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:10/13/2017)... Ky. (PRWEB) , ... October 13, 2017 , ... The ... MPH to become its next President and Chief Executive Officer, succeeding Dr. James C. ... CEO Elect beginning July 1, 2018 until Dr. Puffer’s retirement at the end of ...
(Date:10/13/2017)... ... , ... PurhealthRX , a leading Health and Nutrition Company, is announcing ... full spectrum CBD oil will revolutionize the rapidly growing CBD market by reducing the ... incorporated into liquid products, while reducing costs to end users. , The team of ...
(Date:10/13/2017)... ... October 13, 2017 , ... Lori R. Somekh, founder of ... ElderCounsel, a national organization of elder law and special needs planning attorneys. “Membership in ... It also provides a forum to network with elder law attorneys nationwide,” said Somekh. ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Many families have ... many long-term care insurance companies have a waiver for care if the client has ... period, when the family pays for care, is often waived, so the benefits from ...
(Date:10/13/2017)... York, NY (PRWEB) , ... October 13, 2017 , ... ... influential people in business to advocate for action towards gender equality at their inaugural ... views from around the globe, and reached a social audience of over 3 million. ...
Breaking Medicine News(10 mins):
(Date:10/10/2017)... Pa. , Oct. 10, 2017   West ... in innovative solutions for injectable drug administration, today shared ... West,s ID Adapter for improving the intradermal administration of ... Fourth Skin Vaccination Summit in May 2017 by Dr. ... Lead, Polio Department, World Health Organization (WHO), and recently ...
(Date:10/5/2017)...  In response to the nationwide opioid epidemic, ... (AAOMS) released prescribing recommendations that urge ibuprofen – ... a first-line therapy to manage a patient,s acute ... Recognizing the value and importance of the ... Acute and Postoperative Pain Management" stresses that practitioners ...
(Date:10/4/2017)... Oct. 4, 2017  According to the Centers for Disease Control and ... October . PhysicianOne Urgent Care is helping communities across Massachusetts ... , by offering no-cost* flu shots through the end of the ... certain health insurance regulations. ... time to get a flu shot is by the end of October, ...
Breaking Medicine Technology:
Cached News: