HOME >> MEDICINE >> NEWS
Emselex(R) receives positive CHMP opinion for the treatment of overactive bladder

Basel, 30th July 2004 Novartis Pharma AG announced today that the Committee for Medicinal Products for Human Use (CHMP), adopted a positive opinion recommending that the European Commission (EC) grant a Marketing Authorisation for Emselex (darifenacin hydrobromide), 7.5mg and 15mg, for the treatment of overactive bladder (OAB) in all 25 European Union (EU) countries as well as Norway and Iceland. Upon receipt of the EC approval, Novartis will be able to market Emselex throughout these countries.

"We are delighted by the CHMP's positive opinion for Emselex, to provide overactive bladder sufferers with a new safe and effective treatment option", said Jrg Reinhardt, Global Head of Development Novartis Pharma AG. "Due to its M3 selectivity, Emselex provides effective overactive bladder symptom relief while decreasing the potential risk of safety issues such as cognitive impairment or effects on cardiac function."

OAB affects almost one in six adults in Europe1. Symptoms of overactive bladder are urinary urgency (a sudden compelling desire to pass urine, which is difficult to defer) with or without urge incontinence (involuntary leakage accompanied by urgency), urinary frequency (voiding the bladder too often), and nocturia (waking at night one or more times to void the bladder).

The CHMP based its positive opinion on Emselex's comprehensive data package for OAB. The safety and efficacy of Emselex has been extensively studied in over 90 pre-clinical studies and clinical trials, involving more than 5,000 patients. Pivotal studies explored key endpoints including the reduction in the number of incontinence episodes per week, the reduction in the number of voluntary urination episodes (micturition) per day, the reduction in the episodes and severity of urgency and an increase in the average volume of urine passed per micturition.

The phase III clinical
'"/>


30-Jul-2004


Page: 1 2 3

Related medicine news :

1. UIC professor receives international humanitarian award
2. Mailman School of Public Health receives Manhattan Tobacco Cessation Center grant
3. Epidemiologist Trichopoulos receives $5.8 million Department of Defense Innovator Award
4. GlaxoSmithKline receives unanimous favorable recommendation by FDA Advisory Committee for Boostrix
5. NYU Child Study Center receives grant from the American Red Cross September 11 recovery program
6. Northwestern Memorial Hospital receives $10 million commitment to support preeminent heart program
7. American Academy of Neurology program receives Grassroots Award
8. Orqis receives FDA approval to expand clinical trial of Cancion CRS therapy to 40 centers
9. Mayo Clinic Cancer Center receives SPORE grant for brain cancer research from NCI
10. Pfizers antifungal medicine VFEND receives FDA approval
11. Shire receives US FDA approval of EQUETRO (TM) for bipolar disorder

Post Your Comments:
*Name:
*Comment:
*Email:


(Date:1/14/2019)... BALTIMORE (PRWEB) , ... January 15, 2019 , ... ... of The Center for Inflammatory Bowel and Colorectal Diseases, Institute for Digestive ... minimally invasive, outpatient procedure for treating hemorrhoids., A specially designed instrument known as ...
(Date:1/14/2019)... ... , ... Trees can be overweight too! Giroud Tree and Lawn ... is a great time to clean things up on the property! , Health and ... during windy or icy storms. The crown of the tree should be pruned to ...
(Date:1/14/2019)... , ... January 14, 2019 , ... Dr. Kaveh Kanani D.D.S . is the ... Woodland Hills. This well established general dentist has recently unveiled an inventive method ... missing teeth. When a tooth is missing for an extended period of time, the jawbone ...
(Date:1/13/2019)... ... January 12, 2019 , ... New Vitae Wellness and ... service to the community, providing a variety of residential behavioral health and outpatient ... New Vitae co-founder and owner Adam Devlin. “We are continuing to build ...
(Date:1/13/2019)... ... ... present the following recently reviewed and approved providers for December 2018. , IL Top Docs Include: , ANESTHESIOLOGY, ... Dr. Barbara Amsler , Dr. Naresh Chandan , Dr. Marcie Claybon ... Dr. Amarish Dave , OBGYN, Dr. Aarathi ...
Breaking Medicine News(10 mins):
(Date:1/15/2019)... ... January 15, 2019 , ... HMP, a leader in ... Wound Certification Prep Course (WCPC), the leading comprehensive wound care training program. Based ... management, WCPC will be expanding its course to 12 cities nationwide, including San ...
(Date:1/14/2019)... ... 2019 , ... The Isagenix Legacy Foundation is ... that align with its mission to provide healthy nutrition and support for underserved ... Located in Arizona, California, Georgia, Massachusetts, Maryland, Michigan, and Montana, the nonprofits serve ...
(Date:1/14/2019)... ... January 14, 2019 , ... Dexter foot and ankle podiatry has been serving the Dexter ... your foot and ankle needs! We can help take care of you whether it be ... the foot pain or even any heel or ankle problems. We can help if ...
Breaking Medicine Technology:
Cached News: