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- Topotecan Hospira
Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
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: | L - Antineoplastic and immunomodulating agents L01 - Cytostatics L01X - Other cytostatics L01XX - Other antineoplastic agents 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
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be available in the Community Register. |
European Commission procedures
| 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 | EMEA/H/C/1192/IA/2 | ||||
| 14/09/2010 | Centralised - Variation | EMEA/H/C/1192/IA/1 | ||||
| 10/10/2011 | Centralised - Variation | - | (2011)7248 of 06/10/2011 | |||
| 10/10/2011 | Centralised - Variation | EMEA/H/C/1192/IB/3 | ||||
| Updated with Decision(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 - Variation | 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 |