Novelia®, published on CDE (Center for Drug Evaluation) platform in China!

12/10/2022

Novelia - blue tip to better aim the eye

The Center for Drug Evaluation (CDE) performs regulatory evaluation of new drugs and medical devices to assess if these can be brought to the market in China.  Our multi-dose eye dropper, Novelia®’s publication on  CDE platform means that our delivery system can be referenced through its packaging system DMF number in Drug Product Application in China. With this first milestone achieved, our dossier is now available through a letter of authorization. The pharmaceutical companies can now submit their documentation for the evaluation of their drug products with Novelia® through a letter of authorization.

China, a land of opportunities for ophthalmics.

Ophthalmic pathologies such as myopia, cataract and glaucoma are on the increase around the country (source). It is hence critical to offer treatment solutions to people suffering from these pathologies.
Novelia® is a multi-dose eye dropper system which avoids the need for preservatives in the drug. It prevents bacterial contamination over the duration of treatment through its patented PureFlow® Technology.
0% preservatives, 100% eye protection. It is already available in Europe, Latin America, North America, Oceania, Middle East and Asia Pacific with more than 240 references in OTC and Rx.

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Novelia®,已获得中国药品审评中心(CDE)药包材登记号!

中国药品审评中心(CDE)负责新药和医疗器械上市许可申请的受理和技术审评。我们的多剂量眼用阻菌给药系统Novelia®在CDE完成登记备案意味着制药企业在中国市场可以通过授权书引用其登记号进行制剂产品的关联申报。

中国的眼科市场充满机遇。

在中国,近视、白内障和青光眼等眼科疾病发病率呈上升趋势(资料来源)。因此,针对这些疾病的治疗方案至关重要。

Novelia®是一种多剂量眼用阻菌给药系统,其PureFlow®专利技术可防止使用过程中的细菌污染,避免在药品中添加防腐剂。

0添加防腐剂,100%护眼。Novelia®在欧洲、拉丁美洲、美洲、大洋洲、中东及亚太地区均有销售,涉及240多个已上市的非处方类和处方类滴眼制剂产品。

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