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

thorization Applications (MAAs) for medicines for human use. Their positive opinion forms the scientific basis for the European Commission to issue a binding decision for an MAA or a PUMA, a centralized marketing authorization which is valid throughout all the Member States of the European Union (EU) as well as in the European Economic Area (EEA), namely Norway, Iceland and Liechtenstein. The anticipated timeframe for the European Commission decision is by the fourth quarter of 2011.  A summary of the CHMP opinion will be available here: http://tinyurl.com/2am4ubc.  Please select "B" to access the Buccolam summary opinion.  

"This positive CHMP opinion - the first for a product seeking centralized authorization through a PUMA - is a great step towards the European marketing authorization for Buccolam, a product that addresses significant unmet need for families and caregivers – namely the quick and effective termination of prolonged, acute convulsive seizures in children and adolescents," commented Thierry Darcis, M.D., ViroPharma's vice president, general manager, Europe.  "We will work closely with physicians across Europe on improving the seizure treatment paradigm, and bringing this much-needed emergency medication to market as soon as possible this year."

A Pediatric Use Marketing Authorization (PUMA) is a new type of centralized marketing authorization procedure for medicines that are developed specifically for children and may already be authorized for other indications or routes of administration in adults but are not patented. These medicines benefit from 10 years of market protection as an incentive.  In August 2010, the EMA's Pediatric Committee (PDCO) confirmed that the required Pediatric Investigation Plan (PIP) for Buccolam had been fully completed.  

About Buccolam® (Midazolam, Oromucosal Solution)

