topotecan - EPARs for human use -

FICHA FARMACOLÓGICA de topotecan. 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 24, 2010.-

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

Active Substance
topotecan
International Nonproprietary Name or Common Name
topotecan
Pharmaco-therapeutic Group
Other antineoplastic agents
ATC Code
L01X X17

Therapeutic Indication:
Topotecan is indicated for the treatment of:

- patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy;

- patients with relapsed small cell lung cancer [SCLC] for whom re-treatment with the firstline regimen is not considered appropriate.

Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.

HYCAMTIN capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1).


Date of issue of Marketing Authorisation valid throughout the European Union
12 November 1996

Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use