Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Adcirca   
Auth. number : EU/1/08/476
INN : 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: ADCIRCA is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity.
Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.
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
03/10/2008 Centralised - Authorisation EMEA/H/C/1021 (2008)5707 of 01/10/2008
30/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1021/II/2
22/10/2009 Centralised - Variation EMEA/H/C/1021/IB/3
Updated with Decision(2009)9778 of 30/11/2009
22/10/2009 Centralised - Variation EMEA/H/C/1021/IB/4
Updated with Decision(2009)9778 of 30/11/2009
02/12/2009 Centralised - Variation EMEA/H/C/1021/II/1 (2009)9778 of 30/11/2009
30/03/2010 Centralised - Variation EMEA/H/C/1021/II/5 (2010)2165 of 26/03/2010
03/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1021/IB/7/G
09/11/2010 Centralised - Variation EMEA/H/C/1021/II/6 (2010)7728 of 03/11/2010
20/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1021/IG/31
15/02/2011 Centralised - Variation EMEA/H/C/1021/IA/8/G
Updated with Decision(2011)2946 of 20/04/2011
27/04/2011 Centralised - Variation (2011)2946 of 20/04/2011
27/08/2012 Centralised - Variation EMEA/H/C/1021/II/11/G (2012)6009 of 23/08/2012
29/01/2013 Centralised - Variation EMEA/H/C/1021/WS/321 (2013)491 of 24/01/2013
14/02/2013 Centralised - 2-Monthly update EMEA/H/C/1021/WS/339 (2013)910 of 12/02/2013
24/05/2013 Centralised - Renewal EMEA/H/C/1021/R/15 (2013)3108 of 22/05/2013
19/02/2014 Centralised - Notification EMEA/H/C/1021/N/18