CHMP - Initial marketing authorizations, Europe, September 2005 Part 2

Review of NSAIDs The Committee continual its survey of the accessible notes next to the cardiovascular, gastro-intestinal and buckskin sanctuary of non-selective non-steroidal anti-inflammatory drugs (NSAIDs). It be anticipated that an overall opportunity on the opposing safety aspect considered sheltered by sponsorship of this evaluation will be reach during the Committee's October 2005 rendezvous.

Finalised referral procedures The CHMP finalised a referral progression in advocate of Adartrel (ropinirole), from Laboratoires GlaxoSmithKline, in front of the guidance to empower the medicinal goods for the psychoanalysis of pleasant to stringent idiopathic fidgety legs syndrome. The referral be initiate because of kindness on the subject of efficacy and long-term safety by Spain and The Netherlands downwards Article 29(2) of Directive 2001/83/EC through amended. After review all available authentication the Committee concluded that the benefit-risk reallocate about together for Adartel is useful and that a marketing authorisation should be granted.

Among the gene variants, respectively was differently associated with blood pressure measurements in men versus women. Of 48 SNPs, two influenced blood pressure individual in men, while two other SNPs contribute only in women. All four SNPs demonstrated significant gender-by-gene interchange effects on blood pressure. Two other SNPs also show significant gene-by-gender interactions, but their effects were not significant in either men or women alone. Furthermore, the scientists executive several example where out of the ordinary gene variations were observed to floor show directionally opposed effects on blood pressure in men and women.

Start of referral procedures The CHMP switch on a referral procedure for the generic product Ceftriaxone Tyrol 1g and 2g (ceftriaxone) from Sandoz Ltd, because of differences between the SPC of the reference product and the SPC of the generic product, on the dose of newborn infant. The procedure was initiated by the United Kingdom under Article 29(2) of Directive 2001/83/EC as amended.

"The availability of Protonix For Delayed-Release Oral Suspension afford fully fledged patients who cannot knock spinal column tablets near an forceful and handy mode to excess their erosive gastroesophageal reflux illness (GERD)," say gastroenterologist Richard Lynn, MD, Senior Director, Global Medical Affairs within strut of Wyeth Pharmaceuticals.

The CHMP began a referral procedure for Stamaril and associated tradenames, from Sanofi Pasteur MSD, in coach to harmonise the national SPCs, in pernickety the section dealing with indication and safety aspects, across the European Union. The referral was made by the marketing authorisation holder under Article 30 of Directive 2001/83/EC as amended.

The Committee began referral procedures for Seretide Diskus, Viani Diskus, Seretide Evohaler and Viani Evohaler from GlaxoSmithKline. These products be once relevant in the treatment of asthma. The conglomerate was referred to the CHMP by the marketing authorisation holder under Article 6(13) of Commission Regulation (EC) No 1084/2003. The Committee is claim to gnaw complete whether or not the proposed new building of indication should be granted.

A more detailed CHMP meeting gossip will be published shortly.

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