Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Spedra   
Auth. number : EU/1/13/841
Active substance : avanafil
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: G04BE10 - Avanafil
(See WHO ATC Index)
Indication: Treatment of erectile dysfunction in adult men.
In order for Spedra to be effective, sexual stimulation is required.
Marketing Authorisation Holder: Menarini International Operations Luxembourg S.A.
1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg
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
25/06/2013 Centralised - Authorisation EMEA/H/C/2581 (2013)4017 of 21/06/2013
04/10/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2581/T/1 (2013)6597 of 02/10/2013
13/01/2014 Centralised - Variation EMEA/H/C/2581/IB/2
Updated with Decision(2015)373 of 22/01/2015
03/02/2014 Centralised - Variation EMEA/H/C/2581/IA/4/G
Updated with Decision(2015)373 of 22/01/2015
28/08/2014 Corrigendum (2013)4017 of 21/06/2013
26/01/2015 Centralised - 2-Monthly update EMEA/H/C/2581/II/7 (2015)373 of 22/01/2015
06/03/2015 Centralised - Variation EMEA/H/C/2581/IA/14
Updated with Decision(2015)6539 of 18/09/2015
08/05/2015 Centralised - Variation EMEA/H/C/2581/IB/16/G
Updated with Decision(2015)6539 of 18/09/2015
22/09/2015 PSUSA - Modification EMEA/H/C/2581/PSUSA/10066/201412 (2015)6539 of 18/09/2015
16/12/2015 Centralised - Variation EMEA/H/C/2581/IB/18
Updated with Decision(2016)8346 of 05/12/2016
25/02/2016 Centralised - Variation EMEA/H/C/2581/II/19
Updated with Decision(2016)8346 of 05/12/2016
10/03/2016 Centralised - Variation EMEA/H/C/2581/IB/21
Updated with Decision(2016)8346 of 05/12/2016
07/12/2016 Centralised - Yearly update (2016)8346 of 05/12/2016
24/03/2017 Centralised - Notification EMEA/H/C/2581/N/26
09/11/2017 Centralised - Variation EMEA/H/C/2581/II/27