Navigation Links
Astellas ontvangt handelsvergunning voor VESOMNITM van Nederlandse College ter Beoordeling van Geneesmiddelen
Date:5/23/2013

CHERTSEY, Engeland, May 23, 2013 /PRNewswire/ --

Nederland keurt als eerste nieuwe vaste-dosis combinatiebehandeling goed voor mannen met lagere urinewegsymptomen geassocieerd met BPH

Astellas Pharma EUROPE BV, de Europese dochteronderneming van Astellas Pharma Inc, gebaseerd in Tokyo  (Tokyo: 4503), kondigde vandaag aan dat het Nederlandse College ter Beoordeling van Geneesmiddelen (CBG) een handelsvergunning heeft verleend voor VESOMNI in Nederland.

De handelsvergunning verleend voor VESOMNI is voor "de behandeling van matige tot ernstige opslagsymptomen (urgentie, verhoogde mictie-frequentie) en ledigingsklachten geassocieerd met benigne prostaathyperplasie (BPH) bij mannen die niet voldoende reageren op een behandeling met monotherapie".[1]

Nederland zal de referentielidstaat zijn voor verdere registratie van VESOMNI in Europa als onderdeel van toekomstige Europese procedures voor wederzijdse erkenning.

VESOMNI is een omhulde, tweelaagse tablet met gereguleerde afgifte die geschikt is voor eenmaal daagse behandeling. Elke tablet bevat 6 mg antimuscarinerge solifenacine en 0,4 mg alpha1-adrenoceptorantagonist (α1-blokker) tamsulosine (in het oraal beheerste absorptiesysteem (orally controlled absorbsion system) [OCAS]) (Tocas).

Fase III gegevens toonden aan dat VESOMNI statistisch significante verbeteringen leverde ten opzichte van TOCAS wat opslagparameters en levenskwaliteit betreft voor mannen van 45 jaar of ouder met matige tot ernstige opslagsymptomen en ledigingsklachten.[2] Daarnaast toonde VESOMNI statistisch significante verbeteringen ten opzichte van placebo's met betrekking tot alle belangrijke eindpunten.[2]

In de fase III-studie waren de meest voorkomende bijwerkingen voor VESOMNI een droge mond en constipa
'/>"/>

SOURCE Astellas Pharma Europe B.V.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. First sales of DIFICLIR™ by Astellas Pharma Europe triggers 10 Million Euro Milestone Payment to Optimer Pharmaceuticals
2. Astellas and Fujita Health University Discover Neuronal Maturation Deficits in Patients Suffering from Schizophrenia and Bipolar Disorder
3. Astellas to Close Urogenix, North Carolina-based Urology Research Facility
4. Personal Connections Drive Employee Participation For Changing Tomorrow Day at Astellas
5. Astellas Announces Acceptance of U.S. New Drug Application for Tacrolimus Extended Release Capsules
6. Ambit and Astellas Announce Presentation of Results from Phase 2 ACE Study of Quizartinib in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) at the 54th Annual Meeting of the American Society of Hematology
7. Astellas Highlights Progress to Advance Care of Patients with Genitourinary Cancers at ASCO-GU Annual Meeting
8. Astellas to Drive PGA TOURs New Womens Initiative
9. PGA TOUR Celebrates Official Launch of the Astellas Presents Executive Womens Day Program
10. Astellas and Ambit to End Collaboration for Joint Development and Commercialization of FLT3 Kinase Inhibitors
11. Astellas Pharma Inc.: New Hire Reinforces Global Compliance Structure
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/29/2015)... VIEW, Calif. , July 29, 2015  Efforts ... the growth strategy of pharmaceutical firms in ... . The realization is that an effective working capital ... pricing pressures and patent cliffs. Big pharma companies expect ... returns. Logo - http://photos.prnewswire.com/prnh/20150724/241957LOGO ...
(Date:7/28/2015)... SAN FRANCISCO , July 28, 2015 ... & Johnson, has introduced a new platform of embolic ... an enhanced detachment system designed to improve microcatheter stability ... . The announcement was made here at the Society ... The family of framing, filling and finishing ...
(Date:7/28/2015)... JOLLA, Calif. , July 28, 2015   ... biopharmaceutical company leading the discovery and development of innovative ... financial results and highlights for the quarter ended June ... U.S. financial markets close. Regulus will ... 4, 2015, at 5:00 pm Eastern Daylight Time to ...
Breaking Medicine Technology:Working Capital Management Seizes Priority in North American and European Pharma Industry 2Working Capital Management Seizes Priority in North American and European Pharma Industry 3Working Capital Management Seizes Priority in North American and European Pharma Industry 4Codman Neuro Launches Family Of Coils For Treatment Of Brain Aneurysms 2Codman Neuro Launches Family Of Coils For Treatment Of Brain Aneurysms 3Codman Neuro Launches Family Of Coils For Treatment Of Brain Aneurysms 4Regulus Announces Timing for Second Quarter 2015 Financial Results Webcast and Conference Call 2Regulus Announces Timing for Second Quarter 2015 Financial Results Webcast and Conference Call 3
... Leading health sciences publisher makes key ... UN developing world research access program ... information products and services, today announced that it is ... , a public-private partnership working to achieve the UN,s ...
... (NASDAQ: LMNX ) today announced that it expects ... on Tuesday, November 1, 2011.  A press release announcing ... of trading. (Logo:   http://photos.prnewswire.com/prnh/20100104/LUMINEXLOGO ) ... the operating highlights and financial results for the third quarter ...
Cached Medicine Technology:Elsevier Offers 950 New Health Titles to Research4Life 2Elsevier Offers 950 New Health Titles to Research4Life 3Luminex Corporation Third Quarter Earnings Release Scheduled for November 1, 2011 2Luminex Corporation Third Quarter Earnings Release Scheduled for November 1, 2011 3
(Date:7/29/2015)... ... ... Awareness Month, and in honor of this month, Dr. Melda Isaac of MI-Skin Dermatology and ... as well as how to best treat existing sun damage. Sun damage can range from ... America. Many people do not protect their skin sufficiently when going out in the sun, ...
(Date:7/29/2015)... Madison, Wis. (PRWEB) , ... July 29, 2015 ... ... enrolled its first two patients in a Clinical Performance Study for the Invisiport ... includes 4.4 and 6 French catheter options, offers a less invasive, patient-friendly alternative ...
(Date:7/29/2015)... Toronto, Canada (PRWEB) , ... July 29, 2015 ... ... described as a “forward thinker.” Since the late 1970s, Dr. Cottrell has been ... His new book, The New Earth, documents many of these prognostications. He warns ...
(Date:7/29/2015)... ... July 29, 2015 , ... ... has entered into a partnership with 247Ergo, an ergonomics specialty firm. Purpose of ... Ergonomics projects that the companies undertake could improve worker mobility, functionality and fitness ...
(Date:7/29/2015)... , ... July 29, 2015 , ... ... gastroenterologist, has launched a chewable version of its EndoMune Jr. probiotic supplement for ... tasty, all-natural supplement that children can enjoy to maintain a healthy balance of ...
Breaking Medicine News(10 mins):Health News:July is UV Awareness Month: Learn Top Tips from a Prominent Dermatologist this National UV Awareness Month 2Health News:July is UV Awareness Month: Learn Top Tips from a Prominent Dermatologist this National UV Awareness Month 3Health News:Stealth Therapeutics Inc. Enrolls First Patients in a Clinical Performance Study for the Invisiport Product Line 2Health News:Stealth Therapeutics Inc. Enrolls First Patients in a Clinical Performance Study for the Invisiport Product Line 3Health News:Author Warns Public to Prepare for Imminent Environmental Disaster 2Health News:HealthPostures and 247Ergo Partnership Strengthens America's Wellness 2Health News:HealthPostures and 247Ergo Partnership Strengthens America's Wellness 3Health News:EndoMune Advanced Probiotic adds Chewable Tablet for Kids to Product Line 2Health News:EndoMune Advanced Probiotic adds Chewable Tablet for Kids to Product Line 3
... and interactions between noncoding genes play a much greater ... research, published by Cell Press in the September issue ... identifying tumor-specific signatures associated with diagnosis, prognosis, and treatment ... oncogenes or tumor suppressor genes. More recently, a large ...
... implanted in the skull that detects oncoming seizures, then delivers ... is under study at the Medical College of Georgia. , ... to determine if the neurostimulator device can help patients whose ... constantly monitors electrical activity of the brain, gets accustomed to ...
... LINDA, Calif., Sept. 10 Loma Linda ... Adventist institution located,in Southern California, has chosen ... referrals and outbound reminder calls for its ... physician referrals for breast care, psychology, urology,gynecology, ...
... entries reveal wellness trends of on-staff pharmacists, ... a focus on healthy aging, CHICAGO, Sept. ... the third-annual Health at Work Award: Sprint; Erie ... Library District. Winners,were selected based on their wellness ...
... Merger and Manage Company Company Announces ... 10 Arrow International,Inc. (Nasdaq: ARRO ), a ... critical and cardiac care, reported that Glass,Lewis & Co., ... to,approve Arrow,s planned $45.50 merger with Teleflex Incorporated (NYSE:,TFX) ...
... Robbins & Myers, Inc.,(NYSE: RBN ) announced ... year results for 2007, which ended August 31, 2007, ... live webcast of the conference call,will be held at ... Robbins & Myers will be Peter C. Wallace, President ...
Cached Medicine News:Health News:Altered expression of ultraconserved noncoding RNAs linked to human leukemias and carcinomas 2Health News:Implantable device designed to detect, stop seizures under study at MCG 2Health News:Loma Linda University Medical Center Selects Beryl to Manage Call Center Interactions for Women's Services Programs and Departments 2Health News:ComPsych(R) Corp. Announces Health at Work(SM) Award Winners: Sprint, Erie Insurance, City of Naperville and Green Hills Public Library 2Health News:Glass Lewis Recommends Arrow Shareholders Vote on the White Proxy Card for Merger With Teleflex and for Current Board of Directors at Arrow Annual Meeting 2Health News:Glass Lewis Recommends Arrow Shareholders Vote on the White Proxy Card for Merger With Teleflex and for Current Board of Directors at Arrow Annual Meeting 3
...
...
... Modular Shoulder System* was designed ... a comprehensive range of prosthesis ... patient needs. With the addition ... Nephew offers a more complete ...
...
Medicine Products: