Quantcast

Subscribe to:
POZ magazine
E-newsletters
Join POZ: Facebook MySpace Twitter Pinterest
Tumblr Google+ Flickr MySpace
POZ Personals
Sign In / Join
Username:
Password:
Welcome, Guest. Please login or register.
September 21, 2014, 10:19:26 PM

Login with username, password and session length


Members
  • Total Members: 23515
  • Latest: Sevans
Stats
  • Total Posts: 639721
  • Total Topics: 48559
  • Online Today: 210
  • Online Ever: 585
  • (January 07, 2014, 02:31:47 PM)
Users Online

Welcome


Welcome to the POZ/AIDSmeds Community Forums, a round-the-clock discussion area for people with HIV/AIDS, their friends/family/caregivers, and others concerned about HIV/AIDS.  Click on the links below to browse our various forums; scroll down for a glance at the most recent posts; or join in the conversation yourself by registering on the left side of this page.

Privacy Warning:  Please realize that these forums are open to all, and are fully searchable via Google and other search engines. If you are HIV positive and disclose this in our forums, then it is almost the same thing as telling the whole world (or at least the World Wide Web). If this concerns you, then do not use a username or avatar that are self-identifying in any way. We do not allow the deletion of anything you post in these forums, so think before you post.

  • The information shared in these forums, by moderators and members, is designed to complement, not replace, the relationship between an individual and his/her own physician.

  • All members of these forums are, by default, not considered to be licensed medical providers. If otherwise, users must clearly define themselves as such.

  • Forums members must behave at all times with respect and honesty. Posting guidelines, including time-out and banning policies, have been established by the moderators of these forums. Click here for “Am I Infected?” posting guidelines. Click here for posting guidelines pertaining to all other POZ/AIDSmeds community forums.

  • We ask all forums members to provide references for health/medical/scientific information they provide, when it is not a personal experience being discussed. Please provide hyperlinks with full URLs or full citations of published works not available via the Internet. Additionally, all forums members must post information which are true and correct to their knowledge.

  • Product advertisement—including links; banners; editorial content; and clinical trial, study or survey participation—is strictly prohibited by forums members unless permission has been secured from POZ.

To change forums navigation language settings, click here (members only), Register now

Para cambiar sus preferencias de los foros en español, haz clic aquí (sólo miembros), Regístrate ahora

Finished Reading This? You can collapse this or any other box on this page by clicking the symbol in each box.

Author Topic: European Medicines Agency recommends lifting of suspension for Viracept  (Read 1026 times)

0 Members and 1 Guest are viewing this topic.

Offline newt

  • Member
  • Posts: 3,885
  • the one and original newt
EMEA PRESS RELEASE 20 Sept 2007

European Medicines Agency recommends lifting of suspension for Viracept

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) today recommended the lifting of the suspension of the marketing authorisation for Viracept (nelfinavir, as nelfinavir mesilate), from Roche, and the re-introduction of the medicine onto the market in the European Union.

The marketing authorisation for Viracept was suspended on 6 August 2007, following the contamination during the manufacturing process of several batches of the active substance with ethyl mesilate, a known genotoxic substance.

The CHMP has assessed the corrective and preventive measures put in place by Roche, and these have also been verified by an inspection of the manufacturing site. As a result, the CHMP has been reassured that the cause of the contamination has been eliminated and that future production of Viracept would meet the required quality standards.

The CHMP therefore decided to recommend to the European Commission the lifting of the marketing authorisation suspension. Once this decision has been issued, Roche will be able to resume supply of Viracept to patients.

---ENDS

http://www.emea.europa.eu/pdfs/general/direct/pr/41816807en.pdf

- matt


"The object is to be a well patient, not a good patient"

 


Terms of Membership for these forums
 

© 2014 Smart + Strong. All Rights Reserved.   terms of use and your privacy
Smart + Strong® is a registered trademark of CDM Publishing, LLC.