Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Potactasol   
Auth. number : EU/1/10/660
Active substance : topotecan
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XX - Other antineoplastic agents
Chemical substance: L01XX17 - topotecan
(See WHO ATC Index)
Indication: Topotecan monotherapy is indicated for the treatment of:
- patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.
- patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with thefirst-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.
Marketing Authorisation Holder: Actavis Group PTC ehf.
Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
10/01/2011 Centralised - Authorisation EMEA/H/C/2282 (2011)66 of 06/01/2011
01/12/2011 Centralised - Variation EMEA/H/C/2282/IB/1
Updated with Decision(2012)4756 of 04/07/2012
06/07/2012 Centralised - Variation (2012)4756 of 04/07/2012
13/08/2014 Centralised - Notification EMEA/H/C/2282/N/3
Updated with Decision(2015)6872 of 05/10/2015
17/01/2015 Centralised - Variation EMEA/H/C/2282/IB/4
Updated with Decision(2015)6872 of 05/10/2015
27/04/2015 Centralised - Variation EMEA/H/C/2282/IB/8
Updated with Decision(2015)6872 of 05/10/2015
07/10/2015 Centralised - Renewal EMEA/H/C/2282/R/9 (2015)6872 of 05/10/2015
06/10/2016 Centralised - Notification EMEA/H/C/2282/N/11
12/05/2017 Centralised - Notification EMEA/H/C/2282/N/12
20/03/2018 Centralised - Notification EMEA/H/C/2282/N/14