Topotecan Actavis (topotecan)
- Region
- 🇪🇺 EU
- Active substance
- topotecan
- Company
- Actavis Group PTC ehf
- Status
- Withdrawn
- Therapeutic area
- Uterine Cervical Neoplasms; Small Cell Lung Carcinoma
- EU approval
- Fri 24 Jul 2009
- Designations
- Generic
- Application
- EMEA/H/C/001031
- 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
- 🇪🇺 Topotecan Hospira Authorised · Pfizer Europe MA EEIG
- 🇪🇺 Hycamtin Authorised · Sandoz Pharmaceuticals d.d.
- 🇪🇺 Potactasol Authorised · 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- 🇪🇺 Topotecan Teva Withdrawn · Teva B.V.
- 🇪🇺 Topotecan Eagle Withdrawn · Eagle Laboratories Ltd.
- 🇪🇺 Topotecan SUN Application withdrawn · Sun Pharmaceutical Industries Europe B.V.
- 🇪🇺 Evotopin Withdrawn · Beecham Group plc
Follow Topotecan Actavis
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.