Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Synagis   
Auth. number : EU/1/99/117
INN : palivizumab
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J06 - Immune sera and immunoglobulins
Pharmacological subgroup: J06B - Immunoglobulins
Chemical subgroup: J06BB - Specific immunoglobulins
Chemical substance: J06BB16 - Palivizumab
(See WHO ATC Index)
Indication: Prevention of serious lower respiratory tract disease requiring hospitalisation caused by respiratory syncytial virus (RSV) in children at high risk for RSV disease:
- Children born at 35 weeks of gestation or less and less than 6 months of age at the onset of the RSV season.
- Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months.
- Children less than 2 years of age and with haemodynamically significant congenital heart disease.
Marketing Authorisation Holder: AbbVie Ltd
Maidenhead, SL6 4XE, 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
25/08/1999 Centralised - Authorisation EMEA/H/C/257 (1999)2684 of 13/08/1999
12/10/2000 Centralised - Variation EMEA/H/C/257/N/2 (2000)2785 of 29/09/2000
26/02/2001 Centralised - Variation EMEA/H/C/257/I/4
05/06/2001 Centralised - Variation EMEA/H/C/257/II/5 (2001)1268 of 01/06/2001
28/08/2001 Centralised - Variation EMEA/H/C/257/I/7 (2001)2185 of 24/08/2001
19/12/2001 Centralised - Variation EMEA/H/C/257/II/6
07/03/2002 Centralised - Variation EMEA/H/C/257/I/8 (2002)979 of 05/03/2002
28/05/2002 Centralised - Variation EMEA/H/C/257/II/9 (2002)2024 of 24/05/2002
22/07/2002 Centralised - Variation EMEA/H/C/257/I/10
05/02/2003 Centralised - Variation EMEA/H/C/257/N/11 (2003)481 of 03/02/2003
19/05/2003 Centralised - Variation EMEA/H/C/257/N/14 (2003)1682 of 15/05/2003
03/07/2003 Centralised - Variation EMEA/H/C/257/II/12 (2003)2232 of 30/06/2003
22/10/2003 Centralised - Variation EMEA/H/C/257/II/13 (2003)3953 of 20/10/2003
29/03/2004 Centralised - Variation EMEA/H/C/257/II/15 (2004)1208 of 25/03/2004
02/07/2004 Centralised - Variation EMEA/H/C/257/N/17
Updated with Decision(2004)3485 of 09/09/2004
04/08/2004 Centralised - Variation EMEA/H/C/257/II/16
13/09/2004 Centralised - Renewal EMEA/H/C/257/R/18 (2004)3485 of 09/09/2004
19/11/2004 Centralised - Variation EMEA/H/C/257/IA/20
23/03/2005 Centralised - Variation EMEA/H/C/257/II/23
24/05/2005 Centralised - Variation EMEA/H/C/257/N/24
Updated with Decision(2006)3429 of 25/07/2006
12/01/2006 Centralised - Variation EMEA/H/C/257/IA/25
12/01/2006 Centralised - Variation EMEA/H/C/257/IA/27
12/01/2006 Centralised - Variation EMEA/H/C/257/IA/28
12/01/2006 Centralised - Variation EMEA/H/C/257/IA/26
16/03/2006 Centralised - Variation EMEA/H/C/257/N/30
Updated with Decision(2006)3429 of 25/07/2006
08/06/2006 Centralised - Variation EMEA/H/C/257/II/32
15/06/2006 Centralised - Variation EMEA/H/C/257/IA/40
28/07/2006 Centralised - Variation EMEA/H/C/257/II/33 (2006)3429 of 25/07/2006
28/07/2006 Centralised - Variation EMEA/H/C/257/IA/41
28/07/2006 Centralised - Variation EMEA/H/C/257/IA/43
28/07/2006 Centralised - Variation EMEA/H/C/257/IA/42
07/08/2006 Centralised - Variation EMEA/H/C/257/II/31
