omalizumab - EPARs for human use

FICHA FARMACOLÓGICA de omalizumab Contiene la Monografía en distintos idiomas (de la Unión Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. FEBRERO 19, 2010.-

abrir aquí para acceder al documento EMEA completo:
http://www.ema.europa.eu/humandocs/Humans/EPAR/xolair/xolair.htm

Active Substance
omalizumab
International Nonproprietary Name or Common Name
omalizumab
Pharmaco-therapeutic Group
Other systemic drugs for obstructive airway diseases
ATC Code
R03DX05

Therapeutic Indication:
Adults and adolescents (12 years of age and older):
Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.



Children (6 to <12 years of age):
Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.

Xolair treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma

Date of issue of Marketing Authorisation valid throughout the European Union
25 October 2005

Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use