European Medicines Agency

Type: Organization
Name: European Medicines Agency
First reported 6 hours ago - Updated 50 mins ago - 2 reports

EC, FDA Give Orphan Status to Boehringer’s New Leukemia Drug

Boehringer Ingelheim Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) and European Commission (EC) have granted Orphan Drug Designation to volasertib for acute myeloid leukemia (AML). Volasertib is currently being evaluated ... [Published Drug Discovery and Development - 2 hours ago]
First reported 1 hour ago - Updated 1 hour ago - 1 reports

EMA releases flu vaccine advice

n Union’s (EU) recommendations for next winter’s flu vaccine have been released by the European Medicines Agency (EMA).It said trivalent vaccines for the 2014/2015 season should contain strains of an A/California/7/2009 (H1N1)pdm09-like virus; an A/Texas/50/2012 ... [Published Manufacturing Chemist - 1 hour ago]
First reported 4 hours ago - Updated 1 hour ago - 3 reports

News and press releases: European Medicines Agency update on stolen vials of Herceptin

This is an update from the European Medicines Agency on the latest information relating to the stolen vials of Herceptin (trastuzumab) in Italy. ... [Published Patient safety, news and press releases: human ... - 1 hour ago]
First reported Apr 16 2014 - Updated 7 hours ago - 14 reports

Stolen Herceptin sparks European alert

The European Medicines Agency has sparked an alert after it was told that stolen vials of Roche’s breast cancer medicine Herceptin have been put back into pharma’s supply chain.The vials are believed to have been stolen from Italy - where law enforcement ... [Published Pharmafocus - 7 hours ago]
First reported Apr 16 2014 - Updated 16 hours ago - 8 reports

Discovery of tampered vials leads to Roche cancer drug recall

Roche has recalled nine batches of breast cancer drug Herceptin after tampered vials were discovered in the UK, Finland and Germany.Vials of Roche’s topselling cancer drug are thought to have been stolen in Italy, “tampered with and re-introduced under ... [Published In-Pharmatechnologist - 16 hours ago]
First reported Apr 16 2014 - Updated Apr 16 2014 - 2 reports

European Medicines Agency starts two new safety reviews looking at codeine and testosterone

The European Medicines Agency is embarking on a review of codeine-containing medicines when used for cough and cold in children. A separate review will consider the evidence around testosterone medicines.The new examination of codeine follows a previous ... [Published PJ Online - Apr 16 2014]
First reported Apr 16 2014 - Updated Apr 16 2014 - 1 reports

News and press releases: EMA and EU national competent authorities agree on action plan to address medication errors

The European Medicines Agency and the National Competent Authorities of the European Union (EU) have agreed an action plan to address the issue of medication errors, a major public-health burden. ... [Published Patient safety, news and press releases: human ... - Apr 16 2014]
First reported Apr 15 2014 - Updated Apr 15 2014 - 2 reports

European review prompts warning against “dual blockade” of renin-angiotensin system

Patients with diabetes-related kidney disease should not be given the combination of an angiotensin-receptor blocker (ARB) and an angiotensin-converting enzyme (ACE) inhibitor, says a sub-committee of the European Medicines Agency.The advice is part of ... [Published PJ Online - Apr 15 2014]
First reported Apr 15 2014 - Updated Apr 15 2014 - 1 reports

News and press releases: European Medicines Agency closed 17-21 April 2014

The European Medicines Agency will be closed from 18:30 on Wednesday 16 April and will re-open at 7:30 on Tuesday 22 April 2014. ... [Published Patient safety, news and press releases: human ... - Apr 15 2014]
First reported Apr 15 2014 - Updated Apr 15 2014 - 2 reports

Roche may face EU levies following drug safety breaches

Roche faces a potential $740 million fine from the European Commission after its regulator found a series of pharmacovigilance failures.In 2012 the European Medicines Agency began investigating Roche after ‘deficiencies’ in the manufacturer’s pharmacovigilance ... [Published Pharmafocus - Apr 15 2014]
First reported Apr 15 2014 - Updated Apr 15 2014 - 2 reports

Top stories in health and medicine, April 15, 2014

From MedPage Today: A Different Take on .health Domains. Top level domains (TLD) like .doctor, .med, and .health will certainly provide for a memorable way to promote one’s practice website as compared with what exists today in domain name choices. EMA ... [Published BioPortfolio - Apr 15 2014]

Quotes

The new approval could change some of that. The U K "s Joint Committee on Vaccination and Immunisation, for one, has already recommended that the country's National Health Service switch to the new plan, telling GP it could make the Gardasil program more cost-effective. And last month, Dr. George Kassianos, the Royal College of General Practitioners" head of vaccinations, told the publication the money saved would strengthen the case for extending the country's Gardasil program--currently only for...
...to the four HPV types – 6, 11, 16 and 18 – included in Gardasil®", said Dr Stephen Lockhart Vice President, Development of Sanofi Pasteur MSD. "These results are sustained 3 years after vaccination, which indicates that a 2 dose 0-6 month schedule of Gardasil®, is able to induce high antibody levels for protection against HPV-diseases. " concluded Dr Lockhart
...program for volasertib," said Sabine Luik, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals Inc. "Boehringer Ingelheim is deeply committed to supporting the community of patients living with acute myeloid leukemia, with a current research focus on these older patients who have very limited treatment options."
...Some of the packages of powder have liquid in them, and "evidence of tampering with the rubber stoppers, crimping caps or lids" was apparent on some

