Meeting Highlights From The Committee For Medicinal Products For Human Use, 18-21 June 2007, Europe Positive Opinions

* Atriance (nelarabine), from Glaxo Group Limited, in support of the analysis of T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic leukaemia (T-LBL) of patients enclosed by second regress. Atriance be the 40th stray medicinal article of trade to receive a cheery evaluation. EMEA consideration begin with the sideways of 21 June 2006 beside an winning review circumstance of 203 days. Atriance is the impulsive medicinal product for which an submission be submit using the Product Information Management (PIM) principle. PIM enable the electronic barter of the product gossip plateful of a marketing authorisation application in the European Union. Its aim is to escalate usefulness of the control and exchange of the product information and to increase the characteristic and team spirit of the published product information.

* Gliolan (5-aminolevulinic hydrochloride), from Medac, for the visualisation of malignant tissue during surgery for malignant glioma in developed patients. Gliolan is the 41st orphan medicinal product to receive a positive opinion. EMEA review began on 24 May 2006 with an active review time of 199 days.

* Flebogammadif [human majority immunoglobulin (IVIg)], from Instituto Grifols S.A., for double treatment in immunodeficiency and for immunomodulation in immune-mediated bug. EMEA review began on 27 September 2006 with an active review time of 177 days.

* Rasilez, Enviage, Sprimeo, Tekturna and Riprazo (aliskiren), from Novartis Europharm Ltd, for the treatment of vital hypertension. EMEA review began on 27 September 2006 for Rasilez and on 25 March 2007 for Enviage, Sprimeo, Tekturna and Riprazo with an active review time of 194 for Rasilez and 77 days for Enviage, Sprimeo, Tekturna and Riprazo.

Positive opinion for similar go medicinal products The CHMP adopt positive opinion for three biosimilar medicinal products. Binocrit (Epoetin alfa), from Sandoz GmbH, Epoetin alfa Hexal (Epoetin alfa), from Hexal Biotech Forschungs GmbH, and Abseamed (Epoetin alfa), from Medice Arzneimittel Pütter GMBH & Co, be dependable for the treatment of anaemia associated with confirmed kidney disease and in oncology patients; and to decrease blood transfusion requirements in oncology patients and prior to elective orthopaedic surgery. All three medicinal products relevant be shown to be akin to Eprex/Erypo, the mention medicinal product already authorised in the EU, in the applied indication. EMEA review began on 29 March 2006 with an active review time of 205 days.

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