The marketing authorisation (MA) for Elucirem™ (Gadopiclenol) was granted to Guerbet by the European Commission based on the positive opinion of the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) dated 12 October 2023.

Elucirem的上市许可（MA）™根据欧洲药品管理局人类使用药品委员会（CHMP）2023年10月12日的积极意见，欧盟委员会将（Gadopiclenol）授予了Guerbet。

For the indications approved in the context of this MA, a MRI examination with Elucirem™ requires half the dose of gadolinium compared to that required with existing nonspecific contrast agents, thus answering a major concern of practitioners about gadolinium exposure.[1],[2],[3]

对于本MA中批准的适应症，使用Elucirem进行MRI检查™与现有的非特异性造影剂相比，需要一半剂量的钆，因此回答了从业者对钆暴露的主要担忧。[1] ，[2]，[3]

Invented, designed and manufactured by Guerbet, Elucirem™ was approved by the FDA in September 2022. It is produced in France and in the USA. It will be marketed by Guerbet in the European Union in the following forms: vials and prefilled syringes.

由Elucirem Guerbet发明、设计和制造™于2022年9月获得FDA批准。它在法国和美国生产。Guerbet将以以下形式在欧盟销售：小瓶和预填充注射器。

VILLEPINTE, France, Dec. 11, 2023 /PRNewswire/ -- Guerbet, global leader in contrast products for medical imaging, announced today that the European Commission has approved the marketing in the European Union (EU) of Elucirem™ (Gadopiclenol), a macrocyclic gadolinium-based contrast agent (GBCA), for use in contrast-enhanced magnetic resonance imaging (MRI)..

2023年12月11日，法国维勒平特（VILLEPINTE），医学影像对比产品的全球领导者格尔贝特（Guerbet）今天宣布，欧盟委员会已批准在欧盟（EU）销售Elucirem™（Gadopiclenol），一种基于大环钆的造影剂（GBCA），用于对比增强磁共振成像（MRI）。。

Born of Guerbet innovation, Elucirem™ (Gadopiclenol) is the gadolinium-based contrast agent with the highest relaxivity, in comparison to other available gadolinium-based contrast agents (GBCA). In the European Union, Elucirem is indicated in adults and children aged 2 years and older for contrast-enhanced magnetic resonance imaging (MRI) to improve detection and visualization of pathologies with disruption of the blood-brain-barrier (BBB) and/or abnormal vascularity of:.

出生于Guerbet innovation，Elucirem™与其他可用的钆基造影剂（GBCA）相比，钆基造影剂具有最高的弛豫率。在欧盟，Elucirem适用于2岁及以上的成年人和儿童进行对比增强磁共振成像（MRI），以改善血脑屏障（BBB）破坏和/或异常血管分布的病理检测和可视化：。

the brain, spine, and associated tissues of the central nervous system (CNS);

中枢神经系统（CNS）的大脑，脊柱和相关组织；

the liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system.

肝脏、肾脏、胰腺、乳腺、肺、前列腺和肌肉骨骼系统。

'Elucirem™ is the first half-dose nonspecific gadolinium-based contrast agent. European radiologists will be able to perform MR examinations with half the conventional dose and thus reduce exposure to gadolinium, particularly in persons requiring repeated examinations,' explains Philippe Bourrinet, Vice-President Development, Medical & Regulatory Affairs and Guerbet Group Responsible Pharmacist..

'艾露西勒姆™是前半剂量非特异性钆基造影剂。欧洲放射科医生将能够以常规剂量的一半进行MR检查，从而减少对钆的暴露，特别是在需要反复检查的人群中，”发展、医疗和监管事务副总裁兼盖尔贝特集团负责药剂师菲利普·博里内特解释道。。

The efficacy and safety of Gadopiclenol were evaluated in the context of Guerbet's clinical development plan designed to obtain marketing authorisations worldwide. To date, the European Commission is the second authority to approve Elucirem™, and evaluation of the dossier is on-going in other countries..

在Guerbet旨在获得全球上市许可的临床开发计划的背景下，评估了Gadopiclenol的有效性和安全性。迄今为止，欧盟委员会是第二个批准Elucirem的机构™,其他国家正在对档案进行评估。。

Elucirem™ is produced in France and in the USA. The industrial investment amounts to 22.5 million euros over the past five years. Gadopiclenol active pharmaceutical ingredient and its starting material are manufactured for the USA and Europe on the French sites of Marans (Charente-Maritime) and Lanester (Morbihan).

埃卢西雷姆™在法国和美国生产。在过去五年中，工业投资达到2250万欧元。Gadopiclenol活性药物成分及其原料在法国的马兰（Charente Maritime）和兰斯特（Morbihan）为美国和欧洲制造。

Elucirem™ finished product is then filled in vials at the Aulnay-sous-Bois site (Seine-Saint-Denis, France) for all European countries. Vials for the USA and prefilled syringes for the American and European markets are filled on the Raleigh (USA) site..

埃卢西雷姆™然后在Aulnay sous Bois工厂（法国塞纳圣丹尼斯）为所有欧洲国家将成品装入小瓶中。美国的小瓶和美国和欧洲市场的预填充注射器在罗利（美国）的网站上填充。。

'After its approval by the FDA for the American market, the European marketing authorisation for Elucirem™ reinforces our strategic perspective: combining medical innovation and environmental commitment. This authorisation is ground-breaking for Medical Imaging in Europe,' concludes David Hale, Guerbet CEO..

