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    Committee For Orphan Medicinal Products, May 2007 Meeting - Europe

The seventy-ninth meeting of the Committee for Orphan Medicinal Products (COMP) took place on 30-31 May 2007.

COMP Opinions for Orphan Medicinal Product Designation

The Committee adopted 5 positive opinions on orphan medicinal product designation during this meeting:

-- 1-{3-[3-(4-chlorophenyl)propoxy]propyl}piperidine, hydrochloride, from Bioprojet, for treatment of narcolepsy (review time: day 89)

-- Fampridine, from Dr Ulrich Granzer, for treatment of Guillain-Barré syndrome (review time: day 89)

-- Lusupultide, from ALTANA Pharma AG, for treatment of aspiration pneumonitis requiring intubation and mechanical ventilation (review time: day 89)

-- Recombinant adeno-associated viral vector containing human acid alfa-glucosidase-gene, from The Matthews Consultancy Ltd, for treatment of Pompe Disease (review time: day 89)

-- Rilonacept, Regeneron UK Limited, for treatment of cryopirin-associated periodic syndromes (Familial Cold Urticaria Syndrome (FCUS), Muckle-Wells Syndrome (MWS), and Neonatal Onset Multisystem Inflammatory Disease (NOMID), also known as Chronic Infantile Neurological Cutaneous Articular Syndrome (CINCA)) (review time: day 63)

Withdrawals of Orphan Medicinal Product Applications

The COMP noted that three applications for orphan medicinal product designation were withdrawn during evaluation.

For more information please see the full press release here (pdf)

Publication Date: 2007-06-01 11:00

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