Topotecan Hospira (topotecan)
- Region
- 🇪🇺 EU
- Active substance
- topotecan
- Company
- Pfizer Europe MA EEIG
- Status
- Authorised
- Therapeutic area
- Uterine Cervical Neoplasms; Small Cell Lung Carcinoma
- CHMP opinion
- Thu 18 Mar 2010
- EU approval
- Wed 09 Jun 2010
- Application
- EMEA/H/C/001192
- ATC
- L01CE01
- Official record
- www.ema.europa.eu
Indication
Topotecan monotherapy is indicated for the treatment of patients with relapsed small-cell lung cancer (SCLC) for whom re-treatment with the first-line 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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Hycamtin Authorised · Sandoz Pharmaceuticals d.d.
- 🇪🇺 Potactasol Authorised · Actavis Group PTC ehf
- 🇪🇺 Topotecan Actavis Withdrawn · Actavis Group PTC ehf
- 🇪🇺 Topotecan Teva Withdrawn · Teva B.V.
- 🇪🇺 Topotecan Eagle Withdrawn · Eagle Laboratories Ltd.
- 🇪🇺 Topotecan SUN Application withdrawn · Sun Pharmaceutical Industries Europe B.V.
- 🇪🇺 Evotopin Withdrawn · Beecham Group plc
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