Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Tractocile   
Auth. number : EU/1/99/124
INN : Atosiban
ATC: Anatomical main group: G - Genito urinary system and sex hormones
Therapeutic subgroup: G02 - Other gynecologicals
Pharmacological subgroup: G02C - Other gynecologicals
Chemical subgroup: G02CX - Other gynecologicals
Chemical substance: G02CX01 - Atosiban
(See WHO ATC Index)
Indication: Indicated to delay imminent pre-term birth in pregnant adult women with:
− regular uterine contractions of at least 30 seconds duration at a rate of >= 4 per 30 minutes
− a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of >= 50%
− a gestational age from 24 until 33 completed weeks
− a normal foetal heart rate
Marketing Authorisation Holder: Ferring Pharmaceuticals A/S
Kay Fiskers Plads 11, DK-2300 København S, Danmark

  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
22/05/2000 Centralised - Variation EMEA/H/C/253/N/1 (2000)1246 of 17/05/2000
12/09/2000 Centralised - Variation EMEA/H/C/253/I/2
01/03/2001 Centralised - Variation EMEA/H/C/253/N/3 (2001)287 of 23/03/2001
20/07/2001 Centralised - Variation EMEA/H/C/253/N/4 (2001)2029 of 19/07/2001
12/09/2002 Centralised - Variation EMEA/H/C/253/II/5 (2002)3393 of 10/09/2002
06/03/2003 Centralised - Variation EMEA/H/C/253/II/6 (2003)752 of 04/03/2003
21/06/2004 Centralised - Variation EMEA/H/C/253/II/7 (2004)2242 of 17/06/2004
27/07/2004 Centralised - Variation EMEA/H/C/253/IA/11
07/09/2004 Centralised - Variation EMEA/H/C/253/IB/10
07/09/2004 Centralised - Variation EMEA/H/C/253/IB/12
07/09/2004 Centralised - Variation EMEA/H/C/253/IB/9
07/10/2004 Centralised - Variation EMEA/H/C/253/IA/14
20/12/2004 Centralised - Variation EMEA/H/C/253/IA/15
25/01/2005 Centralised - Authorisation EMEA/H/C/253 (2000)114 of 20/01/2000
02/02/2005 Centralised - Renewal EMEA/H/C/253/R/13 (2005)278 of 31/01/2005
13/07/2005 Centralised - Variation EMEA/H/C/253/IA/16
19/10/2005 Centralised - Variation EMEA/H/C/253/N/17
Updated with Decision(2006)3384 of 20/07/2006
16/11/2005 Centralised - Variation EMEA/H/C/253/IA/18
17/12/2005 Centralised - Variation EMEA/H/C/253/IA/19
17/12/2005 Centralised - Variation EMEA/H/C/253/IA/20
Updated with Decision(2006)3384 of 20/07/2006
27/07/2006 Centralised - Variation (2006)3384 of 20/07/2006
18/08/2006 Centralised - Variation EMEA/H/C/253/II/22
19/10/2006 Centralised - Variation EMEA/H/C/253/IA/29
19/10/2006 Centralised - Variation EMEA/H/C/253/IA/31
19/10/2006 Centralised - Variation EMEA/H/C/253/IA/32
19/10/2006 Centralised - Variation EMEA/H/C/253/IA/30
27/02/2007 Centralised - Variation EMEA/H/C/253/II/23
27/03/2007 Centralised - Variation EMEA/H/C/253/N/33
Updated with Decision(2008)6716 of 04/11/2008
23/05/2007 Centralised - Variation EMEA/H/C/253/IA/37
23/05/2007 Centralised - Variation EMEA/H/C/253/IA/38
06/06/2007 Centralised - Variation EMEA/H/C/253/IB/36
13/07/2007 Centralised - Variation EMEA/H/C/253/N/34
Updated with Decision(2008)6716 of 04/11/2008
24/10/2007 Centralised - Variation EMEA/H/C/253/II/35
09/11/2007 Centralised - Variation EMEA/H/C/253/N/40
Updated with Decision(2008)6716 of 04/11/2008
26/02/2008 Centralised - Variation EMEA/H/C/253/IA/42
29/02/2008 Centralised - Variation EMEA/H/C/253/IB/41
26/03/2008 Centralised - Variation EMEA/H/C/253/IB/44
26/03/2008 Centralised - Variation EMEA/H/C/253/I/B/43
06/11/2008 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/253/T/45 (2008)6716 of 04/11/2008
26/11/2008 Centralised - Variation EMEA/H/C/253/IA/48
26/11/2008 Centralised - Variation EMEA/H/C/253/IA/46
26/11/2008 Centralised - Variation EMEA/H/C/253/IA/47
02/06/2009 Centralised - Variation EMEA/H/C/253/IA/50
Updated with Decision(2009)10764 of 23/12/2009
28/12/2009 Centralised - Renewal EMEA/H/C/253/R/51 (2009)10764 of 23/12/2009
23/03/2011 Centralised - Variation EMEA/H/C/253/IA/52
Updated with Decision(2011)4171 of 07/06/2011
09/06/2011 Centralised - Variation (2011)4171 of 07/06/2011
25/07/2011 Centralised - Variation EMEA/H/C/253/IB/53
Updated with Decision(2012)1185 of 17/02/2012
21/02/2012 Centralised - Variation (2012)1185 of 17/02/2012
07/05/2012 Centralised - Variation EMEA/H/C/253/N/55
Updated with Decision(2014)77 of 09/01/2014
30/08/2012 Centralised - Variation EMEA/H/C/253/N/58
Updated with Decision(2014)77 of 09/01/2014
17/01/2013 Centralised - Variation EMEA/H/C/253/II/59
Updated with Decision(2014)77 of 09/01/2014
05/11/2013 Centralised - Variation EMEA/H/C/253/N/61
Updated with Decision(2014)77 of 09/01/2014
10/01/2014 Centralised - Variation (2014)77 of 09/01/2014