PARSIPPANY, N.J.--(

新泽西州帕西帕尼--(

BUSINESS WIRE

商业热线

)--Zoetis Inc. today announced that it has updated the U.S. label for Librela

)--Zoetis Inc.今天宣布，它已经更新了Librela的美国标签

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(bedinvetmab injection), following its submission of a supplement to the U.S. Food and Drug Administration (FDA). This supplement includes updated labeling based on post-approval experience with Librela in the U.S. since the product launched over a year ago. The company remains confident in the safety and effectiveness of Librela and plans to implement the updated label immediately in its ongoing commitment to supporting veterinarians and pet owners in the use of Librela.

（bedinvetmab注射液），在向美国食品和药物管理局（FDA）提交补充剂后。本增补包括根据Librela自一年多前推出以来在美国获得批准后的经验更新的标签。该公司仍然对Librela的安全性和有效性充满信心，并计划立即实施更新的标签，以支持兽医和宠物主人使用Librela。

The revised label can be found by .

修改后的标签可以通过找到。

clicking here

点击这里

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Librela, a once-monthly injectable monoclonal antibody for the control of pain associated with osteoarthritis (OA) in dogs, was approved for use by the FDA in May 2023 and launched in the U.S. in October 2023. It has been used to treat more than one million dogs in the U.S.

Librela是一种每月一次的可注射单克隆抗体，用于控制与狗骨关节炎（OA）相关的疼痛，于2023年5月被FDA批准使用，并于2023年10月在美国推出。它已被用于治疗美国100多万只狗。

Zoetis has been engaged with the FDA to review post-launch, real-world drug experience data reported to the agency and collected through Zoetis’ pharmacovigilance monitoring of its products’ safety and efficacy. Label updates in the pharmaceutical space are not uncommon, particularly in the first few years after a launch in response to real-world experience data..

Zoetis一直与FDA合作，审查发布后向FDA报告的真实世界药物经验数据，并通过Zoetis对其产品安全性和有效性的药物警戒监测收集这些数据。制药领域的标签更新并不罕见，特别是在根据实际经验数据推出后的头几年。。

Since its launch in Europe four years ago, Librela has improved the lives of millions of dogs suffering from OA pain. With nearly 25 million doses

自四年前在欧洲推出以来，Librela已经改善了数百万患有OA疼痛的狗的生活。近2500万剂

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distributed globally, no individual adverse event sign has been reported at a rate higher than rare, as defined by the European Medicines Agency (EMA) – representing less than 10 occurrences per 10,000 treated animals (where one dose equals one treated animal)

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Pets are at the center of everything we do at Zoetis, and we are constantly working to support veterinarians and pet parents in ensuring they have the resources to make informed decisions for the animals in their care,” said Dr. Richard Goldstein, DVM, DACVIM, DECVIM-CA, Global Chief Medical Officer and Head of Medical Affairs for Zoetis.

宠物是我们在Zoetis所做的一切的中心，我们一直在努力支持兽医和宠物父母，确保他们有资源为他们照顾的动物做出明智的决定，”Richard Goldstein博士说，DVM，DACVIM，DECVIM-CA，Zoetis全球首席医疗官和医疗事务负责人。

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Every medicine has potential benefits and risks, and it’s important for pet owners to work closely with their veterinarians to weigh those appropriately and maintain an open dialogue about their pets’ experiences. With nearly 25 million doses distributed globally, we stand firmly behind Librela, and the positive impact it is having on dogs that suffer from osteoarthritis pain.”.

每种药物都有潜在的益处和风险，宠物主人与兽医密切合作，适当权衡这些药物，并就宠物的经历保持公开对话，这一点很重要。在全球分布近2500万剂的情况下，我们坚定地支持Librela，以及它对患有骨关节炎疼痛的狗产生的积极影响。”。

Providing Resources for Veterinarians & Pet Owners

Beginning immediately, Zoetis will make the updated U.S. Librela label and associated Client Information Sheet available on its website and share them directly with veterinarians. The updated label and Client Information Sheet will be included in future distributions of Librela.

Zoetis将立即在其网站上发布最新的美国Librela标签和相关客户信息表，并直接与兽医分享。更新后的标签和客户信息表将包含在Librela的未来发行版中。

On an ongoing basis, Zoetis provides veterinarians with many resources, including data, research and access to leading experts in the field of osteoarthritis. In the past year, Zoetis has hosted more than 1,000 medical education webinars for veterinarians to support their knowledge and understanding of how to use its products as well as held frequent Librela “office hours” with its Chief Medical Officer Dr.

