Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Glivec   
Auth. number : EU/1/01/198
INN : Imatinib
Orphan status based on designation EU/3/01/021 added on 12/11/2001
Orphan status based on designation EU/3/01/021 removed or expired on 12/11/2011
Orphan status based on designation EU/3/01/061 added on 27/05/2002
Orphan status based on designation EU/3/01/061 removed or expired on 16/04/2012
Orphan status based on designation EU/3/05/304 added on 18/09/2006
Orphan status based on designation EU/3/05/304 removed or expired on 16/04/2012
Orphan status based on designation EU/3/05/305 added on 18/09/2006
Orphan status based on designation EU/3/05/305 removed or expired on 16/04/2012
Orphan status based on designation EU/3/05/320 added on 01/12/2006
Orphan status based on designation EU/3/05/320 removed or expired on 16/04/2012
Orphan status based on designation EU/3/05/340 added on 01/12/2006
Orphan status based on designation EU/3/05/340 removed or expired on 16/04/2012
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
Chemical subgroup: L01XE - Protein kinase inhibitors
Chemical substance: L01XE01 - Imatinib
(See WHO ATC Index)
Indication: Glivec is indicated for the treatment of
- adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is notconsidered as the first line of treatment.
- adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.- adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
- adult patients with relapsed or refractory Ph+ ALL as monotherapy.- adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
- adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.
The effect of Glivec on the outcome of bone marrow transplantation has not been determined.
Glivec is indicated for
- the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).
- the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.- the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.In adult and paediatric patients, the effectiveness of Glivec is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic GIST and DFSP and on recurrence-free survival in adjuvant GIST. The experience with Glivec in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1). Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
Marketing Authorisation Holder: Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, 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
12/11/2001 Centralised - Authorisation EMEA/H/C/406 (2001)3511 of 07/11/2001
07/01/2002 Centralised - Variation EMEA/H/C/406/I/5
27/05/2002 Centralised - Variation EMEA/H/C/406/II/1 (2002)2028 of 24/05/2002
24/12/2002 Centralised - Variation EMEA/H/C/406/II/2, 3, 4 (2002)5506 of 19/12/2002
03/07/2003 Centralised - Annual reassessment EMEA/H/C/406/S/10 (2003)2238 of 30/06/2003
16/08/2003 Centralised - Variation EMEA/H/C/406/II/8 (2003)2621 of 14/07/2003
13/11/2003 Centralised - Variation EMEA/H/C/406/X/6, 7 (2003)4288 of 11/11/2003
02/04/2004 Centralised - Annual reassessment EMEA/H/C/406/S/11 (2004)1321 of 31/03/2004
17/05/2004 Centralised - Variation EMEA/H/C/406/N/15
Updated with Decision(2005)16 of 05/01/2005
04/06/2004 Centralised - Variation EMEA/H/C/406/IB/14
Updated with Decision(2005)16 of 05/01/2005
04/06/2004 Centralised - Variation EMEA/H/C/406/IB/13
Updated with Decision(2005)16 of 05/01/2005
04/06/2004 Centralised - Variation EMEA/H/C/406/IB/12
Updated with Decision(2005)16 of 05/01/2005
21/06/2004 Centralised - Variation EMEA/H/C/406/IA/16
09/11/2004 Centralised - Variation EMEA/H/C/406/IA/18
02/12/2004 Centralised - Variation EMEA/H/C/406/IB/17
07/01/2005 Centralised - Variation (2005)16 of 05/01/2005
08/03/2005 Centralised - Variation EMEA/H/C/406/IA/23
01/04/2005 Centralised - Annual reassessment EMEA/H/C/406/S/19 (2005)1086 of 30/03/2005
06/06/2005 Centralised - Variation EMEA/H/C/406/II/20 (2005)1714 of 02/06/2005
12/07/2005 Centralised - Variation EMEA/H/C/406/II/21, 22 (2005)2729 of 08/07/2005
19/10/2005 Centralised - Variation EMEA/H/C/406/IB/24
Updated with Decision(2006)694 of 28/02/2006
19/10/2005 Centralised - Variation EMEA/H/C/406/IB/25
19/10/2005 Centralised - Variation EMEA/H/C/406/IB/26
27/02/2006 Centralised - Variation EMEA/H/C/406/II/33
02/03/2006 Centralised - Variation EMEA/H/C/406/II/27, 28 (2006)694 of 28/02/2006
22/03/2006 Centralised - Annual reassessment EMEA/H/C/406/S/29 (2006)952 of 20/03/2006
15/05/2006 Corrigendum (2006)952 corr of 11/05/2006
18/09/2006 Centralised - Variation EMEA/H/C/406/II/30, 31, 36 (2006)4183 of 13/09/2006
25/09/2006 Centralised - Renewal EMEA/H/C/406/R/37 (2006)4296 of 21/09/2006
01/12/2006 Centralised - Variation EMEA/H/C/406/II/32, 35, 38, 39, 40 (2006)5916 of 28/11/2006
14/02/2007 Centralised - Variation EMEA/H/C/406/N/44
Updated with Decision(2007)1515 of 28/03/2007
30/03/2007 Centralised - Variation EMEA/H/C/406/II/41, 42 (2007)1515 of 28/03/2007
17/04/2007 Centralised - Annual reassessment EMEA/H/C/406/S/43 (2007)1775 of 13/04/2007
21/08/2007 Centralised - Variation EMEA/H/C/406/IA/46
22/11/2007 Centralised - Variation EMEA/H/C/406/II/45 (2007)5699 of 20/11/2007
19/01/2009 Centralised - Variation EMEA/H/C/406/IA/52
19/01/2009 Centralised - Variation EMEA/H/C/406/IA/57
19/01/2009 Centralised - Variation EMEA/H/C/406/IA/55
19/01/2009 Centralised - Variation EMEA/H/C/406/IA/54
19/01/2009 Centralised - Variation EMEA/H/C/406/IA/51
19/01/2009 Centralised - Variation EMEA/H/C/406/IA/53
19/01/2009 Centralised - Variation EMEA/H/C/406/IA/56
05/05/2009 Centralised - Variation EMEA/H/C/406/II/48, 49, 50 (2009)3452 of 29/04/2009
29/03/2010 Centralised - Variation EMEA/H/C/406/II/59 (2010)2175 of 26/03/2010
29/03/2010 Centralised - Variation EMEA/H/C/406/II/58 (2010)2174 of 26/03/2010
19/05/2010 Centralised - Variation EMEA/H/C/406/IB/60
04/08/2010 Centralised - Variation EMEA/H/C/406/IA/61/G
28/10/2010 Centralised - Variation EMEA/H/C/406/IG/25/G
23/12/2010 Centralised - Variation EMEA/H/C/406/II/62 (2010)9639 of 20/12/2010
04/01/2011 Centralised - Variation EMEA/H/C/406/IB/66/G
11/01/2011 Centralised - Variation EMEA/H/C/406/IA/67/G
11/01/2011 Centralised - Variation EMEA/H/C/406/IB/65/G
21/01/2011 Centralised - Variation EMEA/H/C/406/IG/32/G
28/02/2011 Centralised - Variation EMEA/H/C/406/II/63 (2011)1220 of 21/02/2011
26/05/2011 Centralised - Variation EMEA/H/C/406/II/64 (2011)3729 of 23/05/2011
12/11/2011 Centralised - (orphan status)
19/12/2011 Centralised - Variation EMEA/H/C/406/II/71 (2011)9749 of 14/12/2011
25/01/2012 Centralised - Variation EMEA/H/C/406/II/72, 73 (2012)420 of 20/01/2012
23/02/2012 Centralised - Variation EMEA/H/C/406/II/70 (2012)1262 of 21/02/2012
16/04/2012 Centralised - (orphan status)
26/10/2012 Centralised - Variation EMEA/H/C/406/II/82 (2012)7611 of 23/10/2012
09/11/2012 Centralised - Variation EMEA/H/C/406/IAin/86
Updated with Decision(2013)4192 of 27/06/2013
15/11/2012 Centralised - Variation EMEA/H/C/406/II/84, 85
Updated with Decision(2013)4192 of 27/06/2013
01/07/2013 Centralised - Variation EMEA/H/C/406/II/80 (2013)4192 of 27/06/2013
25/07/2013 Centralised - Variation EMEA/H/C/406/II/89
Updated with Decision(2014)5245 of 18/07/2014
24/10/2013 Centralised - Variation EMEA/H/C/406/II/90
Updated with Decision(2014)5245 of 18/07/2014
19/06/2014 Centralised - Variation EMEA/H/C/406/IA/91
Updated with Decision(2014)5245 of 18/07/2014