“在美国市场获得FDA批准后，Elucirem的欧洲上市许可™强化了我们的战略观点：将医疗创新与环境承诺相结合。Guerbet首席执行官大卫·海尔（DavidHale）总结道，这项授权在欧洲医学成像领域具有开创性意义。。

About Gadopiclenol

关于Gadopiclenol

Gadopiclenol, initially invented by Guerbet, with subsequent contribution of Bracco IP, is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity. The efficacy and safety of Gadopiclenol have been evaluated in MRI of the central nervous system, head and neck, thorax, abdomen, pelvis, and musculoskeletal system (The Summary of Product Characteristics (SmPC) will shortly be available on the EMA website).

Gadopiclenol最初由Guerbet发明，随后由Bracco IP贡献，是一种具有高弛豫率的新型大环钆基造影剂（GBCA）。Gadopiclenol的疗效和安全性已在中枢神经系统，头颈部，胸部，腹部，骨盆和肌肉骨骼系统的MRI中进行了评估（产品特征总结（SmPC）不久将在EMA网站上提供）。

Details of phase III clinical trials are available in the database www.ClinicalTrials.gov: .

有关III期临床试验的详细信息，请访问数据库www.ClinicalTrials.gov：。

Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) Full Text View - ClinicalTrials.gov

Gadopiclenol对中枢神经系统（CNS）磁共振成像（MRI）全文视图的有效性和安全性-ClinicalTrials.gov

Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI) Full Text View -gov

Gadopiclenol在体磁共振成像（MRI）全文视图中的有效性和安全性

About Guerbet

关于Guerbet

At Guerbet, we build lasting relationships to enable people to live better lives. This is our Company Purpose (or Raison d'Être in French). We are a global leader in medical imaging, proposing a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging.

在Guerbet，我们建立持久的关系，使人们生活得更好。这是我们公司的宗旨（法语中的“理由”）。我们是医学成像领域的全球领导者，为诊断和介入成像提供了广泛的医药产品、医疗设备、数字和人工智能解决方案。

A pioneer for 95 years in the field of contrast products, with more than 2,600 employees worldwide, we continuously provide innovative solutions and devote 10% of our sales to Research & Development in four centres in France, Israel and the USA. Guerbet (GBT) is listed in compartment B of Euronext Paris and our turnover was 753 million euros in 2022.

作为对比产品领域95年的先驱，我们在全球拥有2600多名员工，我们不断提供创新解决方案，并将10%的销售额用于法国、以色列和美国四个中心的研发。Guerbet（GBT）被列入巴黎泛欧交易所B区，2022年我们的营业额为7.53亿欧元。

For more information, please visit www.guerbet.com..

欲了解更多信息，请访问www.guerbet.com。。

About the Guerbet / Bracco Imaging Collaboration

关于Guerbet/Bracco成像合作

Bracco Imaging and Guerbet in December 2021 entered a worldwide collaboration on Gadopiclenol manufacturing and research and development activities. Gadopiclenol will be commercialized independently under separate brands. Both Guerbet and Bracco Imaging each own valuable intellectual property on Gadopiclenol.

Bracco Imaging和Guerbet于2021年12月就Gadopiclenol制造和研发活动开展了全球合作。Gadopiclenol将在不同品牌下独立商业化。Guerbet和Bracco Imaging都拥有Gadopiclenol的宝贵知识产权。

Furthermore, after an agreed transition period when Guerbet manufactures Gadopiclenol for both Guerbet and Bracco, both companies will manufacture the Gadopiclenol active ingredient and finished product..

此外，在Guerbet为Guerbet和Bracco生产Gadopiclenol的商定过渡期后，两家公司将生产Gadopiclenol活性成分和成品。。

The strategic collaboration is expected to accelerate access to Gadopiclenol and deliver innovation, as well as better care to patients and caregivers alike.

预计这项战略合作将加速获得Gadopiclenol，实现创新，并为患者和护理人员提供更好的护理。

Forward-looking disclaimer

前瞻性免责声明

This press release may contain forward-looking statements based on the assumptions and forecasts of Guerbet Group Management. They involve known and unknown risks, uncertainties and other factors, which may result in a material difference between the results, financial situation, outcome and future performance of the Group and those presented in these forward-looking statements.

本新闻稿可能包含基于Guerbet集团管理层假设和预测的前瞻性声明。它们涉及已知和未知的风险、不确定性和其他因素，可能导致集团的结果、财务状况、结果和未来业绩与这些前瞻性报表中所列的结果、财务状况、结果和未来业绩之间存在重大差异。

These factors include those mentioned in Guerbet's public documents and available on its website www.guerbet.com. The Group expressly refutes any obligation to publish an update or revise any forward-looking statements contained in this press release in the light of new events or developments..

这些因素包括Guerbet公共文件中提到的因素，并可在其网站www.Guerbet.com上找到。集团明确否认有义务根据新事件或事态发展发布更新或修订本新闻稿中包含的任何前瞻性声明。。

1. PRAC, European Medicines Agency, 20172. FDA Drug Safety Communication, 20173. Brunjes et al. Water Research, 2020

1.PRAC，欧洲药品管理局，20172。FDA药物安全通讯，20173。Brunjes等人，水研究，2020

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Media contact: Claire Lauvernier Directrice de la Communication, Guerbetclaire.lauvernier@guerbet.com

媒体联系人：Claire Lauvernier通信总监，guerbetclaire.lauvernier@guerbet.com