Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Caelyx   
Auth. number : EU/1/96/011
Active substance : Doxorubicin hydrochloride
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01D - Cytotoxic antibiotics
Chemical subgroup: L01DB - Anthracyclines
Chemical substance: L01DB01 - Doxorubicin
(See WHO ATC Index)
Indication: Caelyx is indicated:
- As monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk.
- For treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen.
- In combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.
- For treatment of AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (< 200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease.
Caelyx may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).
Marketing Authorisation Holder: Janssen-Cilag International NV
Turnhoutseweg 30, B-2340 Beerse, België
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
25/06/1996 Centralised - Authorisation EMEA/H/C/89 (96)1660 of 21/06/1996
20/02/1997 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/89/T/1 (97)482 of 18/02/1997
15/05/1997 Centralised - Variation EMEA/H/C/89/I/2, 4 (97)1312 of 07/05/1997
05/08/1997 Centralised - Variation EMEA/H/C/89/II/3 (97)2658 of 29/07/1997
05/08/1999 Centralised - Variation EMEA/H/C/89/II/12 (1999)2503 of 26/07/1999
22/02/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/89/I/15
25/02/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/89/I/16
05/06/2000 Centralised - Variation EMEA/H/C/89/II/14 (2000)1411 of 29/05/2000
25/10/2000 Centralised - Authorisation EMEA/H/C/89/II/13 (2000)2857 of 24/10/2000
30/04/2001 Centralised - Variation EMEA/H/C/89/I/18 (2001)870 of 27/04/2001
09/07/2001 Centralised - Variation EMEA/H/C/89/II/17 (2001)1390 of 05/07/2001
25/09/2001 Centralised - Renewal EMEA/H/C/89/R/19 (2001)2742 of 25/09/2001
21/01/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/89/I/20, 21
21/02/2002 Centralised - Notification EMEA/H/C/89/N/22 (2002)633 of 19/02/2002
17/05/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/89/I/24
17/05/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/89/I/24
14/01/2003 Centralised - Variation EMEA/H/C/89/II/23 (2003)265 of 10/01/2003
24/01/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/89/I/26
19/03/2003 Centralised - Notification EMEA/H/C/89/N/27 (2003)850 of 17/03/2003
08/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/89/I/28
15/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/89/I/29
12/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/89/I/30
17/05/2004 Centralised - Notification EMEA/H/C/89/N/31
Updated with Decision(2005)22 of 05/01/2005
07/01/2005 Centralised - Variation EMEA/H/C/89/II/34 (2005)12 of 05/01/2005
07/01/2005 Centralised - Variation EMEA/H/C/89/II/32 (2005)22 of 05/01/2005
21/02/2005 Centralised - Variation EMEA/H/C/89/II/33 (2005)417 of 17/02/2005
10/03/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/89/IA/35
22/06/2005 Centralised - Notification EMEA/H/C/89/N/36
Updated with Decision(2006)2117 of 19/05/2006
23/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/89/IA/37
11/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/89/IB/39
23/05/2006 Centralised - Renewal EMEA/H/C/89/R/38 (2006)2117 of 19/05/2006
24/10/2006 Centralised - Variation EMEA/H/C/89/II/40 (2006)5116 of 20/10/2006
05/01/2007 Centralised - Notification EMEA/H/C/89/N/42
Updated with Decision(2007)2344 of 30/05/2007
12/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/89/IB/43
17/04/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/89/IA/44
01/06/2007 Centralised - Variation EMEA/H/C/89/II/41 (2007)2344 of 30/05/2007
01/08/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/89/II/46
07/08/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/89/IB/48
08/10/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/89/IB/47
29/10/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/89/IA/49
18/12/2007 Centralised - Variation EMEA/H/C/89/II/45 (2007)6676 of 14/12/2007
22/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/89/IA/50
29/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/89/IB/51
17/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/89/IA/53
19/02/2009 Centralised - Notification EMEA/H/C/89/N/52
Updated with Decision(2010)6782 of 27/09/2010
24/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/89/IB/54
12/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/89/IB/56/G
15/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/89/IA/58
29/09/2010 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/89/T/57 (2010)6782 of 27/09/2010
11/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/89/IA/60
11/11/2010 Centralised - Variation EMEA/H/C/89/IAin/59
Updated with Decision(2011)4173 of 07/06/2011
09/06/2011 Centralised - Variation (2011)4173 of 07/06/2011
28/11/2011 Referral EMEA/H/C/89/A-20/61 (2011)8838 of 24/11/2011
31/05/2012 Centralised - Variation EMEA/H/C/89/IB/62
Updated with Decision(2012)7900 of 29/10/2012
31/05/2012 Referral EMEA/H/C/89/A-20/61 (2012)3606 of 25/05/2012
05/11/2012 Centralised - Variation (2012)7900 of 29/10/2012
19/09/2013 Centralised - Variation EMEA/H/C/89/II/66
Updated with Decision(2014)6511 of 11/09/2014
15/09/2014 Centralised - Yearly update (2014)6511 of 11/09/2014
22/01/2015 Centralised - Notification EMEA/H/C/89/N/76