Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


WITHDRAWN  

Product information

Invented name: Refludan

   This product is authorized under a different brandname in the EU in the folowing languages:
   - Refludin (ES)
Auth. number : EU/1/97/035
INN : Lepirudin
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B01 - Antithrombotic agents
Pharmacological subgroup: B01A - Antithrombotic agents
Chemical subgroup: B01AE - Direct thrombin inhibitors
Chemical substance: B01AE02 - Lepirudin
(See WHO ATC Index)
Indication: Anticoagulation in adult patients with heparin-induced thrombocytopenia (HIT) type II and thromboembolic disease mandating parenteral antithrombotic therapy.The diagnosis should be confirmed by the HIPAA (heparin induced platelet activation assay) or an equivalent test.
Marketing Authorisation Holder: Celgene Europe Limited
1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, 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 continues to be 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
14/03/1997 Centralised - Authorisation EMEA/H/C/122 (97)711 of 13/03/1997
11/07/1997 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/122/T/3 (97)2138 of 09/07/1997
28/08/1997 Centralised - Variation EMEA/H/C/122/I/5 (97)2750 of 27/08/1997
02/02/1998 Other procedure EMEA/H/C/122 (1998)211 of 30/01/1998
23/03/1999 Centralised - Authorisation EMEA/H/C/122/II/8 (1999)693 of 16/03/1999
11/05/2001 Centralised - Variation EMEA/H/C/122/II/10
23/10/2001 Centralised - Variation EMEA/H/C/122/I/11 (2001)2871 of 19/10/2001
11/12/2001 Centralised - Variation EMEA/H/C/122/I/13 (2001)3593 of 21/11/2001
11/02/2002 Centralised - Variation EMEA/H/C/122/II/12 (2002)503 of 06/02/2002
25/02/2002 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/122/T/15 (2002)636 of 19/02/2002
30/04/2002 Centralised - Renewal EMEA/H/C/122/R/14 (2002)1702 of 25/04/2002
15/05/2003 Centralised - Variation EMEA/H/C/122/N/17 (2003)1618 of 12/05/2003
16/07/2003 Centralised - Variation EMEA/H/C/122/II/16 (2003)2631 of 14/07/2003
06/09/2004 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/122/T/18 (2004)3429 of 02/09/2004
05/04/2005 Centralised - Variation EMEA/H/C/122/IB/19
Updated with Decision(2005)4269 of 25/10/2005
30/06/2005 Centralised - Variation EMEA/H/C/122/IA/20
Updated with Decision(2005)4269 of 25/10/2005
05/08/2005 Other procedure
05/08/2005 Centralised - Variation EMEA/H/C/122/IA/22
Updated with Decision(2005)4269 of 25/10/2005
27/10/2005 Centralised - Variation (2005)4269 of 25/10/2005
23/11/2005 Centralised - Variation EMEA/H/C/122/II/21
04/05/2006 Centralised - Variation EMEA/H/C/122/II/24
28/11/2006 Centralised - Variation EMEA/H/C/122/IA/27
07/03/2007 Centralised - Renewal EMEA/H/C/122/R/26 (2007)825 of 05/03/2007
03/05/2007 Centralised - Variation EMEA/H/C/122/II/29
16/10/2007 Centralised - Variation EMEA/H/C/122/IA/31
Updated with Decision(2008)2025 of 20/05/2008
28/01/2008 Centralised - Variation EMEA/H/C/122/II/32
23/03/2008 Centralised - Variation EMEA/H/C/122/N/34
Updated with Decision(2008)2025 of 20/05/2008
22/05/2008 Centralised - Variation (2008)2025 of 20/05/2008
05/06/2008 Centralised - Variation EMEA/H/C/122/II/35
03/07/2008 Centralised - Variation EMEA/H/C/122/N/36
Updated with Decision(2008)6718 of 04/11/2008
06/11/2008 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/122/T/38 (2008)6718 of 04/11/2008
20/02/2009 Centralised - Variation EMEA/H/C/122/II/40
07/09/2011 Centralised - Variation EMEA/H/C/122/IA/41
Updated with Decision(2012)1917 of 19/03/2012
21/03/2012 Centralised - Variation (2012)1917 of 19/03/2012
27/04/2012 Centralised - Withdrawal (2012)2914 of 24/04/2012