Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Myocet   
Auth. number : EU/1/00/141
INN : Doxorubicin
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: First line treatment of metastatic breast cancer in women
Marketing Authorisation Holder: Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, 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
26/07/2000 Centralised - Authorisation EMEA/H/C/297 (2000)2028 of 13/07/2000
23/03/2001 Centralised - Variation EMEA/H/C/297/II/2 (2001)545 of 20/03/2001
03/04/2001 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/297/T/1 (2001)768 of 21/03/2001
07/11/2001 Centralised - Variation EMEA/H/C/297/I/4
25/03/2002 Centralised - Variation EMEA/H/C/297/II/5 (2002)1271 of 21/03/2002
17/04/2002 Centralised - Variation EMEA/H/C/297/I/6 (2002)1463 of 12/04/2002
23/12/2002 Centralised - Variation EMEA/H/C/297/I/7 (2002)5432 of 18/12/2002
13/01/2003 Centralised - Variation EMEA/H/C/297/I/8, 10
20/01/2003 Centralised - Variation EMEA/H/C/297/I/11
20/01/2003 Centralised - Variation EMEA/H/C/297/I/12
26/02/2003 Centralised - Variation EMEA/H/C/297/I/9
02/05/2003 Centralised - Variation EMEA/H/C/297/I/13
25/04/2005 Centralised - Variation EMEA/H/C/297/IA/15
25/04/2005 Centralised - Variation EMEA/H/C/297/IA/16
20/09/2005 Centralised - Renewal EMEA/H/C/297/R/14 (2005)3585 of 15/09/2005
21/04/2006 Centralised - Variation EMEA/H/C/297/IB/17
01/08/2006 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/297/T/18 (2006)3492 of 28/07/2006
23/02/2007 Centralised - Variation EMEA/H/C/297/IA/19
07/06/2007 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/297/T/21 (2007)2444 of 04/06/2007
04/10/2007 Centralised - Variation EMEA/H/C/297/IA/22
01/02/2008 Centralised - Variation EMEA/H/C/297/IA/23
11/06/2008 Centralised - Variation EMEA/H/C/297/IA/24
29/10/2008 Centralised - Variation EMEA/H/C/297/II/25 (2008)6420 of 27/10/2008
26/11/2008 Centralised - Variation EMEA/H/C/297/II/26 (2008)7498 of 24/11/2008
16/10/2009 Centralised - Variation EMEA/H/C/297/IA/28
Updated with Decision(2010)3501 of 26/05/2010
04/01/2010 Centralised - Variation EMEA/H/C/297/II/27
18/01/2010 Centralised - Variation EMEA/H/C/297/IA/29
28/05/2010 Centralised - Variation (2010)3501 of 26/05/2010
07/07/2010 Centralised - Renewal EMEA/H/C/297/R/30 (2010)4719 of 02/07/2010
19/08/2010 Centralised - Variation EMEA/H/C/297/IB/32/G
09/12/2010 Centralised - Variation EMEA/H/C/297/IB/33
16/02/2011 Centralised - Variation EMEA/H/C/297/IA/34
29/03/2011 Centralised - Variation EMEA/H/C/297/II/31/G (2011)2107 of 24/03/2011
25/07/2011 Centralised - Variation EMEA/H/C/297/IB/37
Updated with Decision(2012)1194 of 17/02/2012
07/09/2011 Centralised - Variation EMEA/H/C/297/N/38
Updated with Decision(2012)1194 of 17/02/2012
22/02/2012 Centralised - Variation (2012)1194 of 17/02/2012
30/03/2012 Centralised - Variation EMEA/H/C/297/IA/41
Updated with Decision(2012)7894 of 29/10/2012
21/05/2012 Centralised - Variation EMEA/H/C/297/IB/42
Updated with Decision(2012)7894 of 29/10/2012
05/11/2012 Centralised - Variation (2012)7894 of 29/10/2012
17/01/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/297/T/44 (2013)213 of 14/01/2013
04/10/2013 Centralised - Modification EMEA/H/C/297/PSU/19 (2013)6594 of 02/10/2013
06/05/2014 Centralised - Variation EMEA/H/C/297/IA/50