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Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Alimta
|
| Auth. number : | EU/1/04/290 |
| INN : | pemetrexed |
| ATC: | L - Antineoplastic and immunomodulating agents L01 - Cytostatics L01B - Antimetabolites L01BA - Folic acid analogues L01BA04 - Pemetrexed (See WHO ATC Index) |
| Indication: | Malignant pleural mesothelioma ALIMTA in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer ALIMTA in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology ALIMTA is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy ALIMTA is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology |
| Marketing Authorisation Holder: | Eli Lilly Nederland B.V.
Grootslag 1-5, NL-3991 RA Houten, Nederland |
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 |
| 22/09/2004 | Centralised - Authorisation | EMEA/H/C/564 | (2004)3580 of 20/09/2004 | |||
| 01/02/2006 | Centralised - Variation | EMEA/H/C/564/II/2 | (2006)290 of 30/01/2006 | |||
| 22/05/2006 | Centralised - Variation | EMEA/H/C/564/IB/3 | ||||
| 29/11/2006 | Centralised - Variation | EMEA/H/C/564/IB/10 | ||||
| 30/01/2007 | Centralised - Variation | EMEA/H/C/564/II/4 | (2007)311 of 26/01/2007 | |||
| 16/03/2007 | Centralised - Variation | EMEA/H/C/564/II/6 | (2007)1273 of 14/03/2007 | |||
| 07/11/2007 | Centralised - Variation | EMEA/H/C/564/II/8, 7 | (2007)5431 of 31/10/2007 | |||
| 29/11/2007 | Centralised - Variation | EMEA/H/C/564/IB/11 | ||||
| 25/01/2008 | Centralised - Variation | EMEA/H/C/564/II/12 | (2008)330 of 22/01/2008 | |||
| 10/04/2008 | Centralised - Variation | EMEA/H/C/564/II/9 | (2008)1374 of 08/04/2008 | |||
| 18/06/2008 | Centralised - Variation | EMEA/H/C/564/IB/13 | ||||
| 08/01/2009 | Centralised - Variation | EMEA/H/C/564/II/14 | (2009)27 of 06/01/2009 | |||
| 22/01/2009 | Centralised - Variation | EMEA/H/C/564/IA/17 | ||||
| 25/03/2009 | Centralised - Variation | EMEA/H/C/564/II/16 | ||||
| 11/06/2009 | Centralised - Variation | EMEA/H/C/564/IA/20 | ||||
| 07/07/2009 | Centralised - Variation | EMEA/H/C/564/II/15 | (2009)5482 of 02/07/2009 | |||
| 08/07/2009 | Centralised - Variation | EMEA/H/C/564/IB/21 | ||||
| 30/07/2009 | Centralised - Variation | EMEA/H/C/564/IB/22 | ||||
| 23/09/2009 | Centralised - Renewal | EMEA/H/C/564/R/18 | (2009)7413 of 21/09/2009 | |||
| 10/11/2009 | Centralised - Variation | EMEA/H/C/564/IA/25 | ||||
| 10/11/2009 | Centralised - Variation | EMEA/H/C/564/IA/26 | ||||
| 24/11/2009 | Centralised - Variation | EMEA/H/C/564/IB/24 | ||||
| 12/01/2010 | Centralised - Variation | EMEA/H/C/564/II/23 | ||||
| 08/03/2010 | Centralised - Variation | EMEA/H/C/564/IB/27 | ||||
| Updated with Decision(2010)6440 of 16/09/2010 | ||||||
| 23/03/2010 | Centralised - Variation | EMEA/H/C/564/IA/30 | ||||
| 03/05/2010 | Centralised - Variation | EMEA/H/C/564/II/29/G | ||||
| 14/07/2010 | Centralised - Variation | EMEA/H/C/564/II/28/G | ||||
| 20/09/2010 | Centralised - Variation | - | (2010)6440 of 16/09/2010 | |||
| 15/12/2010 | Centralised - Variation | EMEA/H/C/564/IB/32 | ||||
| 01/02/2011 | Centralised - Variation | EMEA/H/C/564/II/31/G | (2011)567 of 27/01/2011 | |||
| 10/03/2011 | Centralised - Variation | EMEA/H/C/564/IA/34 | ||||
| 26/10/2011 | Centralised - Variation | EMEA/H/C/564/II/33 | (2011)7784 of 24/10/2011 | |||
| 16/12/2011 | Centralised - Variation | EMEA/H/C/564/IB/36/G | ||||
| Updated with Decision(2012)5355 of 23/07/2012 | ||||||
| 27/07/2012 | Centralised - Variation | EMEA/H/C/564/II/37 | (2012)5355 of 23/07/2012 | |||
| 26/10/2012 | Centralised - Variation | EMEA/H/C/564/II/38 | (2012)7621 of 23/10/2012 | |||
| 14/11/2012 | Centralised - Variation | EMEA/H/C/564/IB/40/G | ||||