oetal viability or on fertility in rodents and were not teratogenic in two species. No adverse effects on behaviour, reproduction or development of offspring were reported. The highest dasabuvir dose tested produced exposures equal to 33 to 48-fold (rat) or 12-fold (rabbit) the exposures in humans at the maximum recommended clinical dose.
Dasabuvir was the predominant component observed in the milk of lactating rats, without effect on nursing pups. Elimination half-life in rat milk was slightly shorter than in plasma, AUC was about 2 fold of that in plasma. Since dasabuvir is a BCRP substrate, distribution to the milk may change if this transporter is inhibited or induced by co-administration of other medicinal products. Dasabuvir-derived material was minimally transferred through the placenta in pregnant rats.
6. Pharmaceutical particulars
6.1 List of excipients
Tablet core
Microcrystalline cellulose (E460(i))
Lactose monohydrate
Copovidone
Croscarmellose sodium
Colloidal anhydrous silica (E551)
Magnesium stearate (E470b)
Film-coating
Polyvinyl alcohol (E1203)
Titanium dioxide (E171)
Polyethylene glycol 3350
Talc (E553b)
Iron oxide yellow (E172)
Iron oxide red (E172)
Iron oxide black (E172)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 years
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
Exviera film-coated tablets are supplied in PVC/PE/PCTFE aluminium foil blister packs.
56 tablets (multipack carton containing 4 inner cartons of 14 tablets each).
6.6 Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorisation holder
AbbVie Ltd
Maidenhead
SL6 4XE
United Kingdom
8. Marketing authorisation number(s)
EU/1/14/983/001
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 15 January 2015
10. Date of revision of the text
01/2015
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
http://www.medicines.org.uk/emc/medicine/29785
包装规格：可快速供应：在线联系：2363244352
Exviera（dasabuvir）：56粒x250mg
Viekirax(ombitasvir/paritaprevir/ritonavir)：12,5mg/75mg/50mg*56粒/盒
欧盟批准AbbVie的VIEKIRAX®+EXVIERA®慢性丙肝药物
- 在第三阶段的临床试验中，VIEKIRAX + EXVIERA治愈95-100％基因型1慢性丙型肝炎患者，而小于2％患者经历病毒学失败。
- 耐受性显示超过98％的患者完成了治疗全过程。
- 所有口服，无干扰素方案还获准用于HCV / HIV-1合并感染，患者阿片类药物替代治疗和经历了肝移植手术患者。
- VIEKIRAX+EXVIERA是三个针对病毒不同阶段，机制不同的抗病毒药物联用的首个被批准药品。
2015年1月16日 AbbVie（NYSE：ABBV）宣布，欧盟委员会已批准上市许可的全口服，短程，无干扰素治疗丙肝药物，VIEKIRAX®（ombitasvir/ paritaprevir/利托那韦片剂）+EXVIERA®（dasabuvir片剂）。治疗被批准（有或无利巴韦林RBV）用于患者基因型1（GT1）慢性丙型肝炎病毒（HCV）感染，其中包括那些与代偿性肝硬化，艾滋-1合并感染，阿片类药物替代治疗和肝脏移植患者. 此外，VIEKIRAX含利巴韦林RBV已被批准用于基因型4（GT4）慢性丙型肝炎患者。
“继最近在美国和加拿大的批准，AbbVie的丙型肝炎治疗在欧盟的批准，为整个欧洲的丙肝患者提供新的和有效的治疗”AbbVie首席执行该说 “我们致力于与当地政府和医疗保健系统的合作，以支持患者能够获得VIEKIRAX+ EXVIERA。”
因其为重要的公共健康利益的新药，审批遵循欧洲药品管理局的加速审查。在欧洲大约900万的人感染慢性丙型肝炎，丙肝是肝癌和肝移植的主要原因。在欧洲基因1型患者是最普遍的,占到60%以上，而1B型占到47％。基因型4，最常见于中东，撒哈拉以南非洲和埃及，也正在成为一些欧洲国家，包括意大利，法国，希腊和西班牙蔓延。AbbVie治疗方案被批准在欧盟所有28个成员国的使用，以及在美国，加拿大，瑞士，冰岛，列支敦士登和挪威。
“丙型肝炎是一种复杂的疾病，具有多 |
