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:6/2/2015)... , June 2, 2015 ANI Pharmaceuticals, Inc. ... has received approval from the U.S. Food and Drug ... for Oxycodone Hydrochloride Oral Solution 5mg/5mL. Trailing twelve-month sales ... with three current competitors. ANI expects to begin shipping ... Przybyl , President and CEO of ANI Pharmaceuticals, stated, ...
(Date:6/2/2015)... 2015 San MediTech, the industry leader in ... (CGM) for diabetics, announced its plan to attend the ... Boston on June 5 th ... Glucose Monitoring System (DGMS). The company plans to show ... innovative technologies and advancements made by Chinese medical device ...
(Date:6/2/2015)... -- Integrated Service Solutions, Inc. ("the Company") announced today they are expanding their reach nationally by providing customers with on-site 17025 accredited ... ... ... ... Photo - http://photos.prnewswire.com/prnh/20150601/219758 ...
Breaking Medicine Technology:ANI Pharmaceuticals Announces FDA Approval of Oxycodone Hydrochloride Oral Solution 5mg/5mL 2ANI Pharmaceuticals Announces FDA Approval of Oxycodone Hydrochloride Oral Solution 5mg/5mL 3San MediTech Showcases Smart Glucose Management Cloud Database at 75th ADA 2San MediTech Showcases Smart Glucose Management Cloud Database at 75th ADA 3San MediTech Showcases Smart Glucose Management Cloud Database at 75th ADA 4Integrated Service Solutions, Inc. Announces Nationwide Expansion for On-site Pipette Calibrations 2Integrated Service Solutions, Inc. Announces Nationwide Expansion for On-site Pipette Calibrations 3Integrated Service Solutions, Inc. Announces Nationwide Expansion for On-site Pipette Calibrations 4
(Date:6/2/2015)... The Non-GMO Project offers North America’s ... to rigorous best practices for GMO (genetically modified ... with the Non-GMO Project Standard - that means ... inspections and an annual audit to ensure the ... Systems is and has always been wholeheartedly committed ...
(Date:6/2/2015)... a popular online store selling celebrity inspired fashion products, ... dresses. The company carries more than 1000 styles of ... a wide variety of summer events like wedding and ... quality trendy special occasion dresses and accessories. ... and cotton. Their products feature a wide range of ...
(Date:6/2/2015)... 2015 TranSlice: Reveal from Pixel Film Studios ... Reveal allows Final Cut Pro X users to transition from ... their next screen. , TranSlice Reveal brings back the split ... Pro X users can now transition from one screen ... every panel orientation and direction covered, no transition will look ...
(Date:6/2/2015)... June 02, 2015 The Radiosurgery ... study from the RSSearch® Patient Registry evaluating the ... radiotherapy (SBRT) for the treatment of centrally located ... metastases. , The study, published in the ... ), included 111 patients with 114 centrally located ...
(Date:6/2/2015)... (PRWEB) June 02, 2015 Amercanex, ... tapped Jim Miller to become Amercanex’s new Chief ... cannabis marketplace in which cultivators, wholesale distributors and ... inventories in a fully transparent intra-state market. , ... in the financial technology space, helping innovative technology ...
Breaking Medicine News(10 mins):Health News:Savoury Systems International Receives Non-GMO Project Verification Continuing its Commitment to Provide Customers with Clean Label Ingredients 2Health News:Announcing the release of TranSlice Reveal from Pixel Film Studios - Professional Split Screen Transitions for FCPX. 2Health News:New Study from RSSearch® Patient Registry Highlights Treatment Patterns and Clinical Outcomes of Stereotactic Radiosurgery for Central Lung Tumors 2Health News:New Study from RSSearch® Patient Registry Highlights Treatment Patterns and Clinical Outcomes of Stereotactic Radiosurgery for Central Lung Tumors 3Health News:Amercanex Names Jim Miller to CTO Position 2
... and other factors influence the way// individuals perceive loudness ... report. ,Tinnitus, a ringing, buzzing or whistling sound ... can be acute or chronic, constant or intermittent. Tinnitus ... unknown origin. According to background information in the article, ...
... treatment for new born babies who develop jaundice soon ... researchers say that this increases the likelihood of moles ... life. Such moles are termed melanocytic naevi in medical ... ,like melanoma ,are linked to naevi, the researchers warn ...
... Paris: To ascertain the exact reason that led to the ... France//, officials are conducting detailed tests, though preliminary investigations have ... by the ministry, the death of the birds was sudden, ... keeping healthy. The owner of the farm is pretty ...
... Gov. Ed Rendell will announce a health care reform plan ... to millions of Pennsylvanians who lack coverage. Governor added that ... ,The plan, which was under development for months, ... supported by Mr. Rendell. ,Moreover, Mr. Rendell ...
... surgical procedures may be more likely to develop pneumonia ... those without HIV, according to a report in the ... JAMA/Archives journals. In addition, HIV patients with a preoperative ... the blood) greater than 30,000 per milliliter appear to ...
... states of India migrate to the industrialized regions in India's ... AIDS.// Bihari migrants are estimated to range from two million ... security guards or domestic servants in India's big cities. ... doing," Srivastava, a Bihari aged 48, told Reporters in Patna, ...
Cached Medicine News:Health News:Clinical Factors of Tinnitus Influence Perceived Loudness and Annoyance 2Health News:HIV Patients Have Increased Risk of Pneumonia, Death Following Surgery 2Health News:Poverty Fuels HIV In Poor Indian States 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: