• Powered by Crown Equity Holdings Inc.
      • crown-logo

        Crown Equity Holdings Inc. is publicly traded with the symbol CRWE. The Company primarily provides and offers advertising, branding, marketing solutions and services to boost customer awareness, as well as merchant visibility as a worldwide online multi-media publisher. For list of services offered click here

Post on CRWE World Login
logo Ashburn, UNITED STATES
header-img
  • Home
  • News
  • World
      • World News
      • Español
  • Politics
      • U.S. Legislators
      • Political News
  • Sports
  • Business
      • Markets
      • Hottest Stocks Today
      • CRWEWorld Stocks
      • Blockchain
      • Regulatory
      • Accounting
      • Fundraising Campaigns
      • IPOs
      • Money
      • Career
  • Tech
      • Tech
      • Science
  • Living
      • Arts & Entertainment
      • Family
      • Food
      • Pets
      • Seniors
      • Fashion/Fitness
      • Home & Garden
  • Health
      • Health
      • Pharma & Biotech
  • Opinion
      • Finance
      • Law
      • Healthcare
      • Cannabidiol (CBD)
      • Fashion
      • Podcasts
      • Tech
      • Music
  • Travel
  • Local
      • News
      • Trending Now
      • Real Estate
      • Coupons & Deals
      • Business Directory
  • Jobs
  • More
      • Business 2 Business
      • Press Releases
      • Press Releases Pricing
      • News from GlobeNewswire
      • News from PR Newswire
      • News from Business Wire
      • News from Accesswire
      • Video Channels
      • Beauty
      • Business
      • Comedy
      • Entertainment
      • Fashion
      • Featured
      • Health
      • Instructional
      • News
      • Politics
      • Sports
      • Technology
      • Entertainment
      • Horoscope
      • Sudoku
      • Crossword
      • Games
      • Chat
      • Affiliate | How It Works
      • Join CRWE WORLD Affiliate Program
      • CRWE WORLD Advertising Services Rate
      • Crown Equity Holdings' Overview
      • CRWEWorld Real-Time Global Visitors
      • Content Delivery Solution
        • Contact Us
  • More

Change City


-- OR --
load
load
/assets/img/hottest3.png
/assets/img/hottest2.png

/assets/img/reef2.png
/assets/img/red-line.jpg
/assets/img/reef.png
  • Home
  • Articles
  • News Provided by PR Newswire
21ьз╕ Cweather-icon
/assets/img/hottest3.png
/assets/img/hottest2.png

/assets/img/reef2.png
/assets/img/red-line.jpg
/assets/img/reef.png

Sedana Medical submits market approval application for the drug Sedaconda

News Provided by PR Newswire2020-11-27
13 Views

Sedana Medical submits market approval application for the drug Sedaconda

 
[27-November-2020]
 

STOCKHOLM, Nov. 27, 2020 /PRNewswire/ -- Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has submitted an application for market approval for the drug candidate Sedaconda (isoflurane), formerly known as IsoConDa, for inhaled sedation in intensive care. The application has been submitted to the German Medicines Agency BfArM and a number of other European Medicines Agencies through a so-called DCP procedure.

The application is the starting point of the review process of Sedaconda in 15 of the EU member states, including Norway. If all goes well, Sedana Medical expects an approval in the second half of 2021. After that, an application for a second group of EU countries can be submitted. Normally, it takes about six months to obtain approval for a second group of countries.

"When we get market approval for Sedaconda, we can exclusively launch the treatment inhaled sedation in Europe. The treatment consists of our drug Sedaconda, which is then approved for administration only via our medical device AnaConDa. We have chosen the name Sedaconda to strengthen the connection to Sedana Medical and to the drug's unique area of use, sedation. At the same time, we want to communicate that the drug will be given via AnaConDa by keeping CONDA in the name," said Christer Ahlberg, CEO of Sedana Medical.

In the United Kingdom, which due to Brexit has its own national application process, the application will be submitted separately in the first quarter of 2021. Switzerland also has its own national process, and the application will be submitted in 2021.

"As this is our first application for marketing approval for a drug, it is a crucial milestone for us as a company, but also for making the treatment inhaled sedation available for intensive care worldwide. A European approval will be a very good support in future registration processes in other markets when we work to make inhaled sedation a standard method in intensive care," said Christer Ahlberg.

The market approval application is based on the strong results in Sedana Medical's pivotal phase III study, SED-001. The topline results, announced in July 2020, showed that the study reached its primary goal; to show that Sedaconda (isoflurane), administered with AnaConDa, is an effective sedation method, for ventilator-intensive care patients, which is non-inferior to propofol. The results show that Sedaconda is an effective and safe sedation method.

For additional information, please contact:
Christer Ahlberg
CEO
Sedana Medical AB
Mobile: +46 70 675 33 30
E-mail: christer.ahlberg@sedanamedical.com

Sedana Medical is listed on Nasdaq First North Growth Market in Stockholm.

The company's Certified Adviser is Erik Penser Bank, +46 8 463 83 00, certifiedadviser@penser.se

This information is such that Sedana Medical AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact person above, on November 27, 2020 at 12.45 p.m. (CET).

About Sedana Medical

Sedana Medical AB (publ) has developed and sells the medical device AnaConDa for the administration of volatile anaesthetics. Through a combination of AnaConDa and the candidate drug IsoConDa (isoflurane), Sedana Medical provides inhaled sedation for mechanically ventilated intensive care patients. The company is working to obtain market approval in Europe for inhaled sedation in intensive care with the pharmaceutical IsoConDa® (isoflurane) during the second half of 2021.

Today, mechanically ventilated intensive care patients are sedated intravenously which leads to several challenges for both patients and care givers. Challenges that are solved by inhaled sedation. Based on an estimate of seven to eight million patients being sedated in intensive care due to mechanical ventilation globally, on average three to four days, Sedana Medical estimates the total market potential to SEK 20-30 billion, evenly distributed between the US, Europe and Asia. Three years after market approval in Europe Sedana Medical expects sales of SEK 500 million in Europe and an EBITDA margin of about 40 percent. The company has initiated a process to obtain market approval in the US in 2024. Registration activities have also been initiated in other markets outside the EU.

Sedana Medical has direct sales in the Nordic countries, Germany, Benelux, France, Great Britain and Spain as well as external distributors in parts of the rest of Europe, Australia, Canada, China, India, Israel, Japan, Mexico and South Korea. The company was founded in 2005 and is headquartered in Stockholm, Sweden, with medical device development in Ireland.

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/sedana-medical/r/sedana-medical-submits-market-approval-application-for-the-drug-sedaconda,c3245090

The following files are available for download:

https://mb.cision.com/Main/15764/3245090/1340989.pdf

Release

Cision View original content:http://www.prnewswire.com/news-releases/sedana-medical-submits-market-approval-application-for-the-drug-sedaconda-301181145.html

SOURCE Sedana Medical


Company Codes: Frankfurt:7D2, ISIN:SE0009947534, Stockholm:SEDANA


© 2020 PR Newswire. All Rights Reserved.

The news, reports, views and opinions of authors (or source) expressed are their own and do not necessarily represent the views of CRWE World.


FDA Approves Aurinia Pharmaceuticals' (Nasdaq: AUPH / TSX: AUP) LUPKYNIS (voclosporin) for Adult Patients with Active Lupus Nephritis





/assets/img/cw-stocks.png

/assets/img/wysh-jewels.png

/assets/img/hjli.png

/assets/img/Mars-Parachute-2.png

/assets/img/crweworld-podcast.jpg
Sponsored
Also read
Novartis delivered sales growth and margin expansion. Continued to progress its next wave of medicines in 2020.
Egide: 2020 2nd half Revenue and 2020 revenue
Nyxoah announces full-body 1.5T and 3T MRI compatibility for the Genio® system to treat Obstructive Sleep Apnea (OSA)
Pure Extracts Enters Into Biomass Purchase Agreements To Support Oil Extract Production
Clean Power's PowerTap Signs Definitive Agreement with Andretti Group to Both Install At Existing Gas Stations and To Distribute PowerTap Hydrogen Fueling Stations
CureVac Announces Proposed Public Offering of Common Shares
Covid vaccines: Casino boss resigns after jumping queue
NEC Delivers Submarine Cable Seismic and Tsunami Observation System to Taiwan's Central Weather Bureau


Post on CRWE WorldSign Up for Free E-mail Updates
  • Real Estate Eagle Firm, Real Estate
Signup for free email updates
/assets/img/wall-street-rect2.png
/assets/img/wall-street-sq.png



Join with us
Live Traffic Feed
About CrweWorld
  • About Us
  • Privacy Policy
  • Terms & Conditions
  • Finance Disclaimer
  • Jobs
Subscribe for newsletter
3+2
Contact Info
  • contact@crweworld.com

  • P: (702) 683-8946

  • P: (702) 810-0178

  • 11226 Pentland Downs St, Las Vegas, NV 89141

Tweets by CrweWorld
Tweets by @CrweWorld
  • © 2021 crweworld.com
ad1

/assets/images/ad/crwe_tech.jpg

Your Technology Source, Your Technology Team

Server Maintenance, Web Development, Mobile Application Solutions, SEO Services and more

Contact Us: contact@crwetech.com

www.CRWETech.com

ad2

/assets/images/ad/content-delivery-solution.jpg

 

Our content delivery solution through CRWE WORLD, CRWE Press Release and CRWE Tube gives corporations and businesses a vehicle to expand their exposure

CLICK HERE FOR MORE INFORMATION

ad3

/assets/img/crwe_info.png

CRWE Info ( CRWE.Info ) provides news and updates about Crown Equity Holdings Inc. and the CRWE World platform

www.crwe.info

ad4

/assets/images/ad/crwetube.png

Share your videos. Upload your videos for free on CRWETube

www.CRWETube.com

ad5

/assets/images/ad/ad4.png

 

Place Your Ad Here! Advertise your business online on CRWE WORLD. Your Company, product, or service in front of the world!

Contact Us: contact@crweworld.com

www.CRWEWorld.com

Advertisements

/assets/images/ad/crwe_tech.jpg

Your Technology Source, Your Technology Team

Server Maintenance, Web Development, Mobile Application Solutions, SEO Services and more

Contact Us: contact@crwetech.com

www.CRWETech.com

/assets/images/ad/content-delivery-solution.jpg

 

Our content delivery solution through CRWE WORLD, CRWE Press Release and CRWE Tube gives corporations and businesses a vehicle to expand their exposure

CLICK HERE FOR MORE INFORMATION

/assets/img/crwe_info.png

CRWE Info ( CRWE.Info ) provides news and updates about Crown Equity Holdings Inc. and the CRWE World platform

www.crwe.info

/assets/images/ad/crwetube.png

Share your videos. Upload your videos for free on CRWETube

www.CRWETube.com

/assets/images/ad/ad4.png

 

Place Your Ad Here! Advertise your business online on CRWE WORLD. Your Company, product, or service in front of the world!

Contact Us: contact@crweworld.com

www.CRWEWorld.com

CRWE WORLD Advertising Services RateJoin CRWE WORLD Affiliate Program