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首页> 外文会议>European Congress of Pharmacology >'Regulatory dilemma' of ongoing safety review of drug Gilenya? (fingolimod)-expierence from Medicines and Medical Devices Agency of Serbia-ALIMS
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'Regulatory dilemma' of ongoing safety review of drug Gilenya? (fingolimod)-expierence from Medicines and Medical Devices Agency of Serbia-ALIMS

机译：正在进行的持续安全审查的“监管困境”吉列纳亚州的安全审查？ （Fingolimod） - 来自塞尔维亚 - Alims的药物和医疗器械机构的经验

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Fingolimod (rINN, trade name Gilenya,Novartis) is an immunomodulating drug, approved for treatingmultiple sclerosis. It has reduced the rate of relapses in relapsing-remitting multiple sclerosis by over half, buthas serious adverse effects.Developmental toxicity, including teratogenicity and embryolethality has been reported in rats andrabbits following oral administration of fingolimod during organogenesis.In rats, the most frequently reported fetal visceral malformations were persistent truncus arteriosus andventricular septal defect.Fingolimod affects the receptor (sphingosine 1-phosphate) which is involved in vascular formationduring embryogenesis.During pregnancy and lactation, per oral applied. fingolimod in rats influenced reduction of pupsurvival and a neurobehavioral in the offspring. The effects of fingolimod during labor and delivery has beenunknown.Although, as the risk of bradycardia after the first dose of Gilenya? was known when it was authorised,EMA issued MAA for this bio-drug, on 17/03/2011.According to EU legislation, it is: " prescription only drug" (Rp).But on 20/01/2012 EMA CHMP has begun a review of the benefits and risks of medicine Gilenya?.related to development of the Multiple Sclerosis /MS/. This follows concerns over the effects of the medicine onthe heart after the first dose. The EMA issued on Febraury 29th, 2012, the document titled"Conditions or restrictions with regard to the safe and effective use of the medicinal product /Gylenia/to be implemented by the member states"After reviewing all available non-clinical and clinical data , it was concluded that in Serbia it could beissued only inside the stacionary health institution ("SZR").
机译：Fingolimod（Rinn，商品名Gilenya，Novartis）是一种免疫调节药物，批准用于治疗药物。它降低了重复延迟多发性硬化的复发率超过一半，但严重的不良反应。在组织组织期间口服佛罗里钒术后，在大鼠Andrabbits中据报道，包括致畸性和胚胎性，包括致畸性和胚胎性。大鼠，最常报告的大鼠胎儿内脏畸形是持续的truncus arteriosus andventriculary隔膜缺陷.Fingolimod影响血管形成胚胎发生的受体（鞘氨醇1-磷酸）。每个口服施用妊娠和哺乳期。在大鼠中的佛罗里钒影响了后代的幼苗病毒和神经兽性。劳动和交付期间北美莫德的影响已经存在。虽然，作为吉列纳的第一剂后的Bradycardia的风险？众所周知，当它被授权时，EMA为此生物毒品发布了Maa，于17/03 / 2011年发布了这项生物药物。根据欧盟立法，它是：“只处方药”（RP）。但是在20/01/2012 EMA CHMP的情况下开始审查医学吉伦亚的益处和风险？。与多发性硬化症/ MS / MS / MS /的发展。这涉及在第一剂量后药物对心脏的影响。在审查所有可用的非临床和临床数据后，在2012年2月29日，2012年2月29日发出的文件，标题为“关于安全有效使用药物产品/亚朗尼亚/迄今为止实施的药品/寄币/纳米/待实施”。得出的结论是，在塞尔维亚，它只会陷入稳健的卫生机构（“SZR”）。

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