More Content

All (1327) | News (1137) | Reports (0) | Blogs (144) | Audio/Video (0) | Fact Sheets (1) | Press Releases (21)
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EMA releases flu vaccine advice [Published Manufacturing Chemist - 1 hour ago]
News and press releases: European Medicines Age... [Published Patient safety, news and press releases: human ... - 1 hour ago]
Merck, Sanofi hope for sales expansion with two... [Published FierceVaccines - 1 hour ago]
Gardasil® approved in the European Union for a ... [Published FierceVaccines - 1 hour ago]
EC, FDA Give Orphan Status to Boehringer’s New ... [Published Drug Discovery and Development - 2 hours ago]
Brimonidine gel launched for reduction of eryth... [Published PJ Online - 3 hours ago]
Counterfeits of Roche's Herceptin found in EU s... [Published FiercePharmaManufacturing - 4 hours ago]
European Medicines Agency alerts EU healthcare ... [Published BioPortfolio - 4 hours ago]
Orphan status for BI leukaemia drug in USA and EU [Published Pharma Times - 6 hours ago]
Stolen Herceptin sparks European alert [Published Pharmafocus - 7 hours ago]
Individual Investor Portfolio Update: Rebalance... [Published Seeking Alpha - 8 hours ago]
European Medicines Agency alerts EU healthcare ... [Published PBR - News - 9 hours ago]
JAPAN TOBACCO : Launch of Riona(R)Tablets 250mg... [Published 4 Traders - 10 hours ago]
United Kingdom : GSK receives US approval for o... [Published Pharmacy Choice - 13 hours ago]
Big Pharma On Big Data Collaboration [Published AAPS Pharmceutica - 16 hours ago]
Bristol-Myers Squibb Submits NDAs for Daclatasv... [Published HispanicBusiness.com - 16 hours ago]
Discovery of tampered vials leads to Roche canc... [Published In-Pharmatechnologist - 16 hours ago]
Impax Ships Generic Renvela [Published FDA News - 17 hours ago]
Glaxo's Tanzeum Approved in the U.S. [Published Zacks.com - 19 hours ago]
EMA Reports Vials of Falsified Herceptin Identi... [Published Big News Network - 19 hours ago]
EMA warns about falsifed Herceptin [Published Big News Network - 19 hours ago]
EMA Warns of Falsified Herceptin Vials [Published PharmTech.com - 19 hours ago]
Batches of Herceptin Could Have Been Tampered W... [Published Pharmaceutical & Medical Packaging News - 20 hours ago]
Medicines agency warns of stolen cancer drug [Published Oman Observer - 20 hours ago]
UPDATE 1-EU medicines agency warns of stolen Ro... [Published Big News Network - 21 hours ago]
Questions & Answers: Fees for Pharmacovigilance... [Published European Commission - 22 hours ago]
US, EU generic drug makers call for regulatory ... [Published Processing Magazine - Apr 16 2014]
EMA warns Herceptin vials stolen in Italy sprea... [Published FiercePharma - Apr 16 2014]
New report finds Bydureon safest of new class o... [Published FiercePharma - Apr 16 2014]
European Medicines Agency starts two new safety... [Published PJ Online - Apr 16 2014]
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Blogs

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News and press releases: European Medicines Age... [Published Patient safety, news and press releases: human ... - 1 hour ago]
This is an update from the European Medicines Agency on the latest information relating to the stolen vials of Herceptin (trastuzumab) in Italy. ...
European Medicines Agency alerts EU healthcare ... [Published PBR - News - 9 hours ago]
The European Medicines Agency (EMA) has been informed that vials of the cancer medicine Herceptin (trastuzumab), thought to have been stolen in Italy, including from hospitals, have been tampered with and re-introduced under false credentials into the ...
Regulatory and procedural guideline: European M... [Published Regulatory and procedural guidelines: human and ... - Apr 16 2014]
News and press releases: European Medicines Age... [Published Patient safety, news and press releases: human ... - Apr 16 2014]
The European Medicines Agency (EMA) has been informed that vials of the cancer medicine Herceptin (trastuzumab), thought to have been stolen in Italy, including from hospitals, have been tampered with and re-introduced under false credentials into the ...
News and press releases: EMA and EU national co... [Published Patient safety, news and press releases: human ... - Apr 16 2014]
The European Medicines Agency and the National Competent Authorities of the European Union (EU) have agreed an action plan to address the issue of medication errors, a major public-health burden. ...
1 2 3 4 5 6 7 8 9 10 ...

Press Releases

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Keryx Biopharmaceuticals Announces EMA Validati... [Published GlobeNewswire: Acquisitions News - Apr 02 2014]
DGAP-News: Keryx Biopharmaceuticals Announces E... [Published GlobeNewswire: Acquisitions News - Apr 02 2014]
DGAP-News: Keryx Biopharmaceuticals Announces S... [Published GlobeNewswire: Acquisitions News - Mar 10 2014]
BioMarin Receives Positive Opinion From the CHM... [Published GlobeNewswire: Acquisitions News - Feb 20 2014]
Active Biotech AB Year-end report January - Dec... [Published GlobeNewswire: Advertising News - Feb 13 2014]
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