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:6/25/2016)... ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library on June 21 ... brings up a new, often overlooked aspect of head lice: the parasite’s ability to live ... not a common occurrence, but a necessary one in the event that lice have simply ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... recover from injury. Recently, he has implemented orthobiologic procedures as a method for ... is one of the first doctors to perform the treatment. Orthobiologics are substances ...
(Date:6/24/2016)... Michigan (PRWEB) , ... June 24, 2016 , ... Those ... deal with these feelings, many turn to unhealthy avenues, such as drug or alcohol ... of Marne, Michigan, has released tools for healthy coping following a traumatic event. , ...
(Date:6/24/2016)... Fla. (PRWEB) , ... June 24, 2016 , ... Global ... Trend magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this recognition ... Florida. , Seven Greenberg Traurig Shareholders received special honors as members of this year’s ...
(Date:6/24/2016)... ... ... People across the U.S. are sharpening their pencils and honing their writing ... which patients and their families pay tribute to a genetic counselor by nominating him ... Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. , In April, Genome ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)...  In a startling report released today, National Safety Council ... a comprehensive, proven plan to eliminate prescription opioid overdoses. ... states are tackling the worst drug crisis in recorded U.S. history, ... Kentucky , New Mexico , ... the 28 failing states, three – Michigan , ...
(Date:6/23/2016)... 2016 Research and Markets has announced ... report to their offering. ... a favourable commercial environment for MedImmune to enter. The US ... will serve to drive considerable growth for effective anti-influenza medications. ... cap sales considerably, but development is still in its infancy. ...
(Date:6/23/2016)... , June 23, 2016  Astellas today announced the establishment of Astellas Farma Colombia (AFC), a new affiliate ... in Latin America . ... ... ... ...
Breaking Medicine Technology:
Cached News: