<p>This is a summary of the European public assessment report (EPAR) for Potactasol. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Potactasol.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>Topotecan monotherapy is indicated for the treatment of:<br>- patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy<br>- 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).</p> <p>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 (see section 5.1).</p></div>
Therapeutic Area (MeSH)
ATC Code
L01CE01
ATC Item
N/A
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| topotecan | N/A | topotecan |
EMA Name
Potactasol
Medicine Name
Potactasol
Aliases
N/ANo risk management plan link.
