🇪🇺 HYCAMTIN, oral capsules in European Union

EMA authorised HYCAMTIN, oral capsules on 12 November 1996

Marketing authorisation

EMA — authorised 12 November 1996

  • Application: EMEA/H/C/000123
  • Marketing authorisation holder: Sandoz Pharmaceuticals d.d.
  • Local brand name: Hycamtin
  • 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.
  • Status: approved

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Frequently asked questions

Is HYCAMTIN, oral capsules approved in European Union?

Yes. EMA authorised it on 12 November 1996.

Who is the marketing authorisation holder for HYCAMTIN, oral capsules in European Union?

Sandoz Pharmaceuticals d.d. holds the EU marketing authorisation.