Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: NeuroBloc   
Auth. number : EU/1/00/166
Active substance : Botulinum Toxin Type B
ATC: Anatomical main group: M - Musculo-skeletal system
Therapeutic subgroup: M03 - Muscle relaxants
Pharmacological subgroup: M03A - Muscle relaxants, peripherally acting agents
Chemical subgroup: M03AX - Other muscle relaxants, peripherally acting
Chemical substance: M03AX01 - Botulinum toxin
(See WHO ATC Index)
Indication: Treatment of cervical dystonia (torticollis) in adults.
Marketing Authorisation Holder: Eisai Limited
European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, 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
25/01/2001 Centralised - Authorisation EMEA/H/C/301 (2001)79 of 22/01/2001
23/05/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/I/4
21/06/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/I/2
04/07/2001 Centralised - Notification EMEA/H/C/301/N/3 (2001)1381 of 02/07/2001
06/07/2001 Centralised - Variation EMEA/H/C/301/I/1 (2001)1387 of 04/07/2001
30/10/2001 Centralised - Notification EMEA/H/C/301/N/5 (2001)2981 of 29/10/2001
28/02/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/I/6
19/03/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/I/7
29/04/2002 Centralised - Annual reassessment
18/11/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/I/11
27/11/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/II/10
21/01/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/I/12
11/03/2003 Centralised - Variation EMEA/H/C/301/II/9 (2003)812 of 07/03/2003
17/07/2003 Centralised - Annual reassessment EMEA/H/C/301/S/13 (2003)2644 of 15/07/2003
05/09/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/I/15
18/09/2003 Centralised - Variation EMEA/H/C/301/II/14 (2003)3344 of 16/09/2003
11/12/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/I/18
11/12/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/I/17
03/02/2004 Centralised - Variation EMEA/H/C/301/II/16 (2004)291 of 29/01/2004
25/03/2004 Centralised - Variation EMEA/H/C/301/IA/20
Updated with Decision(2004)5377 of 17/12/2004
21/09/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/II/21
21/09/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/II/22
23/12/2004 Centralised - Annual reassessment EMEA/H/C/301/S/19 (2004)5377 of 17/12/2004
09/02/2005 Centralised - Variation EMEA/H/C/301/IA/26
Updated with Decision(2005)1055 of 29/03/2005
03/03/2005 Centralised - Variation EMEA/H/C/301/II/24 (2005)529 of 28/02/2005
04/04/2005 Centralised - Variation EMEA/H/C/301/II/23 (2005)1055 of 29/03/2005
02/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/II/28
27/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/II/27
13/07/2005 Centralised - Annual reassessment EMEA/H/C/301/S/25 (2005)2741 of 08/07/2005
18/08/2005 Centralised - Variation EMEA/H/C/301/II/29 (2005)3223 of 16/08/2005
01/09/2005 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/301/T/30 (2005)3354 of 26/08/2005
22/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/II/32
21/10/2005 Centralised - Variation EMEA/H/C/301/II/31 (2005)4166 of 19/10/2005
21/11/2005 Centralised - Variation EMEA/H/C/301/II/34 (2005)4507 of 15/11/2005
10/04/2006 Centralised - Renewal EMEA/H/C/301/R/33 (2006)1564 of 06/04/2006
06/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/II/35
23/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/IA/37
31/10/2006 Centralised - Variation EMEA/H/C/301/IA/38
Updated with Decision(2007)1516 of 28/03/2007
30/03/2007 Centralised - Variation EMEA/H/C/301/II/39 (2007)1516 of 28/03/2007
10/08/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/II/42
23/08/2007 Centralised - Variation EMEA/H/C/301/II/41 (2007)4020 of 21/08/2007
27/09/2007 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/301/T/43 (2007)4490 of 25/09/2007
16/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/IA/45
05/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/IA/46
28/02/2008 Centralised - Variation EMEA/H/C/301/II/44 (2008)819 of 26/02/2008
04/09/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/IA/52
08/09/2008 Centralised - Variation EMEA/H/C/301/IA/51
Updated with Decision(2009)700 of 30/01/2009
30/09/2008 Centralised - Notification EMEA/H/C/301/N/50
Updated with Decision(2009)700 of 30/01/2009
02/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/I/B/56
03/02/2009 Centralised - Variation EMEA/H/C/301/II/55 (2009)700 of 30/01/2009
16/02/2009 Centralised - Variation EMEA/H/C/301/IA/57
Updated with Decision(2009)2287 of 25/03/2009
12/03/2009 Centralised - Variation EMEA/H/C/301/IA/60
Updated with Decision(2009)5995 of 23/07/2009
12/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/IB/58
30/03/2009 Centralised - Variation EMEA/H/C/301/II/53 (2009)2287 of 25/03/2009
28/07/2009 Centralised - Variation EMEA/H/C/301/II/61 (2009)5995 of 23/07/2009
21/01/2010 Centralised - Notification EMEA/H/C/301/N/65
Updated with Decision(2010)8634 of 29/11/2010
02/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/II/63
02/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/II/64
25/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/IA/66
20/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/IA/68
08/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/301/IB/69
02/12/2010 Centralised - Renewal EMEA/H/C/301/R/67 (2010)8634 of 29/11/2010
04/02/2011 Centralised - Variation EMEA/H/C/301/IB/70
Updated with Decision(2011)6597 of 16/09/2011
20/09/2011 Centralised - Variation (2011)6597 of 16/09/2011
17/01/2013 Centralised - Variation EMEA/H/C/301/II/78
Updated with Decision(2014)1303 of 21/02/2014
02/07/2013 Centralised - Notification EMEA/H/C/301/N/86
Updated with Decision(2014)1303 of 21/02/2014
25/02/2014 Centralised - Yearly update (2014)1303 of 21/02/2014
26/02/2014 Centralised - Variation EMEA/H/C/301/IB/94
Updated with Decision(2015)1311 of 19/02/2015
23/02/2015 Centralised - Yearly update (2015)1311 of 19/02/2015