Medicines Evaluation Board Netherlands

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Home Medicines Evaluation Board

(7 days ago) Search within English part of Medicines Evaluation Board Search. Main menu. Marketing authorisation medicines for human use. Procedures, dossier requirements, pharmacovigilance, policy. Veterinary Medicinal Products Unit. Marketing authorisation, reporting …

https://english.cbg-meb.nl/

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Netherlands: Medicines Evaluation Board (MEB

(8 days ago) The Medicines Evaluation Board (MEB) assesses and guards the efficacy, safety, and quality of both human and veterinary medicinal products. The MEB is the primary source of information on new medicinal products, new applications, and current risk information in the Netherlands.

https://globaledge.msu.edu/global-resources/resource/10376

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FDA – The Netherlands Medicines Evaluation Board and

(2 days ago) The Netherlands Medicines Evaluation Board and Health and Youth Care Inspectorate is authorized to disclose non-public information to the United States Food and Drug Administration (FDA) regarding

https://www.fda.gov/international-programs/confidentiality-commitments/fda-netherlands-medicines-evaluation-board-and-health-and-youth-care-inspectorate

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The Netherlands Medicines Evaluation Board and Health …

(8 days ago) statement of authority and confidentiality commitment from the netherlands medicines evaluation board and health and youth care inspectorate not to publicly disclose non-public information shared

https://www.fda.gov/international-programs/confidentiality-commitments/netherlands-medicines-evaluation-board-and-health-and-youth-care-inspectorate-fda-confidentiality

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A REVIEW ON MEDICINES EVALUATION BOARD IN …

(1 days ago) Medicines Evaluation Board, Netherlands The MEB is aware of the fact that medicinal products are not always marketed immediately after authorisation. Following the European decentralised or mutual recognition procedures (DCP/MRP), it is possible that medicinal products are authorised but subsequently not released on the Dutch market.

https://storage.googleapis.com/journal-uploads/wjpps/article_issue/1630460103.pdf

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Monitoring the quality and safety of medicines …

(9 days ago) Marketing authorisation of medicines. Drug companies cannot put a new drug on the market unless it has been evaluated and registered by the Medicines Evaluation Board (CBG). This is called marketing authorisation. You can read more about the marketing authorisation procedure for human and veterinary drugs on the CBG’s website.

https://www.government.nl/topics/medicines/monitoring-the-quality-and-safety-of-medicines

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PUBLIC ASSESSMENT REPORT of the Medicines …

(8 days ago) of the Medicines Evaluation Board in the Netherlands Vimovo 500 mg/20 mg, modified-release tablets AstraZeneca B.V., the Netherlands naproxen/esomeprazole (as magnesium trihydrate) This assessment report is published by the MEB pursuant Article 21 (3) and (4) of Directive 2001/83/EC. The report

https://db.cbg-meb.nl/pars/h106235.pdf

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PUBLIC ASSESSMENT REPORT of the Medicines …

(Just Now) of the Medicines Evaluation Board in the Netherlands Acenocoumarol PharmaMatch 1 mg, tablets Pharmamatch B.V., the Netherlands acenocoumarol This assessment report is published by the MEB pursuant Article 21 (3) and (4) of Directive 2001/83/EC. The report comments on the registration dossier that was submitted to the MEB.

https://www.geneesmiddeleninformatiebank.nl/pars/h113318.pdf

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PUBLIC ASSESSMENT REPORT of the Medicines …

(9 days ago) of the Medicines Evaluation Board in the Netherlands Paroxetine 10, 20, 30 and 40 mg tablets I.C.C. B.V., the Netherlands paroxetine hydrochloride This assessment report is published by the MEB pursuant Article 21 (3) and (4) of Directive 2001/83/EC. The report

https://www.geneesmiddeleninformatiebank.nl/pars/h33145.pdf

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Medicines Evaluation Board (MEB) Vac2vac

(1 days ago) The Medicines Evaluation Board (MEB) assesses and monitors the efficacy, risks and quality of human and veterinary medicines, and the safety of novel foods for human consumption. The MEB is an independent administrative body residing under the Government of the Netherlands. The MEB independently decides about the authorisation and monitoring of human medicinal products.

http://www.vac2vac.eu/partners/medicines-evaluation-board-meb

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Heads of Medicines Agencies: National Contacts

