關於世衛組織藥品資格預審:

(責任編輯:lilizhao)

*每年兒童基金會、抗擊艾滋病、結核和瘧疾全球基金和國際藥品采購機制等國際采購機構都要采購或通過這些機構采購數十億美元的藥品,投放到資源有限的國傢的藥物市場上。
*世衛組織藥品資格預審規劃幫助確保采購機構供應的藥品符合可接受的質量、安全性和療效標準。
*到2012年底,世衛組織通過資格預審的藥物清單收入瞭316種用於治療重點疾病的藥品。
*世衛組織通過資格預審的藥物清單現已成為國際采購機構的大宗藥品采購指南,同時也為越來越多的國傢所采用。
*世衛組織藥品資格預審規劃也對活性藥物成分和質量控制實驗室進行資格預審。

英文原文:SANOFI : Menomune? Is the First Quadrivalent Meningococc平價美白面膜|平價美白面膜推薦al Vaccine Prequalified by the WHO

重要事實:

聯合國資格預審評估的目的是,保證候選疫苗滿足WHO在質量、安全性和有效性方面的建議,包括符合由WHO推薦的良好生產規范(GMP)和良好臨床實踐(GCP)標準。Menomune疫苗的資格預審是通過一個精簡程序審查,該程序中,WHO和美國FDA密切合作。

Menomune vaccine is designed for active immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 for use in persons 2 years of age and older. It is the first quadrivalent meningococcal vaccine pre-qualified by the WHO. The WHO notification to UNICEF states that following the evaluation of consistency of final product characteristics, GMP and quality system audits of the manufacturing facilities, and follow-up of implementation of recommendations made by WHO reviewers during the evaluation, Menomune vaccine has been found acceptable. It is manufactured in Pennsylvania, USA.

Indication :Menomune-A/C/Y/W-135 vaccine is indicated for active immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. Menomune-A/C/Y/W-135 vaccine is approved for use in persons 2 years of age and older. Menomune-A/C/Y/W-135 vaccine does not prevent N. meningitidis serogroup B disease.

世衛組織藥品資格預審是世衛組織開展的一個服務項目,用以評估醫藥產品的質量、安全性和療效。在2001年,最初重點關註的是艾滋病毒/艾滋病、結核病和瘧疾治療藥物。2006年,藥品審查范圍進一步擴大,列入瞭促進光采精華露|光采精華露推薦生殖健康的藥品和產品。2008年,又列入瞭用以治療兒童急性腹瀉的鋅片。到2012年底,世衛組織通過資格預審的藥物清單收入瞭316種用於治療重點疾病的藥品。

2013年9月3日訊 /生物谷BIOON/ --賽諾菲(Sanofi)疫苗事業部賽諾菲-巴斯德(Sanofi Pasteur)9月3日宣佈,四價腦膜炎疫苗Menomune已通過世界衛生組織(WHO)的資格預審,成為首個通過WHO資格預審的四價腦膜炎球菌疫苗。

Menomune疫苗旨在用於2歲及以上人群的主動免疫,預防由腦膜炎奈瑟氏菌血清型A、C、Y、W-135引發的侵襲性腦膜炎球菌病。(生物谷Bioon.com)

PRESS RELEASE Menomune? Is the First Quadrivalent Meningococcal Vaccine Prequalified by the WHO - Prequalification Makes the Vaccine Eli青春精華露30ml|青春精華露30ml推薦gible for Purchase by United Nations Agencies -

Lyon, France - September 3, 2013 - Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that one of its quadrivalent vaccines to prevent invasive meningococcal disease has been prequalified by the World Health Organization (WHO). The prequalification procedure accepts Menomune? vaccine for purchase by United Nations Agencies. The UNICEF supply division has been notified of Menomune vaccine's acceptance by the WHO.

The purpose of the United Nations prequalification assessment is to provide assurance that candidate vaccines meet WHO recommendations on quality, safety and efficacy, including compliance with WHO's recommended standards for good manufacturing practice (GMP) and good clinical practice (GCP). This Menomune vaccine prequalification was performed through a streamlined procedure in which the WHO worked closely with the United States Food and Drug Administration (FDA).

賽諾菲腦膜炎疫苗Menomune通過WHO資格預審

"Sanofi Pasteur's commitment to help protect against meningococcal disease began almost 40 years ago with the introduction of a monovalent vaccine that offered protection against serogroup A and a bivalent vaccine that offered protection against serogroups A and C," said Olivier Charmeil, President and Chief Executive Officer, Sanofi Pasteur. "Our commitment to remaining at the forefront of advancing the prevention of meningococcal disease, worldwide, continues today."

Menomune - A/C/Y/W-135 vaccine was first licensed by the U.S. FDA in 1981. It is now licensed in 17 countries with more than 22 million doses shipped worldwide since it first became available.

"The value of a quadrivalent meningococcal vaccine is becoming more and more realized as evidenced by the circulation of the W-135 strain in the western part of the African meningitis belt this past year," explained Luc Kuykens, M.D., M.P.H., Sanofi Pasteur's Chief Medical Officer. "Menomune is a proven vaccine with a 32-year track record of providing broad protection against this serious disease, so we try to keep a stockpile of the vaccine in case of any outbreaks."

About Meningococcal Disease

Although rare, meningococcal disease can cause meningitis (swelling of the brain or spinal cord) or meningococcemia (blood infection). The disease can be spread through common everyday activities, such as sharing eating utensils and drinking glasses, living in close quarters or attending crowded events. Meningococcal disease can be hard to recognize, especially in its early stages, because symptoms are similar to those of more common viral illnesses. Unlike more common illnesses, the disease can progress quickly and may cause death or disability in just a single day. 美白霜哪裡買|韓國美白霜推薦

About Menomune Vaccine

WHO資格預審程序接受Menomu氨基酸潔顏霜|氨基酸潔顏霜哪裡買ne被聯合國各機構采購。聯合國兒童基金會供應司(UNICEF supply division)已被通知Menomune已通過WHO的驗收。

關鍵詞:賽諾菲,腦膜炎疫苗,Menomune,WHO資格預審
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