Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Tyverb   
Auth. number : EU/1/07/440
INN : lapatinib
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: L01XE07 - Lapatinib
(See WHO ATC Index)
Indication: Treatment of adult patients with breast cancer, whose tumours overexpress HER2 (ErbB2);
• in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting (see section 5.1).
• in combination with trastuzumab for patients with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy (see Section 5.1).
• in combination with an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy. The patients in the registration study were not previously treated with trastuzumab or an aromatase inhibitor (see section 5.1). No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population.
Marketing Authorisation Holder: Glaxo Group Ltd
980 Great West Road, Brentford, Middlesex, TW8 9GS, 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
12/06/2008 Centralised - Authorisation EMEA/H/C/795 (2008)2742 of 10/06/2008
02/03/2009 Centralised - Variation EMEA/H/C/795/II/1, 3 (2009)1465 of 26/02/2009
27/03/2009 Centralised - Annual renewal EMEA/H/C/795/RA/2 (2009)2291 of 25/03/2009
08/07/2009 Centralised - Variation EMEA/H/C/795/IA/6
08/07/2009 Centralised - Variation EMEA/H/C/795/IA/7
05/11/2009 Centralised - Variation EMEA/H/C/795/II/8
09/11/2009 Centralised - Variation EMEA/H/C/795/II/5 (2009)8711 of 05/11/2009
22/01/2010 Centralised - Variation EMEA/H/C/795/II/9 (2010)400 of 20/01/2010
29/04/2010 Centralised - Variation EMEA/H/C/795/II/11 (2010)2852 of 27/04/2010
05/05/2010 Centralised - Annual renewal EMEA/H/C/795/R/10 (2010)2944 of 29/04/2010
07/05/2010 Centralised - Variation EMEA/H/C/795/II/4 (2010)3071 of 05/05/2010
21/06/2010 Centralised - Variation EMEA/H/C/795/II/12 (2010)4211 of 17/06/2010
02/08/2010 Centralised - Variation EMEA/H/C/795/II/13 (2001)5383 of 28/07/2010
09/09/2010 Corrigendum (2010)6232 corr of 06/09/2010
21/01/2011 Centralised - Variation EMEA/H/C/795/IG/34/G
Updated with Decision(2011)3720 of 23/05/2011
26/01/2011 Centralised - Variation EMEA/H/C/795/IA/54
09/02/2011 Centralised - Variation EMEA/H/C/795/IB/15
Updated with Decision(2011)3720 of 23/05/2011
12/04/2011 Centralised - Annual renewal EMEA/H/C/795/R/14 (2011)2624 of 08/04/2011
27/05/2011 Centralised - Variation EMEA/H/C/795/II/16 (2011)3720 of 23/05/2011
19/07/2011 Centralised - Variation EMEA/H/C/795/IA/18/G
Updated with Decision(2012)649 of 31/01/2012
02/02/2012 Centralised - Variation (2012)649 of 31/01/2012
17/04/2012 Centralised - Annual renewal EMEA/H/C/795/R/21 (2012)2538 of 13/04/2012
24/05/2012 Centralised - Variation EMEA/H/C/795/IA/25
Updated with Decision(2012)5614 of 31/07/2012
02/08/2012 Centralised - Variation EMEA/H/C/795/II/24 (2012)5614 of 31/07/2012
15/11/2012 Centralised - Variation EMEA/H/C/795/II/27
Updated with Decision(2013)2304 of 17/04/2013
13/12/2012 Centralised - Variation EMEA/H/C/795/II/26
Updated with Decision(2013)2304 of 17/04/2013
18/04/2013 Centralised - Variation EMEA/H/C/795/IG/279
Updated with Decision(2013)4949 of 25/07/2013
19/04/2013 Centralised - Annual renewal EMEA/H/C/795/R/28 (2013)2304 of 17/04/2013
29/07/2013 Centralised - Variation EMEA/H/C/795/II/22 (2013)4949 of 25/07/2013
14/03/2014 Centralised - Annual renewal EMEA/H/C/795/R/30 (2014)1735 of 12/03/2014
24/07/2014 Centralised - Variation EMEA/H/C/795/II/33