European Medicines Agency

European Medicines Agency - Factbites
Where results make sense
About us | Why use us? | Reviews | PR | Contact us

Topic: European Medicines Agency

Note: these results are not from the primary (high quality) database.

In the News (Thu 24 Dec 09)

Northern Trust

Marvin Harrison

Peter Chernin

Gary Locke

Match Play

Penelope Cruz

Mickey Rourke

AR Rahman

Danny Boyle

Hugh Jackman

	European Medicines Agency - Wikipedia, the free encyclopedia
		The Agency has a staff of about 360, and decentralizes its scientific assessment of medicines by working through a computer-linked network of about 3500 experts throughout the EU.
		The majority of existing medicines throughout the European Union's member states remain authorised nationally, but the majority of genuinely novel medicines are authorised through the EMEA.
		This is sent to the European Commission to be transformed into a marketing authorisation valid for the whole of the European Union.
	en.wikipedia.org /wiki/European_Medicines_Agency (447 words)

	European Medicines Agency finalises review of antidepressants in children / adolescents
		The European Medicines Agency (EMA) has issued a press release recommending warnings about the increased risk of suicide attempts and hostility for children and adolescents prescribed an SSRI or SNRI antidepressant --and added warnings about the increased risk of hostility and "emotional lability" for children prescribed Strattera (atomoxetine).
		LONDON, April 25, 2005 - The European Medicines Agency has completed its review of two classes of antidepressants and concluded that they should not be used in children and adolescents except in their approved indications.
		The Agency's committee is therefore recommending the inclusion of strong warnings across the whole of the European Union to doctors and parents about these risks.
	www.ahrp.org /infomail/05/04/26.php (1187 words)

	GENERAL PRINCIPLES EMEA - FDA PARALLEL SCIENTIFIC ADVICE MEETINGS
		Both agencies commit to be cognizant of the other’s formal domestic performance expectations and to exhibit as much flexibility as possible in scheduling parallel scientific advice meetings in order not to impact adversely either agency’s ability to meet their formal domestic performance expectations.
		Each agency will provide their independent advice to the sponsor on the questions posed during the parallel scientific advice, according to their usual procedures.
		The expected advantages from such interactions are increased dialogue between the two agencies and sponsors from the beginning of the lifecycle of a new product, a deeper understanding of the bases of scientific advice, and the opportunity to optimize product development and avoid unnecessary testing replication or unnecessary diverse testing methodologies.
	www.fda.gov /oia/pilotprogram0904.html (1459 words)

	European Medicines Evaluation Agency is ahead of national licensing authorities -- Sauer 317 (7165): 1078 -- BMJ
		European Medicines Evaluation Agency is ahead of national licensing authorities
		European Medicines Evaluation Agency is ahead of national licensing authorities -- Sauer 317 (7165): 1078 -- BMJ
		The key reform introduced with the creation of the agency is the European public assessment report.
	bmj.bmjjournals.com /cgi/content/full/317/7165/1078 (378 words)

	Investor's Business Daily: Breaking News
		European Medicines Agency (EMEA), based in London, is a decentralized agency that serves to protect and promote public and animal health through the evaluation and supervision of medicines for human and veterinary use.
		The European Medicines Agency (EMEA) is a decentralized body of the European Union with headquarters in London.
		The Agency uses the scientific resources of the 25 EU Member States and the 3 European Economic Area States in a network of 42 national competent authorities.
	www.investors.com /breakingnews.asp?journalid=25974293&rb=1 (934 words)

	deseretnews.com Arthritis drugs under review by Europeans
		LONDON &; The European Medicines Agency, a London-based regulator that monitors pharmaceutical safety, is conducting a review of pain relievers in the wake of the withdrawal of the arthritis drug Vioxx from the market.
		The European Medicines Agency, a decentralized body of the European Union, relies in part on a network of 3,000 scientists and experts to conduct studies and make decisions.
		The European agency said on Friday that it was studying the other COX-2 drugs on the market or in development, calling the action a "precautionary measure." Its review is expected to be completed in five or six months.
	deseretnews.com /dn/view/0,1249,595100599,00.html (408 words)

	European Medicines Agency to review drugs in same class as Vioxx - EUbusiness
		The European Medicines Agency is to review all drugs in the same class as Vioxx after US pharmaceutical giant Merck withdrew the arthritis drug, a spokesman for the agency said Friday.
		The European Medicines Agency carried out a review of the drug class which includes Vioxx -- known as COX-2 inhibitors -- at the request of French authorities, but concluded in November 2003 that the products did not need to be withdrawn from the market.
		European Medicines Agency to review drugs in same class as Vioxx
	www.eubusiness.com /Health/041001131539.w0y38c5s (347 words)

	European Medicines Agency statement on the suspension of use of Bextra
		Following discussions with the European Medicines Agency, Pfizer has agreed to the suspension of use of Bextra (valdecoxib) in Europe as an interim measure pending finalisation of the assessment of COX-2 inhibitors.
		The European Medicines Agency has an ongoing safety review of the COX-2 class of medicines.
		The Agency had previously issued a statement on 15 December 2004 concerning safety issues for patients undergoing coronary artery bypass graft (CABG) surgery and serious skin reactions relating to the use of two COX-2 medicines, including Bextra.
	www.medicalnewstoday.com /medicalnews.php?newsid=22580&nfid=rssfeeds (336 words)

	European Medicines Agency's Management Board backs EMEA conflicts of interests policy
		Coordination between the EMEA and the heads of national agencies is necessary for the operation of the European medicines system.
		This is the first year that the European Parliament has been responsible for granting discharge to the Directors of all European agencies under new EU financial rules.
		The European Parliament has given a full discharge to the EMEA Executive Director for the execution of the 2003 budget.
	i-newswire.com /goprint23829.html (499 words)

	EUROPA - Agencies - European Agency for the Evaluation of Medicinal Products
		The European Medicines Agency (EMEA) was established by Council Regulation (EEC) No 2309/93 of 22 July 1993 (OJ L 214 of 24 August 1993).
		The scientific opinions of the Agency are prepared by three committees responsible for medicines for human use (Committee for Proprietary Medicinal Products, CPMP), for veterinary medicines (Committee for Veterinary Medicinal Products, CVMP) and for the designation of 'orphan' medicines for rare diseases (Committee for Orphan Medicinal Products, COMP).
		The Agency cooperates closely with international partners, reinforcing the EU contribution to global harmonisation.
	europa.eu.int /agencies/emea/index_en.htm (218 words)

	The European Medicines Evaluation Agency -- Herxheimer 312 (7028): 394 -- BMJ
		The European Medicines Evaluation Agency -- Herxheimer 312 (7028): 394 -- BMJ
		Firstly, the prompt publication by the agency of European Public
		Agency, and it is evident that its relative openness does not
	bmj.bmjjournals.com /cgi/content/full/312/7028/394 (608 words)

	PJ Online News New European medicines directives agreed
		And on 1 May, the European Medicines Evaluation Agency was renamed the European Medicines Agency (PDF 260K).
		The new directive on human medicines requires European Union member states to change national legislation so that local practices do not hinder the free movement of medicines throughout the union.
		Three updated European directives — on human medicines (PDF 190K), veterinary medicines (PDF 200K) and traditional herbal medicines (PDF 100K) — have been finalised.
	www.pharmj.com /Editorial/20040508/news/p560directivesagreed.html (198 words)

	European Medicines Agency update on non-selective NSAIDs
		By European Medicines Agency, The Agency’s scientific committee, the Committee for Medicinal Products for Human Use (CHMP), concluded, at its meeting of 10-13 October 2005, that, on the basis of the data reviewed, there are no new safety concerns regarding cardiovascular and gastrointestinal safety and serious skin reactions with non-selective NSAIDs (non-steroidal anti-inflammatory drugs).
		As for all medicinal products marketed in the European Union, NSAIDs are being continuously monitored and if there are any concerns impacting on the benefit-risk balance, appropriate actions will be taken.
		The review was carried out at the request of the European Commission to look at non-selective NSAIDs to determine whether there were safety issues that required further action.
	www.rxpgnews.com /article_2645.shtml (522 words)

	Statement from European Medicines Agency on celecoxib
		The European Medicines Agency (EMEA) received summary data on 21 December 2004 from 2 clinical trials (APC and PreSAP trials) relating to celecoxib and is actively reviewing these and other data.
		In addition to the EMEA advice published on 22 October 2004 and pending the outcome of the Agency's review, the national authorities in the Member States have made recommendations for the use of COX-2 inhibitors, including celecoxib (Celebrex, Celebra, etc), to patients and healthcare professionals.
		COX-2 inhibitor medicines available in Europe already contain stringent warnings and precautions on cardiovascular risks.
	www.medicalnewstoday.com /medicalnews.php?newsid=18277&nfid=rssfeeds (354 words)

	The Body: European Medicines Agency Approves Roche's Hepatitis C Drug Pegasys to Treat Patients Co-Infected With HCV, HIV
		The European Medicines Agency on Thursday approved Roche's hepatitis C drug Pegasys for the treatment of patients co-infected with HCV and HIV, Reuters reports.
		European Medicines Agency Approves Roche's Hepatitis C Drug Pegasys to Treat Patients Co-Infected With HCV, HIV
		The Body: European Medicines Agency Approves Roche's Hepatitis C Drug Pegasys to Treat Patients Co-Infected With HCV, HIV
	www.thebody.com /kaiser/2004/dec20_04/pegasys_approval.html (356 words)

	Off-label pediatric antidepressant use at issue in Europe
		Going beyond the warnings issued by FDA and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), the scientific panel of the European Medicines Agency (EMEA) has concluded that none of the newer antidepressants—including fluoxetine—should be used in children or adolescents for depression.
		EMEA recommended that physicians and parents throughout the European Union be warned of the suicide risks with pediatric use of these drugs, which are approved for use in adults for treatment of depression and anxiety.
		Some of the SSRIs/SNRIs are licensed in European countries for treatment of obsessive–compulsive disorder in patients younger than 18, and one is licensed for treatment of attention-deficit/hyperactivity disorder.
	www.pharmacist.com /articles/h_ts_0789.cfm (407 words)

	GAO: Report Abstract
		This report (1) determines how the EU now reviews and approves new drug applications and (2) explains why the European Medicines Evaluation Agency was established, how it operates, and how it is financed.
		European Union Drug Approval: Overview of New European Medicines Evaluation Agency and Approval Process HEHS-96-71 April 5, 1996
		The EU recently changed its drug approval procedures and created a new agency--the European Medicines Evaluation Agency--to approve drugs more quickly and efficiently.
	www.gao.gov /docdblite/summary.php?rptno=HEHS-96-71 (224 words)

	FDA and EU (European Commission and EMEA) Extend Confidentiality Arrangements for Five More Years
		The U.S. Food and Drug Administration (FDA), European Commission (EC), and European Medicines Agency (EMEA) have extended their confidentiality arrangements related to medicinal products for human and veterinary use for five more years, following the positive experience gained since the initial arrangements were signed in September 2003.
		The confidentiality arrangements cover medicinal products that are subject to evaluation or authorized under the centralized procedure, as well as medicinal products that are authorized at the national level by the EU Member States and that are subject to official European Community arbitrations and referrals.
		A pilot programme allowing companies to obtain parallel scientific advice from the two agencies for the development of medicinal products for human use was part of the first phase of implementation.
	www.fda.gov /bbs/topics/news/2005/NEW01257.html (271 words)

	European Report: SWEDE NAMED TO RUN EUROPEAN MEDICINES AGENCY.@ HighBeam Research
		The European Medicines Evaluation Agency in London is to be run by Thomas Lonngren, currently deputy Director-General of the Swedish national medicines agency.
		European Report: SWEDE NAMED TO RUN EUROPEAN MEDICINES AGENCY.@ HighBeam Research
		The above preview is from European Report, October 28, 2000.
	www.highbeam.com /library/doc0.asp?docid=1G1:66448902&refid=ink_tptd_np (174 words)

	H5N1: European Medicines Agency update on the safety of Tamiflu
		European Medicines Agency update on the safety of Tamiflu
		European Medicines Agency update on the safety of Tamiflu (info)
		H5N1: European Medicines Agency update on the safety of Tamiflu
	www.dymaxionweb.com /h5n1/archives/2005/11/european_medici.html (70 words)

	What's New
		Press Release European Medicines Agency appoints new Head of Unit for Veterinary Medicines and Inspections
		Press Release - European Medicines Agency gives first positive opinions for on medicinal products used for use outside the European Union
		Public Statement - CVMP COX-2 Inhibitors in Veterinary Medicine rev 1
	www.emea.eu.int /whatsnewp.htm (861 words)

	International Regulatory Agency Links
		Turkey: General Directorate of Medicines and Pharmaceutics (in Turkish)
		Portugal: National Institute of Pharmacy and Medicines (in Portuguese)
		Germany: Federal Institute of Consumer Health Protection and Veterinary Medicine
	www.globepharm.org /resource_agencies.html (124 words)

	SocietyGuardian.co.uk Health Babies given drugs untested on the young
		The lack of exhaustive trials of adult medicines in children is highlighted in the report by a group of peers looking at the European commission's proposals for paediatric medicines.
		At present drugs must be licensed by the Medicines and Healthcare Products Regulatory Agency after animal research and clinical trials.
		The committee said there was "an overwhelming and urgent need to take effective action at European level to govern clinical trials in children and the authorisation of medicinal products for paediatric use with the minimum of delay".
	www.guardian.co.uk /Society/health/news/0,,1700069,00.html?gusrc=rss (781 words)

	Food Standards Agency - Herbal products
		If the product you are interested in is subject to the provisions of European Union and UK food law, it will be regulated in accordance with its function (e.g.
		In order for us to advise you as to the status of your product as quickly as possible please email further details of the product to herbals@foodstandards.gsi.gov.uk.
		To find out which regulations apply to a particular herbal product or ingredient, you first need to check which category it falls into.
	www.food.gov.uk /foodindustry/herbal (289 words)

	Tougher rules in the UK for advertising of pharmaceutical products - European Public Health Alliance
		Medicines and Healthcare Products Regulatory Agency (MHRA) launched new, tougher guidance on advertising and promotion of medicines.
		The Agency has put in place more streamlined processes to ensure that advertising is reviewed as quickly as possible.
		The Blue Guide: advertising and promotion of medicines in the UK
	www.epha.org /a/1712 (433 words)

	National Patient Safety Agency
		The Medicines and Healthcare products Regulatory Agency will be hosting a conference on New Medicines Legislation.(pdf) The purpose of this event is to inform the Pharmaceutical industry of the revised medicines legislation as adopted by the Council and European Parliament on 31 March 2004.
		The Medicines and Healthcare products Regulatory Agency (MHRA) will host a series of seminars reviewing the implementation of the Blood Safety and Quality Regulations (pdf) which become effective on the 8 November 2005.
		Patient safety is one of the main themes of this year's Health Protection Agency Annual Conference - focusing particularly on HCAIs.
	www.npsa.nhs.uk /press/events?page=2 (256 words)

	BBC NEWS Health Drug withdrawn amid skin concerns
		The European Medicines Agency (EMA) said the withdrawal was as an interim measure pending its a review of a class of drugs known as Cox-2 inhibitors - of which Bextra is one.
		The Medicines and Healthcare products Regulatory Agency, the UK regulator, said 40,000 Britons used the drug, and there were two reports of reactions.
		Professor Kent Woods, chief executive of the Medicines and Healthcare products Regulatory Agency, the UK drugs regulator, said he agreed with the move.
	news.bbc.co.uk /1/hi/health/4421721.stm (383 words)

	Pharmacos Unit F2 Pharmaceuticals V 6.0
		New rules on fees for registration of medicines for human and veterinary use at the European Medicines Agency (EMEA) have been adopted by the Council on 14.11.2005, upon a proposal from the European Commission.
		In order to ensure the enforcement of certain obligations connected with marketing authorisations for medicinal products granted in accordance with Regulation (EC) No 726/2004, Article 84(3) of that Regulation empowers the Commission, at the request of the European Medicines Agency, to impose financial penalties on the holders of marketing authorisations.
		DG Enterprise and Industry wishes to receive comments on the draft Commission regulation laying down the procedure to adopt the maximum amounts and the conditions and methods for collection of financial penalties imposed by the Commission under Regulation No (EC) 726/2004.
	pharmacos.eudra.org /F2/home.html (1056 words)

	IMPLEMENTING THE RECOMMENDATIONS OF THE MMR EXPERT GROUP
		Through active involvement with the European Committee for Proprietary Medicinal Products’ Pharmacovigilance Working Party, the Medicines Control Agency does, and will continue to, work very closely with other European regulatory bodies in monitoring and assessing the safety of vaccines.
		The Medicines Control Agency will continue to work closely with other Member States in the European Union in monitoring vaccine safety issues.
		I am pleased it also sets out the positive response of the Joint Committee on Vaccination and Immunisation, the Committee on Safety of Medicines, and the Medicines Control Agency.
	www.scotland.gov.uk /library5/health/mmrr-00.asp (1056 words)

	www.emea.eu.int
		The European Medicines Agency has finalised a new procedure aimed at putting in place a transparent process for the development, consultation, finalisation and implementation of pharmaceutical guidelines.
		Press Release - European Medicines Agency’s Management Board backs EMEA conflicts of interests policy
		Press Release European Agency finalises new procedure for EU pharmaceutical guidelines
	www.emea.eu.int (1056 words)

Try your search on: Qwika (all wikis)

Topic: European Medicines Agency

Ads by Google

Related Topics

In the News (Thu 24 Dec 09)