive

Einjährige Dicotyledonen

(Unkräuter)

Einjährige

Monocotyledonen

(Ungräser)

Gemeine Quecke

Aufwandmenge: 2 - 3 l/ha

1, 2, 3

O Olive

Mehrjährige

Dicotyledonen

(Unkräuter)

Mehrjährige

Monocotyledonen

(Ungräser)

Aufwandmenge: 4 - 10 l/ha

1, 2, 3

W Ertragsreben

Einjährige Dicotyledonen

(Unkräuter)

Einjährige

Monocotyledonen

(Ungräser)

Gemeine Quecke

Aufwandmenge: 2 - 3 l/ha

1, 2

W Ertragsreben

Mehrjährige

Dicotyledonen

(Unkräuter)

Mehrjährige

Monocotyledonen

(Ungräser)

Aufwandmenge: 4 - 10 l/ha

1, 2

G Brache

Einjährige Dicotyledonen

(Unkräuter)

Einjährige

Monocotyledonen

(Ungräser)

Gemeine Quecke

Aufwandmenge: 2 - 3 l/ha

1, 4

G Brache

Mehrjährige

Dicotyledonen

(Unkräuter)

Mehrjährige

Monocotyledonen

(Ungräser)

Aufwandmenge: 4 - 10 l/ha

1, 4

Brache

Einjährige Dicotyledonen

(Unkräuter)

Einjährige

Monocotyledonen

(Ungräser)

Gemeine Quecke

Aufwandmenge: 2 - 3 l/ha

1, 4

Brache

Mehrjährige

Dicotyledonen

Aufwandmenge: 4 - 10 l/ha

1, 4

A Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

(Unkräuter)

Mehrjährige

Monocotyledonen

(Ungräser)

Mais

Einjährige Dicotyledonen

(Unkräuter)

Einjährige

Monocotyledonen

(Ungräser)

Gemeine Quecke

Aufwandmenge: 2 - 3 l/ha

Anwendung: Bei der Saat.

1, 5, 6

Mais

Mehrjährige

Dicotyledonen

(Unkräuter)

Mehrjährige

Monocotyledonen

(Ungräser)

Aufwandmenge: 4 - 10 l/ha

Anwendung: Bei der Saat.

1, 5, 6

Wiesen und Weiden

Dicotyledonen

(Unkräuter)

Monocotyledonen

(Ungräser)

Aufwandmenge: 4 - 10 l/ha

Anwendung:

Flächenbehandlung; vor

Neuansaat.

1, 4

Wiesen und Weiden

Dicotyledonen

(Unkräuter)

Monocotyledonen

(Ungräser)

Konzentration: 0.5 - 1.5 %

Wartefrist: 3 Woche(n)

Anwendung: Mit

Rückenspritze.

1, 7, 8

Wiesen und Weiden

Dicotyledonen

(Unkräuter)

Monocotyledonen

(Ungräser)

Konzentration: 5 - 10 %

Wartefrist: 3 Woche(n)

Anwendung: Mit

Handspritzgeräten.

1, 7, 8

Bäume und Sträucher (ausserhalb

Forst)

Rosen

Einjährige Dicotyledonen

(Unkräuter)

Einjährige

Monocotyledonen

(Ungräser)

Gemeine Quecke

Aufwandmenge: 2 - 3 l/ha

1, 2

Bäume und Sträucher (ausserhalb

Forst)

Rosen

Mehrjährige

Dicotyledonen

(Unkräuter)

Mehrjährige

Monocotyledonen

(Ungräser)

Aufwandmenge: 4 - 10 l/ha

1, 2

Z Brache

Einjährige Dicotyledonen

(Unkräuter)

Einjährige

Monocotyledonen

(Ungräser)

Aufwandmenge: 2 - 3 l/ha

1, 4

A Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

Gemeine Quecke

Z Brache

Mehrjährige

Dicotyledonen

(Unkräuter)

Mehrjährige

Monocotyledonen

(Ungräser)

Aufwandmenge: 4 - 10 l/ha

1, 4

Forstliche Pflanzgärten

Einjährige Dicotyledonen

(Unkräuter)

Einjährige

Monocotyledonen

(Ungräser)

Gemeine Quecke

Aufwandmenge: 2 - 3 l/ha

1, 2

Forstliche Pflanzgärten

Mehrjährige

Dicotyledonen

(Unkräuter)

Mehrjährige

Monocotyledonen

(Ungräser)

Aufwandmenge: 4 - 10 l/ha

1, 2

Auf und an National- und

Kantonsstrassen

Einjährige Dicotyledonen

(Unkräuter)

Einjährige

Monocotyledonen

(Ungräser)

Gemeine Quecke

Aufwandmenge: 2 - 3 l/ha

1, 9

Auf und an National- und

Kantonsstrassen

Mehrjährige

Dicotyledonen

(Unkräuter)

Mehrjährige

Monocotyledonen

(Ungräser)

Aufwandmenge: 4 - 10 l/ha

1, 9

Böschungen und Grünstreifen

entlang von Verkehrswegen (gem.

ChemRRV)

Einjährige Dicotyledonen

(Unkräuter)

Einjährige

Monocotyledonen

(Ungräser)

Gemeine Quecke

Aufwandmenge: 2 - 3 l/ha

1, 9

Böschungen und Grünstreifen

entlang von Verkehrswegen (gem.

ChemRRV)

Mehrjährige

Dicotyledonen

(Unkräuter)

Mehrjährige

Monocotyledonen

(Ungräser)

Aufwandmenge: 4 - 10 l/ha

1, 9

Ö Grünfläche

Ackerkratzdistel

Stumpfblättriger Ampfer

(Blacken)

Konzentration: 5 - 10 %

Wartefrist: 3 Woche(n)

Anwendung: Mit

1, 7, 10

A Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

Handspritzgeräten (ohne

Rückenspritze).

Ö Offene Ackerfläche

Ackerkratzdistel

Gemeine Quecke

Stumpfblättriger Ampfer

(Blacken)

Winden

Konzentration: 5 - 10 %

Anwendung: Mit

Handspritzgeräten (ohne

Rückenspritze).

1, 10

Auflagen und Bemerkungen:

Keine Niederschläge während mindestens 6 Stunden nach der Behandlung.

Behandlung spätestens bis Ende August. Es dürfen keine grünen Teile der Kulturpflanzen mit dem

Herbizid in Kontakt kommen.

Früchte, welche bei der Behandlung am Boden liegen, dürfen nicht verzehrt werden.

Behandlung bis spätestens 2 Wochen vor der Saat oder Pflanzung.

Die Aufwandmenge bezieht sich auf die effektiv zu behandelnde Fläche.

Behandlung der unbearbeiteten Zwischenreihen bei der Streifenfrässaat.

Beweidung oder Schnitt (Grünfutter oder Konservierung) frühestens 3 Wochen nach der

Behandlung. Ausnahme: Für nicht laktierende Tiere beträgt die Wartefrist 2 Wochen.

Einzelpflanzenbehandlung.

Gemäss Chemikalien-Risikoreduktions-Verordnung (ChemRRV): Nur Einzelpflanzenbehandlung

anderweitig nicht bekämpfbarer Problempflanzen.

10.Einzelpflanzenbehandlung gemäss Direktzahlungsverordnung (DZV).

Gefahrenkennzeichnungen:

Darf nicht in die Hände von Kindern gelangen.

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

einhalten.

H411 Giftig für Wasserorganismen, mit langfristiger Wirkung.

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

Gefahrensymbole und -bezeichnungen:

Kurzkennzeichnung

GHS09

Symbol

Gefahrenbezeichnung 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.

19-10-2018

Dollarama recalls Craft Dough toys

Dollarama recalls Craft Dough toys

The craft dough toy is mislabelled and incorrectly states that it is gluten free. Consumers who are sensitive or allergic to gluten may have an adverse reaction when using the toy.

Health Canada

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Drug agency from China visits Denmark

Drug agency from China visits Denmark

A delegation from the Centre for Drug Evaluation under the China National Medical Products Administration visited the Danish Medicines Agency this week to discuss clinical trials and drug monitoring, among other things. The meeting at the Danish Medicines Agency is part of a Danish-Chinese collaboration under the auspices of the China-Denmark Food and Drug Regulatory Cooperation Centre, which was established with the signing of a collaboration agreement in May of last year, and which aims to strengthen r...

Danish Medicines Agency

24-9-2018

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA has awarded 12 new clinical trial research grants to enhance the development of medical products for patients with rare diseases

FDA - U.S. Food and Drug Administration

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Antimicrobial resistance (AMR) represents a major challenge for Public Health and the scientific community, and requires immediate and drastic solutions. Acquired resistance to certain antimicrobials is already widespread to such an extent that their efficacy in the treatment of certain life‐threatening infections is already compromised. To date, the emergence and spread of AMR has been attributed to the use, misuse or indiscriminate use of antibiotics as th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Preparation of Dutch food consumption data for risk assessment

Preparation of Dutch food consumption data for risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The availability of detailed and high‐quality food consumption data collected at an individual level is essential for assessing the exposure to potential risks in the food chain. During the years 2012–2016, the Dutch National Food Consumption Survey was conducted in the Netherlands as part of the EU Menu survey, following the EFSA 2009 guidance on ‘General principles for the collection of national food consumption data in the view of a pan‐European dietary s...

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

8-9-2018

Gravel Ridge Farms Recalls Cage Free Egg Due to Possible Salmonella Contamination

Gravel Ridge Farms Recalls Cage Free Egg Due to Possible Salmonella Contamination

Gravel Ridge Farms is recalling Cage Free Large Eggs due to a potential contamination of Salmonella. The recall was initiated because reported illnesses were confirmed at locations using Gravel Ridge Farm Eggs, and we are voluntarily recalling out of an abundance of caution.

FDA - U.S. Food and Drug Administration

31-8-2018

Danish Medicines Agency launches new concept for National Scientific Advice

Danish Medicines Agency launches new concept for National Scientific Advice

Today, 31 August 2018, the Danish Medicines Agency is launching a new concept for National Scientific Advice for companies, hospitals and others who request advice on the requirements applicable to clinical investigation and marketing authorisations.

Danish Medicines Agency

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft protocol for the Scientific Opinion on free sugars from all dietary sources, prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel), supported by the ad‐hoc Working Group on Sugars. The draft protocol was endorsed by the Panel for public consultation at its plenary meeti...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

The U.S. Food and Drug Administration (FDA) is warning that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. We required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when we approved the medicine in 2009. Once we receive the final results from the manufacturer, we will conduct a comprehensive review and will update the public with any new inf...

FDA - U.S. Food and Drug Administration

22-8-2018

Dringende Sicherheitsinformation zu Rotating IV pole von GE Healthcare Clinical Systems (Ohmeda Medical)

Dringende Sicherheitsinformation zu Rotating IV pole von GE Healthcare Clinical Systems (Ohmeda Medical)

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

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

22-8-2018

Dringende Sicherheitsinformation zu Minicon Clinical Sample Concentrators von Merck Millipore Ltd

Dringende Sicherheitsinformation zu Minicon Clinical Sample Concentrators von Merck Millipore Ltd

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

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

21-8-2018

Dringende Sicherheitsinformation zu MetaVision Suite, Clinical Information System& EHR von iMDsoft Ltd.

Dringende Sicherheitsinformation zu MetaVision Suite, Clinical Information System& EHR von iMDsoft Ltd.

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

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

8-8-2018

Risks Associated with Use of Rupture of Membranes Tests - Letter to Health Care Providers

Risks Associated with Use of Rupture of Membranes Tests - Letter to Health Care Providers

The FDA is reminding health care providers that tests to detect rupture of the amniotic membranes should not be used without other clinical assessments to make critical patient management decisions.

FDA - U.S. Food and Drug Administration

3-8-2018

Zithromax, Zmax (azithromycin): FDA Warning - Increased Risk of Cancer Relapse With Long-Term Use After Donor Stem Cell Transplant

Zithromax, Zmax (azithromycin): FDA Warning - Increased Risk of Cancer Relapse With Long-Term Use After Donor Stem Cell Transplant

The antibiotic Zithromax, Zmax (azithromycin) should not be given long-term to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients.

FDA - U.S. Food and Drug Administration

27-7-2018

Dringende Sicherheitsinformation zu VITROS Folate; FreePSA; FSH; Prolactin; TSH von Ortho Clinical Diagnostics UK

Dringende Sicherheitsinformation zu VITROS Folate; FreePSA; FSH; Prolactin; TSH von Ortho Clinical Diagnostics UK

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

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

19-7-2018

Radagast Pet Food Inc. recalls Rad Cat Raw Diet Free-Range Pet Food

Radagast Pet Food Inc. recalls Rad Cat Raw Diet Free-Range Pet Food

The pet food may be contaminated with Listeria monocytogenes and there is risk of cross contamination and illness after handling the pet food.

Health Canada

17-7-2018

ALDI Voluntarily Recalls AnnaSea Wasabi Ahi Poke Hawaiian Poke Kits and Limu Ahi Poke Hawaiian Poke Kits Due to Storage at Incorrect Temperature in Area Store

ALDI Voluntarily Recalls AnnaSea Wasabi Ahi Poke Hawaiian Poke Kits and Limu Ahi Poke Hawaiian Poke Kits Due to Storage at Incorrect Temperature in Area Store

Batavia, Ill. Uuly 14, 2018) -ALDI has voluntarily recalled AnnaSea Wasabi Ahi Poke Hawaiian Poke Kits and Limu Ahi Poke Hawaiian Poke Kits sold at one retail store location in North Carolina. While the products are required to remain at frozen temperatures to ensure safety, this store location displayed and sold the products from the cooler section. Because storing the products at temperatures above freezing prior to consumption can render the products unsafe for consumption, ALDI is recalling these items.

FDA - U.S. Food and Drug Administration

11-7-2018

Phase I clinical trials and non-commercial clinical trials now exempt from fees

Phase I clinical trials and non-commercial clinical trials now exempt from fees

Fees are no longer charged for Phase I clinical trials and non-commercial clinical trials of medicines. This is the result of the Growth Plan for Life Science and the Budget for 2018. The new rules entered into force on 1 July 2018.

Danish Medicines Agency

11-7-2018

OCOOW LLC recalls Odie's Solvent-Free Super Penetrating Oil and Odie's Safer Solvent

OCOOW LLC recalls Odie's Solvent-Free Super Penetrating Oil and Odie's Safer Solvent

The recalled products do not have proper consumer chemical hazard packaging and labelling required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

10-7-2018

FDA takes action to support American military personnel by granting an authorization for freeze-dried plasma product to enable broader access while the agency works toward approval of the product

FDA takes action to support American military personnel by granting an authorization for freeze-dried plasma product to enable broader access while the agency works toward approval of the product

FDA granted an EUA to DOD to enable the emergency use of Pathogen-Reduced Leukocyte-Depleted Freeze-Dried Plasma (referred to as French FDP).

FDA - U.S. Food and Drug Administration

6-7-2018

Radagast Pet Food, Inc. Voluntarily Recalls Three Lots of Rad Cat Raw Diet Free-Range Chicken Recipe and One Lot of Pasture-Raised Venison Recipe Because of Possible Health Risk

Radagast Pet Food, Inc. Voluntarily Recalls Three Lots of Rad Cat Raw Diet Free-Range Chicken Recipe and One Lot of Pasture-Raised Venison Recipe Because of Possible Health Risk

Radagast Pet Food, Inc. of Portland, OR is recalling three lots of Rad Cat Raw Diet Free-Range Chicken Recipe because testing results indicate they have the potential to be contaminated with Listeria monocytogenes. The Company is also recalling one lot of Rad Cat Raw Diet Pasture-Raised Venison Recipe because testing results indicate it has the potential to be contaminated with Shiga Toxin producing E. coli O121. This recall is being conducted out of an abundance of caution. Due to Radagast Pet Food’s ...

FDA - U.S. Food and Drug Administration

3-7-2018

DKMA Update June 2018

DKMA Update June 2018

In this issue of DKMA Update you can read about new rules on private individuals' import of medicines, Danish Medicines Agency being key driver in European solution for complex clinical trials and much more.

Danish Medicines Agency

2-7-2018

Fagron Sterile Services Issues Voluntary Nationwide Recall of Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL and Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, in a 5mL syringe Due to Mislabeling

Fagron Sterile Services Issues Voluntary Nationwide Recall of Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL and Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, in a 5mL syringe Due to Mislabeling

Fagron Sterile Services is voluntarily recalling two (2) lots of Neostigmine Methylsulfate 5mL syringes to the user/hospital/clinic level. The specified product lots are being recalled because of a confirmed customer complaint that some syringe units containing Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL are incorrectly labelled as Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL. Secondary packages are properly labelled as Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL.

FDA - U.S. Food and Drug Administration

28-6-2018

Clinical Investigator Inspection List (CLIIL)

Clinical Investigator Inspection List (CLIIL)

The Clinical Investigator Inspection List contains names, addresses, and other pertinent information gathered from inspections of clinical investigators who have performed studies with investigational new drugs.

FDA - U.S. Food and Drug Administration

23-6-2018

Dringende Sicherheitsinformation zu VITROS Na+ Slides von Ortho-Clinical Diagnostics, Inc.

Dringende Sicherheitsinformation zu VITROS Na+ Slides von Ortho-Clinical Diagnostics, Inc.

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

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

18-5-2018

Keytruda (pembrolizumab) or Tecentriq (atezolizumab): FDA Alerts Health Care Professionals and Investigators: FDA Statement - Decreased Survival in Some Patients in Clinical Trials Associated with Monotherapy

Keytruda (pembrolizumab) or Tecentriq (atezolizumab): FDA Alerts Health Care Professionals and Investigators: FDA Statement - Decreased Survival in Some Patients in Clinical Trials Associated with Monotherapy

Early reviews found patients in the monotherapy arms of both trials with PD-L1 low status had decreased survival compared to patients who received cisplatin- or carboplatin-based chemotherapy.

FDA - U.S. Food and Drug Administration

11-5-2018

Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present

Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present

The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.

FDA - U.S. Food and Drug Administration

17-10-2018

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review.

Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD.  https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https://go.usa.gov/xPqku  pic.twitter.com/EYNZANlgr9

FDA - U.S. Food and Drug Administration

11-10-2018

October is #SIDSAwarenessMonth.  Smoking during pregnancy can lead to complications, premature delivery, low birth weight, stillbirth, and SIDS. Make sure your baby is #safetosleep at  https://women.smokefree.gov/  via @FDATobaccopic.twitter.com/i37QX61Bb

October is #SIDSAwarenessMonth. Smoking during pregnancy can lead to complications, premature delivery, low birth weight, stillbirth, and SIDS. Make sure your baby is #safetosleep at https://women.smokefree.gov/  via @FDATobaccopic.twitter.com/i37QX61Bb

October is #SIDSAwarenessMonth. Smoking during pregnancy can lead to complications, premature delivery, low birth weight, stillbirth, and SIDS. Make sure your baby is #safetosleep at https://women.smokefree.gov/  via @FDATobacco pic.twitter.com/i37QX61Bb7

FDA - U.S. Food and Drug Administration

25-9-2018

Conducting clinical trials & preparing a submission for #FDA review?

Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more!  https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.usa.gov/xPqku . pic.twitter.com/Ktqq9Slx0y

FDA - U.S. Food and Drug Administration

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Party with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 26-Sep-2018, To: 26-Sep-2018

European Medicines Agency (EMA) Human Scientific Committees' Working Party with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 26-Sep-2018, To: 26-Sep-2018

This Healthcare Professionals' Working Party (HCPWP) plenary meeting will include discussions on advances in clinical practice and the scientific and regulatory challenges. Members will also be invited to present how they are including regulatory sciences in fellowships and young researchers’ training. Feedback will be given from the representatives of the Scientific Committees.

Europe - EMA - European Medicines Agency

7-9-2018

 2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

Enpr-EMA will hold its tenth annual workshop on 7-8 June 2018 at EMA. The workshop brings relevant stakeholders together to discuss requirements, barriers and opportunities for the conduct of high-quality clinical studies in children. The overall theme of this year’s workshop will be a ‘holistic approach to paediatric research’. Highlights of this year’s workshop include: i) short perspectives of the various stakeholders involved in paediatric research (patient/young people advisory groups, research netw...

Europe - EMA - European Medicines Agency

5-9-2018

Access is a matter of public health. Facilitating dialogue between device makers and payors during planning phase of clinical trials can expedite patient access to safe, effective devices; esp. through collection of clinical evidence that informs regulato

Access is a matter of public health. Facilitating dialogue between device makers and payors during planning phase of clinical trials can expedite patient access to safe, effective devices; esp. through collection of clinical evidence that informs regulato

Access is a matter of public health. Facilitating dialogue between device makers and payors during planning phase of clinical trials can expedite patient access to safe, effective devices; esp. through collection of clinical evidence that informs regulatory and coverage decisions

FDA - U.S. Food and Drug Administration

4-9-2018

Certificates of free sale and export certificates for medical devices

Certificates of free sale and export certificates for medical devices

The TGA has introduced a new process for certificates of free sale and export certificates.

Therapeutic Goods Administration - Australia

22-8-2018

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye:  http://bit.ly/2h2NcHz .pic.twitter.com/ecJErFeiSH

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye: http://bit.ly/2h2NcHz .pic.twitter.com/ecJErFeiSH

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye: http://bit.ly/2h2NcHz . pic.twitter.com/ecJErFeiSH

FDA - U.S. Food and Drug Administration

17-8-2018

Scientific guideline:  Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3, draft: consultation open

Scientific guideline: Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3, draft: consultation open

The present document is a third revision of the existing guideline. It should be considered as general guidance on the development of medicinal products for the treatment of epileptic disorders and should be read in conjunction with other EMA and ICH guidelines, which may apply to these conditions and patient populations. The main changes to the existing guideline include incorporation of the new classification / definitions of seizure types and epilepsies, the acceptance of add-on studies in support o...

