Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Metalyse   
Auth. number : EU/1/00/169
INN : tenecteplase
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: B01AD11 - Tenecteplase
(See WHO ATC Index)
Indication: Metalyse is indicated in adults for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left Bundle Branch Block within 6 hours after the onset of acute myocardial infarction (AMI) symptoms.
Marketing Authorisation Holder: Boehringer Ingelheim International GmbH
Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

  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
28/02/2001 Centralised - Authorisation EMEA/H/C/306 (2001)285 of 23/02/2001
15/10/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/306/II/1
04/04/2002 Centralised - Variation EMEA/H/C/306/II/2 (2002)1379 of 02/04/2002
23/09/2002 Centralised - Variation EMEA/H/C/306/II/3 (2002)3552 of 18/09/2002
29/11/2002 Centralised - Notification EMEA/H/C/306/N/5 (2002)4803 of 27/11/2002
27/01/2003 Centralised - Variation EMEA/H/C/306/II/4 (2003)400 of 23/01/2003
06/06/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/306/I/6
27/06/2003 Centralised - Variation EMEA/H/C/306/I/8 (2003)2084 of 25/06/2003
07/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/306/I/10
25/07/2003 Centralised - Variation EMEA/H/C/306/II/7 (2003)2776 of 23/07/2003
29/01/2004 Centralised - Variation EMEA/H/C/306/II/9, 11 (2004)221 of 27/01/2004
12/10/2004 Centralised - Notification EMEA/H/C/306/N/12
Updated with Decision(2006)499 of 13/02/2006
19/11/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/306/IA/13
17/12/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/306/IB/14
21/12/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/306/IB/17
21/12/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/306/IB/16
12/01/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/306/IB/15
23/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/306/IB/18
14/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/306/IA/24
16/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/306/IB/26
21/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/306/IB/25
23/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/306/II/23
25/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/306/II/22
15/02/2006 Centralised - Renewal EMEA/H/C/306/R/27 (2006)499 of 13/02/2006
19/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/306/IA/29
07/03/2007 Centralised - Variation EMEA/H/C/306/II/28 (2007)824 of 05/03/2007
14/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/306/IA/30
14/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/306/IA/31
27/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/306/IB/33
27/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/306/IB/32
05/03/2009 Centralised - Variation EMEA/H/C/306/IA/34
Updated with Decision(2009)8316 of 21/10/2009
23/10/2009 Centralised - Variation (2009)8316 of 21/10/2009
08/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/306/IB/39
08/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/306/IB/38
08/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/306/IB/37
08/06/2010 Centralised - Variation EMEA/H/C/306/II/35 (2010)3705 of 04/06/2010
29/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/306/II/36
18/02/2013 Centralised - Variation EMEA/H/C/306/IB/43
Updated with Decision(2014)1258 of 20/02/2014
03/02/2014 Centralised - Notification EMEA/H/C/306/N/45
Updated with Decision(2014)1258 of 20/02/2014
24/02/2014 Centralised - Yearly update (2014)1258 of 20/02/2014
25/09/2014 Centralised - Variation EMEA/H/C/306/II/46