Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Cialis   
Auth. number : EU/1/02/237
Active substance : tadalafil
ATC: Anatomical main group: G - Genito urinary system and sex hormones
Therapeutic subgroup: G04 - Urologicals
Pharmacological subgroup: G04B - Other urologicals, including antispasmodics
Chemical subgroup: G04BE - Drugs used in erectile dysfunction
Chemical substance: G04BE08 - Tadalafil
(See WHO ATC Index)
Indication: Treatment of erectile dysfunction in adult males.
In order for tadalafil to be effective, sexual stimulation is required.
CIALIS is not indicated for use by women.
Marketing Authorisation Holder: Eli Lilly Nederland B.V.
Grootslag 1-5, NL-3991 RA Houten, 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
14/11/2002 Centralised - Authorisation EMEA/H/C/436 (2002)4505 of 12/11/2002
09/01/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/436/I/1
09/01/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/436/I/2
27/01/2003 Centralised - Notification EMEA/H/C/436/N/3 (2003)399 of 23/01/2003
25/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/436/I/7
22/10/2003 Centralised - Variation EMEA/H/C/436/II/4 (2003)3966 of 20/10/2003
29/01/2004 Centralised - Variation EMEA/H/C/436/II/6 (2004)242 of 27/01/2004
29/01/2004 Centralised - Variation EMEA/H/C/436/II/5 (2004)213 of 27/01/2004
30/03/2004 Centralised - Variation EMEA/H/C/436/IB/10
Updated with Decision(2004)4701 of 30/11/2004
01/04/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/436/IA/12
01/04/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/436/IA/11
08/07/2004 Centralised - Variation EMEA/H/C/436/II/9 (2004)2719 of 06/07/2004
13/07/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/436/IA/14
20/07/2004 Centralised - Variation EMEA/H/C/436/IB/13
Updated with Decision(2004)4701 of 30/11/2004
01/10/2004 Centralised - Variation EMEA/H/C/436/IA/15
Updated with Decision(2005)1047 of 29/03/2005
02/11/2004 Centralised - Variation (2004)4701 of 30/11/2004
31/03/2005 Centralised - Variation EMEA/H/C/436/II/16 (2005)1047 of 29/03/2005
19/04/2005 Centralised - Variation EMEA/H/C/436/IB/17
Updated with Decision(2005)4267 of 25/10/2005
30/06/2005 Centralised - Variation EMEA/H/C/436/IB/19
Updated with Decision(2005)4267 of 25/10/2005
24/08/2005 Centralised - Variation EMEA/H/C/436/IB/21
Updated with Decision(2005)4267 of 25/10/2005
27/10/2005 Centralised - Variation (2005)4267 of 25/10/2005
18/11/2005 Centralised - Variation EMEA/H/C/436/II/20 (2005)4490 of 15/11/2005
07/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/436/IB/23
14/06/2006 Centralised - Variation EMEA/H/C/436/II/22 (2006)2364 of 12/06/2006
02/08/2006 Centralised - Variation EMEA/H/C/436/II/24, 25 (2006)3540 of 28/07/2006
16/11/2006 Centralised - Variation EMEA/H/C/436/IA/28
Updated with Decision(2007)3108 of 20/06/2007
23/01/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/436/IA/30
02/02/2007 Centralised - Notification EMEA/H/C/436/N/29
Updated with Decision(2007)3108 of 20/06/2007
20/06/2007 Centralised - Variation EMEA/H/C/436/IB/33
Updated with Decision(2007)3920 of 10/08/2007
21/06/2007 Centralised - Variation EMEA/H/C/436/X/26, 27 (2007)3108 of 20/06/2007
07/08/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/436/IA/34
07/08/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/436/IA/35
09/08/2007 Centralised - Variation EMEA/H/C/436/IA/36
Updated with Decision(2007)5213 of 18/10/2007
22/08/2007 Centralised - Variation EMEA/H/C/436/II/31 (2007)3920 of 10/08/2007
28/09/2007 Centralised - Renewal EMEA/H/C/436/R/32 (2007)4381 of 17/09/2007
22/10/2007 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/436/T/37 (2007)5213 of 18/10/2007
15/02/2008 Corrigendum EMEA/H/C/436/T/37 (2007)5213 cor of 13/02/2008
04/03/2008 Centralised - Variation EMEA/H/C/436/II/38 (2008)882 of 29/02/2008
07/03/2008 Centralised - Variation EMEA/H/C/436/IA/41
Updated with Decision(2008)4980 of 03/09/2008
07/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/436/IA/42
07/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/436/IA/44
07/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/436/IA/43
19/03/2008 Centralised - Variation EMEA/H/C/436/II/39 (2008)1137 of 17/03/2008
09/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/436/IB/45
05/09/2008 Centralised - Variation EMEA/H/C/436/II/46 (2008)4980 of 03/09/2008
22/09/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/436/IA/47
21/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/436/IB/48
18/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/436/IB/50
18/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/436/IB/49
02/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/436/IB/51
11/02/2010 Centralised - Variation EMEA/H/C/436/II/52 (2010)418 of 09/02/2010
14/04/2010 Centralised - Variation EMEA/H/C/436/IA/53
Updated with Decision(2010)6237 of 06/09/2010
09/09/2010 Centralised - Variation EMEA/H/C/436/II/54 (2010)6237 of 06/09/2010
29/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/436/IB/56/G
06/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/436/IB/66/G
17/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/436/IG/31
22/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/436/IA/58/G
23/02/2011 Centralised - Variation EMEA/H/C/436/II/55 (2011)1188 of 21/02/2011
24/05/2011 Centralised - Notification EMEA/H/C/436/N/59
Updated with Decision(2012)6391 of 10/09/2012
24/10/2011 Centralised - Notification EMEA/H/C/436/N/61
Updated with Decision(2012)6391 of 10/09/2012
12/09/2012 Centralised - Variation EMEA/H/C/436/II/66 (2012)6391 of 10/09/2012
03/10/2012 Centralised - Renewal EMEA/H/C/436/R/65 (2012)7052 of 01/10/2012
26/10/2012 Centralised - Variation EMEA/H/C/436/II/60 (2012)7658 of 24/10/2012
17/01/2013 Corrigendum (2013)134 of 14/01/2013
23/01/2013 Centralised - Variation EMEA/H/C/436/WS/321 (2013)363 of 21/01/2013
15/02/2013 Centralised - 2-Monthly update EMEA/H/C/436/WS/339/68 (2013)937 of 13/02/2013
26/03/2013 Centralised - Variation EMEA/H/C/436/IB/71
Updated with Decision(2014)1861 of 14/03/2014
14/02/2014 Centralised - Notification EMEA/H/C/436/N/75
Updated with Decision(2014)1861 of 14/03/2014
18/03/2014 Centralised - Yearly update (2014)1861 of 14/03/2014