Navigation Links
ViroPharma Announces Positive CHMP Opinion for Buccolam® (Midazolam, Oromucosal Solution) in the European Union
Date:6/24/2011

EXTON, Pa., June 24, 2011 /PRNewswire/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of a Pediatric Use Marketing Authorization (PUMA) for Buccolam® (midazolam, oromucosal solution), for treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents, from 3 months to less than 18 years.  If approved by the European Commission, Buccolam would be the first product approved through the centralized PUMA procedure.

Buccolam is oral midazolam provided in a pre-measured, age-specific dose formulation for convenient buccal (i.e. via the cavity between the cheek and gum line) delivery. Buccal midazolam has been shown in four clinical studies to be either comparable or superior in both its effectiveness and speed of onset of action to the current standard treatment, rectally-administered diazepam, for terminating pediatric convulsive epileptic seizures.

"The potential approval of Buccolam would address a major challenge for physicians currently prescribing rectally-administered diazepam for acute seizures, namely that it can be difficult to use and may be socially unacceptable in the community," said Professor Ian Wong, Director of the Centre for Paediatric Pharmacy Research at the School of Pharmacy, University of London. "Midazolam is recommended for treating prolonged acute convulsive seizures according to published treatment guidelines in European countries, and the availability of Buccolam – an oromucosal formulation of midazolam – would be an important, convenient and welcomed alternative to treat seizures in pediatric and adolescent patients."

The CHMP is responsible for issuing the EMA's scientific evaluation and opinions on all Marketing Au
'/>"/>

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

Page: 1 2 3 4 5

Related medicine technology :

1. ViroPharmas Cinryze® (C1 Inhibitor [Human]) Granted European Marketing Authorization for Hereditary Angioedema (HAE)
2. ViroPharma to Participate in the Jefferies 2011 Global Healthcare Conference
3. ViroPharma Launches Swell, an Original Documentary Chronicling the Lives of People Living with Hereditary Angioedema
4. ViroPharma Initiates Phase 2 Study of VP 20621 for Prevention of Recurrence of Clostridium difficile Infection (CDI)
5. Halozyme Therapeutics and ViroPharma Announce $83 Million Global Licensing Agreement to Develop Subcutaneous Cinryze® (C1 esterase inhibitor [human])
6. ViroPharma and Halozyme Announce Collaboration for Combination of Recombinant Human Hyaluronidase Enzyme (rHuPH20) Technology with C1 Esterase Inhibitor
7. ViroPharma to Participate In Three May Healthcare Investor Conferences
8. ViroPharma to Release 2011 First Quarter Financial Results On April 28, 2011
9. ViroPharma Initiates Phase 2 Study of C1 Esterase Inhibitor [Human] for Treatment of Antibody-Mediated Rejection (AMR)
10. ViroPharma Launches HAE and Me, A New Online Community to Unite People Living With Hereditary Angioedema
11. ViroPharma Announces Positive CHMP Opinion for Cinryze® (C1 Inhibitor [Human]) in European Union
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/21/2014)... 2014 Asterias Biotherapeutics, Inc. (OTCBB: ASTY), a ... medicine, announced today the appointments of Andrew ("Andy") Arno ... Board of Directors. With these additions, the Asterias Board ... are independent. Andy Arno , 55, ... companies. He is currently Managing Director of Emerging Growth ...
(Date:8/20/2014)... 20, 2014  The National Association of Drug ... achieved by the real-time, pseudoephedrine (PSE) blocking system ... Log Exchange (NPLEx), automatically blocks unlawful PSE sales ... offenders and make arrests. Data released by NPLEx ... blocked the sale of more than 23,478 ...
(Date:8/20/2014)... PLAINFIELD, N.J. , Aug. 20, 2014 PTC Therapeutics, ... will participate at two upcoming investor conferences: - ... Seasons Hotel in Boston on Wednesday, ... Biotech Conference at The Mandarin Oriental Boston on Thursday, September ... present a company update at the Bank of America Merrill ...
Breaking Medicine Technology:Asterias Biotherapeutics Appoints Two Independent Directors and Announces Completion of Series A Common Stock Distribution 2Asterias Biotherapeutics Appoints Two Independent Directors and Announces Completion of Series A Common Stock Distribution 3Asterias Biotherapeutics Appoints Two Independent Directors and Announces Completion of Series A Common Stock Distribution 4Kentucky's Stop-Sale System Achieves Significant Results In Battle Against Meth 2PTC Therapeutics to Participate at Upcoming Investor Conferences 2
(Date:8/21/2014)... Top10BestSEOHosting.com has recently compared many professional ... http://www.top10bestseohosting.com/go/iPage/ ) is one of the best cheap ... manager of Top10BestSEOHosting.com states, “It is hard to ... companies have outperformed their competitors on hosting features, ... get the best web hosting at affordable prices.” ...
(Date:8/21/2014)... Today, Zane Benefits, the #1 Online Health ... credits in 2015. , According to Zane Benefits, premium ... Affordable Care Act (ACA), premium tax credits are available ... through the Health Insurance Marketplaces. , The new article ... of the tax credits, updated for 2015. , ...
(Date:8/21/2014)... NY (PRWEB) August 21, 2014 ... trend among their patients. Alternative medicine is on ... due to millenials. According to The Fiscal Times, ... medical treatments over conventional medicine. , The Fiscal ... how many millenials are embracing alternative medicine. The ...
(Date:8/21/2014)... For many people, finding motivation to exercise is a challenge. ... the approach of Zombies, Run!one of more than 31,000 health ... the growing number of apps that use games to increase ... mobile fitness app makers looking to cash in to help ... to exercise remains to be seen. , "It,s just been ...
(Date:8/21/2014)... 2014 Improv performers from Fun House ... dementia at Silverado Turtle Creek memory care community in ... entertainers ranging from ages 10 to 16, delivers a ... 40-minute set. The troupe's philosophy is that improv is ... them to touch audiences regardless of their circumstance — ...
Breaking Medicine News(10 mins):Health News:iPage Reviews Unveiled Online At Top10BestSEOHosting.com 2Health News:Van Uden Center Sees Growth in Alternative Medicine 2Health News:Playing hunger games: Are gamified health apps putting odds in your favor? 2Health News:Unicorn Clearance Improv Troupe Brings Laughter to Residents with Dementia at Silverado Memory Care 2
... MONDAY, April 4 (HealthDay News) -- Taking aspirin even once ... associated with a marked drop in the risk of developing ... once monthly was linked to a 26 percent reduction in ... the risk of heart disease, was associated with an even ...
... Prostate cancer is the second leading cause of cancer-related death ... reduced the number of deaths from the disease. By ... risk for aggressive disease or diagnosis at a young age, ... screening approach. For that reason, scientists have been looking for ...
... , SUNDAY, April 3 (HealthDay News) -- ... of heart attack four years after the city was ... Chronic stress, not being able to return home ... this situation, said the researchers, who updated their two-year ...
... metabolic syndrome, a constellation of conditions that increases the ... the risk of the two most common types of ... 102nd Annual Meeting 2011, held here April 2-6. ... National Cancer Institute, said approximately one-third of the U.S. ...
... SUNDAY, April 3 (HealthDay News) -- The use of ... dramatically in the United States over the past five ... of these drugs -- widely regarded as the last ... -- is cause for concern because carbapenem-resistant bacteria are ...
... of New Ulm Project, which is merging environmental, peer ... community with the assistance of a healthcare system, worksites ... has shown a 24 percent reduction in the number ... with the previous five-quarter period of evaluation., This study ...
Cached Medicine News:Health News:Monthly Aspirin Use Linked to Lower Pancreatic Cancer Risk 2Health News:Monthly Aspirin Use Linked to Lower Pancreatic Cancer Risk 3Health News:MicroRNA variations associated with earlier prostate cancer diagnosis in African-American men 2Health News:Heart Attack Risk Plagues Post-Katrina New Orleans 2Health News:Metabolic syndrome may increase risk for liver cancer 2Health News:Research Warns of Overuse of Powerful Class of Antibiotics 2Health News:Regional prevention project involving 10,000 adults cuts heart attacks by 25 percent 2Health News:Regional prevention project involving 10,000 adults cuts heart attacks by 25 percent 3
BioSoft alcohol gel hand antiseptic with soothing moisturizers is a fast-acting, broad-spectrum antimicrobial solution. BioSoft alcohol gel hand antiseptic applies easily, requires no rinsing and dri...
... Scrub Care povidone-iodine (PVP-I) antimicrobial solutions ... control in all hospital and health-care settings. ... gel have a broad spectrum of activity, ... bacteria that may cause infection. The new ...
... hand sanitizers like Aplicare No Rinse Isopropyl ... as the recommended product for hand disinfection ... Guidelines for hand hygiene., According to the ... be prevented with better infection control programs. ...
This is long known for its purity and mildness, Castile Soap is also an effective cleaning agent that is used in a variety of applications. It rinses clean while leaving the skin soft and healthy....
Medicine Products: