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.

The CHMP recommended the harmonisation of the translation of product characteristics (SPCs) of three generic medicinal products cover lanzoprazol. Lanzoprazol AbZ and Lanzoprazol-CT be review because of variance in the posology closet involving the SPCs of the suggestion product and the SPCs of the generic products. The procedure was initiated by Germany under Article 29(2) of Directive 2001/83/EC as amended. The procedure for Lanzoprazol-ratiopharm was initiated on like decriminalized justification by Germany and Portugal because of differences in the posology and sign section of the SPCs.

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 CHMP began a referral procedure for the generic product Nifedipine Pharmamatch retard 30 and 60 mg (nifedipine), from Pharmamatch BV. The procedure concerns differences between the SPC of the reference product and the SPC of the generic product relating to contraindications during pregnancy and lactation. It was initiated by the United Kingdom under Article 29 (2) of Directive 2001/83/EC as amended.

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.