Europe - EMA - European Medicines Agency

15-8-2018

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)5555 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/172/17/T/01

Europe -DG Health and Food Safety

15-8-2018

Scientific guideline:  Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1, draft: consultation open

Scientific guideline: Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1, draft: consultation open

The proposed guideline will replace annex to guideline on similar medicinal products containing biotechnology-derived proteins as active substance: Non-Clinical and Clinical Issues - Guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor, EMEA/CHMP/BMWP/31329/2005

Europe - EMA - European Medicines Agency

8-8-2018

The FDA’s Fresh Empire campaign illustrates tobacco prevention messages to multicultural youth in a novel and attention-grabbing way. 

Watch the new ad encouraging teens to live tobacco free: https://www.youtube.com/watch?v=6iBAMnU96UY …

The FDA’s Fresh Empire campaign illustrates tobacco prevention messages to multicultural youth in a novel and attention-grabbing way. Watch the new ad encouraging teens to live tobacco free: https://www.youtube.com/watch?v=6iBAMnU96UY …

The FDA’s Fresh Empire campaign illustrates tobacco prevention messages to multicultural youth in a novel and attention-grabbing way. Watch the new ad encouraging teens to live tobacco free: https://www.youtube.com/watch?v=6iBAMnU96UY …

FDA - U.S. Food and Drug Administration

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

31-7-2018

Scientific guideline:  Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells, draft: consultation open

Scientific guideline: Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells, draft: consultation open

This guideline defines scientific principles and provides guidance for the development and evaluation of medicinal products containing genetically modified cells intended for use in humans and presented for marketing authorisation. Its focus is on the quality, nonclinical aspects and safety and efficacy requirements of genetically modified cells developed as medicinal products.

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

13-6-2018

Scientific guideline:  Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections, draft: consultation open

Scientific guideline: Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections, draft: consultation open

This concept paper proposes the development of a single guideline on the clinical evaluation of medicinal products indicated for treatment of bacterial infections. The development of this single guideline is intended to merge, revise and add to the guidance that is currently included in two separate documents as follows: guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev. 2), adopted in 2011 and in force since 2012 and the addendum ...

Europe - EMA - European Medicines Agency

12-6-2018

EU/3/16/1802 (Quality Regulatory Clinical Ireland Limited)

EU/3/16/1802 (Quality Regulatory Clinical Ireland Limited)

EU/3/16/1802 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)3805 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/197/16/T/01

Europe -DG Health and Food Safety

23-5-2018

Scientific guideline:  Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice, draft: consul

Scientific guideline: Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice, draft: consul

The guideline lays down the principles for the two-step release and shipping of the investigational medicinal products by the qualified person and the sponsor. The guideline also describes the areas of interface between the manufacturer and the sponsor and the required contractual agreements.

Europe - EMA - European Medicines Agency

16-5-2018

Watch LIVE today at 1pm ET: The Great Debate: What is Enough… Women in Clinical Trials.  http://ow.ly/1wzB30jXeX2  #FDAGreatDebatepic.twitter.com/rcnrVp9K8u

Watch LIVE today at 1pm ET: The Great Debate: What is Enough… Women in Clinical Trials. http://ow.ly/1wzB30jXeX2  #FDAGreatDebatepic.twitter.com/rcnrVp9K8u

Watch LIVE today at 1pm ET: The Great Debate: What is Enough… Women in Clinical Trials. http://ow.ly/1wzB30jXeX2  #FDAGreatDebate pic.twitter.com/rcnrVp9K8u

FDA - U.S. Food and Drug Administration

14-5-2018

Celebrate National Women’s Health Week by joining us this Wednesday at 1 p.m. ET for “The Great Debate: What is Enough… Women in Clinical Trials”.  http://ow.ly/GF8m30jTpFn  #NWHW #clinicaltrialspic.twitter.com/mvltDqmK8v

Celebrate National Women’s Health Week by joining us this Wednesday at 1 p.m. ET for “The Great Debate: What is Enough… Women in Clinical Trials”. http://ow.ly/GF8m30jTpFn  #NWHW #clinicaltrialspic.twitter.com/mvltDqmK8v

Celebrate National Women’s Health Week by joining us this Wednesday at 1 p.m. ET for “The Great Debate: What is Enough… Women in Clinical Trials”. http://ow.ly/GF8m30jTpFn  #NWHW #clinicaltrials pic.twitter.com/mvltDqmK8v

FDA - U.S. Food and Drug Administration