欧洲药品局emea已经限制西妥昔单抗和帕尼单抗在这些患者使用。
EMEA, the European Medicines Agency, has already restricted use of cetuximab and panitumumab to such patients.
葛兰素公司同时也在等待欧洲药品局的决定,他们于2006年也递交了申请。
Glaxo is also awaiting a decision from the European Medicines Agency on the application it filed for Cervarix in Europe in March 2006.
欧洲药品局(emea)建议:三期临床试验治疗癫痫症的发起者应当包含足够数量的老年患者。
The European Medicines Agency (EMEA) advises sponsors of epileptic disorder treatments in Phase III trials to use certain primary endpoints and include an adequate number of geriatric patients.
位于伦敦的欧洲药品局称,药品包装袋上的说明里应提醒使用者,服用“达菲”的病人可能会发生痉挛,产生幻想,或者导致精神错乱。
The European Medicines Agency in London said that the information lifted in the packets should warn that convulsions, hallucinations and delirium have all been reported among patients taking Tamiflu.
但是考虑到病人需要一些时间和他们的医生讨论其他的疗法,欧洲药品管理局将允许它继续在市场上留存数月。
But the European Medicines Agency will allow the diabetes drug on the market for a few months, considering patients need some time to discuss with their doctors about other therapies.
免疫接种还得依靠估计在九月底或十月初获得欧洲药品管理局的许可。
The immunisations are dependent on licenses being granted by the European Medicines Agency (EMA), which is expected in late September or early October.
欧洲医药局,类似于美国的食品药品管理局,它具有保证所有新开发的疫苗安全且有效的职能。
The European Medicines Agency, like its U.S. counterpart the Food and Drug Administration, has the task of ensuring any new vaccines are both safe and effective.
欧洲药品管理局(emea)最近完成了有关非类固醇抗炎药(NSAID)吡罗昔康的安全性评价。
The European Medicines Agency (EMEA) has recently completed a review of the safety of the non-steroidal anti-inflammatory drug (NSAID) piroxicam.
今年下半年美国食品药品管理局(FDA)将颁发许可证,欧洲许可证(欧盟)也将很快颁发。
FDA approval of the new device is expected later this year, with European approval (ce) shortly to follow.
这些结果出现在美国食品与药品管理局听证会讨论是否进一步措施抵制该药的两周前,该药已经在欧洲市场上退出。
The findings come two weeks ahead of a U. S. Food and drug Administration public hearing to discuss whether to take further action against the drug, which is already withdrawn in Europe.
欧洲药品管理局公布了其计划给予公众获取信息的数据库的潜在副作用的人力和兽医药品。
The European Medicines Agency has published its plans for granting public access to the information held in its databases of the potential side effects of human and veterinary medicines.
欧洲药品管理局发布了首个针对临床生物标志物资格意见,向公众征求意见。
The European Medicines Agency has released the first qualification opinion for a clinical biomarker for public consultation.
赛诺菲在欧洲的药品食品监督管理局宣布Acomplia的神经副作用超过其有效作用后,于上个月暂停其销售。
Sanofi suspended sales of Acomplia last month, after the European version of the FDA said the drug's psychiatric side effects outweighed its benefits.
欧洲药品管理局(EMA)是欧洲的一个相当于美国食品药物管理局(FDA)的机构。
The European Medicines Agency (EMA), the European equivalent of the US Food and Drug Administration (FDA).
它是中国唯一一家临床前CRO实验室,其研究数据被美国食品药物管理局(FDA)和欧洲药品管理局(emea)接受为重要规章备案文件的一部分。
It is the only preclinical CRO laboratory in China whose data have been accepted by both the FDA and EMEA as part of successful regulatory filings.
它是中国唯一一家临床前CRO实验室,其研究数据被美国食品药物管理局(FDA)和欧洲药品管理局(emea)接受为重要规章备案文件的一部分。
It is the only preclinical CRO laboratory in China whose data have been accepted by both the FDA and EMEA as part of successful regulatory filings.
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