29/08/2006 Centralised - Variation EMEA/H/C/257/IA/44
Updated with Decision(2007)1272 of 14/03/2007
27/09/2006 Centralised - Variation EMEA/H/C/257/II/36
23/10/2006 Centralised - Variation EMEA/H/C/257/II/37
23/10/2006 Centralised - Variation EMEA/H/C/257/II/38
23/10/2006 Centralised - Variation EMEA/H/C/257/II/35
29/11/2006 Centralised - Variation EMEA/H/C/257/II/34
19/12/2006 Centralised - Variation EMEA/H/C/257/II/45
04/01/2007 Centralised - Variation EMEA/H/C/257/N/47
Updated with Decision(2007)1272 of 14/03/2007
16/03/2007 Centralised - Variation (2007)1272 of 14/03/2007
07/05/2007 Centralised - Variation EMEA/H/C/257/II/46
11/05/2007 Centralised - Variation EMEA/H/C/257/IA/53
11/05/2007 Centralised - Variation EMEA/H/C/257/IA/52
11/05/2007 Centralised - Variation EMEA/H/C/257/IA/50
11/05/2007 Centralised - Variation EMEA/H/C/257/IA/51
25/06/2007 Centralised - Variation EMEA/H/C/257/II/49 (2007)3137 of 21/06/2007
24/10/2007 Centralised - Variation EMEA/H/C/257/II/54
19/12/2007 Centralised - Variation EMEA/H/C/257/II/48
20/05/2008 Centralised - Variation EMEA/H/C/257/IA/55
Updated with Decision(2009)562 of 26/01/2009
20/10/2008 Centralised - Variation EMEA/H/C/257/N/56
Updated with Decision(2009)562 of 26/01/2009
28/01/2009 Centralised - Variation (2009)562 of 26/01/2009
15/06/2009 Centralised - Variation EMEA/H/C/257/IA/58
30/07/2009 Centralised - Renewal EMEA/H/C/257/R/57 (2009)6104 of 27/07/2009
01/09/2009 Centralised - Variation EMEA/H/C/257/IA/61
01/09/2009 Centralised - Variation EMEA/H/C/257/IA/60
26/11/2009 Centralised - Variation EMEA/H/C/257/II/59 (2009)9462 of 24/11/2009
23/12/2009 Centralised - Variation EMEA/H/C/257/IA/62
Updated with Decision(2010)1996 of 23/03/2010
23/03/2010 Centralised - Variation (2010)1996 of 23/03/2010
15/09/2011 Centralised - Variation EMEA/H/C/257/II/63 (2011)6517 of 13/09/2011
21/12/2011 Centralised - Variation EMEA/H/C/257/II/64, 65 (2011)9946 of 19/12/2011
29/06/2012 Centralised - Variation (2012)4494 of 27/06/2012
29/06/2012 Centralised - Variation EMEA/H/C/257/IAin/70
Updated with Decision(2012)4494 of 27/06/2012
12/10/2012 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/257/T/76 (2012)7207 of 10/10/2012
08/11/2012 Centralised - Variation EMEA/H/C/257/IAin/78
Updated with Decision(2013)8898 of 04/12/2013
11/01/2013 Centralised - Variation EMEA/H/C/257/N/80
Updated with Decision(2013)8898 of 04/12/2013
21/02/2013 Centralised - Variation EMEA/H/C/257/II/77
Updated with Decision(2013)8898 of 04/12/2013
14/06/2013 Centralised - Variation EMEA/H/C/257/N/90
Updated with Decision(2013)8898 of 04/12/2013
25/07/2013 Centralised - Variation EMEA/H/C/257/II/91
Updated with Decision(2013)8898 of 04/12/2013
24/10/2013 Centralised - Variation EMEA/H/C/257/II/93
Updated with Decision(2013)8898 of 04/12/2013
24/10/2013 Centralised - Variation EMEA/H/C/257/II/92
Updated with Decision(2013)8898 of 04/12/2013
06/12/2013 Centralised - Variation (2013)8898 of 04/12/2013
26/06/2014 Centralised - Variation EMEA/H/C/257/II/99
Updated with Decision(2014)6099 of 22/08/2014
26/08/2014 Centralised - Variation EMEA/H/C/257/X/95 (2014)6099 of 22/08/2014