Navigation Links
STALLERGENES: Oralair(R) Grasses Obtains a Pediatric MA(1) in Germany
Date:1/19/2009

ANTONY, France, January 19 /PRNewswire-FirstCall/ -- Stallergenes S.A. today announced that the Paul Ehrlich Institute, the German agency in charge of regulating biological products, has approved its application for a pediatric extension (5-17 years) of the indications for Oralair(R) Grasses, sublingual tablets for desensitization to grass pollens.

The marketing authorization for adults was granted on June 24, 2008. Oralair(R) Grasses will therefore be marketed for both indications in Germany for the 2009 pollen season.

Stallergenes will now begin a mutual recognition procedure for registration of the product in Europe for both the adult and pediatric indications, with Germany as the reference member state. The pivotal phase III pediatric trial, VO 52.06(2), conducted in 278 allergic rhinoconjunctivitis-sufferers aged between 5 and 17 years in 5 European countries (Denmark, France, Germany, Poland, Spain), confirmed the results of the adult trial: an excellent tolerance profile and a statistically and clinically significant reduction in symptoms. The pediatric and adult dosages are identical.

"This new MA(1) for Oralair(R) Grasses represents an important milestone in the field of pediatric desensitization therapy. Thanks to the quality of the clinical trials conducted during the development of the tablet, grass pollen desensitization therapy has now achieved a level of evidence so far unprecedented in children and in line with the requirements of evidence-based-medecine(3). Children are a core target for desensitization therapy, accounting for around 40% of patients."

"Oralair(R) Grasses has already been well received in adults: both its price and its pre- and coseasonal position fit squarely with the expectations of German allergy specialists. This EBM-documented, well-tolerated and easy-to-take treatment, which is effective from the very first season, is set to quickly becom
'/>"/>

SOURCE Stallergenes
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Stallergenes: New Study VO 56 Highly Positive Results Conducted in an Allergen Challenge Chamber
2. Kibow Biotech Obtains Australian, Chinese and Indian Patents Protecting the Composition and Basic Technology Behind Its Oral Probiotic Formulation for Chronic Kidney Failure
3. Terumo Heart Obtains IRB Approval from the University of Michigan to Initiate DuraHeart(TM) Left Ventricular Assist System U.S. Pivotal Trial
4. First Molecular Tem-PCR Test to Identify Multiple Forms of Staph and MRSA Obtains CLIA Certificate
5. AMT Obtains License to Amgens GDNF Gene to Develop Treatment for Parkinsons Disease with AMTs Proprietary Gene Therapy Platform
6. New Report by Pediatricians Finds Gaps in Preparing to Protect Kids From Pandemic Flu, Offers Recommendations
7. UPDATE: New Report by Pediatricians Finds Gaps in Preparing to Protect Kids From Pandemic Flu, Offers Recommendations
8. Large Controlled Trial of Widely Used Mood Stabilizers Demonstrates Efficacy in Pediatric Bipolar Disorder
9. MedImmune Presents New Pharmaco-Economic Data at American Academy of Pediatrics Regarding Infants at High Risk for RSV
10. Pediatric Pulmonary Expert Comments on Study of Lung Transplants for Cystic Fibrosis
11. Curemark Appoints Preeminent Pediatrics Gastroenterologist
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/2/2015)... 2015 Research and Markets ( http://www.researchandmarkets.com/research/w3n5p6/drug_delivery_in ... new report "Drug Delivery in Central Nervous ... to their offering. The delivery of ... challenge in the treatment of neurological disorders. Drugs ... administered systematically (e.g., by intravenous injection) for targeted ...
(Date:6/2/2015)... , June 02, 2015 Research and Markets ( ... Processing Supplies and Equipment - Global Strategic Business Report" ... comprehensive analytics for the US, Canada , ... Asia-Pacific , Latin America ... provided for the period 2014 through 2020. Also, a seven-year ...
(Date:6/2/2015)... 2015 Research and Markets ( http://www.researchandmarkets.com/research/z9s8mp/laboratory ... "Laboratory Centrifuges - Global Strategic Business Report" ... and forecasts are provided for the period 2014 ... provided for these markets. Market data and analytics ... profiles are primarily based on public domain information ...
Breaking Medicine Technology:Global Drug Delivery in Central Nervous System Diseases Report 2015-2024 - Technologies, Markets and Companies 2Global Drug Delivery in Central Nervous System Diseases Report 2015-2024 - Technologies, Markets and Companies 3Blood Processing Supplies and Equipment Market - Global Strategic Business Report 2015-2020 2Blood Processing Supplies and Equipment Market - Global Strategic Business Report 2015-2020 3Laboratory Centrifuges - Global Strategic Business Report 2014-2020: Developed Markets Slowdown, While Emerging Markets Surge 2
(Date:6/2/2015)... OR (PRWEB) June 02, 2015 ZOOM+, ... of ZOOM+ Performance Health Insurance, announced today the opening ... Clean White 57 - a three-in-one complete dental exam, ... Clean Jr. for kids. Like all ZOOM+ services, ZOOM+Smile ... , “Why shouldn’t the dentist office be as inviting ...
(Date:6/2/2015)... June 02, 2015 Olive ... opening of Surrey’s first fertility clinic. Surrey ... a diverse, young community, with one of ... , Until now patients from Surrey ... to come into Vancouver or Burnaby for ...
(Date:6/2/2015)... 2015 TU-Automotive Detroit is the biggest ... 150+ speakers include senior execs from GM, Chrysler, Mercedes, ... provide a crucial status update on the automotive technology ... just 24 hours to secure one of the remaining ... wait for tomorrow. There are 70 sessions looking across ...
(Date:6/2/2015)... June 02, 2015 Vancouver, BC ... iData Research ( http://www.idataresearch.com ), the bone graft ... bone matrices (DBM) over traditional allograft materials. Because ... and thus an increase in operation time, alternative ... market growth in these synthetic materials is partly ...
(Date:6/2/2015)... National Autism Resource has partnered with ... development agency, to launch its new website and strategic ... new website is designed to help parents and ... autism. The site will expand its product line for ... from easy to understand information and helpful links to ...
Breaking Medicine News(10 mins):Health News:ZOOM+ Opens Its First On-Demand ZOOM+Smile Studio and Reinvents the Dental Exam 2Health News:Olive Fertility Centre Opens First Fertility Clinic in Surrey BC 2Health News:The Connected Car’s Biggest Event is Here – TU-Automotive Detroit 2015 2Health News:Medtronic, DePuy Synthes Shift U.S. Bone Graft Substitute Market Towards Synthetic Demineralized Bone Matrices 2Health News:Medtronic, DePuy Synthes Shift U.S. Bone Graft Substitute Market Towards Synthetic Demineralized Bone Matrices 3Health News:National Autism Resources Launches New Website, Delivering More Products and Services 2Health News:National Autism Resources Launches New Website, Delivering More Products and Services 3
... Action Preserves Beneficiary Access to High Quality Nursing ... JOPLIN, Mo., Aug. 7 Citing the substantial,benefit ... to Protect Senior Care (CPSC) today thanked,Senator Susan ... effort,in Congress to stop the Bush Administration from ...
... Beneficiary Access to High Quality Nursing Home Care;,Helps ... Aug. 7 Citing the substantial,benefit in protecting ... Senior Care (CPSC) today thanked,Senator Elizabeth Dole for ... to stop the Bush Administration from moving forward ...
... 7 The dietary health of children is in,urgent ... only forward-thinking,convenient solutions with a line of fresh, healthy ... Most health guidelines recommend,children consume about 400 calories a ... the Public Interest, a consumer group based in Washington,D.C., ...
... Management, Inc. has a proven track record in supporting ... work with the U.S. Army,s Phase I/II clinical testing ... in Silver Spring, MD. CRM is the premier ... to expand its infectious disease capabilities, it looked to ...
... the next five ... Millennium Research Group, WALTHAM, Mass., Aug. 7 ... Health Imaging Systems 2008 report,the market for adjunct breast ... dedicated breast MRI systems, and,breast-specific gamma imaging (BSGI) systems ...
... with Toledo Children,s Hospital and Good Samaritan Hospital, ... NORTH HOLLYWOOD, Calif., Aug. 7 IPC ... leading national hospitalist,physician group practice company, announced today ... Children,s Hospital in Toledo,Ohio and Good Samaritan Hospital ...
Cached Medicine News:Health News:Senator Susan Collins Praised for Leading Successful Effort to Derail $4.3 Million Maine Medicare Cuts 2Health News:Senator Elizabeth Dole Praised for Leading Successful Effort to Derail $22.1 Million North Carolina Medicare Cuts 2Health News:Kidfresh Offers a Solution to the Rise of Unhealthy Eating Among Children With Fresh and Nutritious Prepared Meals for Kids 2Health News:Clinical Research Management gets contract for trials of therapeutics against infectious diseases 2Health News:Clinical Research Management gets contract for trials of therapeutics against infectious diseases 3Health News:Adjunct Breast Imaging Market to Increase by Almost 28% per Year Through 2013 2Health News:IPC The Hospitalist Company Enters Ohio and Pennsylvania Markets 2
Adjustable speed vortex with inter-changeable heads , 110 V...
Inquire...
Adjustable speed vortex with inter-changeable heads, 110 V...
Use the Mo Bio Vortex adapter to process multiple samples at the same time. The adapter holds tubes horizontally to increase cell lysis and mixing efficiency. Ideal for bead beating procedures....
Medicine Products: