Focus Ultra

Hauptinformation

  • Handelsname:
  • Focus Ultra
  • 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:
  • Focus Ultra
    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-4768
  • Letzte Änderung:
  • 06-09-2017

Packungsbeilage

Produkt:

Handelsbezeichnung: Focus Ultra

Bewilligung beendet: Ausverkaufsfrist: 31.08.2017, Aufbrauchfrist: 31.08.2018

Produktekategorie

Bewilligungsinhaber Eidg. Zulassungsnummer

Herbizid

Leu + Gygax AG

W-4768

Stoff(e)

Gehalt

Formulierungscode

Wirkstoff:

Cycloxydim

10.8 % 100 g/l

EC Emulsionskonzentrat

Anwendungen

A Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

B Erdbeere

Ausfallgetreide

Aufwandmenge: 1.5 - 3

l/ha

Wartefrist: 6 Woche(n)

Anwendung: Vor der Blüte

und nach der Ernte.

B Erdbeere

Einjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 1 - 2 l/ha

Wartefrist: 6 Woche(n)

Anwendung: Vor der Blüte

und nach der Ernte.

B Erdbeere

Mehrjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 4 - 6 l/ha

Wartefrist: 6 Woche(n)

Anwendung: Vor der Blüte

und nach der Ernte.

Kernobst

Steinobst

Ausfallgetreide

Aufwandmenge: 1.5 - 3

l/ha

Anwendung: Frühjahr,

Sommer.

Kernobst

Steinobst

Einjährige Monocotyledonen

(Ungräser) [ausgenommen Poa

annua]

Aufwandmenge: 1 - 2 l/ha

Anwendung: Frühjahr,

Sommer.

A Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

Kernobst

Steinobst

Mehrjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 4 - 6 l/ha

Anwendung: Frühjahr,

Sommer.

W allg.

Ausfallgetreide

Aufwandmenge: 1.5 - 3

l/ha

Anwendung: Frühjahr,

Sommer.

W allg.

Einjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 1 - 2 l/ha

Anwendung: Frühjahr,

Sommer.

W allg.

Mehrjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 4 - 6 l/ha

Anwendung: Frühjahr,

Sommer.

Buschbohne

Karotten

Knollenfenchel

Kohlarten

Ausfallgetreide

Aufwandmenge: 1.5 - 3

l/ha

Wartefrist: 4 Woche(n)

Buschbohne

Karotten

Knollenfenchel

Kohlarten

Einjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 1 - 2 l/ha

Wartefrist: 4 Woche(n)

Buschbohne

Karotten

Knollenfenchel

Kohlarten

Mehrjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 4 - 6 l/ha

Wartefrist: 4 Woche(n)

Knoblauch

Knollensellerie

Lauch

Rande

Schalotten

Tomaten

Zwiebeln

Ausfallgetreide

Aufwandmenge: 1.5 - 3

l/ha

Wartefrist: 8 Woche(n)

Knoblauch

Knollensellerie

Lauch

Rande

Schalotten

Tomaten

Zwiebeln

Einjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 1 - 2 l/ha

Wartefrist: 8 Woche(n)

G Knoblauch

Knollensellerie

Lauch

Rande

Schalotten

Tomaten

Mehrjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 4 - 6 l/ha

Wartefrist: 8 Woche(n)

A Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

Zwiebeln

Kürbisgewächse (Cucurbitaceae)

[Kürbis,

Cornichon/Einlegegurken]

Einjährige Monocotyledonen

(Ungräser)

Mehrjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 1.5 l/ha

Wartefrist: 4 Woche(n)

G Nüsslisalat

Einjährige Monocotyledonen

(Ungräser)

Mehrjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 2 l/ha

Wartefrist: 5 Woche(n)

G Rhabarber

Ausfallgetreide

Aufwandmenge: 1.5 - 3

l/ha

Anwendung: Nach der

Ernte.

G Rhabarber

Einjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 1 - 2 l/ha

Anwendung: Nach der

Ernte.

G Rhabarber

Mehrjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 4 - 6 l/ha

Anwendung: Nach der

Ernte.

