IT Bentazone DK (gl. version)

Primær information

  • Handelsnavn:
  • IT Bentazone DK (gl. version) Flydende middel
  • Lægemiddelform:
  • Flydende middel
  • Sammensætning:
  • 480 g/l bentazon
  • Brugt til:
  • Planter
  • Medicin typen:
  • agrokemiske

Dokumenter

  • for den brede offentlighed:
  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.


    Anmode informationsbrochure for offentligheden.

  • for sundhedspersonale:
  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.


    Anmode informationsbrochure for sundhedspersonale.

Lokation

  • Fås i:
  • IT Bentazone DK (gl. version) Flydende middel
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • SEGES Landbrug & Fødevarer
  • Autorisation status:
  • Udgået
  • Autorisationsnummer:
  • 221-105
  • Sidste ændring:
  • 07-02-2018
  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.

    Anmode informationsbrochure for offentligheden.

19-3-2018

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

22-2-2018

Scientific guideline:  Reflection paper on physical frailty: instruments for baseline characterisation of older populations in clinical trials - First version, adopted

Scientific guideline: Reflection paper on physical frailty: instruments for baseline characterisation of older populations in clinical trials - First version, adopted

This document is intended to describe the recommended instruments for the characterization of the baseline physical frailty status of older patients (i.e. aged ≥ 65 years) enrolled in a clinical trial or other clinical investigation (e.g. registry), to supplement the requirements of ICH E7 Note for guidance and questions and answers.

Europe - EFSA - European Food Safety Authority EFSA Journal

1-2-2018

Scientific guideline:  Rilpivirine film-coated tablets 25 mg product-specific bioequivalence guidance - First version, adopted

Scientific guideline: Rilpivirine film-coated tablets 25 mg product-specific bioequivalence guidance - First version, adopted

This document provides product-specific guidance on the demonstration of the rilpivirine.

Europe - EFSA - European Food Safety Authority EFSA Journal

1-2-2018

Scientific guideline:  Paracetamol oral use immediate release formulations product-specific bioequivalence guidance - First version, adopted

Scientific guideline: Paracetamol oral use immediate release formulations product-specific bioequivalence guidance - First version, adopted

This document provides product-specific guidance on the demonstration of the bioequivalence of paracetamol.

Europe - EFSA - European Food Safety Authority EFSA Journal

1-2-2018

Scientific guideline:  Dronedarone film-coated tablets 400 mg product-specific bioequivalence guidance - First version, adopted

Scientific guideline: Dronedarone film-coated tablets 400 mg product-specific bioequivalence guidance - First version, adopted

This guidance provides product-specific guidance on the demonstration of the dronedarone.

Europe - EFSA - European Food Safety Authority EFSA Journal

1-2-2018

Scientific guideline:  Dolutegravir film-coated tablets 10 mg, 25 mg and 50 mg product-specific bioequivalence guidance - First version, adopted

Scientific guideline: Dolutegravir film-coated tablets 10 mg, 25 mg and 50 mg product-specific bioequivalence guidance - First version, adopted

This guidance provides product-specific guidance on the demonstration of the dolutegravir.

Europe - EFSA - European Food Safety Authority EFSA Journal

1-2-2018

Brexit, change of Reference Member State from UK to DK

Brexit, change of Reference Member State from UK to DK

The Danish Medicines Agency would like to inform marketing authorisation holders that we welcome being the Reference Member State (RMS) for MRP/DCP authorised medicines, should you request Denmark as the future RMS when the UK is leaving the EU.

Danish Medicines Agency

18-12-2017

Scientific guideline:  ICH guideline E17 on general principles for planning and design of multi-regional clinical trials - Step 5 - First version, adopted

Scientific guideline: ICH guideline E17 on general principles for planning and design of multi-regional clinical trials - Step 5 - First version, adopted

The purpose of this document is to outline general principles for the planning and design of multiregional clinical trials with the aim of increasing their acceptability in global regulatory submissions. The document addresses some strategic programme issues as well as aspects specific to the planning and design of confirmatory MRCTs and should be used together with other ICH efficacy guidelines, including E2, E3, E4, E5, E6, E8, E9, E10 and E18.

Europe - EFSA - European Food Safety Authority EFSA Journal

15-12-2017

Scientific guideline:  ICH Guideline S3A: Note for guidance on toxicokinetics: the assessment of systemic exposure in toxicity studies - Questions and answers - Step 5 - First version, adopted

Scientific guideline: ICH Guideline S3A: Note for guidance on toxicokinetics: the assessment of systemic exposure in toxicity studies - Questions and answers - Step 5 - First version, adopted

The S3A guideline was successfully implemented in 1994. However, in recent years, analytical method sensitivity has improved, allowing microsampling techniques to be widely used in toxicokinetic (TK) assessment. This Q&A document focuses on points to consider before incorporating the microsampling method in TK studies, acknowledges its benefits, and some limitations, for assessment of TKs in main study animals and its overall important contribution to the 3Rs benefits (Replacement, Reduction and Refineme...

Europe - EFSA - European Food Safety Authority EFSA Journal

6-10-2017

Scientific guideline:  ICH guideline E18 on genomic sampling and management of genomic data - First version, adopted

Scientific guideline: ICH guideline E18 on genomic sampling and management of genomic data - First version, adopted

The scope of this guideline pertains to genomic sampling and management of genomic data obtained from interventional and non-interventional clinical studies. Genomic research can be conducted during or after a clinical study.

Europe - EFSA - European Food Safety Authority EFSA Journal

5-10-2017

The Danish Medicines Agency is preparing for launch of new EudraVigilance

The Danish Medicines Agency is preparing for launch of new EudraVigilance

On 22 November 2017, the European Medicines Agency will launch a new and improved version of the EudraVigilance database (the European information system of suspected adverse reactions to medicines). More than 11 million reports will be transferred to the new system; consequently, the system will be unavailable for a period of ten working days (8 November to 22 November) before 'Go-live'.

Danish Medicines Agency

20-9-2017

Scientific guideline:  Guideline on clinical investigation of new medicinal products for the treatment of acute coronary syndrome - First version, adopted

Scientific guideline: Guideline on clinical investigation of new medicinal products for the treatment of acute coronary syndrome - First version, adopted

This guideline replaces 'Points to consider on the clinical investigation of new medicinal products for the treatment of acute coronary syndrome (ACS) without persistent ST segment elevation' (CPMP/EWP/570/98).

Europe - EFSA - European Food Safety Authority EFSA Journal

11-9-2017

 DKMA Update

DKMA Update

Our newsletter Danish Pharmacovigilance Update changes name to DKMA Update and will from now on contain information about medicinal products in general, patient safety and life science. DKMA Update is an electronic newsletter intended for anyone who work with medicines, either clinically or in the pharmaceutical industry or the retail industry, and people who would like to gain an insight into our work. The newsletter will continue to focus on the most recent safety updates, but will also focus on other...

Danish Medicines Agency

8-9-2017

Scientific guideline:  Guideline on core SmPC and Package Leaflet for (68Ge/68Ga) generator - First version, adopted

Scientific guideline: Guideline on core SmPC and Package Leaflet for (68Ge/68Ga) generator - First version, adopted

This guideline describes the information to be included in the summary of products characteristics (SmPC) and package leaflet for (68Ge/68Ga) generator.

Europe - EFSA - European Food Safety Authority EFSA Journal

21-8-2017

FDA Releases Specialized CVM-only Version of eSubmitter Tool

FDA Releases Specialized CVM-only Version of eSubmitter Tool

The Center for Veterinary Medicine (CVM) is pleased to announce a CVM-only version of FDA’s eSubmitter tool. This new software package is independent from the FDA eSubmitter program.

FDA - U.S. Food and Drug Administration

16-8-2017

 Testing the exchange of E2B files

Testing the exchange of E2B files

Testing the exchange of E2B ICSRs/SUSARs between the Danish Medicines Agency and companies/sponsors must be completed by Friday 29 September 2017. The reason is that our test environment will be reconfigured to tests with the EMA in connection with the preparations for the changed reporting process for ICSRs that will take effect on 22 November 2017. Tests with sponsors will be resumed after 22 November 2017 since the applicable reporting process for SUSARs will not be changed. Companies that want to s...

Danish Medicines Agency

25-7-2017

 Counterfeit packs of the schizophrenia medicine Xeplion 150 mg

Counterfeit packs of the schizophrenia medicine Xeplion 150 mg

Danish parallel importers and the Danish Medicines Agency have withdrawn a batch of Xeplion 150 mg from hospital pharmacies and 26 private pharmacies due to suspicion of falsification. On the basis of the available data, the Danish Medicines Agency assesses that the patient risk is low. Xeplion 150 mg is a medicine for injection used for the treatment of schizophrenia in adults. The medicinal product is available in hospitals or dispensed on prescription at a pharmacy, and usually the patient is inject...

Danish Medicines Agency

3-7-2017

 New fees for medicinal products, pharmaceutical companies and clinical trials from 1 July 2017

New fees for medicinal products, pharmaceutical companies and clinical trials from 1 July 2017

On 1 July 2017, a new executive order on fees payable for medicinal products, pharmaceutical companies and clinical trials became effective. The new fees involve changes in a number of areas. Changes in relation to marketing authorisations and variations etc. In connection with applications for marketing authorisations and variations etc., the new executive order entails a number of changes to the size of fees and the way in which they are calculated. Changes will be made to:Applications for new marketi...

Danish Medicines Agency

15-6-2017

 New format requirements for marketing authorisation applications

New format requirements for marketing authorisation applications

The Danish Medicines Agency is postponing the phasing-out of NeeS and tightens the format requirements for updating the assessment report prior to MRP/RUP. The phasing-out of NeeS is relevant to submissions for human medicinal products. The tightened format requirement is relevant to submissions for both human and veterinary medicinal products. Parallel import and parallel distribution are not covered. Updated eSubmission Roadmap – phasing-out of NeeS in NP In the absence of a common European plan for t...

Danish Medicines Agency

13-6-2017

Infographic Hygiene in the kitchen Internet version

Infographic Hygiene in the kitchen Internet version

Language English

France - Agence Nationale du Médicament Vétérinaire

6-4-2018

Scientific guideline:  Draft addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements - First version, draft: consultation open

Scientific guideline: Draft addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements - First version, draft: consultation open

This document proposes the development of an addendum to the Guideline on the evaluation of medicines indicated for treatment of bacterial infections CPMP/EWP/558/95 rev 2), to provide specific guidance on paediatric clinical development programmes to support the authorisation of antibacterial agents for treating infectious diseases in children.

Europe - EMA - European Medicines Agency

1-3-2018

 Call for scientific data for use in HMPC assessment work on Hamamelis virginiana L., folium et cortex aut ramunculus destillatum – First version, draft: consultation open

Call for scientific data for use in HMPC assessment work on Hamamelis virginiana L., folium et cortex aut ramunculus destillatum – First version, draft: consultation open

The HMPC invites all interested parties such as pharmaceutical industry associations, health care professional groups, learned societies, consumers and patients’ associations, governmental institutions as well as EU and EEA-EFTA Member States to submit any scientific data that the HMPC should consider at the periodic review of the monograph on Hamamelis virginiana L., folium et cortex aut ramunculus destillatumtowards a possible revision of the monograph and supporting documents. The publication of this ...

Europe - EMA - European Medicines Agency

1-3-2018

 Call for scientific data for use in HMPC assessment work on Hamamelis virginiana L., folium – First version, draft: consultation open

Call for scientific data for use in HMPC assessment work on Hamamelis virginiana L., folium – First version, draft: consultation open

The HMPC invites all interested parties such as pharmaceutical industry associations, health care professional groups, learned societies, consumers and patients’ associations, governmental institutions as well as EU and EEA-EFTA Member States to submit any scientific data that the HMPC should consider at the periodic review of the monograph on Hamamelis virginiana L., folium towards a possible revision of the monograph and supporting documents. The publication of this call is the first step in the proced...

Europe - EMA - European Medicines Agency

1-3-2018

 Call for scientific data for use in HMPC assessment work on Hamamelis virginiana L., cortex – First version, draft: consultation open

Call for scientific data for use in HMPC assessment work on Hamamelis virginiana L., cortex – First version, draft: consultation open

The HMPC invites all interested parties such as pharmaceutical industry associations, health care professional groups, learned societies, consumers and patients’ associations, governmental institutions as well as EU and EEA-EFTA Member States to submit any scientific data that the HMPC should consider at the periodic review of the monograph on Hamamelis virginiana L., cortex towards a possible revision of the monograph and supporting documents. The publication of this call is the first step in the proced...

