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Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Topotecan Hospira   

   This product is authorised under a different brand name in the EU in the following languages:
   - Topotecano Hospira (PT)
Auth. number : EU/1/10/633
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 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: Hospira UK Limited
Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom
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
14/06/2010 Centralised - Authorisation EMEA/H/C/1192 (2010)3881 of 10/06/2010
14/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1192/IA/1
14/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1192/IA/2
10/10/2011 Centralised - Variation EMEA/H/C/1192/IB/3
Updated with Decision(2011)7248 of 06/10/2011
10/10/2011 Centralised - Variation (2011)7248 of 06/10/2011
27/10/2011 Centralised - Variation EMEA/H/C/1192/IB/5
Updated with Decision(2012)3315 of 15/05/2012
25/11/2011 Centralised - Variation EMEA/H/C/1192/IB/4
Updated with Decision(2012)3315 of 15/05/2012
17/05/2012 Centralised - Variation (2012)3315 of 15/05/2012
08/06/2012 Centralised - Variation EMEA/H/C/1192/IB/7
Updated with Decision(2012)7888 of 29/10/2012
11/10/2012 Centralised - Notification EMEA/H/C/1192/N/9
Updated with Decision(2012)7888 of 29/10/2012
31/10/2012 Centralised - Variation (2012)7888 of 29/10/2012
23/07/2013 Centralised - Variation EMEA/H/C/1192/IAIN/13
Updated with Decision(2014)4499 of 27/06/2014
01/07/2014 Centralised - Yearly update (2014)4499 of 27/06/2014
19/12/2014 Centralised - Variation EMEA/H/C/1192/IB/20
Updated with Decision(2015)3724 of 28/05/2015
01/06/2015 Centralised - Renewal EMEA/H/C/1192/R/19 (2015)3724 of 28/05/2015
24/11/2015 Centralised - Variation EMEA/H/C/1192/IAIN/24/G
Updated with Decision(2016)7462 of 14/11/2016
17/06/2016 Centralised - Notification EMEA/H/C/1192/N/28
Updated with Decision(2016)7462 of 14/11/2016
16/11/2016 Centralised - Yearly update (2016)7462 of 14/11/2016
16/02/2017 Centralised - Notification EMEA/H/C/1192/N/30
16/11/2017 Centralised - Notification EMEA/H/C/1192/N/31
13/04/2018 Centralised - Variation EMEA/H/C/1192/IB/32