G Schnittlauch

Ausfallgetreide

Aufwandmenge: 1.5 - 3

l/ha

Anwendung: Nur im

Anzuchtjahr.

G Schnittlauch

Einjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 1 - 2 l/ha

Anwendung: Nur im

Anzuchtjahr.

G Schnittlauch

Mehrjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 4 - 6 l/ha

Anwendung: Nur im

Anzuchtjahr.

Ackerbohne

Einjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 1 - 2 l/ha

Wartefrist: 3 Woche(n)

Ackerbohne

Mehrjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 4 - 6 l/ha

Erbsen

Ausfallgetreide

Aufwandmenge: 1.5 - 3

l/ha

Wartefrist: 4 Woche(n)

Erbsen

Einjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 1 - 2 l/ha

Wartefrist: 4 Woche(n)

Erbsen

Mehrjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 4 - 6 l/ha

Wartefrist: 4 Woche(n)

A Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

Futterrübe

Kartoffeln

Sojabohne

Sonnenblume

Tabak

Zuckerrübe

Ausfallgetreide

Aufwandmenge: 1.5 - 3

l/ha

Wartefrist: 8 Woche(n)

Futterrübe

Kartoffeln

Sojabohne

Sonnenblume

Tabak

Zuckerrübe

Einjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 1 - 2 l/ha

Wartefrist: 8 Woche(n)

Futterrübe

Kartoffeln

Sojabohne

Sonnenblume

Tabak

Zuckerrübe

Mehrjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 4 - 6 l/ha

Wartefrist: 8 Woche(n)

Kenaf

Ausfallgetreide

Aufwandmenge: 4 l/ha

Anwendung: Nachauflauf.

Kenaf

Einjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 2 - 4 l/ha

Anwendung: Nachauflauf.

Mais [Cycloxydim-tolerant]

Ausfallgetreide

Einjährige Monocotyledonen

(Ungräser)

Hirsen

Aufwandmenge: 2 - 3 l/ha

Anwendung: Nachauflauf.

Mais [Cycloxydim-tolerant]

Gemeine Quecke

Mehrjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 4 l/ha

Anwendung: Nachauflauf.

Raps

Ausfallgetreide

Aufwandmenge: 1.5 - 3

l/ha

Wartefrist: 12 Woche(n)

Raps

Einjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 1 - 2 l/ha

Wartefrist: 12 Woche(n)

Raps

Mehrjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 4 - 6 l/ha

Wartefrist: 12 Woche(n)

Z allg.

Einjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 1 - 2 l/ha 2

Z allg.

Mehrjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 4 - 6 l/ha 1, 2

Forstliche Pflanzgärten

Einjährige Monocotyledonen

Aufwandmenge: 1 - 2 l/ha 2

A Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

(Ungräser)

Forstliche Pflanzgärten

Mehrjährige Monocotyledonen

(Ungräser)

Aufwandmenge: 4 - 6 l/ha 1, 2

Ö Offene Ackerfläche

Gemeine Quecke

Konzentration: 1 %

Anwendung: Mit

Rückenspritze.

Auflagen und Bemerkungen:

Der Anwender muss informiert werden, dass sich die Wirkung gegen mehrjährige Ungräser,

insbesondere die Quecke, in der Regel nicht über die Dauer der behandelten Kultur erstreckt.

Angabe der Kulturen und deren Verträglichkeit.

Einzelpflanzenbehandlung gemäss Direktzahlungsverordnung (DZV).

Gefahrenkennzeichnungen:

Zur Vermeidung von Risiken für Mensch und Umwelt ist die Gebrauchsanleitung einzuhalten.

R 38 Reizt die Haut.

R 52/53 Schädlich für Wasserorganismen, kann in Gewässern längerfristig schädliche Wirkungen

haben.

R 65 Gesundheitsschädlich: kann beim Verschlucken Lungenschäden verursachen.

R 67 Dämpfe können Schläfrigkeit und Benommenheit verursachen.

S 02 Darf nicht in die Hände von Kindern gelangen.

S 35 Abfälle und Behälter müssen in gesicherter Weise beseitigt werden.

S 46 Bei Verschlucken sofort ärztlichen Rat einholen und Verpackung oder Etikett vorzeigen.

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

Gefahrensymbole und -bezeichnungen:

Kurzkennzeichnung

Symbol

Gefahrenbezeichnung Gesundheitsschädlich

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.

11-10-2018

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Published on: Wed, 10 Oct 2018 00:00:00 +0200 This report provides a review of existing models for predicting the spatial distribution and abundance of wild boar at various scales (global, continental, national and regional) in order to inform the development of a new model to produce estimates of wild boar abundance at European level. The review identifies and discusses a range of models based on a wide variety of data types, corresponding to those targeted by the data collection model set by ENETwild,...

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions

Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions

FDA issues revised guidance to allow for a more efficient approach to 505(q) petitions and focus more resources on scientific reviews.

FDA - U.S. Food and Drug Administration

20-9-2018

Medicines of the future in focus at World Economic Forum

Medicines of the future in focus at World Economic Forum

Medicines of the future is one of the topics being debated at the meeting of the World Economic Forum, which is currently place right now in Tianjin in China. The Danish Medicines Agency is attending.

Danish Medicines Agency

18-9-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s ongoing efforts to prevent foodborne outbreaks of <i>Cyclospora</i>

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s ongoing efforts to prevent foodborne outbreaks of <i>Cyclospora</i>

he safety of the American food supply is one of the U.S. Food and Drug Administration’s highest priorities. A key part of our work in this space focuses on implementing the principles and measures of the FDA Food Safety Modernization Act (FSMA). The actions directed by FSMA are designed to prevent foodborne illness and food safety problems from happening.

FDA - U.S. Food and Drug Administration

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

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

14-8-2018

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix LLC, is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the U.S. Food and Drug Administration (“FDA”) and found to be contaminated with High Microbial Loads. Additionally, this serves as a update to a previous press release posted on June 30th 2018, concerning Blissful...

FDA - U.S. Food and Drug Administration

27-7-2018

Dringende Sicherheitsinformation zu Xpert MTB/RIF Ultra von Cepheid AB, Solna

Dringende Sicherheitsinformation zu Xpert MTB/RIF Ultra von Cepheid AB, Solna

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

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

19-7-2018

Food additive re-evaluation: EFSA workshop in November focuses on foods for infants below 16 weeks of age

Food additive re-evaluation: EFSA workshop in November focuses on foods for infants below 16 weeks of age

Food additive re-evaluation: EFSA workshop in November focuses on foods for infants below 16 weeks of age

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

13-7-2018

Scientific guideline:  Guideline on good pharmacogenomic practice - First version, adopted

Scientific guideline: Guideline on good pharmacogenomic practice - First version, adopted

This guideline provides recommendations for the conduct of genomic studies in relation to medical therapy in order to provide high quality information on the impact of genomic variability on drug response. Primary focus is on the analysis of genomic germline DNA. The analysis of somatic DNA and genomic biomarkers for cancer treatment is not being discussed and might be developed as an Annex or in separate guidance.

Europe - EFSA - European Food Safety Authority EFSA Journal

28-6-2018

Ambient air quality: ANSES recommends the surveillance of 1,3-butadiene and the enhanced monitoring of ultrafine particles (UFPs) and carbon black

Ambient air quality: ANSES recommends the surveillance of 1,3-butadiene and the enhanced monitoring of ultrafine particles (UFPs) and carbon black

The European monitoring strategy for air quality relies heavily on quality standards for a number of pollutants. Advances in knowledge on the toxicity of substances and their emissions in the atmosphere have shown that certain pollutants that may have an impact on human health are not currently taken into account in regulatory monitoring. ANSES therefore received a formal request from the Ministries of Ecology and Health to propose a list of new priority pollutants for this air quality monitoring to supp...

France - Agence Nationale du Médicament Vétérinaire

25-5-2018

Medical Devices Safety Update Volume 6, Number 3, May 2018

Medical Devices Safety Update Volume 6, Number 3, May 2018

How TGA uses joint replacement registry data; Focus on skills for vacuum-assisted births; TGA reviews product safety of ventilators

Therapeutic Goods Administration - Australia

16-11-2017

Medicines Safety Update, Volume 8, Number 5, October-November 2017

Medicines Safety Update, Volume 8, Number 5, October-November 2017

Ibrutinib - ventricular tachyarrhythmia, hepatitis B reactivation and infection; Improving Product Information; Codeine-containing products - use in children and ultra-rapid metabolisers

Therapeutic Goods Administration - Australia

28-9-2016

The Danish Medicines Agency to strengthen its leadership and professional focus

The Danish Medicines Agency to strengthen its leadership and professional focus

A new division with medical expertise and a general strengthening of the leadership throughout the Agency. This is the essence of the organisational change which will take effect in the Danish Medicines Agency at the turn of the year.

Danish Medicines Agency

8-5-2015

Annual Pharmacovigilance Report 2014

Annual Pharmacovigilance Report 2014

In our annual pharmacovigilance report 2014, you can read about the development in the number of ADR reports, learn about various focus areas and the European collaboration in the pharmacovigilance area as well as see a selection of the ADR signals we processed in 2014, and much more.

Danish Medicines Agency

10-12-2014

Monthly report from the EU Pharmacovigilance Risk Assessment Committee (PRAC) - December 2014

Monthly report from the EU Pharmacovigilance Risk Assessment Committee (PRAC) - December 2014

PRAC held its last meeting for this year on 1-4 December 2014. During its December meeting, the PRAC did not initiate or conclude any safety referral. The Committee focused on the broad spectrum of its responsibilities, which cover all aspects of the risk management of the use of medicines.

Danish Medicines Agency

24-6-2014

Focus on correct dose of Pro-Epanutin

Focus on correct dose of Pro-Epanutin

The Danish Health and Medicines Authority encourages hospitals to pay special attention to the risk of dose errors of the anticonvulsant medicine Pro-Epanutin.

Danish Medicines Agency

28-5-2014

More than 10,000 websites shut down in global operation

More than 10,000 websites shut down in global operation

The recent global Operation PANGEA VII resulted in the shutdown of more than 10,000 websites. The operation focused on combating online sale of counterfeit medicines and making consumers aware that they need to take care of themselves when buying medicines online. Globally, the operation led to 237 arrests, some 540,000 parcels were inspected and over 9.4 million units containing potentially life-threatening medicines were seized – worth an estimated value of more than USD 35 million. More than 10,000 we...

Danish Medicines Agency

24-9-2018

News and press releases:  Companies stepping up efforts to ensure medicine supply post Brexit

News and press releases: Companies stepping up efforts to ensure medicine supply post Brexit

Focus is now on 39 centrally authorised medicines, down from 108

Europe - EMA - European Medicines Agency

21-9-2018

Scientific guideline:  Reflection paper on resistance in ectoparasites, draft: consultation open

Scientific guideline: Reflection paper on resistance in ectoparasites, draft: consultation open

The Committee adopted a new draft reflection paper on ectoparasitic resistance (EMA/CVMP/EWP/310225/2014) for a 11-month period of public consultation. The reflection paper aims to give an overview of the currently known resistance situation in ectoparasites to active substances used in veterinary medicinal products with a special focus on Europe, and to provide a review of the current knowledge on resistance mechanisms.

Europe - EMA - European Medicines Agency

19-9-2018

 12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

This forum brings together regulators with patients, healthcare professionals and industry, to take stock of what we have achieved and what needs to be the focus over the coming years.

Europe - EMA - European Medicines Agency

18-9-2018

 Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

This third meeting between regulators and representatives of industry stakeholder organisations addresses all areas of product-development support, including scientific advice, specifics for paediatric and orphan medicines and support for innovation. The meeting focuses on the implementation of the orphan notice, ‘histology-independent indications’ in the context of orphan designations, the upcoming rollout of a new tool for orphan designation applications, digital technology proposals in medicine develo...

Europe - EMA - European Medicines Agency

12-9-2018

 Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

This information day will update participants on the Agency’s medicine risk management activities and provide advice to marketing authorisation holders and applicants on drafting a risk management plan (RMP) in view of the full implementation of the second revision of the RMP template after the transitional period has elapsed. It will also provide an opportunity for an exchange of experiences with this template between regulators and industry. A dedicated session will discuss the streamlining of safety s...

Europe - EMA - European Medicines Agency

11-9-2018

 Risk assessment guideline focus group meeting, European Medicines Agency, London, UK, From: 19-Sep-2018, To: 19-Sep-2018

Risk assessment guideline focus group meeting, European Medicines Agency, London, UK, From: 19-Sep-2018, To: 19-Sep-2018

The Antimicrobials Working Party of the European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) is holding a focus group meeting with stakeholders to discuss the revision of the antimicrobial veterinary medicinal product risk assessment guideline, following a public consultation on the draft revised guideline ending on 31 October 2018. The meeting will focus on topics identified during this public consultation. This guideline aims to provide guidance to marketing authorisat...

Europe - EMA - European Medicines Agency

11-9-2018

 Focus group meeting  on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

This meeting will allow a direct exchange of views between the Agency’s working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental appr...

Europe - EMA - European Medicines Agency

7-9-2018

 European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency, London, UK, From: 08-Jun-2018, To: 08-Jun-2018

European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency, London, UK, From: 08-Jun-2018, To: 08-Jun-2018

The 2018 face-to-face meeting of Enpr-EMA networks and coordinating members takes place after the annual open workshop on 8 June. The networks meeting will focus on the outcome of the 2018 annual workshop of the 7 June and the action plan for 2018/2019.

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

27-8-2018

Mepsevii (Ultragenyx Germany GmbH)

Mepsevii (Ultragenyx Germany GmbH)

Mepsevii (Active substance: vestronidase alfa) - Centralised - Authorisation - Commission Decision (2018)5714 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4438

Europe -DG Health and Food Safety

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

22-7-2018

The Medical Device Safety Action Plan focuses on five key areas: establishing a safety net, exploring regulatory options, spurring Innovation, advancing cybersecurity and advancing the Total Product Lifecycle approach to Device Safety. Let’s look at each

The Medical Device Safety Action Plan focuses on five key areas: establishing a safety net, exploring regulatory options, spurring Innovation, advancing cybersecurity and advancing the Total Product Lifecycle approach to Device Safety. Let’s look at each

The Medical Device Safety Action Plan focuses on five key areas: establishing a safety net, exploring regulatory options, spurring Innovation, advancing cybersecurity and advancing the Total Product Lifecycle approach to Device Safety. Let’s look at each area pic.twitter.com/aDwVxKGjyA

FDA - U.S. Food and Drug Administration

13-6-2018

Agenda:  Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, November 2018

Agenda: Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, November 2018

The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products.

Europe - EMA - European Medicines Agency

13-6-2018

Agenda:  Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, September 2018

Agenda: Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, September 2018

The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products.

Europe - EMA - European Medicines Agency

25-5-2018

Skin cancer is the most preventable type of cancer. Avoiding sunburn and overexposure to the sun's ultraviolet rays is key:  https://survivorship.cancer.gov/springboard/wellness/sun-safety … #dontfrydaypic.twitter.com/1vzXm28tQC

Skin cancer is the most preventable type of cancer. Avoiding sunburn and overexposure to the sun's ultraviolet rays is key: https://survivorship.cancer.gov/springboard/wellness/sun-safety … #dontfrydaypic.twitter.com/1vzXm28tQC

Skin cancer is the most preventable type of cancer. Avoiding sunburn and overexposure to the sun's ultraviolet rays is key: https://survivorship.cancer.gov/springboard/wellness/sun-safety … #dontfryday pic.twitter.com/1vzXm28tQC

FDA - U.S. Food and Drug Administration

18-4-2018

EU/3/18/2011 (Ultragenyx Germany GmbH)

EU/3/18/2011 (Ultragenyx Germany GmbH)

EU/3/18/2011 (Active substance: Burosumab) - Orphan designation - Commission Decision (2018)2407 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/026/17

Europe -DG Health and Food Safety