The European Medicines Agency said Nov. 19 that it had adopted a positive opinion on extensions of indications for clopidogrel to include the prevention of atherothrombotic and thromboembolic events, including stroke, in people with atrial fibrillation.

Clopidogrel – marketed in the European Union under the names Plavix, Clopidogrel Winthrop, and Iscover – was first granted E.U. marketing authorization in 1998, and is now authorized in member states for the prevention of atherothrombotic events in people with recent myocardial infarction or ischemic stroke, or who have peripheral arterial disease or acute coronary syndrome.

The new indication for clopidogrel covers adult patients with atrial fibrillation who have at least one risk factor for vascular events and who cannot take vitamin K antagonist therapy.

Also on Nov. 19, the agency said that it had adopted a guideline on biosimilar medicines that would pave the way for the authorization of generic versions of the costly human monoclonal antibody–based medications that are increasingly used in cancer and autoimmune diseases.

The guideline, which has yet to be published on the EMA’s Web site and may not be for weeks, “lays down the nonclinical and clinical requirements for monoclonal antibody–containing medicines claiming to be similar to another one already marketed,” the agency said in a statement. The guideline will be open to public consultation for 5 months.

The agency further said that it had adopted a positive opinion on a new mock-up influenza vaccine, Pumarix, from GlaxoSmithKline. The inactivated H5N1 strain that was used in the mock-up, an adjuvanted vaccine, would be replaced with a circulating pandemic strain in the event of a declared influenza pandemic.

The agency adopted a positive opinion on a generic version of Combivir. The generic drug Lamivudine/Zidovudine Teva is indicated for antiretroviral combination therapy in people who are infected with HIV.

Finally, on Nov. 19 the agency said that it had launched a new investigation, brought to it by French health officials, into pediatric suppository preparations containing terpenic derivatives, including camphor, cineole, pine oil, eucalyptus, turpentine, and wild thyme. The preparations, which are used to treat bronchial disorders or congestion, have been reported in association with an increased risk of neurological disorders, including convulsions, in children younger than age 3 years.

And the EMA announced, following up earlier investigations, that it had confirmed prior recommendations for restrictions on medicines containing modafinil that would limit them to the treatment of confirmed narcolepsy. The EMA also finalized a previous recommendation to ban opioid formulations using polymethacrylate-triethylcitrate controlled-release systems, citing their potential for dangerous interaction with alcohol, and reconfirmed an earlier finding that fragments from porcine circovirus discovered in March 2010 in batches of Rotarix, a live attenuated vaccine, did not pose a risk to human health.

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11月19日，欧洲药品管理局(EMA)称其对氯吡格雷的新增适应证持肯定意见，同意该药用于预防动脉粥样硬化血栓形成性和血栓栓塞性事件(包括卒中)的发生，适用对象为具有至少一个血管事件危险因素及不适合接受维生素K拮抗剂治疗的房颤成人患者。

EMA还称已采纳一项生物相似药指南。该指南规定了针对含单克隆抗体的仿制药物的非临床和临床要求，将于近期在其官网发布并进行为期5个月的公众意见征询。

另外，EMA还对葛兰素史克公司生产的新型模拟流感疫苗Pumarix持肯定意见，建议授予该新药上市许可。EMA对梯瓦公司生产的双汰芝(Combivir)仿制药梯瓦拉米夫定/齐多夫定(Lamivudine/Zidovudine Teva)亦持肯定意见，推荐该仿制药用于HIV感染者的抗逆转录病毒联合治疗。

EMA称其已对含萜烯衍生物(包括樟脑、桉叶油素、松油、桉树、松脂、野生百里香)的儿科栓剂展开新调查，因有报道指出，这些制剂在3岁以下儿童中用于治疗支气管疾病或口咽充血时可增加神经系统障碍(包括惊厥)发生的风险。

EMA在对含莫达非尼药物进行再次审查后维持其最初意见，即建议限制这些药物用于治疗发作性睡病。另外，EMA在对控释型阿片类药物进行再次审查后亦最终维持其先前提出的暂停使用这些药物的建议，因为这些药物可能与酒精发生危险的相互作用。EMA再次证实，2010年3月在多个批次减毒活疫苗Rotarix中发现的猪圆环病毒片段不会对人体健康产生危险。

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