Navigation Links
ViroPharma Announces Positive CHMP Opinion for Cinryze® (C1 Inhibitor [Human]) in European Union
Date:3/18/2011

as designated an orphan medicinal product on October 8, 2009. Upon granting of a Centralized Marketing Authorization and retention of the orphan medicinal product designation, Cinryze would be entitled to a period of 10 years market exclusivity in respect of the approved therapeutic indication. This 10-year market exclusivity period could be extended cumulatively to 12 years when the results of all studies conducted in compliance with an agreed pediatric investigation plan are completed and included in the summary of product characteristics.

About Cinryze® (C1 esterase inhibitor [human])

Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product.  In the U.S., Cinryze was approved by FDA for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE.  In the E.U., the recommended indication is for treatment and pre-procedure prevention of angioedema attacks in adults and adolescents with hereditary angioedema (HAE), and routine prevention of angioedema attacks in adults and adolescents with severe and recurrent attacks of hereditary angioedema (HAE), who are intolerant to or insufficiently protected by oral prevention treatments or patients who are inadequately managed with repeated acute treatment.

Severe hypersensitivity reactions to Cinryze may occur.  Thrombotic events have occurred in patients receiving Cinryze for routine prophylaxis, and in patients receiving off-label high dose C1 inhibitor therapy.  Monitor patients with known risk factors for thrombotic events.  With any blood or plasma derived product, there may be a risk of transmission of infectious agents, e.g. viruses and, theoretically, the CJD agent. The risk has been reduced by screening donors for prior exposure to certain virus infections and by manufacturing steps to reduce the risk of viral transmission including pasteurization and nanofiltration.  <
'/>"/>

