Home» Medical News

European Medicines Agency starts review of Pandemrix

Views: 246
Date: 03 Sep 2010
Definition of medical terminology for Narcolepsy.
Agency is investigating whether there is a link between vaccine and cases of narcolepsy

Definition of medical terminology for Medicines.
Definition of medical terminology for Review.
Definition of medical terminology for Narcolepsy.
Injection of a killed microbe in order to stimulate the immune system against the microbe, thereby preventing disease.
Definition of medical terminology for Spontaneous Abortion.
Definition of medical terminology for Influenza.
Injection of a killed microbe in order to stimulate the immune system against the microbe, thereby preventing disease.
Definition of medical terminology for Influenza.
Definition of medical terminology for Sleep.
Definition of medical terminology for Person.
Definition of medical terminology for Environmental Carcinogens.
Definition of medical terminology for Infections.
Definition of medical terminology for Narcolepsy.
1. In dysmorphology (the study of birth defects), the nonrandom occurrence in two or more individuals of a pattern of multiple anomalies (birth defects) not known to be a malformation syndrome (such as Down syndrome), a malformation sequence (of events) or what is called a polytopic field defect (in which all of the defects are concentrated in one particular area of the body).
Definition of medical terminology for Disorder Agents, Movement.
The AAMC is a nonprofit association of the 125 accredited U.S. medical schools; the 16 accredited Canadian medical schools; more than 400 major teaching hospitals and health systems; some 90 academic and professional societies representing 75,000 faculty members; and the nation`s medical students and residents. The purpose of the AAMC is to improve health through the advancement of academic medicine. In pursuing this purpose, the AAMC works "to strengthen the quality of medical education and training, to enhance the search for biomedical knowledge, to advance research in health services, and to integrate education into the provisions of effective health care." The AAMC is responsible for the Medical College Admission Test (MCAT) required of everyone applying to medical school in the U.S. and Canada.
Program Assessment Rating Tool
Definition of medical terminology for Evaluation.
Definition of medical terminology for Safety.
Definition of medical terminology for Risk.
A biological system that enables us to know where our bodies are in the environment and to maintain a desired position.
Definition of medical terminology for Measures.
Definition of medical terminology for Evaluation.
Definition of medical terminology for Disease.
An agency of the United Nations established in 1948 to further international cooperation in improving health conditions.
Definition of medical terminology for Health.
Definition of medical terminology for Organization.
Definition of medical terminology for Medicines.
Definition of medical terminology for Health.
Injection of a killed microbe in order to stimulate the immune system against the microbe, thereby preventing disease.
Definition of medical terminology for Narcolepsy.
Definition of medical terminology for European Union.

The European Medicines Agency has launched a review of Pandemrix on the request of the European Commission to investigate whether there is a link between cases of narcolepsy and vaccination with Pandemrix. A limited number of cases was reported, all collected through spontaneous reporting systems, mainly in Sweden and Finland. Pandemrix, an influenza vaccine, has been used since September 2009 for vaccination against H1N1 influenza in at least 30.8 million Europeans.


Narcolepsy is a rare sleep disorder that causes a person to fall asleep suddenly and unexpectedly. Its precise cause is unknown, but it is generally considered to be triggered by a combination of genetic and environmental factors, including infections.


Although the cases of narcolepsy have been reported in temporal association with the use of Pandemrix, it is at present not known if the vaccine caused the disorder . The Agencya€™s Committee for Medicinal Products for Human Use (CHMP) will look carefully at all of the available data to determine whether there is evidence for a causal association . As part of this evaluation the Committee will also consider the so-called background rate for narcolepsy, i.e. the number of cases that would normally be expected to be diagnosed.


The Committee will be working with experts from across the EU to assess this possible safety concern and any impact on the benefit risk balance of Pandemrix. The Committee will consider at its September 2010 meeting the need for any provisional measures pending completion of the evaluation.


The Agency is also liaising with the European Centre for Disease Prevention and Control (ECDC), international regulatory partners and the World Health Organization (WHO).


The European Medicines Agency will provide updates as new information becomes available.


Notes:



  1. On 24 August 2010, Finlanda€™s National Institute for Health and Welfare recommended that vaccination with Pandemrix be discontinued until the suspected link with narcolepsy is thoroughly evaluated.

  2. Pandemrix has been authorised in the European Union since September 2009. The vaccine was extensively used during the 2009 (H1N1) pandemic, with at least 30.8 million Europeans vaccinated.


