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Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Topotecan Actavis   

   This product is authorised under a different brand name in the EU in the following languages:
   - Topotecán Actavis (ES)
Auth. number : EU/1/09/536
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 relapsed small cell lung cancer [SCLC] for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1). 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
30/07/2009 Centralised - Authorisation EMEA/H/C/1031 (2009)6041 of 24/07/2009
7/12/2009 Centralised - Notification EMEA/H/C/1031/N/1
Updated with Decision(2012)1559 of 06/03/2012
24/07/2011 Centralised - Variation EMEA/H/C/1031/IB/3
Updated with Decision(2012)1559 of 06/03/2012
21/09/2011 Centralised - Variation EMEA/H/C/1031/IB/7/G
Updated with Decision(2012)1559 of 06/03/2012
8/03/2012 Centralised - Variation (2012)1559 of 6/03/2012
29/10/2013 Centralised - Notification EMEA/H/C/1031/N/10
Updated with Decision(2014)3940 of 06/06/2014
11/06/2014 Centralised - Renewal EMEA/H/C/1031/R/11 (2014)3940 of 6/06/2014
13/08/2014 Centralised - Notification EMEA/H/C/1031/N/12
Updated with Decision(2016)411 of 22/01/2016
19/01/2015 Centralised - Variation EMEA/H/C/1031/IB/13
Updated with Decision(2016)411 of 22/01/2016
27/01/2016 Centralised - Yearly update (2016)411 of 22/01/2016