Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Aldara   
Auth. number : EU/1/98/080
INN : Imiquimod
ATC: Anatomical main group: D - Dermatologicals
Therapeutic subgroup: D06 - Antibiotics and chemotherapeutics for dermatological use
Pharmacological subgroup: D06B - Chemotherapeutics for topical use
Chemical subgroup: D06BB - Antivirals
Chemical substance: D06BB10 - Imiquimod
(See WHO ATC Index)
Indication: Imiquimod cream is indicated for the topical treatment of :
- External genital and perianal warts (condylomata acuminata) in adults.
- Small superficial basal cell carcinomas (sBCCs) in adults.
- Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AKs) on the face or scalp in immunocompetent adult patients when size or number of lesions limit the efficacy and/or acceptability of cryotherapy and other topical treatment options are contraindicated or less appropriate.
Marketing Authorisation Holder: Meda AB
Pipers väg 2A, SE-170 73 Solna, Sverige

  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
22/09/1998 Centralised - Authorisation EMEA/H/C/179 (1998)2693 of 18/09/1998
14/03/2000 Centralised - Notification EMEA/H/C/179/N/2 (2000)610 of 09/03/2000
05/06/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/179/I/4
05/06/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/179/I/5
16/07/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/179/I/6
07/08/2000 Centralised - Notification EMEA/H/C/179/N/9 (2000)2366 of 01/08/2000
16/10/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/179/II/8
04/11/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/179/I/10
06/11/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/179/I/11
23/05/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/179/I/13
23/11/2001 Centralised - Variation EMEA/H/C/179/II/12 (2001)3596 of 21/11/2001
18/06/2003 Centralised - Variation EMEA/H/C/179/II/14, 16 (2003)1932 of 13/06/2003
30/06/2003 Centralised - Variation EMEA/H/C/179/II/15 (2003)2128 of 26/06/2003
28/10/2003 Centralised - Renewal EMEA/H/C/179/R/16 (2003)4014 of 24/10/2003
30/01/2004 Centralised - Variation EMEA/H/C/179/II/18 (2004)236 of 27/01/2004
26/02/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/179/IA/21
15/07/2004 Centralised - Variation EMEA/H/C/179/II/20 (2004)2804 of 13/07/2004
12/08/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/179/IA/22
18/10/2004 Centralised - Notification EMEA/H/C/179/N/23
Updated with Decision(2005)4349 of 28/10/2005
01/12/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/179/IA/24
04/11/2005 Centralised - Variation EMEA/H/C/179/II/25 (2005)4349 of 28/10/2005
21/12/2005 Centralised - Notification EMEA/H/C/179/N/28
Updated with Decision(2006)1799 of 27/04/2006
02/05/2006 Centralised - Variation EMEA/H/C/179/II/27 (2006)1799 of 27/04/2006
20/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/179/IA/30
16/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/179/IA/32
05/09/2006 Centralised - Variation EMEA/H/C/179/II/31 (2006)4014 of 01/09/2006
01/12/2006 Centralised - Variation EMEA/H/C/179/II/26 (2006)5927 of 29/11/2006
14/12/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/179/IA/35
14/12/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/179/IA/34
16/01/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/179/IB/37
26/04/2007 Centralised - Variation EMEA/H/C/179/II/36 (2007)1891 of 24/04/2007
03/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/179/II/38
05/09/2007 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/179/T/39 (2007)4164 of 30/08/2007
26/11/2007 Centralised - Notification EMEA/H/C/179/N/40
Updated with Decision(2008)3553 of 07/07/2008
18/02/2008 Centralised - Notification EMEA/H/C/179/N/41
Updated with Decision(2008)3553 of 07/07/2008
09/07/2008 Centralised - Variation EMEA/H/C/179/II/42 (2008)3553 of 07/07/2008
05/09/2008 Centralised - Variation EMEA/H/C/179/II/45 (2008)4981 of 03/09/2008
05/09/2008 Centralised - Renewal EMEA/H/C/179/R/44 (2008)4984 of 03/09/2008
12/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/179/IB/48
01/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/179/IA/50
01/09/2009 Centralised - Variation EMEA/H/C/179/II/46 (2009)6719 of 28/08/2009
03/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/179/IA/51
07/09/2009 Centralised - Variation EMEA/H/C/179/IB/49
Updated with Decision(2010)1791 of 15/03/2010
19/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/179/IA/53
17/03/2010 Centralised - Variation (2010)1791 of 15/03/2010
29/04/2010 Centralised - Variation EMEA/H/C/179/II/52 (2010)2834 of 27/04/2010
15/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/179/IA/54
01/12/2011 Centralised - Notification EMEA/H/C/179/N/56
15/08/2013 Centralised - Notification EMEA/H/C/179/N/60