Hycamtin (topotecan)
- Region
- 🇪🇺 EU
- Active substance
- topotecan
- Company
- Sandoz Pharmaceuticals d.d.
- Status
- Authorised
- Therapeutic area
- Ovarian Neoplasms; Uterine Cervical Neoplasms; Small Cell Lung Carcinoma
- CHMP opinion
- Wed 17 Jul 1996
- EU approval
- Tue 12 Nov 1996
- Application
- EMEA/H/C/000123
- ATC
- L01CE01
- Official record
- www.ema.europa.eu
Indication
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. Topotecan is indicated for the treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy. 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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Topotecan Hospira Authorised · Pfizer Europe MA EEIG
- 🇪🇺 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- 🇪🇺 Topotecan Actavis Withdrawn · Actavis Group PTC ehf
- 🇪🇺 Topotecan Teva Withdrawn · Teva B.V.
- 🇪🇺 Topotecan Eagle Withdrawn · Eagle Laboratories Ltd.
- 🇪🇺 Topotecan SUN Application withdrawn · Sun Pharmaceutical Industries Europe B.V.
- 🇪🇺 Evotopin Withdrawn · Beecham Group plc
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