Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Alimta   
Auth. number : EU/1/04/290
INN : pemetrexed
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01B - Antimetabolites
Chemical subgroup: L01BA - Folic acid analogues
Chemical substance: 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

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
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/7, 8 (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/26
10/11/2009 Centralised - Variation EMEA/H/C/564/IA/25
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
Updated with Decision(2013)8155 of 15/11/2013
19/11/2013 Centralised - Variation (2013)8155 of 15/11/2013
27/02/2014 Centralised - Variation EMEA/H/C/564/N/43