(5 days ago) Medicines Evaluation Board Address Graadt van Roggenweg 500 NL - 3531 AH Utrecht Country Netherlands Phone +31 88 224 80 00 Fax +31 88 224 80 01 Website www.cbg-meb.nl. The United Kingdom (UK) withdrew from the European Union (EU) on …

https://www.hma.eu/nationalcontacts_hum.html?showctr=25

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PUBLIC ASSESSMENT REPORT of the Medicines Evaluation …

(8 days ago) of the Medicines Evaluation Board in the Netherlands Azitromycine Jubilant 250 mg and 500 mg, film-coated tablets Jubilant Pharmaceuticals N.V., Belgium azithromycin (as dihydrate) This assessment report is published by the MEB pursuant Article 21 (3) and (4) of Directive 2001/83/EC. The report

https://db.cbg-meb.nl/pars/h106460.pdf

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PUBLIC ASSESSMENT REPORT of the Medicines Evaluation Board

(6 days ago) Corpus ID: 11903810. PUBLIC ASSESSMENT REPORT of the Medicines Evaluation Board in the Netherlands @inproceedings{Sandoz2011PUBLICAR, title={PUBLIC ASSESSMENT REPORT of the Medicines Evaluation Board in the Netherlands}, author={B. Sandoz}, year={2011} }

https://www.semanticscholar.org/paper/PUBLIC-ASSESSMENT-REPORT-of-the-Medicines-Board-in-Sandoz/7237f83d743dbd4e9b543cac136a04c7fd916b31

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Elisabeth ROOK Medicines Evaluation Board, Netherlands

(3 days ago) Elisabeth ROOK Cited by 533 of Medicines Evaluation Board, Netherlands, Utrecht Read 12 publications Contact Elisabeth ROOK

https://www.researchgate.net/profile/Elisabeth-Rook-2

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PUBLIC ASSESSMENT REPORT of the Medicines Evaluation …

(6 days ago) of the Medicines Evaluation Board in the Netherlands Loratadine Sandoz 10, 10 mg tablets Sandoz B.V., the Netherlands loratadine This assessment report is published by the MEB pursuant Article 21 (3) and (4) of Directive 2001/83/EC. The report

https://www.cbg-meb.nl/binaries/college-ter-beoordeling-van-geneesmiddelen/documenten/rapporten/2010/04/15/par-loratadine/100415-par-loratadine-sandoz10.pdf

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Why children require special attention

(5 days ago) GL on the pharmaceutical development of medicines for paediatric use EMA SME workshop: Focus on quality for medicines containing chemical substances . London 4 April, 2014 . Presented by: Diana van Riet-Nales . Senior Assessor, Medicines Evaluation Board in the Netherlands

https://www.ema.europa.eu/en/documents/presentation/presentation-medicines-evaluation-board-netherlands-paediatric-formulations-diana-van-riet-nales_en.pdf

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PUBLIC ASSESSMENT REPORT of the Medicines Evaluation Board

(3 days ago) PUBLIC ASSESSMENT REPORT of the Medicines Evaluation Board in the Netherlands EU. Procedure Number: NL/H/1267/001/DC. has been cited by the following article: TITLE: Stability Indicating RP-HPLC Method for Estimation of Impurities of Vitamin D3 Analogue and Corticosteroid Used as Antipsoriatic Drugs. An Attempt to Characterize Pre-Calcipotriene

https://www.scirp.org/reference/ReferencesPapers.aspx?ReferenceID=1638139

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Where can I find information about my medication in the

(Just Now) Medicines database. The medicines database contains information about all the drugs authorised for the Dutch market, including homeopathic remedies. The database is managed by the Medicines Evaluation Board (CBG). The CBG also manages the animal medicines database.

https://www.government.nl/topics/medicines/question-and-answer/where-can-i-find-information-about-my-medication-in-the-netherlands

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Putting new medicines on the market Business.gov.nl

(Just Now) Do you run a pharmaceutical business in the Netherlands and do you want to put a new medicine on the market?You need a marketing authorisation from the Medicines Evaluation Board (MEB, College ter Beoordeling van Geneesmiddelen, CBG). Marketing authorisation

https://business.gov.nl/regulation/trading-permit-medicines/

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ICH Q3D elemental impurities & ICH M7 mutagenic impurities

(6 days ago) Senior Assessor, Medicines Evaluation Board in the Netherlands . Aim pharmaceutical development • to design a quality product and its manufacturing process to consistently deliver the intended performance of the product • studies can be a basis for quality risk management. It is important

https://www.ema.europa.eu/en/documents/presentation/presentation-medicines-evaluation-board-netherlands-ich-q3d-elemental-impurities-ich-m7-mutagenic_en.pdf