SOURCE ViroPharma Incorporated
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. ViroPharma to Present at Three Upcoming Healthcare Conferences
2. ViroPharma to Present at the Natixis Bleichroeder Conference
3. ViroPharma To Present at the Acumen BioFin Rodman & Renshaw 9th Annual Healthcare Conference
4. ViroPharma to Release 2008 First Quarter Financial Results on April 30, 2008
5. ViroPharma Announces Discontinuation of HCV-796 Development
6. ViroPharma Announces Completion of Enrollment in Phase 3 Study of Maribavir in Stem Cell Transplant Patients
7. ViroPharma Incorporated Completes Acquisition of Lev Pharmaceuticals
8. ViroPharma Announces Presentation of Cinryze(TM) Data in Acute Treatment of Hereditary Angioedema
9. ViroPharma Announces Discontinuation of Maribavir Phase 3 Study in Liver Transplant Patients
10. ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance
11. ViroPharma Incorporated Reports Third Quarter 2009 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/15/2014)... Dec. 15, 2014 As medical device manufacturers ... Labeling) markup language standard, content teams have a greater ... to work with the standard. Starting January 2015, Data ... webinars on the benefits and the critical aspects of ... be facilitated by Howard Shatz , DCL,s SPL ...
(Date:12/15/2014)... and BOSTON , December ... leading GPCR structure-guided drug discovery and development company, is ... in the United States relating ... these patents in the US significantly strengthens the global ... major pharmaceutical markets. The suite of patents ...
(Date:12/13/2014)... Dec. 12, 2014  Radiologists can transmit their ... to their referring physicians, electronic health records (EHR) ... selected technology.  That was the ... Corporation (ADS) at the recent Radiology Society of ... of radiology reports in this manner also helps ...
Breaking Medicine Technology:Data Conversion Laboratory Helping Life Sciences Content Producers Understand the Impact and Benefits of Structured Product Labeling 2Data Conversion Laboratory Helping Life Sciences Content Producers Understand the Impact and Benefits of Structured Product Labeling 3Heptares Extends Global Patent Protection for GPCR-Focused Drug Discovery Platform With Grant of Core Patents in the United States 2Advanced Data Systems Presents on Interface-Free EHR Communications at RSNA's 2014 Conference: Streamlining Communication of Reports and Images to Referring Physicians 2Advanced Data Systems Presents on Interface-Free EHR Communications at RSNA's 2014 Conference: Streamlining Communication of Reports and Images to Referring Physicians 3
(Date:12/17/2014)... -- Expectant parents should leave prenatal picture-taking to medical ... Use of ultrasound imaging and heartbeat monitors to get ... agency warns. "Although there is a lack ... and heartbeat monitors, prudent use of these devices by ... FDA biomedical engineer, said in an agency news release. ...
(Date:12/17/2014)... HealthDay Reporter , TUESDAY, Dec. 16, ... America, and work commitment is a big reason why, new ... said Dr. Mathias Basner, an assistant professor of sleep and ... of Medicine. A time-use survey of nearly 125,000 Americans, ... main activity exchanged for sleep. Short sleepers -- those who ...
(Date:12/15/2014)... 15, 2014 South Florida’s leading urgent care ... can be a daze of hassle, hustle, and bustle that ... decking halls, to burns when making special meals and heartburn ... can happen at any time. To prevent this season of ... made a list of helpful and healthful holiday tips to ...
(Date:12/15/2014)... News) -- Expert pilots process visual information more efficiently ... better decisions during landings, a new study shows. ... pilots to master, and 36 percent of all airplane ... final approach and landing. Researchers monitored the brain ... pilots while they were at the controls of a ...
(Date:12/15/2014)... 15, 2014 At the leading, long-established ... AutismOne and Focus Autism will welcome ... research on the effects of toxins to children’s health, ... information. , Luminaries such as Dr. Lucija Tomljenovic ... with esteemed, credentialed colleagues of the United States to ...
Breaking Medicine News(10 mins):Health News:FDA Warns Against Fetal 'Keepsake' Videos 2Health News:Work Steals Valuable Sleep Time, Study Finds 2Health News:Work Steals Valuable Sleep Time, Study Finds 3Health News:MD Now Urgent Care Presents Healthy Holiday Tips 2Health News:MD Now Urgent Care Presents Healthy Holiday Tips 3Health News:Study Shows Why Expert Pilots Are Experts 2Health News:AutismOne and Focus Autism Collaborate on Scientific Conference; International Group of Researchers to Present in Chicago, May 2015 2Health News:AutismOne and Focus Autism Collaborate on Scientific Conference; International Group of Researchers to Present in Chicago, May 2015 3
... expands to 12 locations, LEXINGTON, Mass., May ... the seventh largest medical practice of its kind,nationwide, ... with,the opening of an infertility clinic at the ... Place, Suite 250., Dr. Ania Kowalik, board-certified ...
... better than virtual version , , TUESDAY, May 20 (HealthDay ... repeat colonoscopies to detect precancerous growths are less likely ... , "We are doing more colonoscopies among the low-risk ... Dr. Adeyinka Laiyemo, a cancer prevention research fellow at ...
... colorectal signet ring cell carcinoma is a rare but distinctive ... ring cell carcinomas arise in the stomach, with the rest ... metastasis to the colon and rectum must be excluded before ... can be established. , This research, performed by a team ...
... ALLEGAN, Mich., May 20 Perrigo Company,(Nasdaq: ... Papa, Perrigo,s,Chairman and CEO will present at the ... May 21, at 10:00 a.m. (ET) at the ... the following link, http://www.veracast.com/webcasts/citigroup/healthcare08/25105341.cfm ., Perrigo ...
... seen in pulmonary hypertension , , TUESDAY, May 20 (HealthDay ... as a treatment for pulmonary hypertension, according to a ... study, nine patients took the drug for 16 weeks ... The patients also continued to take their standard medications. ...
... May 19 Patrick Hendry lost,his career, home, wife and ... years in and out of the hospital, trying every medication,available. ... therapy, similar to shock therapy., "That was a confusing, ... lost," said Hendry. "It,s difficult to figure out what to ...
Cached Medicine News:Health News:Reproductive Science Center and Lowell General Hospital Announce Partnership in Infertility Treatment 2Health News:Repeat Colonoscopies Underused in High-Risk Patients 2Health News:Repeat Colonoscopies Underused in High-Risk Patients 3Health News:Sorafenib Shows Promise for Heart-Lung Disease 2Health News:Man who Lost Everything Comes to Detroit to Spread Message of Hope 2
Quantel Medical introduces the new Aviso A/B, a new generation high definition ultrasound system in a unique laptop or desktop PC workstation....
... The Paradigm LD400 FT is an affordable ... exam time by at least 40%. It has ... It features rapid setup and easy two-button operation ... friendly. The LD 400 FT is the workhorse ...
... Clear Corneal Diamond Knife is a unique ... Shepard of Santa Maria, California. This special ... need for a quality instrument that could ... Surgical technique. Through professional collaboration between KOI ...
... The Boomerang ClosureWire Vascular Closure ... called Arteriotomy Site-Specific Compression., ,The Boomerang ... between the inside of the arteriotomy ... resulting in a targeted internal compression ...
Medicine Products: