Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Herceptin   
Auth. number : EU/1/00/145
INN : trastuzumab
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
Chemical subgroup: L01XC - Monoclonal antibodies
Chemical substance: L01XC03 - Trastuzumab
(See WHO ATC Index)
Indication: Breast cancer
Metastatic breast cancer
Herceptin is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer: (MBC):
  • - as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor
    positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.
  • - in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.
  • - in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.
  • - in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.
Early breast cancer
Herceptin is indicated for the treatment of adult patients with HER2 positive early breast cancer. (EBC).
  • - following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1).
  • - following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.
  • - in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
  • - in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 4.4 and 5.1).
Herceptin should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay (see sections 4.4 and 5.1).

Metastatic gastric cancer
Herceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. Herceptin should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result. Accurate and validated assay methods should be used (see sections 4.4 and 5.1).
Marketing Authorisation Holder: Roche Registration Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, 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
04/09/2000 Centralised - Authorisation EMEA/H/C/278 (2000)2539 of 28/08/2000
07/01/2002 Centralised - Variation EMEA/H/C/278/I/3
27/05/2002 Centralised - Variation EMEA/H/C/278/II/2 (2002)1983 of 22/05/2002
18/09/2002 Centralised - Variation EMEA/H/C/278/I/5
16/01/2003 Centralised - Variation EMEA/H/C/278/II/4 (2003)309 of 14/01/2003
26/02/2003 Centralised - Variation EMEA/H/C/278/I/6, 7
31/03/2003 Centralised - Variation EMEA/H/C/278/II/8
14/10/2003 Centralised - Variation EMEA/H/C/278/I/9
28/05/2004 Centralised - Variation EMEA/H/C/278/N/12
Updated with Decision(2004)4246 of 22/10/2004
14/06/2004 Centralised - Variation EMEA/H/C/278/II/11 (2004)2114 of 10/06/2004
11/10/2004 Centralised - Variation EMEA/H/C/278/IB/14
26/10/2004 Centralised - Variation EMEA/H/C/278/II/13 (2004)4246 of 22/10/2004
24/11/2004 Centralised - Variation EMEA/H/C/278/II/15
21/12/2004 Centralised - Variation EMEA/H/C/278/IB/16
Updated with Decision(2005)1414 of 28/04/2005
03/05/2005 Centralised - Variation EMEA/H/C/278/II/17 (2005)1414 of 28/04/2005
30/06/2005 Centralised - Variation EMEA/H/C/278/II/18 (2005)2089 of 28/06/2005
09/09/2005 Centralised - Variation EMEA/H/C/278/IA/22
13/09/2005 Centralised - Renewal EMEA/H/C/278/R/19 (2005)3486 of 08/09/2005
01/12/2005 Centralised - Variation EMEA/H/C/278/IA/23
Updated with Decision(2006)2142 of 22/05/2006
21/12/2005 Centralised - Variation EMEA/H/C/278/II/21
10/01/2006 Centralised - Variation EMEA/H/C/278/IA/24
03/05/2006 Centralised - Variation EMEA/H/C/278/II/25
24/05/2006 Centralised - Variation EMEA/H/C/278/II/26 (2006)2142 of 22/05/2006
11/07/2006 Centralised - Variation EMEA/H/C/278/IA/30
01/08/2006 Centralised - Variation EMEA/H/C/278/IB/31
Updated with Decision(2006)5113 of 20/10/2006
03/08/2006 Centralised - Variation EMEA/H/C/278/II/28
20/09/2006 Centralised - Variation EMEA/H/C/278/IA/32
Updated with Decision(2006)5113 of 20/10/2006
28/09/2006 Centralised - Variation EMEA/H/C/278/II/29
24/10/2006 Centralised - Variation EMEA/H/C/278/II/27 (2006)5113 of 20/10/2006
12/02/2007 Centralised - Variation EMEA/H/C/278/N/36
Updated with Decision(2007)1200 of 09/03/2007
27/02/2007 Centralised - Variation EMEA/H/C/278/II/35
13/03/2007 Centralised - Variation EMEA/H/C/278/II/34 (2007)1200 of 09/03/2007
26/04/2007 Centralised - Variation EMEA/H/C/278/II/33 (2007)1899 of 24/04/2007
02/05/2007 Centralised - Variation EMEA/H/C/278/II/37
27/09/2007 Centralised - Variation EMEA/H/C/278/II/38
18/01/2008 Centralised - Variation EMEA/H/C/278/IA/41
Updated with Decision(2008)5018 of 05/09/2008
28/04/2008 Centralised - Variation EMEA/H/C/278/II/40
11/06/2008 Centralised - Variation EMEA/H/C/278/II/42
09/09/2008 Centralised - Variation (2008)5018 of 05/09/2008
11/09/2008 Centralised - Variation EMEA/H/C/278/II/39 (2008)5082 of 09/09/2008
04/12/2008 Centralised - Variation EMEA/H/C/278/II/43 (2008)8008 of 02/12/2008
05/01/2009 Centralised - Variation EMEA/H/C/278/II/44
16/07/2009 Centralised - Variation EMEA/H/C/278/II/45
21/01/2010 Centralised - Variation EMEA/H/C/278/II/47 (2010)344 of 19/01/2010
29/06/2010 Centralised - Variation EMEA/H/C/278/II/49
30/07/2010 Centralised - Renewal EMEA/H/C/278/R/48 (2010)5400 of 28/07/2010
12/08/2010 Centralised - Variation EMEA/H/C/278/II/50 (2010)5622 of 06/08/2010
28/09/2010 Centralised - Variation EMEA/H/C/278/II/52
27/10/2010 Centralised - Variation EMEA/H/C/278/II/51, 54 (2010) 7530 of 25/10/2010
01/02/2011 Centralised - Variation EMEA/H/C/278/II/55 (2011)575 of 27/01/2011
27/04/2011 Centralised - Variation EMEA/H/C/278/II/53 (2011)2952 of 20/04/2011
27/06/2011 Centralised - Variation EMEA/H/C/278/II/56 (2011)4621 of 23/06/2011
21/12/2011 Centralised - Variation EMEA/H/C/278/II/57 (2011)9950 of 19/12/2011
21/02/2012 Centralised - Variation EMEA/H/C/278/II/59 (2012)1184 of 17/02/2012
17/01/2013 Centralised - Variation EMEA/H/C/278/II/62
Updated with Decision(2013)5603 of 26/08/2013
28/08/2013 Centralised - Variation EMEA/H/C/278/X/60 (2013)5603 of 26/08/2013
21/11/2013 Centralised - Variation EMEA/H/C/278/II/69/G
Updated with Decision(2013)9753 of 18/12/2013
23/12/2013 Centralised - Variation EMEA/H/C/278/II/68/G (2013)9753 of 18/12/2013
20/02/2014 Centralised - Variation EMEA/H/C/278/II/74
26/06/2014 Centralised - Variation EMEA/H/C/278/II/80