Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Fortacin   
Auth. number : EU/1/13/881
Active substance : lidocaine / prilocaine
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N01 - Anesthetics
Pharmacological subgroup: N01B - Anesthetics, local
Chemical subgroup: N01BB - Amides
Chemical substance: N01BB20 - combinations
(See WHO ATC Index)
Indication: Fortacin is indicated for the treatment of primary premature ejaculation in adult men.
Marketing Authorisation Holder: Recordati Ireland Ltd
Raheens East, Ringaskiddy Co. Cork, Ireland
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
19/11/2013 Centralised - Authorisation EMEA/H/C/2693 (2013)8151 of 15/11/2013
26/09/2014 Centralised - Variation EMEA/H/C/2693/IA/2/G
Updated with Decision(2015)7208 of 15/10/2015
19/10/2015 Centralised - Yearly update (2015)7208 of 15/10/2015
19/04/2016 Centralised - Variation EMEA/H/C/2693/IA/10/G
Updated with Decision(2017)1931 of 17/03/2017
17/05/2016 Centralised - Variation EMEA/H/C/2693/IB/11/G
Updated with Decision(2017)1931 of 17/03/2017
08/08/2016 Centralised - Notification EMEA/H/C/2693/N/13
Updated with Decision(2017)1931 of 17/03/2017
18/01/2017 Centralised - Notification EMEA/H/C/2693/N/14
Updated with Decision(2017)1931 of 17/03/2017
21/03/2017 Centralised - Yearly update (2017)1931 of 17/03/2017
01/11/2017 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2693/T/19 (2017)7401 of 30/10/2017
15/02/2018 Centralised - Variation EMEA/H/C/2693/IA/22