Zoetis一直为兽医提供许多资源，包括数据、研究和接触骨关节炎领域的顶尖专家。在过去的一年中，Zoetis为兽医举办了1000多场医学教育网络研讨会，以支持他们对如何使用其产品的知识和理解，并与首席医疗官Dr。

Goldstein to address any questions from veterinarians. At the local level, Zoetis assigns field veterinarians to regions in the markets in which it operates to provide ongoing support..

戈尔茨坦将回答兽医的任何问题。在地方一级，Zoetis将现场兽医分配到其运营市场的地区，以提供持续的支持。。

For more information about Librela, visit the Librela website

有关Librela的更多信息，请访问Librela网站

here

在这里

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About Librela

关于Librela

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(bedinvetmab injection)

（bedinvetmab注射液）

Librela is a monoclonal antibody therapy administered in the clinic that targets Nerve Growth Factor (NGF) to control canine OA pain. Librela is similar in many ways to naturally produced antibodies and is metabolized and eliminated via normal protein degradation pathways with minimal involvement of the liver or kidneys.

Librela是临床上使用的一种单克隆抗体疗法，其靶向神经生长因子（NGF）以控制犬OA疼痛。Librela在许多方面与天然产生的抗体相似，并通过正常的蛋白质降解途径代谢和消除，对肝脏或肾脏的影响最小。

Librela also has been approved for use in Europe, Canada, Brazil, Australia, New Zealand, Japan and other markets across South America and Asia. To learn more, please visit .

Librela还被批准在欧洲、加拿大、巴西、澳大利亚、新西兰、日本和南美和亚洲的其他市场使用。要了解更多信息，请访问。

https://www.zoetisus.com/products/dogs/librela-a-new-era-in-treatment

https://www.zoetisus.com/products/dogs/librela-a-new-era-in-treatment

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About Zoetis

关于Zoetis

As the world’s leading animal health company, Zoetis is driven by a singular purpose: to nurture our world and humankind by advancing care for animals. After innovating ways to predict, prevent, detect, and treat animal illness for more than 70 years, Zoetis continues to stand by those raising and caring for animals worldwide – from veterinarians and pet owners to livestock producers.

作为世界领先的动物保健公司，Zoetis有一个独特的目标：通过促进对动物的护理来培育我们的世界和人类。在70多年来不断创新预测、预防、检测和治疗动物疾病的方法之后，Zoetis继续支持世界各地饲养和照顾动物的人，从兽医、宠物主人到牲畜生产者。

The company’s leading portfolio and pipeline of medicines, vaccines, diagnostics and technologies make a difference in over 100 countries. A Fortune 500 company, Zoetis generated revenue of $8.5 billion in 2023 with approximately 14,100 employees. For more information, visit .

该公司领先的药物、疫苗、诊断和技术组合和管道在100多个国家产生了影响。作为财富500强企业，Zoetis在2023年创造了85亿美元的收入，拥有约14100名员工。有关更多信息，请访问。

www.zoetis.com

www.zoetis.com

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IMPORTANT SAFETY INFORMATION: See full Prescribing Information. For use in dogs only. Women who are pregnant, trying to conceive or breastfeeding should take extreme care to avoid self-injection. Hypersensitivity reactions, including anaphylaxis, could potentially occur with self-injection. Librela should not be used in breeding, pregnant or lactating dogs.

重要安全信息：请参阅完整的处方信息。仅供狗使用。怀孕、试图怀孕或哺乳的女性应格外小心，避免自我注射。自我注射可能会发生超敏反应，包括过敏反应。Librela不应用于繁殖，怀孕或哺乳期的狗。

Librela should not be administered to dogs with known hypersensitivity to bedinvetmab. The most common adverse events reported in a clinical study were urinary tract infections, bacterial skin infections and dermatitis..

Librela不应用于已知对bedinvetmab过敏的狗。临床研究中报告的最常见不良事件是尿路感染，细菌性皮肤感染和皮炎。。

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As of December 2024

截至2024年12月

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EMA Veterinary product information (QRD) templates – Annex I Summary of Product Characteristics.

EMA兽医产品信息（QRD）模板–附录I产品特性总结。

https://www.ema.europa.eu/en/documents/template-form/qrd-veterinary-product-information-annotated-template-english-version-91_en.pdf

https://www.ema.europa.eu/en/documents/template-form/qrd-veterinary-product-information-annotated-template-english-version-91_en.pdf

. Accessed 3 February 2025

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