Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


WITHDRAWN  

Product information

Invented name: Nyracta
Auth. number : EU/1/00/139
INN : Rosiglitazone
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A10 - Drugs used in diabetes
Pharmacological subgroup: A10B - Blood glucose lowering drugs, excluding insulins
Chemical subgroup: A10BG - Thiazolidinediones
Chemical substance: A10BG02 - Rosiglitazone
(See WHO ATC Index)
Indication: Diabetes mellitus
Marketing Authorisation Holder: SmithKline Beecham plc
980 Great West Road, Brentford, Middlesex TW8 9GS, 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
26/07/2000 Centralised - Authorisation EMEA/H/C/270 (2000)1800 of 11/07/2000
18/12/2000 Centralised - Variation EMEA/H/C/270/I/2, 3, 4
22/03/2001 Centralised - Variation EMEA/H/C/270/II/1 (2001)617 of 20/03/2001
11/05/2001 Centralised - Variation EMEA/H/C/270/II/5
01/11/2001 Centralised - Variation EMEA/H/C/270/II/6 (2001)2987 of 31/10/2001
10/12/2001 Centralised - Variation EMEA/H/C/270/I/7
23/01/2002 Centralised - Variation EMEA/H/C/270/I/8
07/05/2002 Centralised - Variation EMEA/H/C/270/I/9 (2002)1836 of 02/05/2002
07/06/2002 Centralised - Variation EMEA/H/C/270/I/11
23/09/2002 Centralised - Variation EMEA/H/C/270/I/14 (2002)3549 of 18/09/2002
22/10/2002 Centralised - Variation EMEA/H/C/270/II/12, 13 (2002)4079 of 18/10/2002
13/12/2002 Centralised - Variation EMEA/H/C/270/N/15 (2002)5151 of 11/12/2002
28/04/2003 Centralised - Variation EMEA/H/C/270/II/16 (2003)1431 of 23/04/2003
01/09/2003 Centralised - Variation EMEA/H/C/270/II/18 (2003)3171 of 28/08/2003
01/04/2004 Centralised - Variation EMEA/H/C/270/IB/20
14/07/2004 Centralised - Variation EMEA/H/C/270/IB/23
21/07/2004 Centralised - Variation EMEA/H/C/270/II/21 (2004)2881 of 19/07/2004
22/10/2004 Centralised - Variation EMEA/H/C/270/II/26
09/12/2004 Centralised - Withdrawal (2004)4894 of 07/12/2004