Source : DrugsFreeList.com
Tags: European Medicines, Pandemrix

Latest Medical News

» U.S. Food And Drug Administration Approves Pfizer’s INLYTA (axitinib) For Patients With Previously Treated Advanced Renal Cell Carcinoma (RCC)
-Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved INLYTA® (axitinib), a kinase inhibitor, for the treatment of patients with advanced renal cell carcinoma (RCC)


» Pfizer Announces FDA Acceptance Of New Drug Application For Bosutinib For Patients With Previously Treated Ph Chronic Myeloid Leukemia
Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for standard review of bosutinib as a treatment option for adult patients with previously treated Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML).


» FDA approves Inlyta to treat patients with a type of advanced kidney cancer
The U.S. Food and Drug Administration approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.


» FDA Drug Safety Communication: New risk factor for Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)
The U.S. Food and Drug Administration (FDA) is informing the public that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal leukoencephalopathy (PML).


» FDA. New and Generic Drug Approvals - January 27, 2012
New drugs approved. List of drugs approved by FDA to date January 27, 2012


» FDA. New and Generic Drug Approvals - January 26, 2012
New drugs approved. List of drugs approved by FDA to date January 26, 2012


» FDA. New and Generic Drug Approvals - January 25, 2012
New drugs approved.List of drugs approved by FDA to date January 25, 2012


» FDA. New and Generic Drug Approvals - January 24, 2012
New drugs approved. List of drugs approved by FDA to date January 24, 2012


» FDA. New and Generic Drug Approvals - January 23, 2012
New drugs approved.List of drugs approved by FDA to date January 23, 2012


» FDA. New and Generic Drug Approvals - January 20, 2012
New drugs approved. List of drugs approved by FDA to date January 20, 2012


» FDA. New and Generic Drug Approvals - January 19, 2012
New drugs approved. List of drugs approved by FDA to date January 19, 2012


» FDA. New and Generic Drug Approvals - January 18, 2012
New drugs approved. List of drugs approved by FDA to date January 18, 2012


» FDA expands use of endovascular graft to treat aortic tears
The U.S. Food and Drug Administration expanded the approved usage for an endovascular graft manufactured by W.L. Gore and Associates Inc. to include treatment of life-threatening tears or ruptures of the aorta (thoracic aortic transection).


» FDA approves Voraxaze to treat patients with toxic methotrexate levels
The U.S. Food and Drug Administration approved Voraxaze (glucarpidase) to treat patients with toxic levels of methotrexate in their blood due to kidney failure.


» FDA Drug Safety Communication: New Boxed Warning and Contraindication for Adcetris (brentuximab vedotin)
The U.S. Food and Drug Administration (FDA) is notifying the public that two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death, have been reported with the lymphoma drug Adcetris (brentuximab vedotin).


General Search


Last medical tags:


Torisel, temsirolimus, Inlyta, chronic myeloid leukemia, bosutinib, Inlyta, renal cell carcinoma, kidney cancer, myelin, Tysabri, natalizumab, brain infection, progressive multifocal leukoencephalopathy, FDA, New drugs approval 2012, drugs approved by FDA, FDA, New drugs approval 2012, drugs approved by FDA, FDA, New drugs approval 2012, drugs approved by FDA, FDA, New drugs approval 2012, drugs approved by FDA, FDA, New drugs approval 2012, drugs approved by FDA, FDA, New drugs approval 2012, drugs approved by FDA, FDA, New drugs approval 2012, drugs approved by FDA, FDA, New drugs approval 2012, drugs approved by FDA, thoracic aortic transection, endovascular graft, methotrexate, Voraxaze, cancer chemotherapy drug, glucarpidase, Adcetris, bleomycin, multifocal leukoencephalopathy, CardioGen-82, radiation, FDA, New drugs approval 2012, drugs approved by FDA, FDA, New drugs approval 2012, drugs approved by FDA, FDA, New drugs approval 2012, drugs approved by FDA, raltegravir, Isentress, antiretroviral medicines, Theravance, Relovair, asthma, fluticasone, bronchitis, neuromuscular disease, SMA, muscle atrophy, Resolor, prokinetic, prucalopride, ADHD, psychiatric behavioural disorder, Venvanse, lisdexamfetamine dimesylate, type 2 diabetes mellitus, Actoplus Met XR, pioglitazone, Mylan, Eprosartan Mesylate Tablets, Teveten, antimicrobials, cephapirin, cephalosporin, teriflunomide, Rebif, alanine aminotransferase levels, flu-like symptoms, multiple sclerosis, electrical pulses, implantable pulse generator, Precision Plus Spinal Cord Stimulator, genetic blood clotting disorder, hemophilia A, Advate, bleeding episodes, heart failure, heart transplantation, Pediatric Medical Device Safety, pulsatile cardiac assist device, selective serotonin reuptake inhibitor, SSRI, pulmonary hypertension,
» All tags  
Sitemap