Buccolam is oral midazolam prov
'/>"/>

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:10/22/2014)... AUSTIN, Texas , Oct. 22, 2014 ... announced they have entered into a license and ... to target cancers. PhosImmune possesses technology ... the surfaces of tumor cells in association with ... from proteins that play a role in malignancy, ...
(Date:10/22/2014)... Calif. , Oct. 22, 2014 /PRNewswire/ ... ), a biopharmaceutical company leading the discovery ... today announced that it has demonstrated human ... ongoing clinical study evaluating RG-101, a wholly-owned, ... treatment of hepatitis C virus infection ("HCV").  ...
(Date:10/20/2014)... 20, 2014  Indianapolis interventional medical device maker ... -based 3D visualization leader Synaptive Medical ... Surgeons Annual Meeting that they have joined forces ... The collaboration is the first of its kind ... patient outcomes. NICO,s BrainPath® interventional access technology and ...
Breaking Medicine Technology:Biotech Companies To Co-Discover And Co-Develop Antibodies Targeting Novel Phosphopeptide Tumor Targets 2A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 2A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 3A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 4A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 5A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 6A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 7A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 8Indianapolis' NICO Corporation and Toronto's Synaptive Medical, Inc. Announce First-Ever Intervention-Visualization Partnership with Goal to Improve Standard of Care in Neurosurgery 2Indianapolis' NICO Corporation and Toronto's Synaptive Medical, Inc. Announce First-Ever Intervention-Visualization Partnership with Goal to Improve Standard of Care in Neurosurgery 3Indianapolis' NICO Corporation and Toronto's Synaptive Medical, Inc. Announce First-Ever Intervention-Visualization Partnership with Goal to Improve Standard of Care in Neurosurgery 4Indianapolis' NICO Corporation and Toronto's Synaptive Medical, Inc. Announce First-Ever Intervention-Visualization Partnership with Goal to Improve Standard of Care in Neurosurgery 5
... Mass. , May 5 LightLab Imaging, ... Optical Coherence Tomography (OCT) technology for vascular and other ... and Drug Administration (FDA) for the C7-XR Imaging System ... LightLab,s latest generation Frequency Domain OCT (FD-OCT™) technology, are ...
... May 5 Zimmer Holdings, Inc. (NYSE: ZMH ; SIX: ZMH) ... Care Conference in New York, New York , on May 11, 2010 , ... , , A live ... .  The webcast will be archived for replay following the conference. , ...
Cached Medicine Technology:LightLab Imaging Announces FDA Clearance of C7-XR(TM) Coronary OCT Products in the United States 2LightLab Imaging Announces FDA Clearance of C7-XR(TM) Coronary OCT Products in the United States 3LightLab Imaging Announces FDA Clearance of C7-XR(TM) Coronary OCT Products in the United States 4Zimmer Holdings to Present at Bank of America Merrill Lynch 2010 Health Care Conference 2
(Date:10/22/2014)... Medical Solutions , the nation’s ... announce that our co-founder and CFO, Scott Anderson, ... 100 for 2014. Anderson was also named to ... in the staffing industry,” in 2013.     , Under ... staffing company in the U.S., was named a ...
(Date:10/22/2014)... 22, 2014 Shriners Hospitals for Children® ... change the current location of Shriners Hospitals for Children ... across from the University of Kentucky Albert B. Chandler ... care center, owned and operated by Shriners Hospitals for ... of children and their families well into the future. ...
(Date:10/22/2014)... (PRWEB) October 22, 2014 Best Cheap ... in the world. The site has recently announced that ... hosting supplier for people from around the world. , ... in operation today and is providing various kinds of ... the company insists on offering excellent customer service and ...
(Date:10/22/2014)... of Prussia, PA (PRWEB) October 22, 2014 ... is recognized as an industry leader with over 25 ... award winning team leader in the areas related to ... addition, Mr. Carlson is an Editorial Advisory Board member ... Healthcare Council Educator. Blue Fin Group is a ...
(Date:10/22/2014)... HealthDay Reporter , TUESDAY, Oct. ... men may lead to increased blood pressure, according to a ... rise in blood pressure for young adult women or for ... women drank lightly or moderately, their risk of high blood ... finding parallels studies in older adult men and women," said ...
Breaking Medicine News(10 mins):Health News:Medical Solutions Co-Founder/CFO Scott Anderson Named to Staffing Industry Analysts’ 2014 Staffing 100 2Health News:Medical Solutions Co-Founder/CFO Scott Anderson Named to Staffing Industry Analysts’ 2014 Staffing 100 3Health News:Shriners Hospitals for Children - Lexington Announces Plan to Build New $47 Million Facility 2Health News:Shriners Hospitals for Children - Lexington Announces Plan to Build New $47 Million Facility 3Health News:Best Cheap Hosting USA Has Recently Announced The Best Cheap Web Hosting Companies In 2014 2Health News:Rich Carlson and Marc Duey to Hold Workshop at CBI’s Specialty Pharmacy and Distribution Networks Conference 2Health News:Binge Drinking May Boost Blood Pressure in Young Men 2Health News:Binge Drinking May Boost Blood Pressure in Young Men 3Health News:Binge Drinking May Boost Blood Pressure in Young Men 4
... WEDNESDAY, Dec. 1 (HealthDay News) -- The case of a ... -- and actually got better -- sheds light on how ... suggests. "Our findings in this case report suggest that ... roundworm can alleviate the symptoms of ulcerative colitis," said study ...
... , This release is available in French ... and the brain appear to be even more closely connected ... apparently not confined to the heart, but also affect the ... the level of the brainstem, which leads to insomnia, notably ...
... -- A "virtual biopsy" may help diagnose a degenerative ... others who suffer repeated blows to the head, says ... encephalopathy (CTE) can include memory problems, impulsive and erratic ... marked by an accumulation of abnormal proteins in the ...
... Alex Mitchell, of the Department of Cancer Studies and ... study which has been published in the journal ... screening refers to population based medical tests such as ... detect conditions such as cancer, diabetes or heart ...
... Dec. 1 (HealthDay News) -- A test that measures the ... at an early stage and help doctors evaluate the effectiveness ... as early as possible -- before it destroys the optic ... the researchers, from the Bascom Palmer Eye Institute at the ...
... HealthDay Reporter , TUESDAY, Nov. 30 (HealthDay News) ... directions on the labels of over-the-counter kids, medicines may ... that most of the popular cough-and-cold, pain-relieving, allergy and ... begin with. Nor is there much consistency in product ...
Cached Medicine News:Health News:Worm Therapy Shows Promise for Ulcerative Colitis 2Health News:Worm Therapy Shows Promise for Ulcerative Colitis 3Health News:Insomnia after myocardial infarction 2Health News:Imaging May Reveal Sports-Related Brain Disorder at Early Stage 2Health News:People with mental illness receive inadequate mass screening for prevention of medical conditions 2Health News:Confusing Labeling Found on Many Nonprescription Kids' Meds 2Health News:Confusing Labeling Found on Many Nonprescription Kids' Meds 3
... IMMULITE and IMMULITE 1000 ... with the IMMULITE and IMMULITE ... analyzers which offer simplicity in ... systems can be found in ...
... Anti-Nuclear Antibodies (ANAs) has long been an ... rheumatic diseases. The antigens used in their ... of human or animal nuclei, this has ... Antigens (ENAs). The most commonly measured ENA ...
... Automation, Inc. (DAI) ENA Profile Enzyme-Linked Immunosorbent ... of antibodies in human serum to individually ... Scl-70 and Jo-1 in a single serum ... to be used as an aid in ...
... Enzyme-linked immunosorbent assays for the ... antibodies to extractable nuclear antigens ... Antibodies to Sm aid in ... erythematosus (SLE). ,RNP antibodies aid ...
Medicine Products: