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Lugano--(Switzerland) -
14 May , 2004
The European Commission
has officially adopted on 26 April 2004 the
EMEA (European Agency for the
Evaluation of Medicinal Products) positive scientific opinion on nimesulide
products, that was already expressed by the CPMP
(Committee for Proprietary Medicinal Products) on 24
July 2003 and published on the EMEA website on
1 August 2003.
All Member States, where the nimesulide
products are registered, shall comply with this decision which entails the
implementation of the new Summary of Product
Characteristics (SPC) which is the result of the scientific
conclusion of nimesulide’s positive benefit/risk profile by the CPMP and of the
harmonization process inside the EU.
The details of the European Commission adoption and of the EMEA scientific
opinion can be seen in the EMEA website
http://www.emea.eu.int/htms/human/referral/referral.htm
About Nimesulide
Nimesulide is one of the most prescribed non-steroidal anti-inflammatory drugs
worldwide. It has analgesic and antipyretic properties and a unique mechanism of
action when compared to other NSAIDs. The drug is a sulphonanilide derivative
and it is not related to conventional NSAIDs, which usually present a carboxil
or hydroxil functional group.
The therapeutic effects of Nimesulide are the result of its multifactorial mode
of action, which targets a number of key mediators of the inflammatory process.
The drug is a selective inhibitor of the prostaglandins synthesis enzyme,
cyclo-oxygenase.
Nimesulide has been developed and licensed out by
Helsinn Healthcare SA
and is marketed in over 50 countries worldwide by Helsinn’s partners, both
multinational and leading local pharmaceutical companies, as Aché, Angelini,
Atco, Aventis, Boehringer Ingelheim, Choongwae, CSC, Ergha Healthcare, Ergo
Maroc, Fulford, Gerolymatos, Grünenthal, GSK, Harvester, Helsinn Birex
Therapeutics, Italfarmaco, Lavipharm, Novartis, Pfizer, PT Gala, Rafa,
Robapharm, Roche, Sanofi Synthelabo, Schering-Plough, Therabel, Wyeth.
Nimesulide is available in tablets, granules, suppositories and topical gel
under different brandnames, including Ainex®,
Aulin®, Donulide®,
Edrigyl®,
Eskaflam®, Heugan®,
Mesulid®, Nexen®,
Nimecox®, Nimed®,
Nimedex®, Nisulid®,
Plarium®, Scaflam®,
Scaflan®.
For more information, please visit the product’s website
www.nimesulide.net.
About Helsinn
Helsinn Healthcare SA is a privately owned pharmaceutical group with
headquarters in Switzerland. Helsinn’s core business is the licensing of
pharmaceuticals in therapeutic niche areas. The Company’s business strategy is
to in-license early stage new chemical entities and complete their development
from the performance of pre-clinical/clinical studies and CMC development to the
attainment of market approvals in strategic markets (U.S. and Europe). Helsinn’s
products are out-licensed to its marketing partners for distribution. The active
pharmaceutical ingredients and the finished dosage forms are manufactured at
Helsinn’s cGMP (current Good Manufacturing Practices) facilities and supplied
worldwide to its customers.
For more information, please visit the Company’s website at
www.helsinn.com.
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