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Netherlands stops use of AstraZeneca coronavirus vaccine

(8 days ago) Netherlands stops use of AstraZeneca coronavirus vaccine after reports of side effects. Monday, 15 March 2021. Credit: Belga. The Netherlands has joined other countries in temporarily stopping the administration of the AstraZeneca coronavirus vaccine after the country’s Medicines Evaluation Board expressed concerns about possible side effects.

https://www.brusselstimes.com/news/world-all-news/159951/netherlands-concerned-astrazeneca-coronavirus-vaccine-temporarily-stops-medicines-evaluation-board-ministry-of-health-ireland-norway-denmark-world-health-organisation-ema/

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College ter Beoordeling van Geneesmiddelen / Medicines

(4 days ago) College ter Beoordeling van Geneesmiddelen / Medicines Evaluation Board Graadt van Roggenweg 500 3531 AH Utrecht The Netherlands MUTUAL RECOGNITION PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT Thymovar January 2020

http://www.ircp.anmv.anses.fr/pdf/RPE553.pdf

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Global Regulatory Authority Websites - PDA

(1 days ago) Netherlands: Medicines Evaluation Board (in Dutch) Netherlands: Inspectorate for Health Protection and Veterinary Public Health (in Dutch) Inspectie voor de Gezondheidszorg Ministere van Volksgezondheid, Welzjin en Sport (in Dutch) Norway: Ministry of Health and Care Services Norway: Norwegian Board of Health Supervision

https://www.pda.org/scientific-and-regulatory-affairs/regulatory-resources/global-regulatory-authority-websites

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Acceptability of different oral formulations in infants

(6 days ago) Competing interests Diana van Riet is coordinator/senior assessor at the department of chemical pharmaceutical assessment of the Medicines Evaluation Board in The Netherlands. She is vice chair of the European Medicines Agency's (EMAs) Quality Working Party. Alfred Schobben is a member of the MEB and expert for the EMA.

https://adc.bmj.com/content/98/9/725

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Ragna de Schipper - Regulatory Project Leader - Medicines

(3 days ago) Regulatory Project Leader - Medicine Evaluation Board Randstad 324 connecties. Lid worden en connectie maken Medicines Evaluation Board. Science and Business Management - Being the deputy QPPV in the Netherlands - Maintaining a current and competent level of medical, product, registration, legislation,

https://nl.linkedin.com/in/ragna-de-schipper-3b970053

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The accuracy, precision and sustainability of different

(1 days ago) Affiliations 1 Medicines Evaluation Board, Department of chemical pharmaceutical assessment (DAR/AN/MD) resp. Pharmacotherapeutic Group 3 (ST) resp. Scientific Board (YH), Utrecht, The Netherlands. Electronic address: [email protected] 2 Medicines Evaluation Board, Department of chemical pharmaceutical assessment (DAR/AN/MD) resp. Pharmacotherapeutic Group 3 (ST) resp. …

https://pubmed.ncbi.nlm.nih.gov/24561329/

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Scientific Evaluation Report of the Medicines Evaluation

(4 days ago) Scientific Evaluation Report of the Medicines Evaluation Board of the Netherlands on the assessment of applications for Levosimendan containing products with a 2.5 mg/mL strength and the pharmaceutical form concentrate for solution for infusion for the proposed indication treatment of patients with acutely decompensated severe chronic

https://www.cbg-meb.nl/binaries/college-ter-beoordeling-van-geneesmiddelen/documenten/rapporten/2016/02/04/ser-levosimendan/160204-scientificevaluationreport-levosimendan.pdf

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Inge M Zomerdijk's research works Medicines Evaluation

(9 days ago) Inge M Zomerdijk's 7 research works with 108 citations and 753 reads, including: Introduction or Discontinuation of Additional Risk Minimisation Measures During the Life Cycle of Medicines in Europe

https://www.researchgate.net/scientific-contributions/Inge-M-Zomerdijk-71287556

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Ethics in clinical trial regulation: ethically relevant

(9 days ago) 2 Medicines Evaluation Board, the Netherlands 3 Centre for Medical Ethics, Institute of Health and Society, Faculty of Medicine, University of Oslo, Norway 4 Corresponding author, [email protected] WORD COUNT: 4893 (including tables) Page 2 of 17 Abstract Background

https://www.duo.uio.no/bitstream/handle/10852/71900/Full+version.pdf?sequence=4

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ASTELLAS RECEIVES MARKETING AUTHORISATION FOR …

(6 days ago) NETHERLANDS MEDICINES EVALUATION BOARD . Netherlands first to approve new fixed-dose combination treatment for men with lower urinary tract symptoms associated with BPH . Chertsey, UK, 23 MAY 2013. ASTELLAS PHARMA EUROPE B.V., the European subsidiary of Tokyo-based . Astellas Pharma Inc.(Tokyo:4503), today announced the Dutch Medicines Evaluation

https://www.astellas.com/system/files/news/2018-06/130523_1_Eg.pdf

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College ter Beoordeling van Geneesmiddelen / Medicines

(5 days ago) College ter Beoordeling van Geneesmiddelen / Medicines Evaluation Board Graadt van Roggenweg 500 3531 AH Utrecht The Netherlands DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT Amoxy Active, 697 mg/g, oral powder for pigs and chickens Date: 1 May 2014

http://www.ircp.anmv.anses.fr/pdf/RPE_150.pdf

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Pharmacokinetics and Generic Drug Switching: A Regulator's

(1 days ago) 1 Medicines Evaluation Board, CBG-MEB, P.O. Box 8275, 3503 GB, Utrecht, The Netherlands. 2 Department of Clinical Pharmacy and Toxicology, Maastricht University Medical Centre, Maastricht, The Netherlands. 3 Department of Pharmacy, Radboud University Medical Centre, Nijmegen, The …

https://pubmed.ncbi.nlm.nih.gov/32557345/

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College ter Beoordeling van Geneesmiddelen / Medicines

(5 days ago) College ter Beoordeling van Geneesmiddelen / Medicines Evaluation Board Graadt van Roggenweg 500 3531 AH Utrecht The Netherlands DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT Xylasol 20 mg/ml, solution for injection for cattle, horses, dogs and cats NL/V/158/001 AND

https://mri.cts-mrp.eu/Veterinary/Downloads/NL_V_0158_001_PAR.pdf

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Peter Mol - Hoogleraar - UMCG LinkedIn

(5 days ago) Results: The overall response rate was 34% (N = 1141, ranging from 24% for internists to 46% for community pharmacists). Healthcare providers trusted safety information more when provided by the Dutch Medicines Evaluation Board (MEB) than by the pharmaceutical industry. This was more the case for GPs than for the other healthcare professionals.

https://nl.linkedin.com/in/peter-mol-a9829a27

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The Dutch Commodities Act (Warenwet) Business.gov.nl

(1 days ago) The Commodities Act (in Dutch) applies to all products used by consumers, both food and non-food. It is linked to a large number of separate regulations and decrees that contain rules for specific foods and consumer products. The Act is a framework act that provides general rules …

https://business.gov.nl/regulation/commodities-act/

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Public consultation ‘Introduction of fees to be charged by

(9 days ago) pharmacovigilance’ - Comments from the Medicines Evaluation Board, the Netherlands Introduction The Medicines Evaluation Board (MEB) welcomes the introduction of fees to be charged for pharmacovigilance activities. The principal of charging fees for those activities is endorsed by the MEB. Whereas the pharmacovigilance

https://ec.europa.eu/health/sites/default/files/files/pharmacovigilance/2011-11_phv_fees_pc/08_nl-medicinesevaluationboard_en.pdf

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Heads of Medicines Agencies: CMDh Composition

(7 days ago) Medicines Evaluation Board P.O Box 8275 3503 Utrecht RG The Netherlands. VICE-CHAIRPERSON. Mrs Susanne Winterscheid Federal Institute for Drugs and Medical Devices BfArM Kurt-Georg Kiesinger-Allee 3 D-53175 BONN Germany. AUSTRIA. Member: …

https://www.hma.eu/352.html

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College ter Beoordeling van Geneesmiddelen / Medicines

(5 days ago) College ter Beoordeling van Geneesmiddelen / Medicines Evaluation Board Graadt van Roggenweg 500 3531 AH Utrecht The Netherlands DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT DFV Doxivet 500mg/ml powder for administration via drinking water for chickens and pigs January 2020

https://mri.cts-mrp.eu/Veterinary/Downloads/NL_V_0152_002_PAR.pdf

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EMA-EudraVigilance-Signal-Management-Virtual-Information-Day

(Just Now) This virtual live Information Day will focus on the ISO 27953-2:2011 as well as ISO 11239:2012 standards which will become applicable as of 30 June 2022 for all reporting to EudraVigilance. It will also highlight the impact on EV and Signal Management with regard to COVID-19 and provides an update on the revision of the existing ICH-E2D.

https://www.diaglobal.org/en/ema/conference-listing/2021/11/ema-eudravigilance-signal-management-virtual-information-day

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Dr Carla Herberts, Medicines Evaluation Board, CT-TRACS Co

(5 days ago) Dr Carla Herberts, Medicines Evaluation Board, CT-TRACS Co-Chair, Netherlands. Medicines Evaluation Board [email protected] CTG Catapult and HESI –CT-TRACS Workshop 14 February 2018. Disclaimer The contents of this presentation represent the personal views of the speaker only;

https://hesiglobal.org/wp-content/uploads/sites/11/2018/03/CGT-Seminars-Series_Wednesday_CTTRACS-Carla_Herberts.pdf

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2 Decembe 201r 3 H. van den Berg +31882248346 Enclosed

(7 days ago) Enclosed please find the reactio ofthn e Medicines Evaluation Board in the Netherlands regarding the public consultation on the PIP guideline. Yours sincerely, Prof.Dr. H.G.M. Leufkens Chairman . c B G M E B Public consultation on the paediatric regulation No 1901/2006 Comments from the Medicines Evaluatio Boardn th, e Netherlands. Introduction

https://ec.europa.eu/health/sites/default/files/files/paediatrics/2014_pc_pcpip/meb.pdf

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Home Medicine shortages and defects notification centre

(Just Now) The Medicine shortages and defects notification centre is coordinated by the Medicines Evaluation Board (MEB) and the Health and Youth Care Inspectorate (IGJ). The notification centre is commissioned by the Ministry of Health, Welfare and Sport (VWS). Notifications from patients, pharmacists, wholesalers and health care providers

https://www.medicineshortagesdefects.nl/

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The Dutch bid for the European Medicines Agency

(9 days ago) knowledge between experts from EU medicines regulatory agencies. Furthermore, the Dutch Medicines Evaluation Board is willing and able to provide a similar level of scientific support to EMA as it currently enjoys from the National Competent Authorities in the UK. Finally, The Netherlands’ commitment, as

https://www.consilium.europa.eu/media/21805/amsterdam-ema-bidbook.pdf

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REVIEW OF THE EXISTING RECOMMENDATIONS FOR …

(9 days ago) Medicines Evaluation Board in Netherlands recommends that Xylometazoline Hydrochloride Nasal Spray 1mg/ml (0.1%) be used in adults and children over 10 years of age. The prescribing information may vary with brands eg Triofan® (xylometazoline 4 Graf P, Juto JE. Sustained use of xylometazoline nasal spray shortens the decongestive response and

https://www.who.int/selection_medicines/committees/expert/19/applications/ENT_28_AC_R.pdf

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Safety considerations for chloroquine and

(3 days ago) To the Editor. Based on a demonstrated in vitro effect on SARS-CoV-2 and its known safety profile, both chloroquine and hydroxychloroquine (CQ/HCQ) are currently being used off label to treat COVID-19 [].However, although the safety of CQ/HCQ is well established in malaria or autoimmune disease, COVID-19 patients could be more vulnerable to side effects because of their …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7228887/

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Wendy van Loon - Assessor quality chemical-pharmaceutical

(Just Now) Dutch Medicines Evaluation Board (Netherlands) Apr 2016 - Present 5 years 3 months. Assessment of the quality part (module 3) of the dossier of chemical-pharmaceutical products Regulatory Scientific Advisor Vitaco Health (NZ) Limited Sep 2014 - Jul 2016 1 year 11

https://nz.linkedin.com/in/wendy-van-loon-646918a1

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Pharmaceuticals: Regulatory Agencies >> globalEDGE: Your

(3 days ago) The Medicines Evaluation Board (MEB) assesses and guards the efficacy, safety, and quality of both human and veterinary medicinal products. The MEB is the primary source of information on new medicinal products, new applications, and current risk information in the Netherlands.

https://globaledge.msu.edu/industries/pharmaceuticals/regulatory-agencies

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Astellas Pharma Europe BV (2014) Vesomni 6 mg/0.4 mg

(3 days ago) Article citations More>>. Astellas Pharma Europe BV (2014) Vesomni 6 mg/0.4 mg Modified-Release Tablets. Public Assessment Report of the Medicines Evaluation Board in the Netherlands, Solifenacin Succinate/Tamsulosin Hydrochloride, Vesomni SPC, The Netherlands.

https://www.scirp.org/reference/ReferencesPapers.aspx?ReferenceID=1921387

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