Europe - EMA - European Medicines Agency

1-3-2018

 Call for scientific data for use in HMPC assessment work on Echinaceae angustifolia DC., radix – First version, draft: consultation open

Call for scientific data for use in HMPC assessment work on Echinaceae angustifolia DC., radix – First version, draft: consultation open

The HMPC invites all interested parties such as pharmaceutical industry associations, health care professional groups, learned societies, consumers and patients’ associations, governmental institutions as well as EU and EEA-EFTA Member States to submit any scientific data that the HMPC should consider at the periodic review of the monograph on Echinaceae angustifolia DC., radix towards a possible revision of the monograph and supporting documents. The publication of this call is the first step in the pro...

Europe - EMA - European Medicines Agency

24-2-2018

New Version of Nasal Flu Vaccine to Return for Next Season

New Version of Nasal Flu Vaccine to Return for Next Season

Title: New Version of Nasal Flu Vaccine to Return for Next SeasonCategory: Health NewsCreated: 2/22/2018 12:00:00 AMLast Editorial Review: 2/23/2018 12:00:00 AM

US - MedicineNet

22-2-2018

Mark your calendars for #PatientEngagement in the National Evaluation System for Health Technology (NEST) one-day workshop sponsored by the UMD CERSI & FDA. Click the link for more info:  https://goo.gl/CqZF4k  #NEST #MedicalDevice #safety

Mark your calendars for #PatientEngagement in the National Evaluation System for Health Technology (NEST) one-day workshop sponsored by the UMD CERSI & FDA. Click the link for more info: https://goo.gl/CqZF4k  #NEST #MedicalDevice #safety

Mark your calendars for #PatientEngagement in the National Evaluation System for Health Technology (NEST) one-day workshop sponsored by the UMD CERSI & FDA. Click the link for more info: https://goo.gl/CqZF4k  #NEST #MedicalDevice #safety

FDA - U.S. Food and Drug Administration

20-2-2018

TGA presentation: Scheduling working group meeting one, 9 February 2018

TGA presentation: Scheduling working group meeting one, 9 February 2018

On this page: Disclaimer | Presentation | Transcript | Print version

Therapeutic Goods Administration - Australia

2-1-2018

TGA presentation: Wearable Technologies Conference, 7 December 2017

TGA presentation: Wearable Technologies Conference, 7 December 2017

On this page: Disclaimer | Presentation | Transcript | Print version

Therapeutic Goods Administration - Australia

18-12-2017

Scientific guideline:  Draft ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management - Step 2b - First version, draft: consultation open

Scientific guideline: Draft ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management - Step 2b - First version, draft: consultation open

This new guideline is proposed to provide guidance on a framework to facilitate the management of post-approval chemistry, manufacturing and controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. This guideline aims to promote innovation and continual improvement, and strengthen quality assurance and reliable supply of product, including proactive planning of supply chain adjustments. The guideline strives to promote, for regulators (assessors and inspectors), an ...

Europe - EMA - European Medicines Agency

18-12-2017

Scientific guideline:  Draft ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management - Step 2b - Annexes - First version, draft: consultation open

Scientific guideline: Draft ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management - Step 2b - Annexes - First version, draft: consultation open

Annexes to the 'Draft ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management - Step 2b - Annexes - First version'

Europe - EMA - European Medicines Agency

15-12-2017

TGA presentation: Adoption of TGO 91 - prescription medicine labelling, 28 November 2017

TGA presentation: Adoption of TGO 91 - prescription medicine labelling, 28 November 2017

On this page: Disclaimer | Presentation | Transcript | Print version

Therapeutic Goods Administration - Australia

22-11-2017

Regulatory and procedural guideline:  EudraVigilance - European database of suspected adverse reactions related to medicines: user manual for online access via the adrreports.eu portal - Version 2.0

Regulatory and procedural guideline: EudraVigilance - European database of suspected adverse reactions related to medicines: user manual for online access via the adrreports.eu portal - Version 2.0

This manual provides instructions on how to use the adrreports.eu portal to obtain access in EudraVigilance to reports of suspected adverse reactions (also referred to as undesirable effects or side effects) related to medicines.

Europe - EMA - European Medicines Agency

21-11-2017

PCXX BUGGLEGUM NEUTRAL GL (Sodium Fluoride) Gel [Ross Healthcare Inc.]

PCXX BUGGLEGUM NEUTRAL GL (Sodium Fluoride) Gel [Ross Healthcare Inc.]

Updated Date: Nov 21, 2017 EST

US - DailyMed

30-10-2017

Updated Gene-Classifier Test Pinpoints Benign Thyroid Nodules

Updated Gene-Classifier Test Pinpoints Benign Thyroid Nodules

A multicenter, double-blind clinical study on the latest-generation ThyroSeq version 3 (University of Pittsburg/CBLPath) gene-classifier test validates its high negative predictive values (NPV) in identifying thyroid nodules of indeterminate cytology, potentially sparing patients from unnecessary surgeries.

US - RxList

22-9-2017

Regulatory and procedural guideline:  External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use (version 1.3), adopted

Regulatory and procedural guideline: External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use (version 1.3), adopted

This document provides guidance to industry on practical aspects of the implementation of the Agency's policy on the publication of clinical data for medicinal products for human use. It covers guidance on the procedural aspects of the submission of clinical reports, the anonymisation of clinical reports and the identification and redaction of commercially confidential information in clinical reports. It also includes a checklist for the 'Redaction Proposal Document' package. This guidance is revised per...

Europe - EMA - European Medicines Agency

17-8-2017

GL. SUPRARENALES GL. THYREOIDEA HYPOPHYSIS Liquid [Uriel Pharmacy Inc.]

GL. SUPRARENALES GL. THYREOIDEA HYPOPHYSIS Liquid [Uriel Pharmacy Inc.]

Updated Date: Aug 17, 2017 EST

US - DailyMed

15-8-2017

Calcitriol

Calcitriol

Calcitriol is a synthetic version of Vitamin D3 used to treat calcium deficiency with hypoparathyroidism (decreased functioning of the parathyroid glands) and metabolic bone disease in people with chronic kidney failure.

US - RxList

1-8-2017

Scientific guideline:  Reflection paper on the pharmaceutical development of medicines for use in the older population - First version, draft: consultation open

Scientific guideline: Reflection paper on the pharmaceutical development of medicines for use in the older population - First version, draft: consultation open

The reflection paper describes aspects that medicines developers may consider when designing medicines for older people, such as selecting appropriate routes of administration and dosage forms, dosing frequency, excipients, container closure systems, devices and technologies, and user instructions in the product information.

Europe - EMA - European Medicines Agency

1-8-2017

Scientific guideline:  Concept paper on the development of guidance on the non-clinical evaluation of radiopharmaceuticals - First version, draft: consultation open

Scientific guideline: Concept paper on the development of guidance on the non-clinical evaluation of radiopharmaceuticals - First version, draft: consultation open

This concept paper is intended to seek external stakeholder views on potential guidance development related to overarching considerations for non-clinical data in support of clinical development and approval of radiopharmaceuticals. This guidance is intended to complement currently available guidelines (such as ICH M3(R2), ICH S6(R1), ICH S9 or the EMA Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products) and includes the differ...

Europe - EMA - European Medicines Agency

28-7-2017

Scientific guideline:  Draft dronedarone film-coated tablets 400 mg product-specific bioequivalence guidance - First version, draft: consultation open

Scientific guideline: Draft dronedarone film-coated tablets 400 mg product-specific bioequivalence guidance - First version, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of dronedarone film-coated tablets

Europe - EMA - European Medicines Agency

28-7-2017

Scientific guideline:  Draft paracetamol oral use, immediate release formulations product-specific bioequivalence guidance - First version, draft: consultation open

Scientific guideline: Draft paracetamol oral use, immediate release formulations product-specific bioequivalence guidance - First version, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of paracetamol

Europe - EMA - European Medicines Agency

28-7-2017

Scientific guideline:  Draft dolutegravir film-coated tablets 10 mg, 25 mg and 50 mg product-specific bioequivalence guidance - First version, draft: consultation open

Scientific guideline: Draft dolutegravir film-coated tablets 10 mg, 25 mg and 50 mg product-specific bioequivalence guidance - First version, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of dolutegravir film-coated tablets

Europe - EMA - European Medicines Agency

23-6-2017

Senate Unveils Bill to Repeal and Replace ACA

Senate Unveils Bill to Repeal and Replace ACA

A Senate Republican bill to repeal and replace the Affordable Care Act (ACA) that debuted today is a gentler version of what the House passed last month in many respects and a harsher version in others.

US - RxList

9-6-2017

FDA Approves First Generic Truvada in US

FDA Approves First Generic Truvada in US

The US Food and Drug Administration (FDA) has approved the first generic version of emtricitabine/tenofovir disoproxil (Truvada, Gilead Sciences) to both treat and prevent HIV infections in this country, the agency announced today.

US - RxList