Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Protopic   
Auth. number : EU/1/02/201
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: Protopic 0.03% ointment is indicated in adults, adolescents and children from the age of 2 years.
Flare treatment
Adults and adolescents (16 years of age and above)
Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.
Children (2 years of age and above)
Treatment of moderate to severe atopic dermatitis in children who failed to respond adequately to conventional therapies such as topical corticosteroids.
Maintenance treatment
Treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).
Marketing Authorisation Holder: Astellas Pharma Europe B.V.
Sylviusweg 62, NL-2333 BE Leiden, Nederland

  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/374 (2002)935 of 28/02/2002
07/10/2002 Centralised - Variation EMEA/H/C/374/I/2, 3, 4
11/10/2002 Centralised - Variation EMEA/H/C/374/N/1 (2002)3865 of 09/10/2002
12/11/2002 Centralised - Variation EMEA/H/C/374/I/6
13/11/2002 Centralised - Variation EMEA/H/C/374/I/5 (2002)4444 of 08/11/2002
24/04/2003 Centralised - Variation EMEA/H/C/374/I/7 (2003)1261 of 09/04/2003
22/09/2003 Centralised - Variation EMEA/H/C/374/I/13
24/09/2003 Centralised - Variation EMEA/H/C/374/I/8 (2003)3419 of 22/09/2003
22/12/2003 Centralised - Variation EMEA/H/C/374/IA/17
Updated with Decision(2004)771 of 04/03/2004
29/01/2004 Centralised - Variation EMEA/H/C/374/II/12 (2004)212 of 27/01/2004
01/03/2004 Centralised - Variation EMEA/H/C/374/II/18
04/03/2004 Centralised - Variation EMEA/H/C/374/II/14 (2004)742 of 02/03/2004
08/03/2004 Centralised - Variation EMEA/H/C/374/II/9, 10, 11 (2004)771 of 04/03/2004
25/05/2004 Centralised - Variation EMEA/H/C/374/II/19 (2004)1942 of 19/05/2004
01/12/2004 Centralised - Variation EMEA/H/C/374/IA/22
11/02/2005 Centralised - Variation EMEA/H/C/374/IA/23
11/03/2005 Centralised - Variation EMEA/H/C/374/IB/24
11/05/2005 Centralised - Variation EMEA/H/C/374/N/21
Updated with Decision(2005)1809 of 10/06/2005
14/06/2005 Centralised - Variation EMEA/H/C/374/II/25 (2005)1809 of 10/06/2005
27/07/2005 Centralised - Variation EMEA/H/C/374/IA/26
12/09/2005 Centralised - Variation EMEA/H/C/374/IA/27
Updated with Decision(2006)1343 of 29/03/2006
19/10/2005 Centralised - Variation EMEA/H/C/374/IA/28
Updated with Decision(2006)1343 of 29/03/2006
27/02/2006 Centralised - Variation EMEA/H/C/374/IA/29
31/03/2006 Centralised - Variation (2006)1343 of 29/03/2006
14/06/2006 Referral EMEA/H/C/374/A-20/662 (2006)2371 of 12/06/2006
22/11/2006 Centralised - Renewal EMEA/H/C/374/R/30 (2006)5670 of 20/11/2006
07/05/2007 Centralised - Variation EMEA/H/C/374/II/31 (2007)2040 of 03/05/2007
30/08/2007 Centralised - Variation EMEA/H/C/374/IA/32
30/08/2007 Centralised - Variation EMEA/H/C/374/IA/33
03/07/2008 Centralised - Variation EMEA/H/C/374/IB/35
23/02/2009 Centralised - Variation EMEA/H/C/374/IB/39
23/02/2009 Centralised - Variation EMEA/H/C/374/IB/38
23/02/2009 Centralised - Variation EMEA/H/C/374/IB/37
04/03/2009 Centralised - Variation EMEA/H/C/374/II/34 (2009)1460 of 26/02/2009
09/04/2009 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/374/T/40 (2009)2872 of 07/04/2009
11/09/2009 Centralised - Variation EMEA/H/C/374/IA/41
09/04/2010 Centralised - Variation EMEA/H/C/374/IA/42/G
14/10/2010 Centralised - Variation EMEA/H/C/374/IB/44/G
14/02/2011 Centralised - Variation EMEA/H/C/374/IB/45
28/02/2011 Centralised - Variation EMEA/H/C/374/II/43/G (2011)1211 of 21/02/2011
27/06/2011 Centralised - Variation EMEA/H/C/374/II/46 (2011)4630 of 23/06/2011
29/06/2012 Centralised - Variation EMEA/H/C/374/IB/48
Updated with Decision(2012)6143 of 30/08/2012
03/09/2012 Centralised - Variation EMEA/H/C/374/II/49 (2012)6143 of 30/08/2012
19/12/2012 Centralised - Variation EMEA/H/C/374/N/52
Updated with Decision(2013)9737 of 18/12/2013
31/01/2013 Centralised - Variation EMEA/H/C/374/IAin/53
Updated with Decision(2013)9737 of 18/12/2013
13/11/2013 Centralised - Variation EMEA/H/C/374/IA/54
Updated with Decision(2013)9737 of 18/12/2013
23/12/2013 Centralised - Variation (2013)9737 of 18/12/2013