Saturday, September 6, 2008

EMEA - Committee For Medicinal Products For Human Use - 23-26 January 2006 - Initial Marketing Authorisation Applications




Similar pure medicinal products The CHMP adopt the hasty afloat belief in favour of a of the same kind biological medicinal article of retail. The product, Omnitrope be manufactured via Sandoz GmbH and contain a DNA-recombinant maturity hormone.



It is stand for for the healing of growth disruption and growth hormone a smaller amount inwardly offspring and adults. Omnitrope is akin to Genotropin, the extract medicinal product already authorised in the EU.



Other Pfizer initiatives: Zithromax/chloroquine clinical research program -- Pfizer scientists at this time be developing a forthcoming malaria psychotherapy labour by its widely in days gone by particular antibiotic Zithromax. Dosed in pairing with chloroquine, Zithromax have demonstrated appreciative grades resistant malaria in a pilot analysis. Clinical study are ongoing at 19 centers in 10 countries in South America, Southeast Asia, Southwest Asia and Africa.



-- Remicade (infliximab), Centocor B.V., to extend its indication to include treatment of a little to fully great ulcerative colitis. Remicade was first authorised in the European Union on 13 August 1999 and is currently approved for the treatment of rheumatoid arthritis, Crohn's illness, ankylosing spondylitis, psoriatic arthritis and psoriasis.



-- TachoSil (Human fibrinogen and human thrombin), Nycomed Austria GmbH, to amend the indication by delete the successive publication: 'Efficacy has spinster been demonstrated in liver surgery'.



TachoSil was first authorised in the European Union on 8 June 2004 and is approved for supportive treatment in surgery for progress of haemostasis where on loam established technique are poor.



The CHMP also recommended the commendation of Bondenza (ibandronic acid) and Bonviva (ibandronic acid) 3mg/3ml tablets for shot. Bondenza and Bonviva be first authorised in the European Union on 23 February 2004 and are both indicated for the treatment of osteoporosis. This will is for intravenous direction once all 3 months relate to once respectively day and once monthly oral administration once authorised.



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