Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Topotecan Hospira   

   This product is authorized under a different brandname in the EU in the folowing languages:
   - Topotecano Hospira (PT)
Auth. number : EU/1/10/633
INN : topotecan
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
Chemical subgroup: L01XX - Other antineoplastic agents
Chemical substance: L01XX17 - Topotecan
(See WHO ATC Index)
Indication: Monotherapy: treatment of patients with relapsed small cell lung cancer (SCLC); in combination with cisplatin: carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease
Marketing Authorisation Holder: Hospira UK Limited
Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, 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/2
14/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1192/IA/1
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