A new market reference added to Safe’n’Sound®, our passive safety device platform

NEMERA NEWS

A new market reference added to Safe’n’Sound®, our passive safety device platform

hulio 1

Safe’n’Sound® is on the market in Europe with a newly registered injectable medication.
The commercial launch of HULIO™ (Adalimumab Biosimilar) was initiated in selected European markets on October 19,2018.
Hulio, developed by developed by Fujifilm Kyowa Kirin Biologics Co., Ltd. and marketed in the European Union by Mylan N.V. is approved as a biosimilar for the same indications as the reference product, Humira.

This formulation received market authorizations with Terumo proprietary PLAJEX™ pre-filled syringe, in combination with Nemera 1ml Safe’n’Sound add-on safety device.

http://newsroom.mylan.com/2018-10-19-Mylan-Launches-Hulio-TM-Biosimilar-Adalimumab-in-Markets-Across-Europe
https://www.terumo-europe.com/en-emea/news/terumo-announces-european-launch-of-biosimilar-using-terumo%E2%80%99s-plajex%E2%84%A2-pre-fillable-syringes

PARENTERAL SafenSoundR platform range

In the parenteral industry, needlestick injuries are a global concern, all the more with the growing trend of self-administration. According to World Health Organization, over 3 million exposures to blood occur every year, resulting in health, psychological and cost issues.

To ensure adherence and user well-being, Nemera has developed Safe’n’Sound®, a fully passive safety device for prefilled syringes. With an ergonomic and robust design, it helps in preventing needle stick injuries, providing a user-friendly protection for healthcare professionals or patients

This add-on device has been developed for healthcare professionals, patients with self-administered prescribed medications, or individuals that assist self-injecting patients.

Safe’n’Sound® is a customizable platform, compatible with prefilled ISO standard glass syringes as well as PLAJEX™ COP syringe, for 1ml or 2.25ml.

Not only does Safe’n’Sound® improve users safety and injection, but also the device complies with the recommendations of the World Health Organization, US FDA (US Federal Needle stick Prevention Act, 2000) and the EU Medical Device Regulation 2017/745 (MDR) .

 

To find out more, contact us.


About NEMERA

Nemera is a world leader in the design, development and manufacturing of drug delivery devices for the pharmaceutical, biotechnology and generics industries.
Nemera offers a comprehensive portfolio of products and services across ophthalmology, nasal, inhalation, dermal, transdermal and parenteral delivery.
Nemera’s vision is to be the most patient-centric drug delivery device company. Nemera always puts patients first, providing high-quality solutions that have a demonstrable impact on patients’ health, including off-the-shelf innovative systems, customized design development and GMP contract manufacturing.