Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Rapilysin   
Auth. number : EU/1/96/018
INN : Reteplase
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B01 - Antithrombotic agents
Pharmacological subgroup: B01A - Antithrombotic agents
Chemical subgroup: B01AD - Enzymes
Chemical substance: B01AD07 - Reteplase
(See WHO ATC Index)
Indication: Rapilysin is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left Bundle Branch Block within 12 hours after the onset of acute myocardial infarction AMI symptoms.
Marketing Authorisation Holder: Actavis Group PTC ehf.
Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

  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
30/08/1996 Centralised - Authorisation EMEA/H/C/105 (96)2454 of 29/08/1996
19/03/1998 Centralised - Variation EMEA/H/C/105/II/4 (1998)693 of 18/03/1998
16/04/1998 Centralised - Variation EMEA/H/C/105/I/6 (1998)950 of 15/04/1998
07/10/1998 Centralised - Variation EMEA/H/C/105/II/7 (1998)2830 of 05/10/1998
25/03/1999 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/105/I/9 (1999)744 of 19/03/1999
13/04/1999 Centralised - Variation EMEA/H/C/105/I/10 (1999)896 of 08/04/1999
01/06/2000 Centralised - Variation EMEA/H/C/105/II/11 (2000)1412 of 29/05/2000
13/03/2001 Centralised - Variation EMEA/H/C/105/I/13
22/03/2001 Centralised - Variation EMEA/H/C/105/II/12 (2001)610 of 20/03/2001
11/05/2001 Centralised - Variation EMEA/H/C/105/II/14
09/10/2001 Centralised - Variation EMEA/H/C/105/I/15
15/11/2001 Centralised - Renewal EMEA/H/C/105/R/16 (2001)3521 of 09/11/2001
04/04/2002 Centralised - Variation EMEA/H/C/105/II/17 (2002)1370 of 27/03/2002
26/03/2003 Centralised - Variation EMEA/H/C/105/I/20
26/03/2003 Centralised - Variation EMEA/H/C/105/I/18
02/05/2003 Centralised - Variation EMEA/H/C/105/I/19
26/06/2003 Centralised - Variation EMEA/H/C/105/I/22
11/08/2003 Centralised - Variation EMEA/H/C/105/II/21 (2003)2993 of 07/08/2003
25/06/2004 Centralised - Variation EMEA/H/C/105/II/23
23/09/2004 Centralised - Variation EMEA/H/C/105/II/24
27/04/2005 Centralised - Variation EMEA/H/C/105/II/26
07/10/2005 Centralised - Variation EMEA/H/C/105/N/25
Updated with Decision(2005)4293 of 27/10/2005
31/10/2005 Centralised - Variation EMEA/H/C/105/II/27 (2005)4293 of 27/10/2005
09/12/2005 Corrigendum EMEA/H/C/105/II/27
09/12/2005 Centralised - Variation EMEA/H/C/105/IA/28
Updated with Decision(2006)3720 of 10/08/2006
14/08/2006 Centralised - Renewal EMEA/H/C/105/R/29 (2006)3720 of 10/08/2006
09/02/2007 Centralised - Variation EMEA/H/C/105/N/30
Updated with Decision(2007)3031 of 14/06/2007
19/06/2007 Centralised - Variation EMEA/H/C/105/II/31 (2007)3031 of 14/06/2007
24/06/2008 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/105/T/32 (2008)3202 of 20/06/2008
15/07/2008 Centralised - Variation EMEA/H/C/105/IA/34
22/07/2008 Centralised - Variation EMEA/H/C/105/IA/33
Updated with Decision(2009)2611 of 31/03/2009
02/04/2009 Centralised - Variation (2009)2611 of 31/03/2009
12/08/2009 Centralised - Variation EMEA/H/C/105/II/35
06/05/2010 Centralised - Variation EMEA/H/C/105/N/36
23/03/2012 Centralised - Variation EMEA/H/C/105/N/38
02/05/2012 Centralised - Variation EMEA/H/C/105/N/39