Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


WITHDRAWN  

Product information

Invented name: Protopy
Auth. number : EU/1/02/202
INN : Tacrolimus
ATC: Anatomical main group: D - Dermatologicals
Therapeutic subgroup: D11 - Other dermatological preparations
Pharmacological subgroup: D11A - Other dermatological preparations
Chemical subgroup: D11AH - Agents for atopic dermatitis, excluding corticosteroids
Chemical substance: D11AH01 - Tacrolimus
(See WHO ATC Index)
Indication: Treatment of moderate to severe atopic dermatitis in adults
Marketing Authorisation Holder: Astellas Pharma GmbH
Neumarkter Str. 61, D-81673 München, 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
05/03/2002 Centralised - Authorisation EMEA/H/C/375 (2002)936 of 28/02/2002
07/10/2002 Centralised - Variation EMEA/H/C/375/I/2, 3, 4
10/10/2002 Centralised - Variation EMEA/H/C/375/N/1 (2002)3832 of 08/10/2002
11/11/2002 Centralised - Variation EMEA/H/C/375/I/5 (2002)4431 of 07/11/2002
24/04/2003 Centralised - Variation EMEA/H/C/375/I/6 (2003)1269 of 10/04/2003
24/09/2003 Centralised - Variation EMEA/H/C/375/I/7 (2003)3418 of 22/09/2003
01/03/2004 Centralised - Variation EMEA/H/C/375/II/11
17/06/2004 Centralised - Variation EMEA/H/C/375/IA/10
Updated with Decision(2004)3057 of 02/08/2004
04/08/2004 Centralised - Variation EMEA/H/C/375/II/12, 17 (2004)3057 of 02/08/2004
01/12/2004 Centralised - Variation EMEA/H/C/375/IA/19
11/02/2005 Centralised - Variation EMEA/H/C/375/IA/20
11/03/2005 Centralised - Variation EMEA/H/C/375/IB/21
11/05/2005 Centralised - Variation EMEA/H/C/375/N/18
Updated with Decision(2005)1808 of 10/06/2005
14/06/2005 Centralised - Variation EMEA/H/C/375/II/22 (2005)1808 of 10/06/2005
27/07/2005 Centralised - Variation EMEA/H/C/375/IA/23
27/07/2005 Centralised - Variation EMEA/H/C/375/IA/23
12/09/2005 Centralised - Variation EMEA/H/C/375/IA/24
Updated with Decision(2006)1342 of 29/03/2006
19/10/2005 Centralised - Variation EMEA/H/C/375/IA/25
Updated with Decision(2006)1342 of 29/03/2006
27/02/2006 Centralised - Variation EMEA/H/C/375/IA/26
31/03/2006 Centralised - Variation (2006)1342 of 29/03/2006
14/06/2006 Referral EMEA/H/C/375/A-18/662 (2006)2370 of 12/06/2006
22/11/2006 Centralised - Renewal EMEA/H/C/375/R/27 (2006)5671 of 20/11/2006
07/05/2007 Centralised - Variation EMEA/H/C/375/II/31 (2007)2038 of 03/05/2007
26/08/2008 Centralised - Withdrawal (2008)4656 of 22/08/2008